The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are used for crowns, bridges or overdentures on at least four implants in the mandibular arch or six implants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implant ø 3.5 mm and SPI® ELEMENT implant ø 3.5 mm:
These implants are not suitable for applications in areas where pronounced rotation and/or bending movements are expected to subject the implant to large bending movements.

Restoration of posterior teeth in the upper or lower jaw -
Single-tooth restoration of canines and central incisors in the upper jaw -
Any application involving retentive anchors -

Device Description

The Thommen SPI® Dental Implant System with TST Surface (the modified design) is a self tapping, root form, endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and treated with the TST implant surface process, in the area intended to contact bone. The modified TST Surface is available on all implants in the SPI® Dental Implant System. The system is constructed of materials that have a long clinical history of proven acceptance and performance.

AI/ML Overview

This 510(k) summary describes a device modification to an existing dental implant system. The core of the submission focuses on demonstrating substantial equivalence to a predicate device, particularly concerning a new surface treatment (TST Surface). As such, a traditional "study" proving acceptance criteria with performance metrics, ground truth, and statistical analysis as one might find for an AI/ML diagnostic device is not applicable here.

Instead, the submission relies on the established safety and effectiveness of the predicate device and demonstrates that the modified device's characteristics (intended use, operating principle, basic design, materials, packaging, sterilization) are substantially equivalent.

Therefore, many of the requested categories (2-9) do not have direct answers in this document because they pertain to a different type of device evaluation.

However, I can extract the closest equivalent information for the acceptance criteria and implied "performance."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: Same as predicate device.	"has the same intended use"
Operating Principle Equivalence: Same as predicate device.	"uses the same operating principle"
Basic Design Equivalence: Same as predicate device.	"incorporates the same basic design" (modified to include new surface)
Materials Equivalence: Same as predicate device.	"incorporates the same materials" (commercially pure grade titanium)
Packaging & Sterilization Equivalence: Same as predicate.	"is packaged and sterilized using the same materials and processes" (gamma irradiation at 25 kGy)
Biocompatibility: Materials have a long clinical history.	"constructed of materials that have a long clinical history of proven acceptance and performance."
Conformity to Standards: Meets relevant chemical and mechanical standards.	"meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2."
Sterility Assurance Level (SAL): Meets specified SAL.	Sterilization validated by gamma irradiation at 25 kGy (2.5 Mrad) to achieve SAL 10^-6 according to ISO 11137.

Note: The "acceptance criteria" here are inferred from the requirements for demonstrating substantial equivalence for a device modification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study assessing device performance on a clinical or imaging dataset. The "test" is the demonstration of substantial equivalence through comparison of device characteristics and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication of a test set occurred.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a training set.

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

Not applicable. This device does not involve a training set.

Summary

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510(k) Summary

Special 510(k): Device Modification

SPI® Dental Implant System, TST Surface

ADMINISTRATIVE INFORMATION

502

Manufacturer Name:	Thommen Medical AGHauptstrasse 87CH-4437 WaldenburgSwitzerlandTelephone +41 61 965 90 20FAX +41 61 965 90 21
Official Contact:	Orlando Antunes

DEVICE NAME

Classification Name: Trade/Proprietary Name: Common Name:

Implant, Endosseous, Root-Form (DZE) SPI® Dental Implant Endosseous dental implant

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 II device (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004). The product code for "Implant, Endosseous, Root-Form" is DZE.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implants have been established by FDA. However, the Thommen dental implant meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.

PREDICATE DEVICE INFORMATION

The principal predicate device for this modification is the Thommen Medical AG, SPI® Dental Implant System, cleared by FDA under K0030345, K022038, K030689, K034014.

PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SPI® Dental Implants will be packaged in a radiation sterilizable package consisting of a primary container, with implant and auxiliary parts, sealed with a peel-off wrapping. The sterile packs will be grouped into storage packs. Sterilization will be accomplished by means of Co°

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K051502

510(k) Summary _______________________________________________________________________________________________________________________________________________________________

gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization will be validated by the gamma inadiation at a nominal dose of 20 11137 Sterilization of Health Care Products — Radiation bloburden method, according to 100 TTS7 Storillation of Medical AG intends to meet for the Stemization: The Stemlity acourance level (evice is not represented to be "pyrogen free."

