SYNERGY FLOW

K013400 · Coltene/Whaledent, Inc. · EBF · Dec 10, 2001 · Dental

Device Facts

• Record ID: K013400
• Device Name: SYNERGY FLOW
• Applicant: Coltene/Whaledent, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Class II, IV fillings in anterior teeth Small fillings in posterior teeth Fillings of minimal cavities Blocking out undercuts

Device Story

Synergy Flow is a resin-based dental restorative material used by dentists in clinical settings. It is applied to tooth cavities to restore structure and aesthetics. The material is placed into the cavity preparation and cured to harden. It serves as a restorative filling for specific cavity classes and as a liner or base for blocking out undercuts in dental procedures. It benefits patients by providing a durable, tooth-colored material for repairing dental decay or structural defects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based dental restorative material. Classified as Class II under 21 CFR 872.3690. Product code EBF.

Indications for Use

Indicated for patients requiring Class II and IV anterior tooth restorations, small posterior tooth restorations, minimal cavity fillings, and blocking out of undercuts.

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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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 0 2001

Mr. H. J. Vogelstein Official Correspondent Coltene/Whaledent, Incorporate 750 Corporate Drive Mahwah, New Jersey 07430-2009

Re: K013400

Trade/Device Name: Synergy Flow Regulation Number: 872.3690 Regulation Name: Tooth Shade, Resin Regulatory Class: II Product Code: EBF Dated: October 12, 2001 Received: October 15, 2001

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.

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.

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### Page 2 - Mr. Vogelstein

You must comply with all the Act's requirements, including, but not limited to: registration r od intist comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF Rever) (QS) regulation (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct 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 I his lower will and 1. 900 to even expantial equivalence of your device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and cautionally = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the receinter Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K013400

# SYNERGY® Flow Indications

(Revised 04 December 2001)

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- ······· Class II, IV fillings in anterior teeth
- •••••••• Small fillings in posterior teeth
- ······· Fillings of minimal cavities
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- ••••••••••• Blocking out undercuts
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A. Vogelstein

Susan Punner

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