Implantswiss Dental Implant System, Implantswiss Dental Abutment System

K181266 · Novodent SA · DZE · Nov 1, 2018 · Dental

Device Facts

• Record ID: K181266
• Device Name: Implantswiss Dental Implant System, Implantswiss Dental Abutment System
• Applicant: Novodent SA
• Product Code: DZE · Dental
• Decision Date: Nov 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

Device Story

System comprises titanium/titanium alloy endosseous dental implants and abutments; implants feature Sandblasted Rough Acid-etched (SRA) surface. Implants placed in upper/lower jaw arches via conventional two-stage or single-stage surgical process; immediate loading restricted to anterior mandible. Abutments (Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator, Multi-Unit) connect to implants to support prosthetic restorations (crowns, bridges, overdentures). Used in dental clinics by trained clinicians. Output is physical support for dental prosthetics; aids in restoring patient chewing function and oral rehabilitation.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, implantation, chemical analysis). Sterilization validated per ISO 11137-1 (gamma) and ISO 17665-1 (steam). Shelf-life validated via accelerated/real-time aging (ASTM F1886, ASTM F1929-15, BS EN 868-5). Mechanical fatigue testing performed per ISO 14801 on worst-case implant/abutment combinations. Surface analysis conducted via SEM and EDS.

Technological Characteristics

Materials: Titanium Ti6Al4V ELI (ASTM F136-13) and Titanium Grade 4 (ASTM F67-13). Surface: Sandblasted Rough Acid-etched (SRA). Design: Threaded root-form bone/tissue level implants with internal hexagon/octagonal interfaces. Sterilization: Gamma (implants), steam (abutments). Connectivity: N/A (mechanical device).

Indications for Use

Indicated for surgical placement in upper/lower jaw arches to restore chewing function in partially or fully edentulous patients. Immediate loading restricted to anterior mandible using four splinted-interforminal implants. Abutments support crowns, bridges, and overdentures. Abutment models <4mm height restricted to multi-unit loading.

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

• Implance Dental Implant System, Implance Dental Abutment System (K160221)

Reference Devices

• Straumann Dental Implant System (K150938)
• LOCATOR RTx (K150295)
• NobelActive Multi Unit Abutment (K072570)

Submission Summary (Full Text)

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November 1, 2018

Novodent SA % H. Semih Oktay, PhD President CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, Maryland 21401

Re: K181266

Trade/Device Name: Implantswiss Dental Implantswiss Dental Abutment System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 27, 2018 Received: October 2, 2018

Dear H. Semih Oktay, PhD:

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. 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 located 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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

1050.

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# Indications for Use

510(k) Number (if known)

#### K181266

Device Name

Implantswiss Dental Implant System, Implantswiss Dental Abutment System

#### Indications for Use (Describe)

Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(K) SUMMARY

# SUBMITTER

# NOVODENT SA

Y-PARC Technopole Avenue des Sciences 11 CH-1400 Yverdon-les-Bains Switzerland Office: [phone] [phone]

Official Correspondent: H. Semih Oktay, Ph.D.

CardioMed Device Consultants, LLC

1783 FOREST DRIVE #254 ANNAPOLIS, MD 21401 USA Phone: [phone] Email: [e-mail]

Date of Summary: November 1, 2018

# DEVICE

| Proprietary name | Implantswiss Dental Implant System |
|-------------------------|-------------------------------------|
| | Implantswiss Dental Abutment System |
| Common Name | Implant, Endosseous, Root-Form |
| Classification Name | Endosseous Dental Implant |
| Regulatory Class | II |
| Primary Product Code | DZE |
| Subsequent Product Code | NHA |
| Regulation Number | 21 CFR 872.3640 |

# PREDICATE DEVICE

Primary Predicate Device:

Implance Dental Implant System, Implance Dental Abutment System - K160221

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Reference Devices:

Straumann Dental Implant System - K150938

LOCATOR RTx - K150295

NobelActive Multi Unit Abutment - K072570

### Device Description

The Implantswiss Dental Implant and Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments.

The Implantswiss Dental Implants are provided as bone level or tissue level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process.

