SPI@ ELEMENT Dental Implant 0 3.5 mm

SPI@ ELEMENT Dental Implant 0 3.5 mm
Summary Letter:
Thommen Medical AG
C/O Mr. Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, California 92130
Re: KO30689
Trademevice Name: SPI@ ELEMENT Dental Implant 0 3.5 mm
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: DZE
Dated: March 4,2003
Received: March 4,2003
Dear Mr. Larson:
We have reviewed your Section 5 1 O(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 I1 (Special Controls) or class I11 (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 2 1, 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 (2 1 CFR Part 80 1); 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 53 1-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 1 O(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 Sol), please contact the Office of Compliance at (30 1) 594-46 13. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. pov/cdrh/dsma/dsmamain .html
Sincerely yours,
Susan Runner, DDS, MA
Interim Director
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
Thommen Medical AG
Hauptstrasse 87
CH-4437 Waldenburg
Switzerland
Telephone +41 61 965 90 20
FAX +41 61 965 90 21
Orlando Antunes
MAR 2 6 2003
DEVICE NAME
Classification Name: Implant, Endosseous (DZE)
Trade/Proprietary Name:
Common Name: Endosseous Dental Implant
SPl@ ELEMENT Dental Implant
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051 144.
INTENDED USE
The Thommen SP$ ELEMENT Dental Implant is intended to be surgically placed in the bone of the
maxillary and/or mandibular arch to provide support forcrowns, bridges or overdentures. SPl@ ELEMENT implant 0 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 SP$ ELEMENT implants 0 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: SPl@ ELEMENT implants 0 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 SPl@ ELEMENT implant 0 3.5 mm connected with a bar Edentulous lower and upper jaw: Complete bridges in combination with 0 4.2 mm, 5.0 mm or 6.0 mmSPl implants Contraindications for the use of SP? ELEMENT implant 0 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
-The previously cleared SPP ELEMENT Dental.lmplant KO03045 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 SP$ ELEMENT Dental Implant 0 3.5 mm. Other SPP 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 SPl@ ELEMENT Dental Implant is a two-stage root formendosseous dental implant
made of commercially pure grade titanium. The implant surface issmooth 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.