DEFINITE

K993514 · Degussa - Ney Dental, Inc. · EBF · Feb 24, 2000 · Dental

Device Facts

• Record ID: K993514
• Device Name: DEFINITE
• Applicant: Degussa - Ney Dental, Inc.
• Product Code: EBF · Dental
• Decision Date: Feb 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V. Since Definite® is light cured, it is offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.

Device Story

Definite® is a light-cured dental composite restorative material. It is supplied as a single-paste system in compules. The system is used in conjunction with Etch&Prime® 3.0, a self-etching adhesive. The device is intended for use by dental professionals in a clinical setting to restore tooth structure for Class I through Class V cavities. The material is applied to the prepared tooth cavity and cured using a dental light-curing unit to harden the composite, providing a restorative filling for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured dental composite restorative material; single-paste system; supplied in compules; used with self-etching adhesive (Etch&Prime® 3.0).

Indications for Use

Indicated for dental patients requiring Class I through Class V 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

FEB 2 4 2000

Thomas B. Cameron, Ph.D. Official Correspondent Director of R&D and Q.A. Degussa-Ney Dental, Incorporated 65 West Dudley Town Road Bloomfield, Connecticut 06002-1316

Re : K993514 Definite® Trade Name: Regulatory Class: II Product Code: EBF January 4, 2000 Dated: Received: February 7, 2000

Dear Dr. Cameron:

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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Paqe 2 - Dr. Cameron

the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 beqin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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

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 K993514

DEVICE NAME: Definite

INDICATIONS FOR USE:

Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V. Since Definite® is light cured, it is offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
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OR

| Over-The-Counter-Use (Optional Format 1-2-96) | |
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(Division Sign-Off) Pamela Scott for Susan Runner

Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K993514 |
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