SPl@ EASY Dental Implant Protective Cap

SPl@ EASY Dental Implant Protective Cap
Statement Letter:
Thommen Medical AG
C/O Mr. Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, California 92130
Re: KO33346
Trademevice Name: SPI@ EASY Dental Implant Protective Cap
Regulation Number: 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: I11
Product Code: NHA
Dated: October 17,2003
Received: October 20, 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 reclqssified 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 111 (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 53 1-542 of the Act); 2 1 CFR 1000- 1050.
This letter will allow you to begin marketing your device as described in your Section 5 1O(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 (2 1 CFR Part 80 l), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 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. ~ov/cdrWdsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological Health
Infection Control and Dental Devices
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
RepresentativelConsuItant: Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, CA 92130
Telephone: (858) 792-1235
FAX: (858) 792-1 236
DEVICE NAME
Classification Name: Abutment, Implant, Dental, Endosseous (NHA)
Trade/Proprietary Name: SPl@ EASY Dental Implant Protective Cap
Common Name: Endosseous Dental Implant System component
INTENDED USE
The Thommen SPl@ EASY Dental Implant Protective Cap is intended to be used in conjunction with SPl@ System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
DEVICE DESCRIPTION
The Thommen SPl@ EASY Dental Implant Protective Cap is an endosseous dental implant component made from polyetheretherketone (PEEK). The Protective Cap may be used for maintaining the gingival contour, replacing or augmenting the use of the Gingiva Former. If it is used to augment the function of the Gingiva Former, it is placed after the Gingiva Former is removed and the abutment is placed, but before the final restoration is placed. The Protective Cap also serves to protect the coronal aspect of the abutment from damage and the patientÇƒÙs tongue from injury during the time the final restoration is being fabricated.
The Protective Cap will be offered in sizes to fitall SPl@ EASY abutments and may be used with all SPl@ System dental implants.