INTENDED USE

The Thommen SPI® Dental Implant System is intended to be surgically placed, either i he Thommen of 1 - Donal Implant of the maxillary and/or mandibular arch to provide support innnediately of delayed, in the bons of the manaly managements can be loaded immediately if they are for crowns, bridges of overdentures. Of I - Dontal implants in the maxillary arch.

Contraindications for the use of SPI®CONTACT implant ø 3.5 mm and SPI®ELEMENT implant ø 3.5 mm:

5.3 frim.
These implants are not suitable for applications in areas where pronounced rotation and These implants are not sultable for applications in arguested to large bending movements.

Restoration of posterior teeth in the upper or lower jaw -
Single-tooth restoration of canines and central incisors in the upper jaw -
Any application involving retentive anchors ..

DEVICE DESCRIPTION

The design of this implant has been modified to use a new surface treatment that will be marketed The design of this implant Tax boon from of the SPI® Dental Implant System as the of I Demar implant TOT Sunacouse with the modified implant, and will be sold under the SPI® Dental Implant System name.

The Thommen SPI® Dental Implant System with TST Surface (the modified design) is a self tapping, root form, endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and and treated with the TST implant ouridos to omooth to contact bone. The modified TST Surface is available on all Sunate procose, in the around system is constructed of materials that have a long clinical history of proven acceptance and performance.

EQUIVALENCE TO MARKETED PRODUCT

The modified SPI® Dental Implant TST Surface has the following similarities to the predicates:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

JUN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051502

K051502
Trade/Device Name: SPI® Dental Implant System, TST Surface Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 3, 2005 Received: June 7, 2005

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bection 910(t) procession is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the encreating to the enactment date of the Medical Device interstate conminence pror to thay 20, 1976, and existed in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Federal F00d, Drug, and Cosment 110 (Pres) ............................................................................................................................... approval appreadon (1 Mr.). I The general controls provisions of the Act include confors provisions of the Fist - Inc. Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see above) into examines. Existing major regulations affecting to (FMA), It inay of Subject to back address of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous receinents 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 Please be advised that FDA S Issualice of a successor its with other requirements
mean that FDA has made a determination that your career Federal agencies mean that FDA nas made a decemmanon that 50 an administered by other Federal agencies.
of the Act or any Federal statutes and regulations administration to: penistration of the Act or any rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing prestice You must comply with an the Act 3 requirements, made good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); group manufacturing practice and listing (21 CPR Part 807), labeling (21 CFR regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and i requirements as set forth in the quality systems (QD) regarities (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)
the success of the support of all and start of the spivalence of your device to This letter will allow you to begin marketing your as fromwalerse of your device to a
premarket notification. The FDA finding of substantial equivalerseand thus, new premarket notification. The PDA miding of babbatines of a vour 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 Patt 801), If you desire specific advice for your device on our sales . Also, please note the regulation please contact the Office of Comphanee at (210) 210 - 11 - 1 CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 8) entified, "Misbranding by reference to promation on your responsibilities under the Act from the may obtain other general miorination on your responser Assistance at its toll-free Division of Simall Manazara
number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Indications for Use

(051507

Applicant: Thommen Medical AG

510(k) Number (if known):

Device Name: SPI® Dental Implant System, TST Surface

Indications for Use:

The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgicaly placed, The Thommen STT - Denan Implant By Ren, the maxillary and/or mandibular acchton or distancediately either immediately or delayed, in the both of the mazinal Junlants can be loaded immediately if
support for crowns, bridges or overdentures. SPI® Dental Implants can be loads support for crowns, bridges of overdents in the mandibular arch or six implants in the maxillary arch.

Contraindications for the use of SPI® CONTACT implant ø 3.5 mm and SPI® ELEMENT implant ø 3.5 mm:

miplant 0 3.5 mm.
These implants are not suitable for applications in areas where pronounced rotation and I hese inipiants are not sunable for uppers implant to be subjected to large bending movements.

Restoration of posterior teeth in the upper or lower jaw -
Single-tooth restoration of canines and central incisors in the upper jaw -
Any application involving retentive anchors -

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulley for MSR

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

Page of

510(k) Number: K 0515

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.