UNIQA® Dental Implants System
Device Facts
| Record ID | K251188 |
|---|---|
| Device Name | UNIQA® Dental Implants System |
| Applicant | Uniqa Dental, Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jun 25, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
UNIQA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
Device Story
System comprises endosseous dental implants, healing caps, abutments, and superstructures; used in surgical/restorative dentistry to anchor prosthetic teeth. Implants feature titanium alloy (Ti6Al4V ELI) construction with tapered body designs and two surface treatment options (Pure & Porous or SBA). Device is surgically placed in jaw bone by clinicians; supports immediate or delayed loading protocols. Output is a stable foundation for prosthetic restoration. System includes various abutment types (DLOC, Ball, Straight, Multi-Unit) for screw-retained or cement-retained restorations. Benefits include restoration of chewing function and esthetics. Performance verified via mechanical fatigue/static testing (ISO 14801) and biocompatibility assessments.
Clinical Evidence
No clinical data included. Bench testing only: fatigue and static testing per ISO 14801, sterilization validation (VDmax, steam), endotoxin testing (USP <85>, <161>), biocompatibility (cytotoxicity, pyrogenicity), and surface characterization (XPS, EDS).
Technological Characteristics
Materials: Titanium alloy Ti6Al4V ELI. Sensing/Actuation: Mechanical fixation. Energy: None. Form factor: Root-form endosseous implants (3.3-5.0mm diameter) and various abutments. Connectivity: None. Sterilization: Gamma irradiation (implants) or steam (abutments). Surface: Sand-blasted/acid-etched (SBA) or Hydroxyapatite/Calcium Phosphate sand-blasted/acid-etched (Pure & Porous).
Indications for Use
Indicated for surgical/restorative placement in upper/lower jaw bone to support prosthetic devices (artificial teeth) for chewing function restoration in partially or fully edentulous adult patients. Includes immediate loading protocol if primary stability is achieved. Conical Mini implants (Ø3.3mm) restricted to mandibular central/lateral incisors and maxillary lateral incisors; requires splinting if multiple narrow implants are used.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
Predicate Devices
- UNIQA® Dental Implants System (K180598)
Reference Devices
- NobelActive® (K142260)
- MIS® Dental Implant System (K040807)
- MIS® V3 Conical Connection Dental Implant (K163349)
- MIS® Internal Hex Dental Implant System (K180282)
- NobelActive® Multi Unit Abutment (K072570)
- SGS® Dental Implant System (K182219)
- ZEST LOCATOR® Angled Abutment (K252944)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
Uniqa Dental, Ltd.
% Daniela Levy
Regulatory & Quality Consultant
Sterling Medical Registration
22750 Califa Street
Woodland Hills, California 91367
June 25, 2026
Re: K251188
Trade/Device Name: UNIQA® Dental Implants System
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: DZE, NHA
Dated: May 27, 2026
Received: May 28, 2026
Dear Daniela Levy:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251188 - Daniela Levy
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device' (https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K251188 - Daniela Levy
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ANDREW I. STEEN -S
Andrew I. Steen
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K251188
Device Name
UNIQA® Dental Implants System
Indications for Use (Describe)
UNIQA Dental® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
Type of Use (Select one or both, as applicable)
☑
Prescription Use (Part 21 CFR 801 Subpart D)
☐
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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K251188
## Section 4 - 510(k) Summary (21 CFR 807.92)
510(k) Number K251188
1 Type of Submission Premarket Notification (21 CFR 807.90(e)) 510(k) Traditional
2 Submission Owner UNIQA DENTAL LTD.
Dima Goberman - CEO
2 Ha-Tsoran street
Netanya 4250602
Israel
3 Official Correspondent Sterling Medical Registration
Contact Person Daniela Levy - Regulatory & Quality Consultant
22750 Califa Street
Woodland Hills, CA 91367
Phone: 1-213-787-3027
Email: sterlingmedical2017@gmail.com
www.Sterlingmedicalregistration.com
4 Submission Date June 24, 2026
5 Device Trade Name UNIQA® Dental Implants System
6 Regulation Description Endosseous Dental Implants Abutment
7 Classification Product Code Primary : DZE
Device Name : Implant, endosseous, root-form
Regulation No : 872.3640
Class : II
Panel : Dental
Product Code Secondary : NHA
Name : Abutment, implant, dental, endosseous
Class : II
Panel : Dental
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# 8 Identification of Legally Marketed Predicate Devices :
# **Primary Predicate:**
UNIQA® Dental Implants System K180598, UNIQA Dental Ltd
# Reference Predicate for Implants:
NobelActive® K142260, Nobel Biocare AB
# Reference Predicates for Abutments:
MIS® Dental Implant System K040807, MIS Implant Technologies Ltd
MIS® V3 Conical Connection Dental Implant K163349, MIS Implant Technologies Ltd
MIS® Internal Hex Dental Implant System K180282, MIS Implant Technologies Ltd
NobelActive® Multi Unit Abutment K072570, Nobel Biocare AB;
SGS® Dental Implant System K182219, SGS® International Ltd
ZEST LOCATOR® Angled Abutment K252944, Zest Anchors, LLC
# 9 Device Description: :
The UNIQA® Dental Implant System, as cleared for marketing under 510K K180598, consists of Internal Hex Dental Implants, Conical Connection Dental Implants, Healing Caps, Dental Abutments and Superstructures. UNIQA® Dental Implants and Abutments are made of titanium alloy Ti6Al4V Eli.
This submission introduces a minor design improvement to the external implant body of the approved K180598 Dental Implants – Internal Hex & Conical Connection, featuring a slight tapering for an enhanced design.
