Implantswiss Dental Implant System and Implantswiss Dental Abutment System

K200867 · Novodent SA · DZE · Apr 28, 2020 · Dental

Device Facts

• Record ID: K200867
• Device Name: Implantswiss Dental Implant System and Implantswiss Dental Abutment System
• Applicant: Novodent SA
• Product Code: DZE · Dental
• Decision Date: Apr 28, 2020
• Decision: SESE
• Submission Type: Special
• 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 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. All digitally designed Premill abutments for use with the Implantswitt Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.

Device Story

System comprises titanium/titanium alloy endosseous dental implants and abutments; used to support prosthetic restorations (crowns, bridges, overdentures). Implants placed in jaw arches via surgical procedure (single or two-stage); provide root-form base for prosthetic attachment. Abutments link implants to prosthetics. Premill abutments require CAD/CAM design and manufacture at validated milling center. Used by dental clinicians in clinical settings. Output is stable mechanical foundation for dental prostheses; benefits patient by restoring chewing function and oral aesthetics.

Clinical Evidence

Bench testing only. Fatigue testing performed per ISO 14801 on worst-case bone level implant/abutment assemblies. Biocompatibility leveraged from predicate per ISO 10993. Sterilization validated per ISO 11137-1/11737-2 (implants) and ISO 17665-1/17665-2 (abutments). Packaging integrity verified via ASTM F1886, ASTM F1929-15, and BS EN 868-5:2009.

Technological Characteristics

Materials: Commercially Pure Titanium Grade 4 (ASTM F-67) and Titanium Ti6Al4V ELI (ASTM F-136). Surface: Sandblasted Rough Acid-etched (SRA). Design: Threaded root-form bone level implants; Morse taper internal hex/octagonal interface. Sterilization: Gamma (implants), steam (abutments). Connectivity: None (mechanical).

Indications for Use

Indicated for surgical placement in upper/lower jaw arches to provide root-form attachment for single/multiple prosthetic units to restore chewing function in partially or fully edentulous patients. Immediate loading restricted to anterior mandible using four splinted-interforminal implants. Abutments with <4mm post height restricted to multi-unit loading (bridge/overdenture).

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

• Implantswiss Dental Implant System and Implantswiss Dental Abutment System (K181266)

Reference Devices

• Implance Dental Implant System (K160221)
• Multi-unit Abutment Plus (K161416)
• LOCATOR RTx (K150295)
• DIO CAD/CAM Abutment (K181037)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 28, 2020

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

Re: K200867

Trade/Device Name: Implantswiss Dental Implant System and Implantswiss Dental Abutment System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 31, 2020 Received: April 1, 2020

Dear H. Oktay:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200867

#### Device Name

Implantswiss Dental Implant System and 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 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. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summarv

(as required by 21 CFR 807.92)

# Implantswiss Dental Implant System Implantswiss Dental Abutment System

510(k) K200867

#### 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: 28 April 2020

#### DEVICE

| Proprietary name | Implantswiss Dental Implant System<br>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: | K181266 - Implantswiss Dental Implant System<br>Implantswiss Dental Abutment System |
| Reference Devices: | K160221 - Implance Dental Implant System<br>Implance Dental Abutment System<br>K161416 - Multi-unit Abutment Plus<br>K150295 - LOCATOR RTx<br>K181037 - DIO CAD/CAM Abutment |

#### Device Description

The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments.

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

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submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices.

The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex).

The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function.

The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters 0 5.5 mm. 0 6.5 mm. 0 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm.

Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm.

Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm.

Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm.

Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm.

Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm.

Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm.

Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm.

Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.

#### 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

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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. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.

#### Substantial Equivalence Comparison

The additional models of the Implantswiss Dental Implant System are equivalent to the primary predicate implants cleared in K181266.

The additional models of the Implantswiss Dental Abutment System are comparable to the predicate and reference devices cleared in K181266, K160221, K150295, K161416, and K181037.

