(76 days)
A nano-filled, light-cured, clear resin intended for use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. Due to its photo-initiators, it may be cured by all common dental curing lights.
DuraFinish All-Cure is a nano-filled, light-cured, clear a gloza ond now as the use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces. Due to its added photo-initiators, it may be cured by any common dental curing light.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental product called "DuraFinish All-Cure Resin Glaze," detailing its classification, intended use, and substantial equivalence to a predicate device, but it does not include performance data or studies against specific acceptance criteria.
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Ko80549
510(k) SUMMARY
MAY 1 3 2008
Submitter:
Contact:
Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 TEL: 631-249-1134 FAX: 631-249-1242
Daniel R. Schechter, Esq., RAC VP, Regulatory Affairs Parkell, Inc. 300 Executive Drive Edgewood, NY 11717
Coating, Filling Material, Resin
Parkell Resin Glaze (K040599)
26 February 2008
Resin Glaze
DuraFinish All-Cure
Common Name:
Trade Name:
Submission Date:
Classification Name:
Equivalence:
Description/Intended Use:
DuraFinish All-Cure is a nano-filled, light-cured, clear a gloza ond now as the use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces. Due to its added photo-initiators, it may be cured by any common dental curing light.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2008
Mr. Daniel R. Schechter, Esq. Vice President, Regulatory Affairs Parkell, Incorporated 300 Executive Drive Edgewood, New York 11717
Re: K080549
Trade/Device Name: DuraFinish All-Cure Resin Glaze Regulation Number: 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: February 26, 2008 Reccived: February 27, 2008
Dear Mr. Schechter:
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. Schechter
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 (QS) 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) promarket 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sytay. Mckeen Ons
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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Indications for Use
K080549 510(k) Number (if known):
Device Name: DuraFinish All-Cure Resin Glaze
Indications for Use:
A nano-filled, light-cured, clear resin intended for use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. Due to its photo-initiators, it may be cured by all common dental curing lights.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Marley for MR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080549
Page 1 of
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.