UNIQA® Dental Implants are available in two options of surface treatment (1) Pure & Porous, P&P - which consists of Hydroxyapatite and Calcium Phosphates sand blast large particles following acid etched ; or (2) SBA - which consists of sand blast large particles with acid etched:
Conical Hex Connection Dental Implants with the following measurements:
Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm;
Internal Hex Dental Implants with the following measurements:
Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm;
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Additionally, this submission introduces range of dental abutments compatible with UNIQA® Dental Implant System. Abutment screws are included in the abutment packaging but are also available separately.
- ○ **Healing caps** consist of titanium alloy, CNC machined, introducing the following platforms and measurements:
For internal hex:
RP - Ø4 Gingival Height 3mm
WP Ø 6.3, 7 - Gingival Height 2,3,4,5,6,7mm
WP Ø7 - Gingival Height 2,3,4,5,6,7mm
For conical connection:
MP Ø4 - Gingival Height - 3,4,5,7mm; Ø4.5 Gingival Height - 2,3,4,5 ,6 ,7mm;
RP Ø4 - Gingival Height - 3,5,7mm; Ø4.5, Ø5, Ø6, Ø7 Gingival Height - 2,3,4,5, 6, 7mm
- ○ **DLOC Attachments** are intended for overdenture restoration. Consist of titanium alloy, CNC machined with or without coloring anodize. Available straight and angulated at 9°, 15°, 30°, introducing the following platforms and measurements for internal hex / conical connection:
Straight - RP, WP - Gingival Height 1, 2, 3, 4, 5, 6, 7mm
Straight - MP - Gingival Height 1, 2, 3, 4, 5, 6mm
RP Angle 9°, 15°, 30° - Gingival Height 1,2,3mm
MP Angle 9°, 15° - Gingival Height 1,2,3mm
Related silicon, metal caps are available.
- ○ **Ball Attachments** are intended for overdenture restoration. Consist of titanium alloy, CNC machined with or without coloring anodize. Available straight and angulated at 9°, 15°, 30°, introducing the following platforms and measurements for internal hex / conical connection:
Straight - RP, Gingival Height 0.5,1,2,3,4,5,6,7mm
Straight - MP - Gingival Height 0.5, 1,2,3,4,5,6 mm
RP Angle 9°, 15°, 30° - Gingival Height 1,2,3mm
MP Angle 9°, 15° - Gingival Height 1,2,3mm
Related silicon, metal caps are available.
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UNIQADENTAL
- ○ **Straight Abutments with Shoulder** are intended for cement restoration, consist of titanium alloy, CNC machined, introducing the following platforms and measurements for internal hex:
RP Gingival Height 5mm
RP Ø6 Gingival Height 1,2,3,4,5mm
- ○ **Straight Abutments** are intended for cement restoration, consist of titanium alloy, CNC machined, introducing the following platforms and measurements for internal hex/conical connection:
RP Ø4.5, 5,6,7 Gingival Height 1,2,3,4,5mm
MP Ø4.5 Gingival Height 1,2,3,4,5mm
- ○ **Angled 15° / 25° Abutments** are intended for cement restoration, consist of titanium alloy, CNC machined, introducing the following platforms and measurements for conical connection:
RP - Angle 15°, 25° - Gingival Height 1,2,3,4mm
MP - Angle 15°, 25° - Gingival Height 1,2,3mm
- ○ **Straight Multi-Unit Abutments D- Type** are intended for screw restoration, consist of titanium alloy, CNC machined, machined with or without coloring anodize, introducing the following platforms and measurements for internal hex/conical connection:
RP - Gingival Height 1,2,3,4,5mm
MP - Gingival Height 1,2,3,4,5mm
Included related components healing caps, temporary sleeves.
- ○ **17°/30° Angled Multi-Unit Abutments D-Type** are intended for screw restoration, consist of titanium alloy, CNC machined, machined with or without coloring anodize, introducing the following platforms and measurements for internal hex/conical connection:
RP - Angle 15°, 30° - Gingival Height 1,2,3,4mm
MP - Angle 15°, 30° - Gingival Height 1,2,3,4mm
Included related components healing caps, temporary sleeves.
- ○ **Straight Multi-Unit Abutments V-Type** are intended for screw restoration, consist of titanium alloy, CNC machined, machined with or without coloring anodize, introducing the following platforms and measurements for internal hex/conical connection:
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RP - Gingival Heights 0.5,1,2,3,4,5, 6mm
MP - Gingival Heights 0.5,1,2,3,4,5mm
Included related components healing caps, temporary sleeves.
