UNIQA Dental Implants System

K180598 · Uniqa Dental, Ltd. · DZE · Aug 8, 2018 · Dental

Device Facts

• Record ID: K180598
• Device Name: UNIQA Dental Implants System
• Applicant: Uniqa Dental, Ltd.
• Product Code: DZE · Dental
• Decision Date: Aug 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments. 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

Endosseous dental implant system; includes implants (conical hex or internal hex designs), cover screws, healing caps, and various abutments. Implants feature tapered, double-thread geometry; surface treatments include Pure & Porous (hydroxyapatite/calcium phosphates) or sand-blasted/acid-etched (SBA). Used by dental surgeons in clinical settings for tooth replacement. Implants placed in jaw bone to support prosthetic devices; immediate loading permitted under specific stability conditions. Healthcare providers select components based on clinical needs; output is a stable foundation for prosthetic restoration, improving patient chewing function. System components are titanium alloy (Ti6Al4V ELI).

Clinical Evidence

No clinical data included. Bench testing performed: fatigue testing (ISO 14801), biocompatibility (ISO 10993-5), sterilization validation (ISO 11137, ISO 17665), and shelf-life testing (ASTM F-1980).

Technological Characteristics

Materials: Titanium alloy Ti6Al4V ELI (ASTM F-136). Design: Endosseous, root-form, tapered, double-thread. Connection: Internal hex or conical (22° angulation). Surface: Hydroxyapatite/calcium phosphate (Pure & Porous) or sand-blasted/acid-etched (SBA). Sterilization: Gamma radiation or moist heat.

Indications for Use

Indicated for surgical and restorative placement in upper or lower jaw bone to support prosthetic devices (artificial teeth) and restore chewing function. Includes immediate loading when primary stability and occlusal loading are appropriate. Conical Mini implants (Ø3.3mm) indicated only for mandibular central/lateral incisors and maxillary lateral incisors in partially edentulous jaws; requires splinting for adjacent narrow implants.

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

• MIS Implant Technologies Ltd Implants System (K040807)

Reference Devices

• MIS Implant Technologies Ltd Implants System (K163349)
• Astra Tech AB OsseoSpeed TX (K101732)
• Nobel Biocare Multi Unit Abutment (K072570)
• A.B. Dental Devices Ltd (K132125)
• A.B. Dental Devices Ltd (K112440)
• Dentin Dental Implants System (K120530)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 8, 2018

UNIQA DENTAL LTD. % Daniela Levy Regulatory Consultant Sterling Medical Registration 22815 Ventura Blvd. Woodland Hills, California 91364

Re: K180598

Trade/Device Name: UNIOA® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 14, 2018 Received: May 23, 2018

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 (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. 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.

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL" in a smaller, green, sans-serif font. The logo is simple and clean, with a focus on the company name.

### SECTION 4

# Indication for Use Statement

510(k) Number (if known): K180598 Device Name: UNIQA® Dental Implants System Indications for Use (Describe)

### 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.

UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.

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)

区Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use(21 CFR 801 Subpart

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for UNIQA Dental. The word "UNIQA" is in large, green, sans-serif font, with a small, dark red square above the "I". Below "UNIQA" is the word "DENTAL" in a smaller, green, sans-serif font. The overall design is simple and modern.

# SECTION 5 -

# 510(k) Number K180598

- 1 Type of Submission Premarket Notification (21 CFR 807.90(e)) 510(k) Traditional

| 2 | Submission Owner | UNIQA DENTAL LTD. | | | | |
|---|--------------------------------------------------------|-----------------------------------------------------------------------|--|--|--|--|
| | | Dima Goberman - CEO | | | | |
| | | 26 Tom Lantos blvd., Alon Center | | | | |
| | | Netanya 4276001 | | | | |
| | | Israel | | | | |
| | | Tel : [phone] | | | | |
| | | Fax : [phone] | | | | |
| 3 | Official Correspondent<br>Contact Person | Sterling Medical Registration<br>Daniela Levy - Regulatory Consultant | | | | |
| | | 22815 Ventura blvd. | | | | |
| | | Woodland Hills, CA 91364 | | | | |
| | | Phone: [phone] | | | | |
| | | Email: [e-mail] | | | | |
| 4 | Date Prepared | Tuesday, August 7, 2018 | | | | |
| 5 | Device Trade Name | UNIQA® Dental Implants System | | | | |
| 6 | Regulation Description | Endosseous Dental Implants Abutment | | | | |
| 7 | Classification | Primary Product Code: DZE | | | | |
| | | Device Name : Implant, endosseous, root-form | | | | |
| | | Regulation No : 872.3640 | | | | |
| | | Class : II | | | | |
| | | Panel : Dental | | | | |
| | | Secondary Product Code: NHA | | | | |
| 8 | Reason for the Premarket Notification Submission | : New Device | | | | |
| 9 | Identification of Legally Marketed Predicate Devices : | | | | | |

