PRE-VISION FILL

K993602 · Heraeus Kulzer, Inc. · EBF · Dec 15, 1999 · Dental

Device Facts

• Record ID: K993602
• Device Name: PRE-VISION FILL
• Applicant: Heraeus Kulzer, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All temporary fillings and temporary restorations using inlay and onlay restorations.

Device Story

PreVision FILL is a dental material used for temporary fillings and restorations, including inlays and onlays. It is applied by dental professionals in a clinical setting to provide temporary coverage for prepared teeth. The device functions as a restorative material to protect the tooth structure and maintain space until the final restoration is placed. It is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Dental restorative material for temporary use. Formulated for inlay and onlay applications. Class II device, product code EBF.

Indications for Use

Indicated for patients requiring temporary fillings and temporary restorations for inlay and onlay 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

DEC 1 5 1999

Ms. Cheryl V. Zimmerman Manager Quality Operations and Regulatory Affairs Heraeus Kulzer, Inc. 4315 S. Lafayette Blvd. South Bend, Indiana 46614-2517

K993602 Re: PreVision Fill Trade Name: Requlatory Class: II Product Code: EBF Dated: October 22, 1999 Received: October 25, 1999

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Zimmerman

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

A. 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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510(k) Number (if Known):

Device Name: Prevision® FILL

Indications For Use:

All temporary fillings and temporary restorations using inlay and onlay restorations.

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

Concurrence of CDRH, Office of Device evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number __