- ○ **Temporary Sleeves for Multi-Unit Abutments** are intended to be for used with UNIQA’s Multi Units abutments. Consist of titanium alloy, CNC machined, machined with or without coloring anodize, introducing the following platforms and measurements for internal hex/conical connection:
Gingival Height - 1.5,3,4,6,8,12mm for V-type
#### 10 Indication for Use:
UNIQA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
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UNIQADENTAL
11 Substantial Equivalence
Dental Implants
| Table No.1 | Subject Device | Primary Device | Reference Device | | |
| --- | --- | --- | --- | --- | --- |
| Technical Characteristic | UNIQA Implant Conical = UV11/UV11s Implant & UNIQA Internal Hex = UH8/UH8s Implant | Conical Implant, Pure&Porous, P&P / SBA Conical Implant, Internal Hex, Pure&Porous, P&P / SBA | Nobel Active | | SE Discussion |
| FDA 510(k) No. | K251188 | K180598 | K142260 | | |
| Manufacturer | UNIQA Dental Ltd. | UNIQA Dental Ltd. | Nobel Biocare AG | | |
| Device design DZE | Endosseous Dental Implant | Endosseous Dental Implant | Endosseous Dental Implant | | No Differences |
| Product Image | | | | | Subject Device implant design is the same as Primary device having more tapered body contour in similar to the reference device. |
| Connection Type | Internal Hex, and Conical Connection, cone angulation 11° (22°) | Internal Hex, and Conical Connection, cone angulation 11° (22°) | Internal conical connection, cone angulation 12° (24°) | | No Differences From primary device |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread | Tapered, Double Thread | | No Differences |
| Length mm | UNIQA Dental Implants (Internal Hex & Conical Connection) are cleared by K180598 – this submission introduces a minor design change to the implant body contour, making it more tapered. 3.3 Ø: 8,10, 11.5, 13, 16 3.75 Ø: 8,10, 11.5, 13, 16 4.2 Ø: 8,10, 11.5, 13, 16 5.0 Ø: 8,10, 11.5, 13, 16 | 3.3 Ø: 8,10, 11.5, 13, 16 3.75 Ø: 8,10, 11.5, 13, 16 4.2 Ø: 8,10, 11.5, 13, 16 5.0 Ø: 8,10, 11.5, 13, 16 | 3.5 Ø: 8.5,10, 11.5, 13, 15, 18 4.3 Ø: 8.5,10, 11.5, 13, 15, 18 5.0 Ø: 8.5,10, 11.5, 13, 15, 18 5.5 Ø: 7, 8.5,10, 11.5, 13, 15 | | From primary device, the new minor change of more tapered design is similar to the reference device. |
| Material | Titanium Alloy Ti6Al4V ELI | Titanium Alloy Ti6Al4V ELI | Titanium grade CP4 | | No Difference Subject device is identical to Primary Device |
| Surface Treatment | (a) Pure&Porous- Hydroxyapatite & Calcium sand blast large particles following acid etched or (b) SBA –Aluminum Oxide Al2O3 sand | (a) Pure&Porous- Hydroxyapatite & Calcium sand blast large particles following acid etched or | TiUnite / TiUltra | | No Difference Subject device is identical to Primary Device. |
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**UNIQA DENTAL**
| | blast large particles following acid-etched | (b) SBA –Aluminum Oxide Al2O3 sand blast large particles following acid-etched | | |
| --- | --- | --- | --- | --- |
| Operation | Surgical Implantation Procedure, Conventional Dental Drill Protocol | Surgical Implantation Procedure, Conventional Dental Drill Protocol | Surgical Implantation Procedure, Conventional Dental Drill Protocol | No Differences Subject device is identical to Primary Device. |
| Sterilization | Gamma Irradiation, Single Use | Gamma Irradiation, Single Use | Gamma Irradiation, Single Use | No Differences Subject device is identical to Primary Device. |
| Packaging | Double packaging | Double packaging | Double packaging | No Differences Subject device is identical to Primary Device. |
| Used under similar conditions of use | Fully or partially edentulous patients | Fully or partially edentulous patients | Fully or partially edentulous patients | No Differences Subject device is identical to Primary Device. |
| Population | Adults | Adults | Adults | No Differences Subject device is identical to Primary Device. |
| Indication for Use | UNIQA Dental ® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors | UNIQA Dental ® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular | NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. | No Differences Subject devices are identical to Primary Device. |
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**UNIQA DENTAL**
| | must be splinted if using two or more narrow implants adjacent to one another. | central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. | | |
| --- | --- | --- | --- | --- |
# **Indication for Use**
| Table 1. SE Indication for Use | Primary Device | Reference Device | Reference Device | |
| --- | --- | --- | --- | --- |
| UNIQA Dental Implants System | UNIQA Dental Implants System | MIS V3 Conical Connection implants | MIS Dental Implants System | SE Discussion |
| Abutments System | Abutments System | Abutments System | Abutments System | |
| K251188 | K180598 | K163349 | K040807 | N/A |
| UNIQA Dental Ltd. | UNIQA Dental Ltd. | MIS Implants Technologies ltd | MIS Implants Technologies ltd | N/A |
| UNIQA Dental ® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two | UNIQA Dental ® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two | MIS V3 Conical Connection Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. | The MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. | No Differences Subject Devices -additional measurements and abutments are identical to Primary Device UNIQA K180598 or similar to the References Devices – MIS K163349, K040807. UNIQA Indication for use are the same as the Primary Device K180598. The Subject Device |
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| or more narrow implants adjacent to one another. | or more narrow implants adjacent to one another. | | | |
| --- | --- | --- | --- | --- |
| Reference Device Angular Ball Attachment | Reference Device Locator Angled Abutment | Reference Device Angular Ball Attachments | Reference Device *NobelActive Multi Unit Abutment* | SE Discussion |
| --- | --- | --- | --- | --- |
