Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.

Device Description

Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "SPI® Titanium Base for CAD/CAM". This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving the device meets specific acceptance criteria in the manner one might describe for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set size) are not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to the demonstration of "substantial equivalence" to predicate devices based on design, materials, intended use, and operating principles, rather than performance metrics from a formal clinical or technical study against predefined thresholds.

Here's a breakdown based on the information provided and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Characteristics)
Same intended use as predicate devices	Intended for use in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.
Same operating principle as predicate devices	Functions as a foundation for customized CAD/CAM abutments and restorations.
Same basic design as predicate devices	Consists of a titanium base/post used in CAD/CAM fabrication of custom dental implant abutments/restorations and an abutment screw.
Same or very similar materials as predicate devices	Made from commercially pure titanium, grade 4 (ASTM F67) for the base, and titanium alloy, Ti-6Al-7Nb (ASTM F1295) for the abutment screw. Predicate devices also use commercially pure titanium or titanium alloy.
Similar packaging and sterilization methods as predicate devices	Packaged in similar materials and sterilized using similar methods as predicate devices.
Encompass the same range of physical dimensions/configuration	Encompasses the same range of physical dimensions, including sizes and configuration as predicate devices.
Differences in technological characteristics do not raise new issues of safety or efficacy	Not explicitly detailed, but implied by the overall claim of substantial equivalence with no new issues of safety or efficacy.

2. Sample size used for the test set and the data provenance

Not Applicable. This submission is for a dental abutment demonstrating substantial equivalence to predicate devices, not a diagnostic or AI device requiring a test set of data. The "study" here refers to the comparison of the device's characteristics against those of already cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. See point 2.

4. Adjudication method for the test set

Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a hardware device (dental abutment), not an AI-driven or diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

Not Applicable in the traditional sense of a diagnostic study. The "ground truth" for this submission is established by the known characteristics and regulatory clearance of the predicate devices. The new device's characteristics are compared against these established devices.

8. The sample size for the training set

Not Applicable. No training set is used for this type of submission.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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510(k) Summary

APR 2 0 2011

THOMMEN MEDICAL AG SPI® Titanium Base for CAD/CAM K102804

April 19, 2011

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Thommen Medical AGHauptstrasse 26dCH-4437 Waldenburg, Switzerland
	Telephone:	+41 61 965 90 20
	Fax:	+41 61 965 90 21
Official Contact:	Orlando Antunes
Representative/Consultant:	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
	Fax:	+1 (858) 792-1236
	Email:	lschulz@paxmed.com
		kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	SPI® Titanium Base for CAD/CAM
Common Name:	Endosseous dental implant abutment21 CFR 872.3630, Class II
Product Code:	NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

INTENDED USE

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DEVICE DESCRIPTION

Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Laya System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.

EQUIVALENCE TO MARKETED DEVICE

Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, SPI® Titanium Base for CAD/CAM is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, cleared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553;

FRIADENT GmbH, FRIADENT PLUS Dental Implant Systems, cleared under K040170;

Implant Innovations, Inc., 3i Patient-Specific Dental Abutments and Overdenture Bars. cleared under K032263; and

Sybron Implant Solutions GmbH, Pitt-Easy Dental Implant System, cleared under K083297.

The subject device and the predicate devices are all made of commercially pure titanium or titanium alloy. The subject and predicate devices encompass the same range of physical dimensions, including sizes and configuration. All of the devices consist of a titanium base/post used in CAD/CAM fabrication of custom dental implant abutments/restorations and an abutment screw. The custom CAD/CAM component is bonded to the titanium base. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in technological characteristics do not raise new issues of safety or efficacy. Information provided to demonstrate substantial equivalence included a detailed list of subject and predicate device characteristics.

Overall, SP1® Titanium Base for CAD/CAM 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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DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, cleared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553:

FRIADENT GmbH, FRIADENT PLUS Dental Implant Systems, cleared under K040170;

Implant Innovations, Inc., 3i Patient-Specific Dental Abutments and Overdenture Bars, cleared under K032263: and

Sybron Implant Solutions GmbH, Pitt-Easy Dental Implant System, cleared under K083297.

Overall, SP1® Titanium Base for CAD/CAM 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like strokes above a wavy line, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

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

Thommen Medical AG C/O Linda K. Schulz PaxMed International. LLC Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130

APR 2 0 2011

Re: K102804

Trade/Device Name: SPI® Titanium Base for CAD/CAM Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 15, 2011 Received: April 18, 2011

Dear Mrs. 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 - Mrs. 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,

Nh for

Anthony 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

K102804 510(k) Number:

Device Name:

SPI® Titanium Base for CAD/CAM

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

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number:

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.)