TITAN Dental Implant System - 510K Submissions

TITAN Dental Implant System
Statement Letter:
Titan Implants, Incorporated
C/O Mr. Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, California 92130
Re: K042971
Trade/Device Name: TITAN Dental Implant System
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: II
Product Code: DZE
Dated: October 25, 2004
Received: October 28, 2004
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.
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 5 10(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 (240) 276-0115. 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,
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: Titan Implants, Inc.
18 Columbia Ave.
Bergenfield, NJ 07621
Telephone (201) 439-0027
Fax (201) 439-1145
Official Contact: Cyril Chen
Representative/Consultant: Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, CA 92130
Telephone (858) 792-1235
FAX (858) 792-1236
Classification Name: Implant, Dental, Endosseous (DZE)
Abutment, Implant, Dental, Endosseous (NHA)
Trade/Proprietary Name: TITAN Dental Implant System
Common Name: Endosseous Dental Implant
Endosseous Dental Implant Abutmen
INTENDED USE
The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdenturcs.
DEVICE DESCRIPTION
Design Characteristics
The TITAN Dental Implant System is comprised of 26 root-form solid screw-type implant designs and a broad range of abutment designs, all of which are based on existing dental implant systems that are cleared for marketing in the United States. Implant design features include external shapes that are cylindrical (15 designs), tapered (10 designs) and stepped (I design). Both transgingival and submerged designs are included. External implant thread forms include V, square and buttress designs. Anti-rotational features
include external and internal design elements. All implants are made from titanium or titanium alloys conforming to ASTM and ISO standards. Surfaces include as-machined surfaces, grit blasted and acid etched surfaces, surfaces treated with resorbable blast media (RBM) and surfaces coated with plasma-sprayed titanium (TPS) or hydroxyapatite (HA). Diameters range from 3.25 mm to 6.5 mm, and lengths from 5.0 mm to 20.0 mm..
Abutment designs include long and short conical abutments, stepped abutments, gold cylinder abutments, gold/plastic castable abutments and ball head abutments. Antirotational features include external and internal design elements. All abutments are made from titanium or titanium alloys conforming to ASTM and ISO standards or from gold alloy. Surfaces include as-machined surfaces and surfaces treated with titanium nitride.
Platform diameters range from 3.25 mm to 6.5 mm.
Abutment screws appropriate to each implant/abutment combination, healing abutments, temporary abutments and laboratory components are included in the TITAN Dental