RETRACTOFOAM

K050013 · Coltene/Whaledent AG · ELW · Feb 9, 2005 · Dental

Device Facts

• Record ID: K050013
• Device Name: RETRACTOFOAM
• Applicant: Coltene/Whaledent AG
• Product Code: ELW · Dental
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

For the temporary opening/widening of the sulcus.

Device Story

RetractoFoam is a dental impression material used for temporary gingival sulcus retraction. Applied by dental professionals in a clinical setting to facilitate impression taking; device functions by physically widening the sulcus to allow for accurate dental impressions. Output is the physical displacement of gingival tissue. Benefits include improved visualization and access for dental procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Impression material for dental sulcus retraction. Class II device (Product Code ELW).

Indications for Use

Indicated for temporary opening or widening of the gingival sulcus in dental patients.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coltene/Whaledent AG C/O Mr. Henry J. Vogelstein Official Corespondent 1349 Lexington Avenue New York. New York 10128

Re: K050013

Trade/Device Name: RetractoFoam Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 30, 2004 Received: January 03, 2005

Dear Mr. Vogelstein:

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.

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## Page 2 - Mr. Vogelstein

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. or the ret of 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 and nound (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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 510(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), n for a contact the Office of Compliance at [phone]. 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 may octain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Ove

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Coltène/Whaledent AG 510(k) Submission

KO50013

510(k) Number (if known): ating

Device Name: retractoFoam

Indications for Use:

For the temporary opening/widening of the sulcus.

× Prescription Use (21 CFR Part 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sura Runres

ിശാസ് Sien-Off) Crision of Anesinesiology, General Hospital, Intection Control, Dental Devices

Number: koscg13