Thommen Milling Abutment for CAD/CAM

K151984 · Thommen Medical AG · NHA · Mar 10, 2016 · Dental

Device Facts

• Record ID: K151984
• Device Name: Thommen Milling Abutment for CAD/CAM
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Mar 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Thommen Milling abutments for CAD/CAM 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. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.

Device Story

Milling Abutment for CAD/CAM is a titanium dental abutment blank used by dental laboratories to fabricate patient-specific abutments. Clinicians prescribe the custom design; laboratories use the 3Shape CAD/CAM system to design the abutment based on patient anatomy. Designs are sent to a Thommen-validated milling center for manufacturing. The final custom abutment is then sterilized and placed by a clinician to support crowns, bridges, or overdentures on Thommen System implants. The device facilitates functional and aesthetic dental restoration by providing a patient-specific interface between the implant and the prosthetic superstructure.

Clinical Evidence

No clinical data were included in this submission. Evidence consists of bench testing: sterilization validation (ISO 17665-1/2), biocompatibility evaluation (ISO 10993-1), input/output validation for the Thommen Medical library, and static/dynamic compression-bending fatigue testing (ISO 14801).

Technological Characteristics

Titanium abutment blanks; diameters 3.5mm–6.0mm; heights 12mm–15mm; max angulation 20°; min wall thickness 0.4mm. Compatible with Thommen ELEMENT and CONTACT implants. Sterilization via moist heat. CAD/CAM design workflow.

Indications for Use

Indicated for patients requiring dental prosthetic support (crowns, bridges, overdentures) in the maxillary or mandibular arch using Thommen System dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• CORE 3D Abutment System for Digital Prosthetic Solutions (K122295)

Reference Devices

• Blue Sky Bio Dental Implant System (K073713)
• SPI Dental Implant Abutments (K031747)
• SPI Dental Implant, INICELL (K090154)
• Nobel Biocare Brånemark System (K022582, K934825)
• Zimmer Tapered Screwvent (K013227, K061410, K072589)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

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

March 10, 2016

Thommen Medical AG c/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K151984

Trade/Device Name: Milling Abutment for CAD/CAM Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 10, 2016 Received: February 11, 2016

Dear Ms. 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 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Tina Kiang S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K151984

Device Name

Milling Abutment for CAD/CAM

Indications for Use (Describe)

Thommen Milling abutments for CAD/CAM 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.

All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

## Thommen Medical AG

# Milling Abutment for CAD/CAM K151984

March 7, 2016

#### ADMINISTRATIVE INFORMATION

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

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Milling Abutment for CAD/CAM |
|----------------------------|------------------------------------|
| Common Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Classification Regulation: | 21 CFR 872.3630, Class II |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |

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#### INDICATIONS FOR USE

Thommen Milling abutments for CAD/CAM 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.

All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.

| K122295 | CORE 3D Abutment System for<br>Digital Prosthetic Solutions | CORE 3D Protech, S.L. | Primary Predicate |
|------------------------------------------|-------------------------------------------------------------|-----------------------|-------------------|
| K073713 | Blue Sky Bio Dental Implant | Blue Sky Bio, LLC | Reference |
| | System | | Predicate |
| K031747<br>SPI® Dental Implant Abutments | | Thommen Medical, AG | Reference |
| | | | Predicate |
| K090154 | SPI® Dental Implant, INICELL® | Thommen Medical, AG | Reference |
| | | | Predicate |

### PREDICATE INFORMATION

#### DEVICE DESCRIPTION

The Milling Abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM System to fabricate a customized abutment made of titanium. Each patient-specific abutment is individually prescribed by the clinician. Minimum wall thickness allowed for the final abutment is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height of the abutment is no greater than 15 mm and no shorter than 4.5 mm. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. Final abutments are to be sterilized prior to intraoral placement.

Milling Abutment for CAD/CAM is available in five diameters (3,5 mm, 4,0 mm, 5,0 mm, 6,0 mm) and two heights (12 mm and 15 mm). The Ø3.5 mm abutment is provided in the 12 mm height. All other diameters are provided in the 15 mm height. Each abutment is supplied with a corresponding screw. Milling Abutment for CAD/CAM is compatible with the Thommen Implant System ELEMENT and CONTACT implants.

#### PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included the following: sterilization according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products – Moist heat - Part 2: Guidance on the application of ISO 17665-1; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process which determined that no further biocompatibility testing is required because all

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510(k) Summary Page 3 of 4

materials and processing are identical to the abutments cleared in K031747: Input/output validation for the Thommen Medical library performed to ensure accuracy and conformance to the parameters outlined for the Thommen Milling Abutment for CAD/CAM. Validation confirmed that accuracy was consistent and parameter limits were maintained in final device manufacturing. Static and dynamic compression -bending testing were performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.

No clinical data were included in this submission.

#### EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles predicate devices shown above. Below are summary tables showing technical comparison between the subject device and the primary predicate devices.

| Subject Device | Primary Predicate Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thommen Medical AG | CORE 3D Protech, S.L. |
| Milling Abutment for<br>CAD/CAM | Core 3D Abutment System for Digital Prosthetic Solutions |
| K151984 | K122295 |
| Indications for use | |
| Thommen Milling abutments for<br>CAD/CAM are intended to be<br>used in conjunction with | The CORE 3D abutment system for digital prosthetic solutions are dental abutments<br>placed into a dental implant to provide support for dental prosthetic restorations. The<br>abutments include: |
| Thommen System dental<br>implants in the maxillary and /or<br>mandibular arch to provide<br>support for crowns, bridges and<br>overdentures. | • Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM<br>designed superstructure may be fitted to complete a two-piece dental abutment;<br>• Titanium Abutment Blanks with a pre-machined implant connection where the upper<br>portion may be custom-milled in accordance with a patient-specific design using<br>CAD/CAM techniques |
| All digitally designed<br>abutments for use with<br>Thommen Milling abutments<br>for CAD/CAM are intended<br>to be sent to a Thommen<br>validated milling center for<br>manufacture. | • Abutment Screws to permanently fix the abutments to the underlying implant. Core 3D<br>abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges<br>and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.<br>Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D<br>allowable range of design specifications and be provided as straight abutments only.<br>Core 3D abutments and are compatible for use with the following dental Implants:<br>• Nobel Biocare Brånemark System (K022582, K934825)<br>• Zimmer Tapered Screwvent (K013227, K061410, K072589) |
| Design | |
| CAD/CAM Blank | CAD/CAM Blank,<br>Titanium Base |
| Cement-retained | Cement-retained |
| Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit |
| 3.5 - 6.0 | 3.5 - 5.7 |
| Internal Hex | Internal Hex,<br>External Hex |

The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments. Both abutments are being used in conjunction with dental implants for the purpose of supporting dental prostheses and are CAD/CAM custom abutments fabricated at a milling center.

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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 length of the implants, and diameter, gingival height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and to be sterilized using similar methods.

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