The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

Device Description

The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.

AI/ML Overview

This 510(k) submission (K092248) for the Thommen Medical AG SPI® Customizable Gingiva Former does not contain the type of study data and acceptance criteria that would typically be found for a device requiring performance evaluation against specific metrics, especially for AI/ML-enabled devices.

This submission is a Special 510(k) for a device modification, specifically for an "Endosseous dental implant abutment." Special 510(k)s often involve modifications to already cleared devices where the changes do not significantly alter the fundamental scientific technology or intended use. In such cases, the review focuses on ensuring that the modifications do not raise new questions of safety and effectiveness, often relying on comparisons to the predicate device and established performance standards, rather than new extensive clinical or performance studies with detailed acceptance criteria and statistical analysis.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, etc.) are not applicable or present in this document.

Here's an analysis based on the provided text, addressing the requested information where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated or applicable in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics with acceptance criteria for a new type of study.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The evaluation relies on the device description, intended use, and comparison to predicate devices, along with adherence to general controls.

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

Not applicable. No ground truth establishment process is described, as there isn't a performance study generating new data for evaluation.

4. Adjudication Method

Not applicable. No performance study data requiring adjudication is presented.

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

Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would undergo such a study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical dental implant component, not an algorithm.

7. Type of Ground Truth Used

Not applicable. There is no ground truth data in the context of a performance study for this device type.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of Device and Approval Context:

Device Name: SPI® Customizable Gingiva Former
Intended Use: Used with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
Classification: Class II (Endosseous Dental Implant Abutment)
Nature of Submission: Special 510(k) for a device modification. This implies the core technology and safety/effectiveness principles were established by previous predicate devices.
Key Argument for Equivalence:
- Same intended use
- Same operating principle
- Same or similar materials
- Same basic design
- Same packaging materials and processes

The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" for a 510(k) submission, and it is "proven" by demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the predicates, as outlined in the "Equivalence to Marketed Product" section.

No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical strength limits with associated test results) are detailed in the provided portion, which is common for Special 510(k)s focusing on material or design modifications where existing general controls and predicate device performance are considered sufficient. If mechanical testing (e.g., fatigue, fracture) was performed to support the modification, the specific acceptance criteria and results would typically be in a separate section of the 510(k) submission, often referencing ISO or ASTM standards, but they are not provided in this excerpt.

Summary

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510(k) Summary

REVISED 510(k) Summary

Ko92248

Thommen Medical AG Special 510(k): Device Modification

SPI® Customizable Gingiva Former

SEP 2 5 2009

ADMINISTRATIVE INFORMATION

Manufacturer Name

Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone: +41 61 965 90 20 Fax: +41 61 965 90 21

Official Contact:

Orlando Antunes

Representative/Consultant

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone 1 (858) 792-1235 Fax 1 (858) 792-1236 Email: 1schulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	SPI® Customizable Gingiva Former
Common Name:	Endosseous dental implant abutment
Classification Regulations:	Abutment, Implant, Dental, Endosseous21 CFR 872.3630, Class II
Product Code:	NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch
Establishment Registration Number:	3003836985
Owner/Operator Number:	9051144

INTENDED USE

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DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

Predicate devices: K051527, K033346, K023645 and K031747.

The SPI® Customizable Gingiva Former has the following similarities to the unmodified predicate devices:

· has the same intended use,
· uses the same operating principle,
· uses the same or similar materials
· incorporates the same basic design, and
· is packaged using the same materials and processes.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 2 5 LUUS

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

Re: K092248

Trade/Device Name: SPI® Customizable Gingiva Former Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 17, 2009 Received: September 18, 2009

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.

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 i 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Un for

Susan Runner, D.D.S., M.A. Acting Division 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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REVISED Indications for Use

Applicant: Thommen Medical AG

510(k) Number (if known):

Device Name: SPI® Customizable Gingiva Former

Indications for Use:

The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPT® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Kein Muluy for MSP

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, 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.)