DETAX IMPLANTLINK SEMI

K100247 · Detax GmbH & Co. KG · EMA · Jul 23, 2010 · Dental

Device Facts

• Record ID: K100247
• Device Name: DETAX IMPLANTLINK SEMI
• Applicant: Detax GmbH & Co. KG
• Product Code: EMA · Dental
• Decision Date: Jul 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DETAX implantlink® semi is designed for the temporary luting of implant-retained restorations. Requires no separating agents. Luted restorations can be removed. with standard devices (i.e. Crown Butler, Corona Fix).

Device Story

DETAX implantlink® semi is a dental cement used for temporary luting of implant-retained restorations. It allows for the removal of luted restorations using standard dental devices such as Crown Butler or Corona Fix. The material requires no separating agents. It is intended for professional use by dentists in a clinical setting to secure temporary implant restorations, facilitating future removal or replacement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement (Product Code: EMA) classified under 21 CFR 872.3275. Material properties allow for temporary adhesion and subsequent removal of implant-retained restorations without the need for separating agents.

Indications for Use

Indicated for temporary luting of implant-retained restorations in patients requiring removable dental prosthetics.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 2-3 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Detax GmbH & Company KG C/O Ms. Dagmar Mäser Regulatory Consultant Maeser Bussiness Support International, V.O.F Amstel 320-1 Amsterdam. Netherland D-76275

Re: K100247

Trade/Device Name: DETAX implantlink® semi Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 12, 2010 Received: July 13, 2010

Dear Ms. Mäser:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

Page 2- Ms. Mäser

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

## INDICATION FOR USE

510(k) Number (if known):

K 100247

Device Name:

DETAX implantlink® semi

## INDICATION FOR USE:

DETAX implantlink® semi is designed for the temporary luting of implant-retained restorations.

Requires no separating agents. Luted restorations can be removed. with standard devices (i.e. Crown Butler, Corona Fix).

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Kei M. Luy to MSP

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100247

Concurrence of CDRH, Office of Device Evaluation (ODE)

1/1 | Page