The Thommen SPI " ELEMENT Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ELEMENT implant Ø 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SP1 ELEMENT implants Ø 3.5 mm is recommended whenever possible. These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements (e.g. use of single implants for the restoration of canines).

Partially edentulous lower and upper jaw:

SPI® ELEMENT implants Ø 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw.

Edentulous lower jaw:

4 SPI® ELEMENT implant Ø 3.5 mm connected with a bar

Edentulous lower and upper jaw:

Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mm SP1® implants

Device Description

The previously cleared SP® ELEMENT Dental Implant K003045 is not a subject of this Special 510(k). The design of this implant has been modified to make a smaller diameter (3.5 mm) implant that will be marketed as the SPP ELEMENT Dental Implant Ø 3.5 mm. Other SPY ELEMENT Dental Implant System accessories have not been modified, are suitable for use with the modified implant, and will be sold under the SPP Dental Implant System name.

The Thommen SPI® ELEMENT Dental Implant is a two-stage root formendosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in four lengths (8 mm, 11 mm, 14 mm, 17 mm) with one new diameter (3.5 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving device performance. The document describes a 510(k) premarket notification for a dental implant, focusing on demonstrating substantial equivalence to a predicate device rather than presenting new performance study data against predefined acceptance criteria.

The information primarily details:

Device Name: SPI® ELEMENT Dental Implant Ø 3.5 mm
Manufacturer: Thommen Medical AG
Classification: Class III, Endosseous Dental Implant (21 CFR 872.3640, Product Code DZE)
Predicate Device: HA-Ti Dental Implants (K003045, K901927)
Device Description: Two-stage root form implant, made of commercially pure grade titanium (CP Grade 4, meeting ASTM F67 and ISO 5832-2). Surface is smooth machined transgingival, sandblasted and acid-etched in bone contact area. Available in 8mm, 11mm, 14mm, 17mm lengths with a 3.5mm diameter.
Intended Use & Indications for Use: Support for crowns, bridges, or overdentures in specific locations with adequate bone structure, with contraindications for certain applications (e.g., posterior teeth, single-tooth canines/central incisors in the upper jaw, retentive anchors).
Similarities to Predicate: Same intended use, operating principle, basic design (with new diameter), materials, packaging, and sterilization.
Sterilization: Co gamma irradiation at 25kGy (2.5 Mrad), validated by bioburden method per ISO 11137, with a sterility assurance level (SAL) of 10^-6.

Since the document is a 510(k) submission focused on substantial equivalence, it does not include the following details:

Table of Acceptance Criteria and Reported Device Performance: Not present. The submission aims to show the new device is as safe and effective as a legally marketed one, not to meet specific performance metrics through a clinical trial or direct performance testing studies beyond material and sterilization standards.
Sample Size and Data Provenance for Test Set: Not applicable as a formal performance study with a test set against acceptance criteria is not described.
Number and Qualifications of Experts for Ground Truth: Not applicable.
Adjudication Method: Not applicable.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned.
Standalone (Algorithm Only) Performance Study: Not applicable as this is a physical medical device, not an AI algorithm.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set Was Established: Not applicable.

Summary

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ADMINISTRATIVE INFORMATION

Manufacturer Name:	Thommen Medical AGHauptstrasse 87CH-4437 WaldenburgSwitzerlandTelephone +41 61 965 90 20FAX +41 61 965 90 21	MAR 2 6 2003
Official Contact:	Orlando Antunes

DEVICE NAME

Classification Name:	Implant, Endosseous (DZE)
Trade/Proprietary Name:	SPI® ELEMENT Dental Implant
Common Name:	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 III device (21 CFR 872.3640). The product code for "Implant, Endosseous" is DZE.

CONFORMANCE WITH PERFORMANCE STANDARDS

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

PREDICATE DEVICE INFORMATION

The principal predicate devices for this modification are the HA-Ti Dental Implants, cleared by FDA on July 12, 2001 under K003045 and on Jan 04, 1991 under K901927. Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental AG and has renamed it the SP1 Dental Implant System, inclusive of the SP10 ELEMENT Dental Implant.

PACKAGING/LABELING/PRODUCT INFORMATION

Thommen SP10 ELEMENT Ø 3.5 mm dental implants will be packaged in a radiationsterilizable 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 gamma irradiation at a nominal dose of 25kGy (2.5 Mrad). Sterlization will be validated by the bioburden method, according to ISO 11137 (Sterilization of Health Care Products - Radiation Sterilization). The sterility assurance level (SAL) thatThommen Medical AG intends to meet for the SPP ELEMENT Dental Implant Ø 3.5 mm is 10°. The device is not represented to be "pyrogen free."

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INTENDED USE

The Thommen SPY ELEMENT Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

SP® ELEMENT implant Ø 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SP1® ELEMENT implants Ø 3.5 mm is recommended whenever possible.

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements (e.g. use of single implants for the restoration of canines).

Partially edentulous lower and upper jaw:

SP1® ELEMENT implants Ø 3.5 mm are suitable foralloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw.

Edentulous lower jaw:

4 SP1® ELEMENT implant Ø 3.5 mm connected with a bar

Edentulous lower and upper jaw:

Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mmSPI implants

Contraindications for the use of SPP ELEMENT implant Ø 3.5 mm:

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

EQUIVALENCE TO MARKETED PRODUCT

The modified SP1® ELEMENT Dental Implant Ø 3.5 mm has the following similarities to the predicate SPI® ELEMENT Dental Implant:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design, (with the addition of a new diameter),
· 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 & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

MAR 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030689

Trade/Device Name: SPI® ELEMENT Dental Implant Ø 3.5 mm Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 4, 2003 Received: March 4, 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 (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 (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 yours.

Susan Romer

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

KO30689 510(k) Number:

Device Name: SPI® ELEMENT Dental Implant Ø 3.5 mm

Indications for Use:

Partially edentulous lower and upper jaw:

Edentulous lower jaw:

4 SPI® ELEMENT implant Ø 3.5 mm connected with a bar

Edentulous lower and upper jaw:

Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mm SP1® implants

Contraindications for the use of SPI® ELEMENT implant 9 3.5 mm:

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

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

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but I'm not doing that. I'm doing something else.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

Kevin Mulry for MSR

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nesthesiology, General Hospital, trol. Dental Device

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510(k) Number: K030689

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.