The Implantswiss Bone Level Implants have diameters of 3.3mm, 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The 3.3mm and 3.7mm diameter Bone Level Implants are composed of Titanium Ti6Al4V ELI – ASTM F136-13. The 4.3mm, 4.8mm and 5.5mm diameter Bone Level Implants are composed of Titanium Grade 4 – ASTM F67-13.

The Implantswiss Tissue Level Implants have diameters of 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 10mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The Tissue Level Implants are composed of Titanium Grade 4 – ASTM F67-13.

The Implantswiss Dental Abutment System consists of Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator and Multi-Unit Abutments.

Bone Level Couple Abutments have diameters Ø 3.7mm and Ø 4.5mm. Tissue Level Couple Abutments have diameters Ø 5.2mm and Ø 6.4mm.

Bone Level Angled Abutments with 15° angles have diameters Ø 3.7mm and Ø 4.5mm. Bone Level Angled Abutments with 25° angles have a diameter of Ø 4.5mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5mm.

Bone Level Solid Abutments have diameters of Ø 3.7mm and Ø 4.5mm. Tissue Level Solid Abutments have diameters of Ø 3.5mm and Ø 4.3mm.

Bone Level O-ring Abutments have diameters of Ø 2.9mm and Ø 4.5mm.

Bone Level Multi Abutments have diameters of Ø 3.7mm and Ø 4.5mm. Tissue Level Multi Abutments have a diameter of Ø 5.2mm.

Bone Level Octa Abutments have diameter of Ø 4.8mm. Tissue Leyel Octa Abutments have a diameter of Ø 3.5mm.

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Tissue Level Synocta Abutments have a diameter of Ø 3.5mm.

Bone Level Healing Abutments have diameters of Ø 3.7mm and Ø 4.5mm. Tissue Level Healing Abutments have a diameter of Ø 5.2mm.

Bone Level Locator Abutments have diameter of Ø 3.86mm. Tissue Level Healing Locator have diameter of Ø 3.86 mm.

Bone Level Multi-Unit Abutments with 17 angle have a diameter Ø 4.8mm.

# Indication for Use

Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splintedinterforminal placed implants. Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

#### Substantial Equivalence Comparison

The Implantswiss Dental Implant System is comparable to the K160221- Implance Dental Implant System, Implance Dental Abutment System as the primary predicate and the reference predicate device Straumann Dental Implant System (K150938).

The Implantswiss Dental Abutment System is comparable to the primary predicate devices Implance Dental Abutment System (K160221) and reference predicate devices LOCATOR RTx (K150295) and NobelActive Multi Unit Abutment (K072570).

