PARAPOST PARACORE AUTOMIX 5ML

K052820 · Coltene/Whaledent AG · EBF · Jan 9, 2006 · Dental

Device Facts

• Record ID: K052820
• Device Name: PARAPOST PARACORE AUTOMIX 5ML
• Applicant: Coltene/Whaledent AG
• Product Code: EBF · Dental
• Decision Date: Jan 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts

Device Story

ParaPost ParaCore Automix 5ml is a dental resin material used by dentists for core build-ups and post cementation. The device is supplied in an automix delivery system. It functions as a restorative material to provide structural support for teeth requiring crowns or other restorations. The clinician applies the material directly to the prepared tooth or post space. It hardens to form a stable foundation for subsequent dental procedures. The device is intended for professional use in a clinical dental setting.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tooth shade resin material; automix delivery system; Class II device; Regulation 872.3690; Product Code EBF.

Indications for Use

Indicated for core build-ups and cementation of posts in dental patients requiring restorative procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 9

Coltene/Whaledent AG C/O Mr. II.J. Vogelstein Consultant Henry J. Vogelstein 1349 Lexington Avenue New York, New York 10128

Re: K052820

Trade/Device Name: ParaPost ParaCore Automix 5ml Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 9, 2005 Received: December 12, 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. 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 (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.

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), please 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 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/cdrh/industry/support/index.html.

Sincerely yours.

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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Coltène/Whaledent AG 510(k) Submission ParaPost ParaCore automix 5ml Indications for use

## Indications for use

Kosz8zo 510(k) Number (if known): n/k

Device Name:

ParaPost ParaCore automix 5ml

Indications for use:

- ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts

X Prescription Use: _ (21 CFR Part 801 Subpart D)

Over-the Counter Use: _ (21 CFR Part 807 Subpart C)

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

and/or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punner

Sydney General Hosp

Edwards, Lifesci Devices

K052820