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| | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject | Predicate |
| 510k # | This submission | K181266 |
| Manufacturer | Novodent SA | Novodent SA |
| Indication | Implantswiss Dental Implant System is indicated to use for surgical<br>placement in the upper and lower jaw arches, to provide a root form<br>means for single and multiple units' prosthetic appliance attachment<br>to restore a patient's chewing function. Implantswiss Dental Implant<br>can be placed with a conventional two stage surgical process with an<br>option for transmucosal healing or they can be placed in a single<br>stage surgical process for immediate loading. Immediate loading is<br>restricted to the anterior mandible based on four splinted-<br>interforminal placed implants.<br>Implantswiss Dental Abutment System is used with a dental implant<br>to provide support to prosthetic restorations such as crown, bridge<br>and overdentures in partially or fully edentulous patients. Octa and<br>Multi-Unit Abutment models that contain an abutment post height<br>less than 4 mm are indicated only for multi-unit loading, such as a<br>bridge or overdenture. All digitally designed Premill abutments for<br>use with the Implantswiss Dental Abutment System are intended to<br>be sent to a Novodent validated milling center for manufacture. | Implantswiss Dental Implant System is indicated to use for surgical<br>placement in the upper and lower jaw arches, to provide a root form<br>means for single and multiple units' prosthetic appliance attachment<br>to restore a patient's chewing function. Implantswiss Dental Implant<br>can be placed with a conventional two stage surgical process with an<br>option for transmucosal healing or they can be placed in a single<br>stage surgical process for immediate loading. Immediate loading is<br>restricted to the anterior mandible based on four splinted-<br>interforminal placed implants.<br>Implantswiss Dental Abutment System is used with a dental implant<br>to provide support to prosthetic restorations such as crown, bridge<br>and overdentures in partially or fully edentulous patients. Octa and<br>Multi-Unit Abutment models that contain an abutment post height<br>less than 4 mm are indicated only for multi-unit loading, such as a<br>bridge or overdenture. |
| Design | Threaded root-form bone level implants with hybrid designs and<br>Morse taper internal hexagon or internal octagonal abutment interface | Threaded root-form bone or tissue level implant with hybrid and<br>straight designs and Morse taper internal hexagon or internal<br>octagonal abutment interface. |
| Implant<br>Sizes<br>Bone Level | 3.3x8, 3.3x10, 3.3x12, 3.3x14<br>3.7x8, 3.7x10, 3.7x12, 3.7x14 | 3.3x8, 3.3x10, 3.3x12, 3.3x14<br>3.7x8, 3.7x10, 3.7x12, 3.7x14<br>4.3x8, 4.3x10, 4.3x12, 4.3x14<br>4.8x8, 4.8x10, 4.8x12, 4.8x14<br>5.5x8, 5.5x10, 5.5x12 |
| Implant<br>Sizes<br>Tissue Level | Not applicable | 3.7x8, 3.7x10, 3.7x12, 3.7x14<br>4.3x8, 4.3x10, 4.3x12, 4.3x14<br>4.8x8, 4.8x10, 4.8x12, 4.8x14<br>5.5x8, 5.5x10, 5.5x12 |
| | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System |
| | Subject | Predicate |
| 510k # | This submission | K181266 |
| Materials | Commercially Pure Titanium Grade 4 | Commercially Pure Titanium Grade 4: Ø4.3, 4.8, 5.5 BL, all TL<br>Titanium Ti6Al4V ELI: Ø3.3, 3.7 BL implants |
| Surface<br>treatment | | Sandblasted Rough Acid-etched (SRA) surface |
| Sterilization | | Gamma |
| Standards for<br>Titanium | ASTM F-67 | ASTM F-67 &<br>ASTM F-136 |

## Implantswiss Dental Implant System and Implantswiss Dental Abutment System Substantial Equivalence

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### Implantswiss Dental Implant System Substantial Equivalence Comparison

The additional models of the Implantswiss Dental Implants are the same or similar to the primary predicate Implantswiss Dental Implant System (K181266) with respect to indication for use, design, size and dimensions and material composition.

