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

VARIOeco 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).

AI/ML Overview

This document is a 510(k) summary for the Thommen Medical AG VARIOeco dental implant abutment. It establishes substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a formal study with statistical endpoints. Therefore, most of the requested information regarding acceptance criteria, study sample sizes, expert involvement, and ground truth establishment is not present in this type of submission.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance acceptance criteria for the VARIOeco abutment in the way a clinical trial or performance study would. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" assessment is primarily a comparison of intended use, technological characteristics, and materials to established devices.

Feature/Characteristic	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (VARIOeco)
Intended Use	Must be the same as or very similar to predicate devices.	"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." (Same as predicates)
Operating Principle	Must be the same as predicate devices.	"uses the same operating principle" (as predicates)
Basic Design	Must be the same as predicate devices.	"incorporates the same basic design" (as predicates)
Materials	Must be the same or very similar to predicate devices.	Abutment: CPTi Gr 4; Burn-out sleeve: POM (Same or very similar to predicates)
Physical Dimensions	Must encompass the same range as predicate devices.	Platform diameters: 3.5, 4.0, 4.5, 5.0, 6.0 mm (Encompasses same range as or similar to predicates in overall scope)
Packaging & Sterilization	Must be similar to predicate devices.	"similar packaging and is sterilized using the same materials and processes" (as predicates)

2. Sample Size for Test Set and Data Provenance

Not applicable. This is a 510(k) premarket notification for demonstrating substantial equivalence based on a comparison of device characteristics, not a study involving a test set of data or human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth as typically understood in a study context (e.g., for diagnostic accuracy) is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of a performance study to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, and its approval process does not typically involve such studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

No, a standalone performance study in the context of an algorithm or AI is not applicable. This is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The U.S. FDA's substantial equivalence determination means that the new device (VARIOeco) is as safe and effective as a legally marketed device (predicate device).

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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 +41 61 965 90 20 Telephone: Fax: +41 61 965 90 21

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: +1 (858) 792-1235 +1 (858) 792-1236 Fax: lschulz@paxmed.com Email: kthomas@paxmed.com

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

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 AGVARIOeco	Thommen Medical AGSPI® EASY 4.0AbutmentK071453	Thommen Medical AGSPI® Dental ImplantAbutmentsK031747	Altatec GmbHCAMLOG® Vario SRAbutmentsK103252
Indicationsfor Use	Thommen VARIOecodental implantabutments are intendedto be used inconjunction withThommen Systemdental implants in themaxillary and/ormandibular arch toprovide support forcrowns, bridges andoverdentures.	The Thommen SPI®EASY Ø 4.0 Abutmentis intended to be used inconjunction with SPI®System dental implantsin the maxillary and/ormandibular arch toprovide support forcrowns, bridges or.overdentures.	Thommen SPI® DentalImplant Abutments areintended to be used inconjunction with SPI®System dental implantsin the maxillary and/ormandibular arch toprovide support forcrowns, bridges oroverdentures.	CAMLOG® Vario SRcomponents for crown andbridge restorations:Occlusal screw-retainedcrown, bridge and barconstructions onCAMLOG® implants (withJ and K article numbers) inthe anterior and posteriorregion of the maxilla andmandibleCAMLOG® Vario SRcomponents for barrestorations:- Anchorage of implant-supported full dentures forthe edentulous maxilla andmandible in combinationwith 2, 4 or moreCAMLOG® implants (withJ and K article numbers)
Restoration	Single or multi-unit	Single or multi-unit	Single or multi-unit	Single or multi-unit
Abutment(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 - abutmentPOM - Burn-out sleeve	CPTi Gr 4 - abutmentPOM - Burn-out sleeve	CPTi Gr 4 - abutmentPOM - Burn-out sleeve	CPTi Gr 4 - abutmentTi-6Al-4V - abutmentPOM - 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

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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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)