COMPOGLASS FLOW

K974577 · Ivoclar North America, Inc. · EBF · Jan 30, 1998 · Dental

Device Facts

• Record ID: K974577
• Device Name: COMPOGLASS FLOW
• Applicant: Ivoclar North America, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects) Restorations in deciduous teeth Intermediary restorations Anterior Class III restorations

Device Story

Compoglass Flow is a dental restorative material used by dentists in clinical settings. It is indicated for Class V cavities, deciduous teeth restorations, intermediary restorations, and anterior Class III restorations. The device functions as a filling material to repair tooth structure damaged by caries or erosion. It is applied directly by the clinician to the prepared tooth cavity. The material provides a restorative benefit by replacing lost tooth structure, thereby restoring function and aesthetics to the patient's dentition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compoglass Flow is a dental restorative material. Specific material composition, polymerization mechanism, and physical dimensions are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects), restorations in deciduous teeth, intermediary restorations, and anterior Class III restorations.

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

JAN 30 1998

Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

K974577 Re : Compoglass Flow Trade Name: Regulatory Class: II Product Code: EBF December 2, 1997 Dated: Received: December 8, 1997

Dear Mr. Mancuso:

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, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with ... _ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531

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Page 2 - Mr. Mancuso

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 ene regaration Chororou, (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

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation ---Center for Devices and Radioloqical Health

Enclosure

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510(k) NUMBER (IF KNOWN): K974577

Compoglass Flow DEVICE NAME:

INDICATIONS FOR USE:

- Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects)
- Restorations in deciduous teeth
- Intermediary restorations
- Anterior Class III restorations

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

| Supper of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974577 |
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter-Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |