Thommen Implant System

K171795 · Thommen Medical AG · DZE · Sep 29, 2017 · Dental

Device Facts

• Record ID: K171795
• Device Name: Thommen Implant System
• Applicant: Thommen Medical AG
• Product Code: DZE · Dental
• Decision Date: Sep 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Implant: The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw. VARIOunite PF 3.0: Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth). Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture. VARIOunite: Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

Device Story

Thommen Implant System consists of endosseous dental implants (ELEMENT PF 3.0) and associated abutments (VARIOunite). Implants are self-tapping, root-form, made of commercially pure titanium, available in various lengths. Used by dental surgeons in one-stage or two-stage procedures to replace missing teeth. Abutments support provisional/final crowns, bridges, or overdentures. Digitally designed abutments are manufactured at Thommen-validated milling centers. System restores chewing function by providing stable anchorage for prosthetic restorations. Clinical benefit is the replacement of missing teeth in the anterior maxilla and mandible.

Clinical Evidence

Bench testing only. Includes radiation and steam sterilization validation (ISO 11137, ISO 17665), biocompatibility (ISO 10993-1), LAL endotoxin testing, shelf-life/packaging integrity (ASTM F88, F1886, F1929, F3039, ISO 11607), and mechanical fatigue testing (ISO 14801). No clinical data included.

Technological Characteristics

Materials: Commercially pure (CP) titanium (implant), titanium alloy (abutment/screw). Design: Internal connection, self-tapping root-form. Dimensions: 3.0 mm diameter; 8.0-14.0 mm lengths. Abutments: Straight or angled (up to 20°). Sterilization: Radiation or steam. Connectivity: Compatible with CAD/CAM digital workflows via validated milling centers.

Indications for Use

Indicated for patients requiring dental implants to restore chewing function via single or multi-unit prostheses (crowns, bridges, overdentures). ELEMENT PF 3.0 is limited to replacement of upper lateral incisors and lower central/lateral incisors. VARIOunite PF 3.0 is limited to anterior maxilla and mandible. Contraindications include lack of primary stability or insufficient occlusal loading conditions.

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

• SPI® Dental Implant ELEMENT (K093615)

Reference Devices

• VARIOunite (K160244)
• SPI® Titanium Base for CAD/CAM (K102804)
• Milling Abutment for CAD/CAM (K151984)
• VARIOeco (K121334)
• OsseoSpeed™ Plus (K120414)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in a simple, black-and-white design, and the text is in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Thommen Medical AG % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

September 29, 2017

Re: K171795

Trade/Device Name: Thommen Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 31, 2017 Received: September 1, 2017

Dear Linda Schulz:

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. Runner -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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# Indications for Use

510(k) Number (if known)

K171795

Device Name

Thommen Implant System

Indications for Use (Describe)

#### Implant:

The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.

#### VARIOunite PF 3.0:

Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).

Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

## VARIOunite:

Thommen Medical VARIQunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

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

| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------|
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### 510(k) Summary

#### Thommen Medical AG

#### Thommen Implant System K171795

September 29, 2017

[e-mail]

#### ADMINISTRATIVEINFORMATION

| Manufacturer Name | Thommen Medical AG<br>Neckarsulmstrasse 28<br>2540 Grenchen, Solothurn, Switzerland<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Daniel Snetivy, PhD<br>Chief Technology Officer |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH<br>Kevin A. Thomas, PhD<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

#### DEVICE NAME AND CLASSIFICATION

| Thommen Implant System |
|------------------------------------|
| Dental implant |
| Dental implant abutment |
| Implant, endosseous, root form |
| Endosseous dental implant abutment |
| 21 CFR 872.3640, Class II |
| DZE, NHA |
| Dental Products Panel |
| Dental Devices Branch |
| |

#### PREDICATE DEVICE INFORMATION

Primary Predicate K093615, SP1® Dental Implant ELEMENT, Thommen Medical AG

Reference Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM, Thommen Medical AG K121334, VARIOeco, Thommen Medical AG K120414, OsseoSpeed™ Plus, Astra Tech AB

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## INDICATIONS FOR USE

## Implant:

The ELEMENT PF 3.0 is suitable for use in one-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw.

## VARIOunite PF 3.0:

Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).

Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

## VARIOunite:

Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.

Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

## DEVICE DESCRIPTION

ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.

## PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: radiation sterilization validation to an SAL of 10to according to ISO 11137-1, ISO 11137-2; Steam sterilization validation to an SAL of 106 according to ISO 17665-1 and ISO 17665-2; biocompatibility evaluation according to ISO 10993-1 by reference to K093615, K160244, K102804 and K121334; Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance documents Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; shelf life testing for detecting seal leaks according to ASTM F88/F88M, seal strength testing according to ASTM F1886/1886M, seal integrity testing according to ASTM F1929, dye penetration testing according to ASTM F3039, testing for packaging of terminally sterilized medical devices according to ISO 11607-1, and ISO 11607-2, and mechanical testing according to ISO 14801 to ensure that the subject device is strong enough for its intended use.

No clinical data were included in this submission.

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## EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.

| | Indications for Use Statement |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | |
| Thommen Implant<br>System<br>Thommen Medical<br>AG | Implant:<br>The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function.<br>The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth;<br>prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for<br>replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw.<br>VARIOunite PF 3.0:<br>Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for<br>fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior<br>teeth).<br>Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated<br>milling center for manufacture.<br>VARIOunite:<br>Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental<br>implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.<br>Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated<br>milling center for manufacture. |
| Primary Predicate | |
| K093615<br>SPI® Dental Implant<br>ELEMENT<br>Thommen Medical<br>AG | SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is<br>intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary<br>stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may<br>be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.<br>Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in<br>areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending<br>movements.<br>Restoration of posterior teeth in the upper and lower jaw Single-tooth restoration of canines and central incisors in the upper jaw Any application involving retentive anchors |
| Reference<br>Predicates | |
| K160244<br>VARIOunite<br>Thommen Medical<br>AG | VARIOflex: Thommen Medical VARIOflex abutments are intended to be used in conjunction with Thommen System<br>dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. |
| K102804<br>SPI® Titanium Base<br>for CAD/CAM<br>Thommen Medical<br>AG | VARIOtemp: Thommen Medical VARIOtemp abutments are intended to be used in conjunction with Thommen System<br>dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. |
| K151984<br>Milling Abutment for<br>CAD/CAM<br>Thommen Medical<br>AG | Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and<br>the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges. |
| K121334<br>VARIOeco<br>Thommen Medical<br>AG | Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental<br>implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures.<br>All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a<br>Thommen validated milling center for manufacture. |
| | Thommen VARIOeco dental implant abutments are intended to be used in conjunction with Thommen System dental<br>implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. |

| Comparison of Indications for Use Statements | |
|----------------------------------------------|--|
|----------------------------------------------|--|

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| | Indications for Use Statement |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 120414<br>OsseoSpeed™ Plus<br>Astra Tech AB | Implants:<br>The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations<br>and with the following clinical protocols:<br>replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeedTM Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.<br>Abutments: |
| | Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.<br>Atlantis Abutments: |
| | The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous; patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.<br>The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous; patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. |