- . The new implant models have the same intended use. The only difference for the subject and primary predicate Indications for Use is in reference to milling a new abutment type and this difference is acceptable as discussed in the applicable abutment section
- The new implant models in the Implantswiss Dental Implant System have the same maximum implant diameter. Bench testing on the worst-case dental implant of the subject devices found acceptable fatigue resistance properties. The primary predicate fating addresses the worstcase assembly of subject devices.
- . The minimum/maximum implant lengths for the additional models of the Implantswiss Dental Implant System are 8 mm - 14 mm, the same as for the predicate.
- The additional models, diameter 3.3 mm 3.7 mm and length 8 -14 mm implant, have the same . surface treatment as the predicate device Implantswiss Dental Implant System and Implantswiss Dental Abutment System (K181266) in the surface treatment.
- . The additional implant models in the Implantswiss Dental Implant System are all bone level implants, whereas the original had both bone level and tissue level designs.
- . The additional models are manufactured from Commercially Pure Titanium Grade 4, whereas the predicate models were available in both pure titanium and titanium alloy.

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# Implantswiss Dental Abutment System Substantial Equivalence Comparison

| | Subject Device | Predicate Device | Reference Device |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implance Dental Implant<br>Implance Dental Abutment System |
| Manufacturer | NOVODENT SA | NOVODENT SA | AGS Medikal İth. İhr. Tic. Ltd. Şti. |
| 510(k) No. | This submission | K181266 | K160221 |
| Material | Bone Level: Titanium Ti6A14V ASTM F-136<br>Tissue Level: Titanium Grade 4 ASTM F-67<br>Screw: Titanium Ti6Al4V ELI ASTM F136 | Bone Level: Titanium Ti6A14V ASTM F-136<br>Tissue Level: Titanium Grade 4 ASTM F-67<br>Screw: Titanium Ti6Al4V ELI ASTM F136 | Bone Level: Titanium Ti6Al4V ELI ASTM<br>F-136<br>Tissue Level: Commercially Pure Titanium<br>Grade 4 ASTM F-67<br>Screw: Titanium Ti6Al4V ELI ASTM<br>F136 |
| Surface Treatment | Machine Surface | Machine Surface | Machine Surface |
| Sterile | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) |
| Couple Abutment<br>Design | Image: Couple Abutment Design | Image: Couple Abutment Design | Image: Couple Abutment Design |
| Couple Abutment<br>Diameters<br>(mm) | Bone Level Implant: Ø 5.5 mm, Ø 6.5 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm<br>Tissue Level Implant: Ø 5.2 mm, Ø 6.4<br>mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5<br>mm, Ø 5.5 mm, Ø 6.5 mm<br>Tissue Level Implant: Ø 5.2 mm, Ø 6.4<br>mm |
| | Angled Abutment<br>Design | Image: Angled Abutment Design | Image: Angled Abutment Design |
| Angled Abutment<br>Diameters<br>(mm) | Bone Level Implant (15°, 25°): Ø 5.5 mm,<br>Ø 6.5 mm<br>Tissue Level Implant (25°): Ø 3.5 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,<br>Ø 5.5 mm, Ø 6.5 mm<br>Tissue Level Implant (25°): Ø 3.5 mm |
| | Subject Device | Predicate Device | Reference Device |
| Trade Name | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implance Dental Implant<br>Implance Dental Abutment System |
| Manufacturer | NOVODENT SA | NOVODENT SA | AGS Medikal İth. İhr. Tic. Ltd. Şti. |
| Solid Abutment Design | Image: Solid Abutment Design Subject Device | Image: Solid Abutment Design Predicate Device | Image: Solid Abutment Design Reference Device |
| Solid Abutment Diameters (mm) | Bone Level Implant: Ø 5.5 mm, Ø 6.5 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 Abutment Design | Image: O-ring Abutment Design Subject Device | Image: O-ring Abutment Design Predicate Device | Image: O-ring Abutment Design Reference Device |
| O-ring Abutment Diameters (mm) | Bone Level Implant: Ø 3.42 mm, Ø 3.7 mm<br>Tissue Level Implant: Ø 3.5 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 Abutment Design | Image: Multi Abutment Design Subject Device | Image: Multi Abutment Design Predicate Device | Image: Multi Abutment Design Reference Device |
| Multi Abutment Diameters (mm) | Bone Level Implant: Ø 5.5 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 |
| | Subject Device | Predicate Device | Reference Device |
| Trade Name | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implantswiss Dental Implant System,<br>Implantswiss Dental Abutment System | Implance Dental Implant<br>Implance Dental Abutment System |
| Manufacturer | NOVODENT SA | NOVODENT SA | AGS Medikal İth. İhr. Tic. Ltd. Şti. |
| Healing Abutment<br>Design | Image: Healing Abutment Design Subject Device | Image: Healing Abutment Design Predicate Device | Image: Healing Abutment Design Reference Device |
| Healing Abutment<br>Diameters<br>(mm) | Bone Level Implant: Ø 5.5 mm, Ø 6.5 mm<br>Tissue Level Implant: Ø 6.4 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm<br>Tissue Level Implant: Ø 5.2 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 3.7 mm, Ø 6.4 mm |
| Brief Comparison | The additional models of the subject device have the same basic design with additional diameters as compared to the predicate device<br>(K181266). Additional dimensional features not addressed by the primary predicate are addressed by the reference device, K160221,<br>by identical dimensions or a range which encompasses the subject dimensions. | | |