| K180282 MIS Internal Hex Dental Implant System | K252944 ZEST LOCATOR® Angled Abutment, Zest Anchors, LLC | K182219 SGS International Ltd | K072570 Nobel Biocare AB | Subject Device UNIQA'S angular Ball attachments share similar indications as the Reference Devices SGS K182219 and MIS K180282. Subject Device UNIQA'S angular DLOC abutments share similar indications as the Reference Devices SGS K182219 and Zest K252944; The Subject Device UNIQA Multi Unit Abutment is the same as the Primary Device UNIQA K180598, just introducing new profile height 4mm which is in similar to the Reference Device Nobel Multi Unit K072570. |
| MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only. | The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient. | SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors. Two Stage Implants: P7N, P1D, P5D, P7D. PEEK Temporary Abutments are not to exceed 30 days. | The NobelActiveMulti-unit Abutment a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. | |
### Dental Abutments
| 1.1. Table No.2 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | UNIQA Healing Caps | UNIQA Healing Caps | MIS Healing Caps | SE Discussion |
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| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | MIS Implant Technologies Ltd | |
| --- | --- | --- | --- | --- |
| 510k | K251188 | K180598 | K163349, K040807 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | Healing Caps | Healing Caps | Healing Caps | No differences |
| Dimensions mm Gingival Height=GH Length=L Diameter= Ø | Internal: Standard - Ø4 GH3 Wide Ø 6.3, 7 - GH 2,3,4,5,6,7 Wide Ø7 - GH 2,3,4,5,6,7 Conical: MP Ø4- GH-3,4,5,7; Ø4.5- GH-2,3,4,5,6,7 RP Ø 4-GH-3,5,7 RP- Ø 4.5,5,6,7 GH-2,3,4,5,6,7 | Internal: Slim, NP - GH 2,3,4,5,6,7 Standard Ø4,4.5- GH- 2,3,4,5,6,7 Wide Ø5.5 - GH- 2,3,4,5,6,7 Narrow Ø4- GH- 5,7 Conical mini - Ø4,4.5,- GH-3,4,5 Conical - Ø4,4.5,5,6,7 - GH-3,4,5 | Internal: NP 4.0,4.3ø, GH-2,3,4,5,6,8mm RP 4.0,4.8,5.5ø, GH-3,4,5,6mm WP 5.0,5.5,6.5ø, GH-3,4,5,6mm Conical: NP 3.3,4.0,4.8ø, GH-2,3,4,5,6,8mm RP 3.9,4.8,5.8ø, GH-2,3,4,5,6,7,8mm WP 5.5,6.3ø, GH-2,3,4,5mm | No differences Subject Device is in the limits of Primary Device and/or Reference Device. |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface Treatment | CNC Machined | CNC Machined | CNC Machined with or without coloring anodize | No differences from Subject Device. |
| Connection | Internal Hex Conical Connection | Internal Hex Conical Connection | Internal Hex Conical Connection | No differences |
| Operation | Screw Retained | Screw Retained | Screw Retained | No differences |
| Sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Provided Sterile, Single Use (IFU MPUI101) | Subject Device is the same as Primary Device |
| 1.2. Table No.3 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | DLOC attachment abutment | Locator Abutments | MIS - LOCKIT Abutments | SE Discussion |
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| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | MIS Implant Technologies Ltd | |
| --- | --- | --- | --- | --- |
| 510k | K251188 | K180598 | K163349, K040807 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | DLOC attachment abutment | Locator Abutments | LOCKIT Abutments | No differences |
| Dimensions mm Gingival Height=GH Length=L Diameter=Ø | GH 1, 2, 3, 4, 5, 6, 7 RP,WP MP GH 1, 2, 3, 4, 5, 6 | GH 1, 2, 3, 4, 5 RP,WP | GH 0,1,2,3,4,5,6 NP, SP, WP | Subject Device is the same as Primary Device Added heights: 6mm is within the limits of the Reference Device. An additional 7mm is not within the limits but is very similar. It is considered a minor difference with no effect since UNIQAs' abutments line includes 7mm height in other UNIQA K180598 abutments designs such as Healing caps 2-7mm, ball attachment 0.5-7mm. |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface Treatment | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | No differences from Primary Device. |
| Connection | Internal Hex Conical Connection | Internal Hex Conical Connection | Internal Hex Conical Connection | No differences |
| Related Components | Silicon caps soft, standard, strong, housing cap – for all overdenture restoration. Added: Silicon Cap soft | Silicon caps soft, standard, strong, housing cap – for all overdenture restoration | Silicon Caps range and metal housing | No differences |
| Operation | Overdenture Screw Retained | Overdenture Screw Retained | Overdenture Screw Retained | No differences |
| Sterilization | Non Sterile, Single Use | Non Sterile, Single Use | Non Sterile, Single Use | No differences |
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| | Steam sterilization | Steam sterilization | Steam sterilization | |
| --- | --- | --- | --- | --- |
| 1.3. Tabi - No.4 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | DLOC attachment, angular | S35-S7 - S-lock Angular Abutment | ZEST Locator Angled Abutment | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | SGS International Ltd | Zest Anchors, LLC | |
| S10k | K251188 | K182219 | K252944 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | DLOC Attachment, angular | S35-S7 - S-lock S5-S7 - Easy-Fix Angular Abutment Angular Abutment | Locator Angled Abutment | Subject Device has a similar design to the primary device and reference device. (Note: In the Zest locator image the screw is not shown, but basically the Subject Device and the Reference Devices share similar design, clinical use and technological characteristics) |
| Dimensions mm Gingival Height=GH | RP Angle 9°, 15°, 30° GH 1,2,3 MP Angle 9°, 15° GH 1,2,3 | GH 1,2,3 - Angle 17 GH 1,2,3 - Angle 30 RP | GH 2.5 - 7.5 mm - Angle 15 NP, RP, WP | Subject Device has a slight difference vs Primary Device and the Reference Device since only Subject Device has 9°, this raises no significant difference, since this small angle is covered by the worse scenario of the 30° angle. |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No Differences |
| Surface Treatment | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with TiN | No Differences from primary device |
| Connection | Internal Hex Conical Connection | Internal Hex | Internal Hex Conical Connection | No differences |
| Related Components | Silicon caps soft, standard, strong, housing cap – for all overdenture restoration. Added: Silicon Cap soft | | Silicon caps and metal | No Differences |
