Thommen SP1® Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

Device Description

Thommen SP1® Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving performance against acceptance criteria.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in the provided text.

The document primarily provides administrative information, device classification, predicate device information, intended use, and a statement of equivalence to marketed products.

Here's a breakdown of why each requested point cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish new performance criteria or report performance data. It relies on the equivalence to devices that would have already met such criteria.
2. Sample sized used for the test set and the data provenance: No new performance study or test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant in an equivalence submission of this type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new test set is described.
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: This is a physical medical device (dental abutment), not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable as this is not a machine learning/AI device.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

This document is a 510(k) submission for Thommen SPI® Dental Implant Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices: the HA-Ti Dental Implant System (K901927) and SPI Easy Dental Implant Abutment (K023645).

The basis for equivalence is stated as:

Same intended use
Same operating principle
Same basic design
Same materials (commercially pure grade titanium)
Same packaging materials and processes

The device is intended for use in conjunction with SPI System dental implants to support crowns, bridges, or overdentures in the maxillary and/or mandibular arch. No new performance studies or data are presented to establish acceptance criteria for the device itself; rather, its compliance is inferred through its similarity to already approved devices.

Summary

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ADMINISTRATIVE INFORMATION	JUL 2 2003	K031747
Manufacturer Name:	Thommen Medical AGHauptstrasse 87CH-4437 WaldenburgSwitzerlandTelephone +41 61 965 90 20FAX +41 61 965 90 21	JUL 2 2003
Official Contact:	Orlando Antunes
Representative/Consultant:	Floyd G. LarsonPaxMed International4329 Graydon RoadSan Diego, CA 92130Telephone (858) 792-1235FAX (858) 792-1236
DEVICE NAME
Classification Name:	Abutment, Implant, Dental, Endosseous (NHA)
Trade/Proprietary Name:	SPI® Dental Implant Abutments
Common Name:	Endosseous Dental Implant Abutment

ESTABLISHMENT REGISTRATION NUMBER

The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.

DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as a Class III device (21 CFR 872.3640). The product code for "Abutment, Implant, Dental, Endosseous" is NHA.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implant abutments have been established by FDA. However, CP titanium Grade 4 used to manufacture Thommen dental implant abutments meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.

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PREDICATE DEVICE INFORMATION

The predicate devices for this modification are the HA-Ti Dental Implant System, cleared by FDA on January 4, 1991 under K901927 and SPI Easy Dental Implant Abutment (Thommen A.G.), cleared on November 13, 2002 under K023645, Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental and has renamed it the SPI® System.

PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI® Dental Implant Abutments will be packaged and sold non-sterile. The device is not represented to be "pyroqen free. All cataloques will be amended to include the modified devices, consistent with the information shown for existing devices.

INTENDED USE

Thommen SPI® Dental Implant Abutments are intended to be used in conjunction with SPI System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

The modified SPI® Dental Implant Abutments have the following similarities to the predicate HA-Ti Dental Implant Abutment and Thommen SP1® Dental Implant Abutment:

· have the same intended use,
· use the same operating principle,
· incorporate the same basic design,
· incorporate the same materials, and
· are packaged using the same materials and processes.

In summary, the modified Thommen SP1® Dental Implant Abutments described in this submission are, in our opinion, substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2003

Thommen Medical, AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K031747

Trade/Device Name: SPI Dental Implant Abutment Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: June 3, 2003 Received: June 5, 2003

Dear Mr. Larson:

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 such 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 - Mr. Larson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Suser Runre

Susan Runner, DDS, MA Interim 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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Applicant: Thommen Medical AG

510(k) Number:

Device Name: SPI® Dental Implant Abutment

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

Kein Muluy for MSR

, General Hospital. n of Anesthesiolor Infection Control. De

510(k) Number: K031741 iv

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.)