- Primary Predicate:
MIS Implant Technologies Ltd Implants System K040807;

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Reference Devices:

MIS Implant Technologies Ltd Implants System K163349; Astra Tech AB OsseoSpeed TX K101732 Nobel Biocare Multi Unit Abutment K072570; A.B. Dental Devices Ltd K132125, K112440; Dentin Dental Implants System K120530; in terms of intended use, indication for use, raw material, technological characteristics and performance. The primary predicate and referenced devices are Class II medical devices.

- 10 Device Description:
UNIQA® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; The Dental Implants provided in two types of design:(a) Conical Hex; (b) Internal Hex; Each implant design is available in two options of surface treatment (1) Pure & Porous, P&P which consists of Hydroxyapatite and Calcium Phosphates; or (2) SBA - which consists of sand blast large particles with acid etched;

Dental Implants:

Conical Implant, Pure & Porous, P&P -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, SBA -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, Internal Hex, Pure & Porous, P&P -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Conical Implant, Internal Hex, SBA -

Measurements: Diameters 3.3, 3.75, 4.2, 5.0 mm with lengths 8, 10, 11.5, 13, 16 mm; Dental Abutments:

Dental Abutments Internal Hex Connection: Locator Abutments, Angled Anatomic Abutments 15°, 25°, Angled Abutments 15°, 25°, Angled Multi Unit Abutments D-type 179,300 (provided also as set), Temporary Sleeves for Multi Unit D-type, Straight Multi Unit Abutments D-type, Ball attachment abutments, Healing Caps (Narrow, Regular, Wide), Straight anatomic abutment, Straight abutments (Regular, Wide), Straight

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abutment with shoulder( Reqular, Wide), Snap on Transfer abutments, Straight Multi Unit Abutments D-type.

Dental Abutments Conical Connection: Healing Caps (Mini, Regular), Transfer Abutments (Mini, Regular), Transfer Abutment Regular, Straight Multi Unit Abutments C-type, Sleeves for Multi Unit C-type.

- 11 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.

UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments.

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.

- 12 Performance Standards or Special Controls
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought . titanium 6-aluminium 4-vanadium alloy.
- . ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.
- . ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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- ISO 11737-2: 2009 Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ASTM F-1980 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems . for Medical Devices
- . ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1
- . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- FDA guidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
- Chemical and SEM analysis performed on implants per Class II Special Controls . Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
- Endotoxin batch testing protocol per FDA Guidance Document Submission and . Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

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### 13 Substantial Equivalence