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| | | Silicon caps soft, standard, strong, housing cap – for all overdenture restoration | | |
| --- | --- | --- | --- | --- |
| *Operation* | Overdenture Screw Retained | Overdenture Screw Retained | Overdenture Screw Retained | No Differences |
| *Sterilization* | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | No differences |
| 1.4. Table No.5 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | Ball Attachment | Ball Attachment | Ball Attachment | SE Discussion |
| *Manufacturer* | UNIQA Dental Ltd | UNIQA Dental Ltd | MIS Implant Technologies Ltd | |
| *510k* | K251188 | K180598 | K163349, K040807 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| *Product Image* | Ball Attachment | Ball Attachment | Ball Attachment | No differences |
| *Dimensions mm* *Gingival Height=GH* | RP GH- 0.5,1,2,3,4,5,6, 7 MP - GH 0.5, 1,2,3,4,5,6 | RP GH 0.5,1,2,3,4,5,6, 7 | GH 1,2,3,4,5 NP,SP,WP 4/0,4,4,5,0 | Subject Device is the same as Primary Device. |
| *Material* | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| *Surface Treatment* | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | No differences |
| *Connection* | Internal Hex Conical Connection | Internal Hex | Internal Hex Conical Connection | No differences |
| *Related Components* | Silicon Cap soft, ExtraSoft: | Metal Cap/housing, Silicon Cap soft, standard, Strong: | Metal Caps, Silicon Caps | No Differences |
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| | | | | |
| --- | --- | --- | --- | --- |
| *Operation* | Overdenture Screw Retained | Overdenture Screw Retained | Overdenture Screw Retained | No differences |
| *Sterilization* | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | No differences |
| 1.5. Table No.6 | | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- | --- |
| Technical Characteristic | | Ball Attachment, angular | Angular Ball Attachment | Angulated ball attachment anchor | SE Discussion |
| *Manufacturer* | | UNIQA Dental Ltd | SGS International Ltd | MIS Implant Technologies Ltd | |
| 510k | | K251188 | K182219 | K180282 | |
| Product Code | | NHA | NHA | NHA | No differences |
| Regulation Description | | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| *Product Image* | | Ball Attachment, angular | S3-S7 - Angular Ball Attachment | Angulated ball attachment anchor | The Subject Device features a ball attachment with angulation similar to both primary and reference device. |
| *Dimensions mm* *Gingival Height=GH* | | RP Angle 9°, 15°, 30° GH 1,2,3 MP Angle 9°, 15° GH 1,2,3 | RP GH 1,2,3 - Angle 17 GH 1,2,3 - Angle 30 | GH 2 Angle 15°, 25° NP,SP,WP | Subject Device has a similar design to the primary device and reference device. (Note: In the Zest locator image the screw is not shown, but basically the Subject Device and the Reference Devices share similar design, clinical use and technological characteristics) |
| *Material* | | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No Differences |
| *Surface Treatment* | | CNC Machined | CNC Machined | CNC Machined | No Differences |
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| | with or without coloring anodize | with or without coloring anodize | with or without coloring anodize | |
| --- | --- | --- | --- | --- |
| Connection | Internal HexConical Connection | Internal Hex | Internal HexConical Connection | No differences |
| Related Components | Silicon Cap soft, ExtraSoft: | Silicon caps soft, standard, strong, housing cap | Metal Caps, Silicon Caps | No Differences |
| Operation | Overdenture Screw Retained | Screw Retained | Overdenture Screw Retained | No differences |
| Sterilization | Non Sterile, Single UseSteam sterilization | Non Sterile, Single UseSteam sterilization | Non Sterile, Single UseSteam sterilization | No differences |
| 1.6. Table No.7 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | Straight Anatomic Abutment | Straight Anatomic Abutment | Transfer Abutment | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | UNIQA Dental Ltd | |
| 510k | K251188 | K180598 | K180598 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | Straight Abutment with Shoulder | Straight Anatomic Abutment | Transfer Abutment | Subject Device is the same as Primary Device and Similar to Reference Device. |
| Dimensions mm Gingival Height=GH | RP GH 5\( \emptyset \) 6 GH 1,2,3,4,5 | GH 1,2,3,4RP,WP | GH 1,2,3,4,5MP,RP,WP 4.4,5.0, 6.0 | The specifications of the Subject Device fall within the limits of both the Primary Device and the Reference Device. |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface | CNC Machined | CNC Machined | CNC Machined | No differences |
| Connection | Internal Hex | Internal Hex | Conical Connection | Subject Device is the same as |
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| | | | | Primary Device |
| --- | --- | --- | --- | --- |
| *Compatible Implant System* | UNIQA Internal Hex Implant | UNIQA Internal Hex Implant | UNIQA Conical Connection Implant | Subject Device is the same as Primary Device. |
| *Operation* | Cement Restoration | Cement Restoration | Cement Restoration | No differences |
| *Sterilization* | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | No differences |
| 1.7 | Table No.8 | Subject Device | Primary Device | | |
| --- | --- | --- | --- | --- | --- |
| Technical Characteristic | | Straight Abutment | Transfer Abutment | | SE Discussion |
| *Manufacturer* | | UNIQA Dental Ltd | UNIQA Dental Ltd | | |
| *510k* | | K251188 | K180598 | | |
| Product Code | | NHA | NHA | | No differences |
| Regulation Description | | Endosseous dental implant abutment | Endosseous dental implant abutment | | |
| *Product Image* | | Straight Abutment | Transfer Abutment | | Subject Device is similar to Primary Device |
| *Dimensions mm* | | RP Ø 4.5, 5,6,7 GH-1,2,3,4,5 | GH 1,2,3,4,5 | | Subject Device is in the limits of Primary Device. |
| *General Height=GH* | | MP Ø 4.5 GH-1,2,3,4,5 | MP,RP,WP 4.4,5.0, 6.0 | | |
| *Material* | | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | | No differences |
| *Surface* | | CNC Machined | CNC Machined | | No differences |
| *Connection* | | Conical Connection | Internal Hex Conical Connection | | No differences |
| *Operation* | | Cement Restoration | Cement Restoration | | No differences |