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| | Implantswiss Dental<br>Implant System,<br>Implantswiss Dental<br>Abutment System | Primary Predicate<br>Implance Dental Implant<br>System,<br>Implance Dental<br>Abutment System | Reference Predicate<br>Straumann Dental Implant<br>System |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | K181266 | K160221 | K150938 |
| Manufacturer | Novodent SA | AGS Medikal Urunleri Ith.<br>Ihr. Tic. Ltd. Sti. | Straumann USA, LLC |
| Indication | Implantswiss Dental<br>Implant System is indicated<br>to use for surgical<br>placement in the upper and<br>lower jaw arches, to<br>provide a root form means<br>for single and multiple<br>units' prosthetic appliance<br>attachment to restore a<br>patient's chewing function.<br>Implantswiss Dental<br>Implant can be placed with<br>a conventional two stage<br>surgical process with an<br>option for transmucosal<br>healing or they can be<br>placed in a single stage<br>surgical process for<br>immediate loading.<br>Immediate loading is<br>restricted to the anterior<br>mandible based on four<br>splinted-interforminal<br>placed implants.<br>Implantswiss Dental<br>Abutment System is used<br>with a dental implant to<br>provide support to<br>prosthetic restorations such<br>as crown, bridge and<br>overdentures in partially or<br>fully edentulous patients.<br>Octa and Multi-Unit<br>Abutment models that<br>contain an abutment post<br>height less than 4 mm are<br>indicated only for multi-<br>unit loading, such as a<br>bridge or overdenture. | Implance Dental Implant<br>System is indicated to use<br>for surgical placement in the<br>upper and lower jaw arches,<br>to provide a root form means<br>for single and multiple units'<br>prosthetic appliance<br>attachment to restore a<br>patient's chewing function.<br>Implance Dental Implant<br>can be placed with a<br>conventional two stage<br>surgical process with an<br>option for transmucosal<br>healing or they can be<br>placed in a single stage<br>surgical process for<br>immediate loading.<br>Immediate loading is<br>restricted to the anterior<br>mandible based on four<br>splinted-interforminal<br>placed implants.<br>Implance Dental Abutment<br>System is used with a<br>dental implant to provide<br>support to prosthetic<br>restorations such as crown,<br>bridge and overdentures in<br>partially or fully edentulous<br>patients. Octa Abutment<br>models that contain an<br>abutment post height less<br>than 4 mm are indicated<br>only for multi-unit loading,<br>such as a bridge or<br>overdenture. | Straumann Dental Implants are<br>indicated for oral endosteal<br>implantation in the upper and<br>lower jaw and for the<br>functional and esthetic oral<br>rehabilitation of edentulous<br>and partially dentate patients.<br>Straumann dental implants can<br>also be used for immediate or<br>early implantation following<br>extraction or loss of natural<br>teeth. Implants can be placed<br>with immediate function on<br>single-tooth and or multiple<br>tooth applications when good<br>primary stability is achieved<br>and appropriate occlusal<br>loading, to store chewing<br>function. The prosthetic<br>restorations used are single<br>crowns, bridge and partial or<br>full dentures, which are<br>connected to the implants by<br>the corresponding elements<br>(abutments). |

# Implantswiss Dental Implant System Substantial Equivalence Comparison

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| System<br>Components | Dental implant and closing<br>screw | Dental implant and closing<br>screw | Dental implant and transfer<br>piece |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Threaded root-form bone<br>or tissue level implant with<br>hybrid and straight designs<br>and Morse taper internal<br>hexagon or internal<br>octagonal abutment<br>interface<br>Tissue Level Dental<br>implant' machined length<br>is 2.65 mm | Threaded root-form bone or<br>tissue level implant with<br>hybrid and straight designs<br>and Morse taper internal<br>hexagon or internal<br>octagonal abutment<br>interface | Implant-Abutment<br>connection for Bone Level:<br>-Narrow CrossFit (NC)<br>-Regular CrossFit (RC)<br>Implant-Abutment<br>connection for Tissue Level:<br>-Narrow Neck CrossFit<br>(NNC)<br>-Regular Neck (RN)<br>-Wide Neck (WN)<br>Tissue Level Dental implant'<br>machined length is 1.8 and<br>2.8 mm respectively Narrow<br>Neck CrossFit (NNC) and<br>both Regular Neck (RN) and<br>Wide Neck (WN) |
| Implant Sizes<br>Bone Level | 3.3x8, 3.3x10, 3.3x12,<br>3.3x14<br>3.7x8, 3.7x10, 3.7x12,<br>3.7x14<br>4.3x8, 4.3x10, 4.3x12,<br>4.3x14<br>4.8x8, 4.8x10, 4.8x12,<br>4.8x14<br>5.5x8, 5.5x10, 5.5x12 | 3.3x8, 3.3x10, 3.3x12,<br>3.3x14<br>3.7x8, 3.7x10, 3.7x12,<br>3.7x14<br>4.3x8, 4.3x10, 4.3x12,<br>4.3x14<br>4.8x8, 4.8x10, 4.8x12,<br>4.8x14<br>5.5x8, 5.5x10, 5.5x12 | 3.3x8, 3.3x10, 3.3x12,<br>3.3x14, 3.3x16<br>4.1x6, 4.1x8, 4.1x10, 4.1x12,<br>4.1x14, 4.1x16<br>4.8x6, 4.8x8, 4.8x10, 4.8x12,<br>4.8x14, 4.8x16 |
| Implant Sizes<br>Tissue Level | 3.7x8, 3.7x10, 3.7x12,<br>3.7x14<br>4.3x8, 4.3x10, 4.3x12,<br>4.3x14<br>4.8x8, 4.8x10, 4.8x12,<br>4.8x14<br>5.5x8, 5.5x10, 5.5x12 | 3.7x8, 3.7x10, 3.7x12,<br>3.7x14<br>4.3x8, 4.3x10, 4.3x12,<br>4.3x14<br>4.8x8, 4.8x10, 4.8x12,<br>4.8x14<br>5.5x8, 5.5x10, 5.5x12 | 3.3x8, 3.3x10, 3.3x12,<br>3.3x14, 3.3x16<br>4.1x6, 4.1x8, 4.1x10, 4.1x12.<br>4.1x14, 4.1x16<br>4.8x6, 4.8x8, 4.8x10, 4.8x12,<br>4.8x14, 4.8x16 |
| Materials | Commercially Pure<br>Titanium Grade 4 &<br>Titanium Ti6Al4V ELI | Titanium Grade 4 &<br>Titanium Ti6Al4V | Commercially Pure Titanium<br>Grade 4<br>Transfer piece-titanium-<br>6aluminum-7niobium alloy<br>(TAN) |
| Surface<br>treatment | Sandblasted Rough Acid-<br>etched (SRA) surface | Resorbable Blast Media<br>(RBM) surface treatment | Sandblasting Large grit Acid<br>etching (SLA) surface<br>treatment |
| Sterilization | Gamma | Gamma | Gamma |
| Standards for<br>Titanium | ASTM F-67 &<br>ASTM F-136 | ASTM F-67 &<br>ASTM F-136-13 | ASTM F-67 |