| Characteristic | Conical Implant, Pure<br>& Porous, P&P Cat #<br>UCI | MIS - SEVEN Implants | MIS V3 Conical<br>Connection implants | OsseoSpeed TX S | A.B. Dental<br>Implant system | DENTIN Dental<br>Implant system |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Primary Predicate | Reference Device | Reference Device | Reference<br>Device | Reference Device |
| 510(k) number | K180598 | K040807 | K163349 | K101732 | K132125 | K120530 |
| Manufacturer | UNIQA Dental Ltd. | MIS Implants<br>Technologies Itd | MIS Implants<br>Technologies Itd | Astra Tech AB | A.B. Dental<br>Device Itd | DENTIN Implants<br>Technologies Ltd |
| Product Name | Conical Implant, Pure &<br>Porous, P&P | SEVEN Implants | MIS V3 Conical<br>Connection Dental<br>Implant System | OsseoSpeed TX S | 15 Conical<br>Implant | RAPID Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double<br>Thread | Tapered, Double<br>Thread | Cylindrical tapered<br>apex, threaded | Tapered, Double<br>Thread | Tapered |
| Measurements:<br>Ø / Length mm | 3.3 Ø: 8 ,10, 11.5, 13,<br>16<br>3.75 Ø: 8 ,10, 11.5, 13,<br>16<br>4.2 Ø: 8 ,10, 11.5, 13,<br>16<br>5.0 Ø: 8 ,10, 11.5, 13,<br>16 | 3.75 Ø: 8 ,10, 11.5,<br>13,16<br>4.2 Ø: 8 ,10, 11.5, 13,<br>16<br>5.0 Ø: 8 ,10, 11.5, 13,<br>16 | 3.3 Ø: 10, 11.5, 13, 16<br>4.3 Ø: 8 ,10, 11.5, 13,<br>16<br>4.9 Ø: 8 ,10, 11.5, 13,<br>16<br>5.0 Ø: 8 ,10, 11.5, 13,<br>16 | 3.0 Ø: 11, 13, 15<br>3.5 Ø: 8, 9, 11, 13, 15,<br>17<br>4.0 Ø: 6, 8, 9, 11,<br>13,15, 17<br>5.0 Ø: 9, 11, 13, 15, 17 | 3.5 Ø: 8 ,10,<br>11.5, 13, 16 | 3.3 Ø: 8 ,10, 11.5, 13,<br>16<br>3.75 Ø: 8 ,10, 11.5,<br>13, 16<br>4.2 Ø: 8 ,10, 11.5, 13,<br>16<br>5.0 Ø: 7, 8 ,10, 11.5,<br>13<br>6.0 Ø: 7, 8 ,10, 11.5,<br>13 |
| Connection<br>Type | Internal conical<br>connection, cone<br>angulation 22° | Internal hex | Internal conical<br>connection, cone<br>angulation 12° | Internal conical<br>connection, cone<br>angulation 21º | Internal Hex | Internal Hex |
| Material | Titanium Alloy Ti6Al4V<br>ELI | Titanium Alloy Ti6Al4V<br>ELI | Titanium Alloy Ti6Al4V<br>ELI | Titanium grade 4 | Titanium Alloy<br>Ti6Al4V ELI | Titanium Alloy Ti6Al4V<br>ELI |
| Surface<br>Treatment | Clean&Porous, P&P<br>(Hydroxyapatite and<br>Calcium Phosphates) | Sand Blast and acid-<br>etched | Sand Blast and acid-<br>etched | TiO2-blasted<br>fluoridemodified surface | Hydroxyapatite<br>and Calcium<br>Phosphates | Sand Blast & Acid<br>Etched |
| Self tapping | Yes | Yes | Yes | Yes | Yes | Yes |
| Indication for Use | UNIQA Dental ® Dental Implants | The MIS Dental Implant System | MIS V3 Connection Dental Implant System | The OsseoSpeed Implants | A.BDENTAL DEVICES® | DENTIN® Dental Implants System |
| | 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. UNIQA Conical Connection Implants: #UCI & #UC7 are to be used only with straight abutments. 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 | 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. | 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. | are intended to be used: to replace missing teeth in single or multiple unit applications within the mandible or maxillafor immediate placement in extraction sites and partially or completely healed alveolar ridge situationsfor both one- and two stage surgical proceduresespecially well in soft bone applications where implants with other implant surface treatments may be less effectivetogether with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriatetogether with immediate loading protocol for single tooth restorations on implants 8 mm or longerwith its 3.0 S product line for maxillary lateral incisors and mandibular lateral and central incisors. | 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. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: I2,I5,I6BI. One Stage: I6, I6b, I6B. One Stage & One-Piece 3.0 mm diameter implants: I6, I6B, I6BI, are intended for | 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. DENTIN® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: CLASSIC, RAPID, PRESTIGE. One Stage Implants: ONE PIECE DENTIN® ONEPIECE Implants 3.0 mmd are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants. |
| Indication for<br>Use | | | | | placement at the<br>mandibular<br>central and<br>lateral incisors<br>and maxillary<br>and lateral<br>incisors.<br>Indicated also<br>for denture<br>stabilization<br>using multiple<br>implants. One<br>stage & One-<br>Piece 2.4 mm<br>diameter<br>implants for<br>temporary use or<br>long term use:<br>I6, I6b, permit<br>immediate splint<br>stability and long<br>term fixation of<br>new or existing<br>crown, bridge<br>and prosthesis.<br>P14 Angulated<br>Abutment<br>Adapter is to be<br>used with<br>implant diameter<br>4.2mm and<br>higher. | |
| Self tapping | ✓ | Gamma Ray | ✓ | ✓ | ✓ | ✓ |
| Sterilization | Gamma Ray…