SPI® ART Abutment is 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.

SPI ART Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

Device Description

The design of the SPI ART Abutment System has been modified to add additional abutments to fit the 3.5 mm and 4.0 mm platform components.

AI/ML Overview

This 510(k) summary for the SPI® ART Abutment describes the device and its intended use, but it does not include any acceptance criteria or details of a study that proves the device meets specific performance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device. This means the manufacturer is asserting that the new device is as safe and effective as the predicate, based on similarities rather than new performance testing against specific criteria for this modification.

Therefore, I cannot populate the table or answer most of the questions as the requested information is not present in the provided text.

Here's a breakdown of what can be said based on the provided text:

Acceptance Criteria and Device Performance (Not Provided)

The document does not describe specific numerical or qualitative acceptance criteria for the SPI® ART Abutment's performance.
There are no reported device performance metrics against any such criteria.

Study Information (Not Applicable for this Submission Type)

This submission describes a modification to an existing device (adding new sizes). The primary "study" or justification for equivalence is based on the similarities to the predicate device, not new performance testing in the way typical for a de novo device.

Sample size used for the test set and the data provenance: Not applicable. No new performance testing on a "test set" is described. The basis for equivalence is the similarity to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described for performance testing of this modification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 dental implant abutment, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of Equivalence Claimed:

The manufacturer states the SPI® ART Abutment (specifically the 3.5 mm and 4.0 mm platform components) is substantially equivalent to the unmodified predicate SPI® ART Abutment because they:

Have the same intended use.
Use the same operating principle.
Incorporate the same basic design.
Incorporate the same materials.
Are packaged using the same materials and processes.

This 510(k) is a Special 510(k) for a device modification, which typically relies on demonstrating that the change does not significantly affect the safety or effectiveness, often by showing it retains the characteristics of the predicate device. It is not a submission that would typically include new, extensive performance testing data against specific acceptance criteria for the modified device itself.

Summary

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0(k) Summary

SPI® ART Abutment

K073141

510(k) Summary

Thommen Medical AG Special 510(k): Device Modification

SPI® ART Abutment

ADMINISTRATIVE INFORMATION

DEC 0 5 2007

Manufacturer Name:

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

Official Contact:

Representative/Consultant:

Orlando Antunes

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: flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Product Code: Classification Panel: Reviewing Branch:

SPI® ART Abutment Dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3630), Class II NHA Dental Products Dental Devices

ESTABLISHMENT REGISTRATION

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

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510(k) Summary

INTENDED USE

SPI® ART Abutment is 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.

SPI ART Abutment is contraindicated for free-end bridges or bridges with more than one intermediate pontic element.

DEVICE DESCRIPTION

The design of the SPI ART Abutment System has been modified to add additional abutments to fit the 3.5 mm and 4.0 mm platform components.

EQUIVALENCE TO MARKETED PRODUCT

The SPI ART Ø 3.5 mm and 4.0 mm abutments have the following similarities to the unmodified predicate SPI ART 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 SPI ART Abutment described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2007

Thommen Medical, AG C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K073141

Trade/Device Name: SP1® ART Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 6, 2007 Received: November 7, 2007

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 (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.

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Snytte y. Michie O ins.

Chiu Lin, Ph.D. 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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pecial 510(k): Device Modification

SPI® ART Abutment

Indications for Use

510(k) Number (if known):

Device Name:

SPI® ART Abutment

Indications for Use:

SPI® ART Abutment is intended to be used in conjunction with SP10 System dental implants in SP1 ART Abulinent is meetica to 60 assume in to provide support for crowns, bridges or overdentures.

SPI ART Abutment is contraindicated for free-end bridges with more than one intermediate pontic element.

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

Signature

(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of

407314 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.)