| *Sterilization* | | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | | No differences |
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| 1.8. Table No.9 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | 15 ° / 25° Abutment | 15 ° / 25° Angled Anatomic Abutments/ Abutment with Shoulder | Cementable angulated abutment 10°/15°/20°/25° | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | MIS Implant Technologies Ltd | |
| 510k | K251188 | K180598 | K163349, K040807 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | 15 ° / 25° Abutment | 15 ° / 25° Angled Anatomic Abutments/ Abutment with Shoulder | Cementable angulated abutment | Subject Device is similar to Primary Device and Reference Device |
| Dimensions mm Gingival Height=GH | Conical MP - GH 1,2,3 - Angle 15, 25 RP - GH 1,2,3,4 - Angle 15, 25 | RP GH 1,2,3,4 - Angle 15, 25 | NP,RP,WP GH 1,2,3 – Angle 10, 15, 20,25 Total Length – 9, 10, 11,12 | Subject Device is similar and is within the limits of Primary Device and Reference Device |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface | CNC Machined | CNC Machined | CNC Machined | No differences |
| Connection | Conical connection | Internal Hex | Internal Hex Conical Connection | Subject Device is similar and is within the limits of Primary Device and Reference Device. |
| Operation | Cement Restoration | Cement Restoration | Cement Restoration | No differences |
| Sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | No differences |
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| 1.9. Table No.10 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | Straight Multi Unit Abutments D-Type | Straight Multi Unit Abutments D-Type | Straight Multi Unit Abutments | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | MIS Implant Technologies Ltd | |
| 510k | K251188 | K180598 | K163349, K040807 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | Straight Multi Unit Abutments D-Type | Straight Multi Unit Abutments D-Type | Straight Multi Unit Abutments | Subject Device is similar to Primary Device |
| Dimensions mm Gingival Height=GH | RP - GH 1,2,3,4,5 MP - GH 1,2,3,4,5 | RP GH 1,2,3,4 | NP, RP, WD Diameter: Regular GH 1,2,3,4,5 | Subject Device is similar and is within the limits of Primary Device and Reference Device. UNIQA K180598 consists also of Multi Unit V-Type for conical connection Heights 0.5,1,2,3,4,5. |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface Treatment | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | No differences |
| Connection | Internal Hex Conical Connection | Internal Hex | Internal Hex Conical Connection | No differences |
| Related Components | Healing Caps, Temporary sleeves, screws | Healing Caps, Temporary sleeves, screws | Healing Cap, Temporary cylinder, screws | No differences |
| Operation | Screw Retained | Screw Retained | Screw Retained | No differences |
| Sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | No differences |
| Subject Device | Primary Device | Reference Device |
| --- | --- | --- |
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| 1.10. Table No.11 | | | | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | 17"/30" Angled Multi Unit Abutments D- Type | 17"/30" Angled Multi Unit Abutments D- Type | NobelActive Multi Unit Abutment | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | Nobel Biocare AB | |
| 510k | K251188 | K180598 | K072570 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | 17"/30" Angled Multi Unit Abutments D- Type | 17"/30" Angled Multi Unit Abutments D- Type | NobelActive Multi Unit Abutment | Subject Device is similar to Primary Device |
| Dimensions mm Gingival Height=GH | MP - GH 1,2,3,4 - Angle 17, 30 RP - GH 1,2,3,4 - Angle 17, 30 | RP GH 1,2,3 - Angle 17, 30 | NP,RP GH 1.5,2.5,3.5,4.5 Angle 0, 17, 30 | Subject Device is similar and is within the limits of Primary Device and Reference Device |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V | No differences Subject Device is similar to Primary Device |
| Surface Treatment | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | No differences |
| Connection | Internal Hex Conical Connection | Internal Hex | Internal Hex Conical Connection | No differences |
| Related Components | Healing Caps, Temporary sleeves, screws | Healing Caps, Temporary sleeves, screws | Healing Caps, Temporary sleeves, screws | No Differences |
| Operation | Screw Retained | Screw Retained | Screw Retained | No Differences |
| Sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Sterile Gamma Irradiation, Single Use | Subject Device the same as Primary Device |
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| 1.11. Table No.13 | Subject Device | Primary Device | Reference Device | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | Straight Multi Unit Abutments V-Typ | Straight Multi Unit Abutments V-Type | Straight Multi Unit Abutments | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | MIS Implant Technologies Ltd | |
| 510k | K251188 | K180598 | K163349, K040807 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | Straight Multi Unit Abutments V-Type | Straight Multi Unit Abutments V-Type | Straight Multi Unit Abutments | No differences |
| Dimensions mm Gingival Height=GH | RP - GH 0.5,1,2,3,4,5, 6 MP - GH 0.5,1,2,3,4,5 | RP GH 0.5,1,2,3,4,5 | GH 1,2,3,4,5 NP,RP,WP | Subject Device is similar to the Primary Device and Reference Device. The 6mmL for internal hex is a minor change since this a straight abutment which exist in other UNIQA K180598 abutments designs such as: Healing caps 2-7mm, ball attachment 0.5-7mm, UNIQA Multi Unit D-type for conical connection. |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface Treatment | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | No differences |
| Connection | Internal Hex Conical Connection | Internal Hex | Internal Hex Conical Connection | No differences |
| Related Components | Healing Cap, Sleeve, screws | Healing Cap, sleeve, screws | Healing Cap, cylinder sleeve, screws | No differences |
| Operation | Screw Retained | Screw Retained | Screw Retained | No differences |
| Sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | No differences |