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The Implantswiss Dental Implant System is the same or similar to the primary predicate Implance Dental Implant System with respect to indication for use, design, size and dimensions and material composition.

The Implantswiss Dental Implant System maximum implant diameter is the same as the primary predicate Implance Dental Implant System.

The Implantswiss Dental Implant System differs from the primary predicate with respect to the surface treatment.

The Implantswiss Dental Implant System is the same or similar to the reference predicate Straumann Dental Implant System with respect to indication for use, design, material composition and surface treatment. The Implantswiss Dental Implant System has the same surface modification which is sandblasted and following double acid-etching with reference predicate Straumann Dental Implant System (K150938). The Implantswiss Dental Implant System differs with respect to maximum implant diameter and minimum/maximum lengths. The Implantswiss Dental Implant has a maximum implant diameter of 5.5 mm while the reference predicate has a maximum implant diameter of 4.8 mm.

The Implantswiss Tissue Level Dental Implant's machined neck (cuff height) length is 2.65 mm while reference predicate Tissue Level Dental Implant's machined neck length is 1.8 and 2.8 mm respectively Narrow Neck CrossFit and both Regular Neck and Wide Neck. Minimum/maximum implant lengths for the Implantswiss Dental Implant System are 8 mm - 14 mm versus 6mm - 16mm for the reference predicate.