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| | Subject Device | Predicate Device | Reference Device |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Trade Name | Implantswiss Dental Implant<br>System<br>Implantswiss Dental<br>Abutment System | Implantswiss Dental Implant<br>System<br>Implantswiss Dental<br>Abutment System | LOCATOR RTx |
| Manufacturer | NOVODENT SA | NOVODENT SA | Zest Anchors, LLC |
| 510(k) No. | This submission | K181266 | K150295 |
| Material | Abutments- Titanium Ti6Al4V ELI ASTM F-136 | Abutments- Titanium Ti6Al4V ELI ASTM F-136 | Titanium |
| Sterile | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) |
| Locator<br>Abutment<br>Design | | | |
| Diameters<br>(mm) | $Ø$ 3.86 mm | $Ø$ 3.86 mm | $Ø$ 3 - 7 mm |
| Cuff Height<br>(mm) | 6mm (for 3.3 mm diameter<br>implant) | 1-2-3-4-5 mm (for 3.3<br>diameter implant)<br>1-2-3-4-5-6 mm (for 3.7 mm,<br>4.3 mm, 4.8 mm and 5.5 mm<br>diameter implant) | 1, 2, 3, 4, 5, and 6 mm (for<br>3.0 mm – 7.0 mm diameter<br>implant) |
| Brief<br>Comparison | The primary predicate and reference device Indications for Use do not include any device-<br>specific language for the Locator abutment that would need to be included in the subject<br>Indications for Use. The Implantswiss Locator abutment is same design as the predicate<br>(K181266) and proposes an additional cuff height option for the 3.3mm diameter implant<br>compatible locator abutment. The abutment gingival height and abutment post height are<br>within the range of the reference device (K150295). | | |

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| | Subject Device | Predicate Device | Reference Device |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------|
| Trade Name | Implantswiss Dental Implant System<br>Implantswiss Dental Abutment System | Implantswiss Dental Implant<br>Implantswiss Dental Abutment System | Multi-unit Abutments Plus |
| Manufacturer | NOVODENT SA | NOVODENT SA…