# Comparison of Technological Characteristics

| | Subject<br>Device | Primary<br>Predicate<br>Device | Reference Predicate Devices | | | | | |
|----------------------------------|------------------------------------|----------------------------------------------|-----------------------------|----------------------------------------------------|-----------------------------------------------|----------------------------|------------------------------------|--|
| | Thommen<br>Implant<br>System | K093615<br>SPI® Dental<br>Implant<br>ELEMENT | K160244<br>VARIOunite | K102804<br>SPI®<br>Titanium<br>Base for<br>CAD/CAM | K151984<br>Milling<br>Abutment for<br>CAD/CAM | K121334<br>VARIOeco | K120414<br>OsseoSpeed™<br>Plus | |
| | Thommen<br>Medical AG | Thommen<br>Medical AG | Thommen<br>Medical AG | Thommen<br>Medical AG | Thommen<br>Medical AG | Thommen<br>Medical AG | Astra Tech<br>AB | |
| Design | | | | | | | | |
| Implant Body<br>Diameter<br>(mm) | 3.0 | 3.5, 4.0, 4.5,<br>5.0, 6.0 | NA | NA | NA | NA | 3.0, 3.6, 4.2,<br>4.8, 5.4 | |
| Implant<br>Length (mm) | 8, 9.5, 11,<br>12.5, 14 | 6.5, 8.0, 9.5,<br>11, 12.5 | NA | NA | NA | NA | 6.0, 8.0, 9.0,<br>11, 13, 15, 17 | |
| Abutment<br>Diameter<br>(mm) | 3.0, 3.5, 4.0,<br>4.5, 5.0, 6.0 | 6.0 | 3.5, 4.0, 4.5,<br>5.0, 6.0 | 3.5, 4.0, 4.5,<br>5.0, 6.0 | 3.5, 4.0, 4.5,<br>5.0, 6.0 | 3.5, 4.0, 4.5,<br>5.0, 6.0 | 3.0, 3.6, 4.2,<br>4.8, 5.4 | |
| Abutment<br>Design | Straight or<br>Angled<br>(max 20°) | Straight | Straight | Straight or<br>Angled<br>(max 20°) | Straight or<br>Angled<br>(max 20°) | Straight | Straight or<br>Angled<br>(max 30°) | |
| Restoration | Single or<br>multi-unit | Single or<br>multi-unit | Single or<br>multi-unit | Single or<br>multi-unit | Single or<br>multi-unit | Single or<br>multi-unit | Single or<br>multi-unit | |
| Implant<br>Connection | Internal | Internal | Internal | Internal | Internal | Internal | Internal | |
| Material | | | | | | | | |
| Implant | CP Titanium | CP Titanium | NA | NA | NA | NA | CP Titanium | |

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| | Subject<br>Device | Primary<br>Predicate<br>Device | Reference Predicate Devices | | | | |
|----------|-----------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------|
| | Thommen<br>Implant<br>System<br><br>Thommen<br>Medical AG | K093615<br>SPI® Dental<br>Implant<br>ELEMENT<br><br>Thommen<br>Medical AG | K160244<br>VARIOunite<br><br>Thommen<br>Medical AG | K102804<br>SPI®<br>Titanium<br>Base for<br>CAD/CAM<br><br>Thommen<br>Medical AG | K151984<br>Milling<br>Abutment for<br>CAD/CAM<br><br>Thommen<br>Medical AG | K121334<br>VARIOeco<br><br>Thommen<br>Medical AG | K120414<br>OsseoSpeed™<br>Plus<br><br>Astra Tech<br>AB |
| Abutment | CP Titanium<br>Titanium<br>Alloy | CP Titanium | CP Titanium | CPTitanium | CPTitanium | CP Titanium | Titanium<br>Alloy<br>Zirconia,<br>Gold, PEEK |
| Screw | Titanium<br>Alloy | Titanium<br>Alloy | Titanium<br>Alloy | Titanium<br>Alloy | Titanium<br>Alloy | Titanium<br>Alloy | Titanium<br>Alloy |

Subject device implants and healing caps are substantially equivalent to K093615 implants and healing caps in body and cover design, connection design, material, surface, and intended use. The subject device ELEMENT Ø 3.0 mm implant is 0.5 mm narrower than the predicate ELEMENT Ø 3.5 mm implant. The hex interface remains the same. The ELEMENT Ø 3.0 mm implant is substantially equivalent to the OsseoSpeed™ Plus Ø 3.0 mm implant (K120414) in diameter, length, and intended use.

Subject device VARIOunite and Gingiva Former abutments are substantially equivalent to K160224 and K120414 abutments in material, design and function. The expanded indication for VARIOunite to be used as a TiBase with CAD/CAM zirconia superstructure is substantially equivalent to that of SP1® Titanium Base for CAD/CAM (K102804) using the same materials and processes. The subject device is substantially equivalent to K151984 in that all digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

Small differences in language in the Indications for Use Statements among the subject device, the predicate devices do not change the intended use. All are implant systems placed in the maxilla or mandible to support single or multi-unit prostheses and restore chewing function.

## CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and angle of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.