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| | Subject Device | Reference Predicate Device |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NOVODENT SA | AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. |
| Trade Name | Implantswiss Dental Implant System | Implance Dental Implant System |
| 510(k) No. | K181266 | K160221 |
| Indication | Implantswiss Dental Implant System is<br>indicated to use for surgical placement in<br>the upper and lower jaw arches, to<br>provide a root form means for single and<br>multiple units' prosthetic appliance<br>attachment to restore a patient's chewing<br>function. Implantswiss Dental Implant<br>can be placed with a conventional two<br>stage surgical process with an option for<br>transmucosal healing or they can be<br>placed in a single stage surgical process<br>for immediate loading. Immediate<br>loading is restricted to the anterior<br>mandible based on four splinted-<br>interforminal placed implants.<br>Implantswiss Dental Abutment System is<br>used with a dental implant to provide<br>support to prosthetic restorations such as<br>crown, bridge and overdentures in<br>partially or fully edentulous patients.<br>Octa and Multi-Unit Abutment models<br>that contain an abutment post height less<br>than 4 mm are indicated only for multi-<br>unit loading, such as a bridge or<br>overdenture | Implance Dental Implant System is indicated<br>to use for surgical placement in the upper and<br>lower jaw arches, to provide a root form<br>means for single and multiple units' prosthetic<br>appliance attachment to restore a patient's<br>chewing function.<br>Implance Dental Implant can be placed with<br>a conventional two stage surgical process<br>with an option for transmucosal healing or<br>they can be placed in a single stage surgical<br>process for immediate loading. Immediate<br>loading is restricted to the anterior mandible<br>based on four splinted-interforminal placed<br>implants.<br>Implance Dental Abutment System is used<br>with a dental implant to provide support to<br>prosthetic restorations such as crown, bridge<br>and overdentures in partially or fully<br>edentulous patients. Octa Abutment models<br>that contain an abutment post height less<br>than 4 mm are indicated only for multi-unit<br>loading, such as a bridge or overdenture. |
| Material | Bone Level: Titanium Ti6Al4V ELI<br>ASTM F-136<br>Tissue Level: Commercially Pure<br>Titanium Grade 4 ASTM F-67<br>Screw: Titanium Ti6Al4V ELI ASTM<br>F136 | Bone Level: Titanium Ti6Al4V ASTM F-<br>136<br>Tissue Level: Titanium Grade 4 ASTM F-67<br>Screw: Titanium Ti6Al4V ASTM F136 |
| Surface<br>Treatment | Machine Surface | Machine Surface |
| Sterile | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) |
| Couple<br>Abutment<br>Design | Image: Couple Abutment Design | Image: Couple Abutment Design |
| Couple<br>Abutment<br>Diameters<br>(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm<br>Tissue Level Implant: Ø 5.2 mm, Ø 6.4 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mm<br>Tissue Level Implant: Ø 5.2 mm, Ø 6.4 mm |
| Angled<br>Abutment<br>Design | Image: Angled Abutment Design | Image: Angled Abutment Design |
| Angled<br>Abutment<br>Diameters<br>(mm) | Bone Level Implant (15°): Ø 3.7 mm,<br>Bone Level Implant (25°): Ø 4.5 mm,<br>Tissue Level Implant (15°): Ø 3.5 mm | Bone Level Implant (15°): Ø 3.7 mm,<br>Bone Level Implant (15°, 25°): Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mm |
| Solid<br>Abutment<br>Design | Image: Solid Abutment Design | Image: Solid Abutment Design |
| Solid<br>Abutment<br>Diameters<br>(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm<br>Tissue Level Implant: Ø 3.5 mm, Ø 4.3 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mm<br>Tissue Level Implant: Ø 3.5 mm, Ø 4.3 mm |
| O-ring<br>Abutment<br>Design | Image: O-ring Abutment Design | Image: O-ring Abutment Design |
| Diameters<br>(mm) | Bone Level Implant: Ø 2.9 mm, Ø 4.5 mm, | Bone Level Implant: Ø 2.9 mm, Ø 3.42 mm, Ø 3.5 mm, Ø 4.5 mm,<br>Tissue Level Implant: Ø 3.5 mm |
| Multi<br>Abutment<br>Design | Image: Multi Abutment Design | Image: Multi Abutment Design |
| Diameters<br>(mm) | Bone Level Implant: Ø 3.7 mm, Ø 4.5mm<br>Tissue Level Implant: Ø 5.2 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm<br>Tissue Level Implant: Ø 5.2 mm |
| Octa<br>Abutment<br>Design | Image: Octa Abutment Design | Image: Octa Abutment Design |
| Diameters<br>(mm) | Bone Level Implant: Ø 4.8 mm<br>Tissue Level Implant: Ø 3.5 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm,<br>Ø 5.5 mm, Ø 6.5 mm<br>Tissue Level Implant: Ø 3.7 mm, Ø 6.4 mm |
| Syoncta<br>Abutment<br>Design | Image: Syoncta Abutment Design | Image: Syoncta Abutment Design |
| Diameters<br>(mm) | Tissue Level Implant: Ø 3.5 mm…