SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: 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.

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

Device Description

The design of the Thommen Medical AG SPI® Dental Implant System implants has been modified to include new sizes and corresponding abutments that will be marketed as the SPI® Dental Implant, ELEMENT. All features other than these implant sizes remain the same as the currently marketed SP1® ELEMENT implants. Other components of the SP10 Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

AI/ML Overview

I am sorry, but the provided text describes a 510(k) summary for a dental implant device (SPI® Dental Implant, ELEMENT) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing performance studies with specific statistical metrics.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method for a test set.
MRMC comparative effectiveness study details.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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K093615

MAR - 4 2010

510(k) Summary Thommen Medical AG SPI® Dental Implant, ELEMENT February 25, 2010

ADMINISTRATIVE INFORMATION

Manufacturer Name:

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

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 +1 (858) 792-1236 Fax:

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Classification Regulations:

Product Code

Classification Panel: Reviewing Branch:

SPI® Dental Implant, ELEMENT Endosseous dental implant; Endosseous dental implant abutment 21 CFR 872.3640 21 CFR 872.3630 DZE NHA Dental Products Panel Dental Devices Branch

INTENDED USE

SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

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

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICES

Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPI Dental Implant, ELEMENT is substantially equivalent in indications and design principles to predicate devices (K090154, K051502, K050712, K050258. K033984, K010185, K926501), each of which has been determined by FDA to be substantially equivalent to preamendment devices. A comparison of the surface area of the Thommen Medical 6.5mm implant with that of a predicate short implant (Straumann Standard Implant 6.0 mm) showed that the Thommen Medical implant has a greater surface area than the predicate. Overall, the SPI Dental Implant, ELEMENT has the following similarities to the predicate devices:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a flowing line representing the body.

Public Health Service

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

Thommen Medical, AG C/O Ms. Linda K. Schulz Senior Regulatory Affairs Specialist Paxmed International, LLC 11234 EL Camino Real, Suite 200 San Diego, California 92130

MAR - 4 2010

Re: K093615

Trade/Device Name: SPI® Dental Implant, ELEMENT Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product: DZE Dated: February 25, 2010 Received: February 1, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), please go to

http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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SPI® Dental Implant, ELEMENT

510(k) Summary

K093615

Indications for Use

510(k) Number (if known):

Device Name: SPI® Dental Implant, ELEMENT

Indications for Use:

SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental-Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. .

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

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.

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

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

	RSBetz DDS for Dr. K. P. Muly
(Division Sign-Off)
	Division of Anesthesiology, General Hospital
	infection Control, Dental Devices
510(k) Number:	K093615

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.