SPI¨? CONTACT Dental Implant

SPI¨? CONTACT Dental Implant
Statement Letter:
Thommen Medical, AG
C/O Ms. Floyd G. Larson
President
Paxmed International
4329 Graydon Road
San Diego, California 92130
Re: K034014
Trade/Device Name: SPI Contact dental Implant
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: lII
Product Code: DZE
Dated: December 22, 2003
Received: December 24, 2003
Dear Ms. 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.
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/cdrkddsma/dsmamain.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
Summary Information:
Manufacturer Name: Thommen Medical AG
Hauptstrasse 87
CH-4437 Waldenburg
Switzerland
Telephone +41 61 965 90 20
FAX +41 61 965 90 21
Official Contact: Orlando Antunes
Representative/Consultant: Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, CA 92130
Telephone (858) 792-1235
FAX (858) 792-1236
DEVICE NAME
Classification Name: Implant, Dental, Endosseous (DZE)
Trade/Proprietary Name: SPI¨? CONTACT 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.
INTENDED USE
The Thommen SPI¨? CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillar~ and/or mandibular arch to provide support for crowns, bridges or overdentures. SPIR CONTACT implants can be loaded immedialely if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Contraindications for the use of SPI¨? CONTACT implant o 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 moments.
- 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
Design Characteristics
Thommen SPI¨? CONTACT Dental Implants are threaded, tapered, endosseous dental implants made of commercially pure titanium and intended for use with the SPI¨? System abutments and instruments. The implants are offered in lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm.
Material Composition
SPI¨? CONTACT Dental Implants are made of pure titanium according to ASTM F 67 Grade 4/ISO 5832-2 GR4B. The surface of the threaded portion of the SPI¨? CONTACT Dental Implant is sandblasted and acid etched. The 1.5 mm collar is smooth machined -for subgingival and transgingival use.