| | Subject Device | Primary Device | Reference Device | |
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UNIQA DENTAL
| 1.12. Table No.14 | | | | |
| --- | --- | --- | --- | --- |
| Technical Characteristic | Temporary Sleeve for Multi Unit | Temporary Sleeve for Multi Unit | Temporary Abutment for Multi Unit Abutment | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | Nobel Biocare AB | |
| 510k | K251188 | K180598 | K072570 | |
| Product Code | NHA | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | Temporary sleeve for MUA | Temporary sleeve for MUA | Temporary Abutment for Multi-unit | No differences |
| Dimensions mm Gingival Height=GH | Internal/Conical Length-1.5,3,4,6,8,12 for V-type | Internal Total length - 10mm, 12mm Conical Total length - 12mm | Length 10mm 3.0, NP, RP, WP 1.5, 3 Slim Length 6.5, 7.5 | No differences The subject device is in the limits of Primary Device and Reference Device |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | No differences |
| Surface Treatment | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | CNC Machined with or without coloring anodize | No differences |
| Connection | Internal Hex Conical Connection | Internal Hex Conical Connection | For all Nobel Platforms: External hex, Internal Conical Connection, Internal Tri-channel | No differences |
| Operation | Screw Retained | Screw Retained | Screw Retained | No differences |
| Sterilization | Non Sterile, Single Use Steam sterilization | Non Sterile, Single Use Steam sterilization | Sterile Gamma Irradiation, Single Use | Subject Device the same as Primary Device |
| Subject Device | Primary Device |
| --- | --- |
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UNIQADENTAL
| 1.13. Table No.15 | | | |
| --- | --- | --- | --- |
| Technical Characteristic | Abutment Screws | Abutment Screws | SE Discussion |
| Manufacturer | UNIQA Dental Ltd | UNIQA Dental Ltd | |
| 510k | K251188 | K180598 | |
| Product Code | NHA | NHA | No differences |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment | |
| Product Image | Screw for MUA sleeve, D-type / D-type s5 Screw for MUA sleeve D-type s3 Screw for MUA sleeve D-type Torx6 Screw for MUA sleeve D-type s6 Torx6 Screw for MUA sleeve D-type Long Torx6 Screw for MUA sleeve V-type / M-Type Screw for MUA sleeve V-type Torx6 / M-type Torx6 | Screw for MUA sleeve, D-type Screw for MUA sleeve, C-type Screw for abutment /abutment Mini / angled abut. | Added screws has a slight change which raise no difference as verified by static and fatigue test. |
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UNIQA DENTAL
| | Screw for MUA sleeve V-type s5 Screw for MUA sleeve V-type s5 Torx6 Screw for MUA sleeve V-type s6 Torx6 Screw for abutment / angled abut. | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| *Dimensions mm* | Screw type | Length | Shaft diameter | Screw type | Length | Shaft diameter | The subject device is in the limits of Primary Device. Assembling connection-implant/ abutment/ screw has been verified by static and fatigue test according to ISO 14801. |
| | Screw for MUA sleeve, D-type / D-type s5 | 3.9 | 1.4 | Screw for MUA sleeve, D-type | 3.9 | 1.5 | |
| | Screw for MUA sleeve D-type s3 | 4.5 | 1.4 | Screw for angled MUA, D-type | 6.8 | 1.4 | |
| | Screw for MUA sleeve D-type Torx6 | 5.2 | 1.15 | Screw for abutment | 8.3 | 1.4 | |
| | Screw for MUA sleeve D-type s6 Torx6 | 4.2 | 1.38 | Screw for MUA sleeve, V-type | 8.1 | 1.4 | |
| | Screw for MUA sleeve D-type Long Torx6 | 4.2 | 1.5 | Screw Mini Conical | 3.9 | 1.5 | |
| | Screw for MUA sleeve V-type | 4.5 | 1.4 | Screw Regular Conical | 10.2 | 1.54 | |
| | Screw for MUA sleeve V-type | 3.9 | 1.5 | Screw for MUA sleeve, C-type | 8.4 | 1.93 | |
| | Screw for MUA sleeve V-type Torx6 | 5.2 | 1.5 | | 4.3 | 1.54 | |
| | Screw for MUA sleeve V-type s5 | 5 | 1.5 | | | | |
| | Screw for MUA sleeve V-type s5 Torx6 | 5 | 1.4 | | | | |
| | Screw for MUA sleeve V-type s6 Torx6 | 4.2 | 1.8 | | | | |
| | Screw for MUA sleeve M-type | 3.9 | 1.6 | | | | |
| | Screw for MUA sleeve M-type Torx6 | 4.42 | 1.6 | | | | |
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**UNIQADENTAL**
| | Screw for abutment Torx6 Internal Hex RP | 7.7 | 1.4 | | |
| --- | --- | --- | --- | --- | --- |
| | Screw for abutment Internal Hex RP | 8 | 1.4 | | |
| | | 7.5 | 1.4 | | |
| | | 10.2 | 1.13 | | |
| | | 8.4 | 1.55 | | |
| | | 7.5 | 1.55 | | |
| | Screw for abutment Conical | 10.2 | 1.54 | | |
| | | 10.2 | 1.13 | | |
| | | 8.4 | 1.93 | | |
| | | 8.4 | 1.55 | | |
| | | 7.5 | 1.55 | | |
| | Screw for angled MUA D-type Conical | 8.9 | 1.25 | | |
| | | 7.3 | | | |
| *Material* | Titanium alloy Ti-6Al-4V-ELI. | | Titanium alloy Ti-6Al-4V-ELI. | | No differences |
| *Surface Treatment* | CNC Machined with or without coloring anodize | | CNC Machined with or without coloring anodize | | No differences |
| *Connection* | Internal Hex Conical Connection | | Internal Hex Conical Connection | | No differences |
| *Operation* | Screw Retained | | Screw Retained | | No differences |
| *Sterilization* | Non Sterile, Single Use Steam sterilization | | Non Sterile, Single Use Steam sterilization | | No differences |
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## 12 Summary of Equivalence:
UNIQA® Dental Implants System, Subject Device is similar in design, intended use, raw material, specifications and surface to its similar devices Primary Device UNIQA K180598, and References Devices: MIS® K163349, K040807, K180282, Nobel Biocare® K142260, K072570, SGS® K182219 and ZEST LOCATOR® K252944. The SE Table presented the technical parameters of each device compared to the Primary Device and/or Reference Device evaluating the differences. No significant differences are presented by UNIQA Subject Device. The UNIQA fatigue test results demonstrated high mechanical resistance (per ISO 14801). Fatigue and static test protocols are presented in the Mechanical Testing Section. The differences between Subject Device and Predicate Device and/or Reference Device did not alter the intended use and new issues of safety and effectiveness were not raised. Therefore, it can be considered that Subject Device is substantial equivalent to its Primary Device and/or Reference Device.
