Porta Implant
Porta Implant
Statement Letter
Dr. Gerhard Polzer
Director, Regulatory Affairs
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
D-75 179 Pforzheim
GERMANY
Re: KO30312
Trade/Device Name: Porta Implant
Regulation Number: 21 CFR 872.3060
Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use
Regulatory Class: I1
Product Codes: EJT
Dated: January 27,2003
Received: January 30,2003
Dear Dr. Polzer:
We have reviewed your Section 5 10(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 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 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 (2 1 CFR Part 807); labeling (2 1 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); 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 (2 1 CFR Part 80 l), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30 1) 594-4639. 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 may be obtained 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/dsmaniain.html
Sincerely yours,
L L W Susan Runner, DDS, MA
Interim Director
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
Submitter of 510(k): Wieland Dental + Technik GmbH & Co. KG
Schwenninger Str. 13
D-75179 Pforzheim
Germany
Phone: +49-7231-3705-0
Contact person: Dr. Gerhard Polzer
Phone: t49-7231-3705-219
Date of Summary: 2003-01 -27
Trade name: Porta Implant
Classification name: Alloy, gold based, for clinical use
Device description
PORTA IMPLANT is a gold-palladium-platinum ceramic alloy with high contents of noble metals (97,6%) intended for dental technicians to fabricate dental restorations.
It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. At porcelain fusing temperatures, it has a high sagresistance and therefore it is suitable for manufacturing of implant supraconstructions.
PORTA IMPLANT is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard IS0 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
PORTA IMPLANT can be veneered with suitable dental ceramics and with dental composites.
Votes:20
Comments: 0