VARIOECO

K121334 · Thommen Medical AG · NHA · Aug 14, 2012 · Dental

Device Facts

• Record ID: K121334
• Device Name: VARIOECO
• Applicant: Thommen Medical AG
• Product Code: NHA · Dental
• Decision Date: Aug 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Thommen VARIOeco dental implant 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.

Device Story

VARIOeco is a titanium dental implant abutment system used to support crowns, bridges, and overdentures in the maxillary or mandibular arch. The device is used in a clinical dental setting by a dentist or dental specialist. It consists of a titanium abutment, a laboratory burn-out cap (POM), and an abutment screw. The abutment is attached to a Thommen System dental implant; the burn-out cap is used during the fabrication of porcelain-fused-to-metal (PFM) restorations. The output is a stable, implant-supported prosthetic restoration. By providing a secure interface between the dental implant and the final restoration, the device enables functional tooth replacement, improving patient masticatory function and aesthetics.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Materials: CPTi Grade 4 (abutment), POM (burn-out sleeve). Design: Titanium abutment with burn-out cap and screw. Dimensions: 3.5, 4.0, 4.5, 5.0, 6.0 mm platform diameters. Interface: Compatible with Thommen System dental implants (ELEMENT, CONTACT, ONETIME). Sterilization: Standard methods consistent with predicates.

Indications for Use

Indicated for patients requiring support for crowns, bridges, or 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

• SPI® EASY 4.0 Abutment (K071453)
• SPI® Dental Implant Abutments (K031747)
• CAMLOG® Vario SR Abutments (K103252)

Submission Summary (Full Text)

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AUG

1 4 2012

# 510(k) Summary

## Thommen Medical AG

# K121334

# VARIOeco

June 27, 2012

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland [phone] Telephone: Fax: [phone]

Official Contact:

Representative/Consultant:

Holger Jakob, Head of Quality Management/Regulatory Affairs

Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] [phone] Fax: [e-mail] Email: [e-mail]

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: VARIOeco 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 Dental Devices Branch Reviewing Branch:

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### INTENDED USE

Thommen VARIOeco dental implant 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.

### DEVICE DESCRIPTION

V ARIOeco abutments are titanium dental implant abutments for use with Thommen System dental implants for fabrication of porcelain-fused-to-metal (PFM) restorations. VARIOeco includes two abutment designs, one for single tooth (crown) and one for multi-tooth (bridge) restorations. A laboratory burn-out cap and abutment screw are provided together with the abutment in the VARIOeco set. Both VARIOeco abutment designs are provided in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to Thommen System dental implants (ELEMENT, CONTACT and ONETIME).

## EQUIVALENCE TO MARKETED DEVICE

Thommen Medical AG has submitted information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices. VARIOeco is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Thommen Medical AG. SPI® EASY 4.0 Abutment - K071453. Thommen Medical AG, SPI® Dental Implant Abutments - K031747, Altatec GmbH, CAMLOG® Vario SR Abutments - K103252,

The subject VARIOeco abutment and predicates straight SPI EASY Abutment and straight VarioSR Abutment are all titanium abutments with a burn-out plastic sleeve for restoration fabrication.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. They encompass the same range of physical dimensions, including platform diameter, abutment height and abutment/implant interface. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

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| | Subject Device | Predicate Devices | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Thommen Medical AG<br>VARIOeco | Thommen Medical AG<br>SPI® EASY 4.0<br>Abutment<br>K071453 | Thommen Medical AG<br>SPI® Dental Implant<br>Abutments<br>K031747 | Altatec GmbH<br>CAMLOG® Vario SR<br>Abutments<br>K103252 |
| Indications<br>for Use | Thommen VARIOeco<br>dental implant<br>abutments are intended<br>to be used in<br>conjunction with<br>Thommen System<br>dental implants in the<br>maxillary and/or<br>mandibular arch to<br>provide support for<br>crowns, bridges and<br>overdentures. | The Thommen SPI®<br>EASY Ø 4.0 Abutment<br>is intended to be used in<br>conjunction with SPI®<br>System dental implants<br>in the maxillary and/or<br>mandibular arch to<br>provide support for<br>crowns, bridges or.<br>overdentures. | Thommen SPI® Dental<br>Implant Abutments are<br>intended to be used in<br>conjunction with SPI®<br>System dental implants<br>in the maxillary and/or<br>mandibular arch to<br>provide support for<br>crowns, bridges or<br>overdentures. | CAMLOG® Vario SR<br>components for crown and<br>bridge restorations:<br>Occlusal screw-retained<br>crown, bridge and bar<br>constructions on<br>CAMLOG® implants (with<br>J and K article numbers) in<br>the anterior and posterior<br>region of the maxilla and<br>mandible<br>CAMLOG® Vario SR<br>components for bar<br>restorations:<br>- Anchorage of implant-<br>supported full dentures for<br>the edentulous maxilla and<br>mandible in combination<br>with 2, 4 or more<br>CAMLOG® implants (with<br>J and K article numbers) |
| Restoration | Single or multi-unit | Single or multi-unit | Single or multi-unit | Single or multi-unit |
| Abutment<br>(Ø mm) | 3.5, 4.0, 4.5, 5.0, 6.0 | 4.0 | 3.5, 4.5, 5.0, 6.0 | 3.8, 4.3, 5.0, 6.0 |
| Material | CPTi Gr 4 - abutment<br>POM - Burn-out sleeve | CPTi Gr 4 - abutment<br>POM - Burn-out sleeve | CPTi Gr 4 - abutment<br>POM - Burn-out sleeve | CPTi Gr 4 - abutment<br>Ti-6Al-4V - abutment<br>POM - Burn-out sleeve |

Overall, VARIOeco has the following similarities to the predicate devices:

- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.

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

AUG 1 4 2012

THOMMEN Medical, AG C/O Ms. Linda K. Schulz PaxMed International, Limited Liability Company 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K121334

Trade/Device Name: VARIOeco Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 27, 2012 Received: June 28, 2012

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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#### Page 2- Ms. Schulz

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h For

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary

# Indications for Use

510(k) Number:

×121334

Device Name: VARIOeco

Indications for Use:

Thommen VARIOeco dental implant 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Runner

(Division Sign-Off) Division of Anesthesiology; General Hospital Infection Control, Dental Devices

510(k) Number: k121334