## 13 Performance Testing:
Clinical Testing - No clinical data is included in this submission.
**Fatigue Test and Static Tests** were conducted in accordance with:
ISO 14801:2016 Dentistry – Implants - Dynamic fatigue test for endosseous dental implants; The selected fatigue-test configurations represent the worst-case implant–abutment loading conditions, including Regular and Mini Platforms, 30° Multi-Unit Abutments, 30° Ball Attachments. The results demonstrated high mechanical performance of the UNIQA® Dental Implants and Abutments.
**Sterilization Validation Test** was conducted:
in order to ensure safety and effectiveness related to UNIQA® Dental Implants for additional VDmax method- Test results have demonstrated that the SAL of 10$^{-6}$ was achieved and all testing requirements were met. The test was conducted in accordance with ISO 11737-1:2018 /AMD 1:2021, ISO 11737-2:2019, ISO 11137-1:2006 /Amd 2:2018, ISO 11137-2:2013/Amd 1:2022, AAMI TIR /ISO 13004:2022-10.
**Endotoxin Testing** was conducted in accordance with:
USP<85>Bacterial Endotoxins Test, USP <161> Medical Devices Bacterial Endotoxin and Pyrogen Tests. Endotoxin (LAL) testing is performed to ensure that bacterial endotoxin
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levels on sterile dental implants remain below the allowable limit to prevent pyrogenic reactions in patients, and all UNIQA® test results have met the acceptance criteria.
**Steam Sterilization Test** was conducted in accordance with:
ISO 17665:2024 Sterilization of health care products Moist heat. The test was conducted in order to ensure safety and effectiveness or additional steam sterilization method related to UNIQA® Dental Abutments - Test results have demonstrated that the SAL of 10$^{-6}$ was achieved and all testing requirements were met.
**Packaging Testing** was conducted in accordance with:
ISO 11607-1:2019 /Amd 1:2023, ASTM F 1929-15, ASTM F88/F88M-21; to verify the integrity of UNIQA® sterile packaging and that confirm that the sterile barrier is maintained.
**Biocompatibility Testing** was conducted:
Cytotoxicity test was conducted in accordance with ISO 10993-11:2017, USP-NF – <151> Pyrogen Test, ISO 10993-5:2009 ; The test covered titanium abutments (Ti6Al4V Eli), anodized abutments to verify that the manufacturing process and cleaning process did not change the biocompatibility profile UNIQA. Test results met the criteria. Material mediated pyrogenicity test was conducted in accordance with ISO 10993-11, USP-NF – <151> Pyrogen Test (2017) - all test results met the criteria. The test item met the requirements for the absence of pyrogens.
#### **Surface Treatment Test**
UNIQA's Dental implants are provided in two options of surface treatment (1) 'SBA' - Sand Blast of Aluminum Oxide SLA following acid etched (2) 'Pure&Porous' - Sand Blast of Hydroxyapatite Calcium Phosphate following acid etched; X-ray Photoelectron Spectroscopy (XPS) and Energy Dispersive Spectroscopy (EDS) were conducted to verify elemental composition and surface cleanliness. Testing confirmed that the modified surfaces met the expected morphological and chemical characteristics, including appropriate cleanliness and composition consistent with the device's design specifications.
#### **MRI Safety**
Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices.' Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system to include all variations (all
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compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment”, including magnetically induced displacement force and torque.
**Risk Management** was conducted in accordance with:
EN ISO 14971:2019 Medical devices – Application of risk management to medical devices. The results of the non-clinical testing demonstrated that UNIQA Subject Devices met the established performance specifications per intended use. The non-clinical testing also demonstrated that UNIQA Subject Devices do not raise different questions of substantial equivalence when compared to the Primary Device and References Devices.
# 14 Conclusion:
As verified by Substantial Equivalence, Risk Management and Non-Clinical Testing UNIQA® Dental Implants System shares similarity to its Primary Device and References Devices in terms of intended use, indication for use, raw material, technological characteristics and performance. Therefore, UNIQA® Dental Implants system is substantially equivalent to its predicate devices.
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