(32 days)
A nanofilled, light-cured, clear resin intended for use by a indications I or Goor Amanonization of a glaze and sealant 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 impart high only and restoration durability and resistance to abrasive wear. This is exportune is substantially equivalent to other FDA-certified devices (cited above) marketed in the USA. It functions in a manner similar to them and is intended for the same use as these predicate devices.
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. Cures without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. This material is substantially equivalent to other FDA-certified devices (cited above) marketed in the USA. It functions in a manner similar to them and is intended for the same use as these predicate devices.
The provided text is a 510(k) summary for a medical device (Resin Glaze) and correspondence from the FDA. It does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on general administrative and classification details, including:
- Submitter and contact information
- Submission date
- Trade and common name of the device
- Classification information
- Equivalence to predicate devices
- Description and Intended Use
- FDA's letter of substantial equivalence approval
Therefore, I cannot provide the requested information about acceptance criteria and a study to prove device performance based on the given text.
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:
510(k) SUMMARY
| Submitter: | Parkell, Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: 631-249-1134FAX: 631-249-1242 |
|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 |
| Submission Date: | 15 April 2003 |
| Trade Name: | Currently Not Available |
| Common Name: | Resin Glaze |
| Classification Name: | Coating, Filling Material, Resin |
| Equivalence: | belleGlaze, LuxaGlaze, Biscover XT, Biscover Polish |
| Description/Intended Use: | A nano-filled, light-cured, clear resin intended for use bya duly licensed professional as a glaze and sealer forcomposite resin restorations or for acrylic, bis-acryland/or composite temporary materials. It can be used toimpart high sheen and seal to appropriate surfaces.Cures without oxygen-inhibition and is expected toextend restoration durability and resistance to abrasivewear. This material is substantially equivalent to otherFDA-certified devices (cited above) marketed in theUSA. It functions in a manner similar to them and isintended for the same use as these predicate devices. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2004
Dr. Nelson J. Gendusa Director of Research Parkell, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735
Re: K040599
Trade/Device Name: Resin Glaze Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: April 01, 2004 Received: April 05, 2004
Dear Dr. Gendusa:
Wc 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 referented 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 - Nelson J. Gendusa, DDS
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) 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), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
fthuhsh
for,
Chiu S. Lin. PhD 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
510(k) Number (if known): K040599
Device Name: Resin Glaze
Indications For Use: A nanofilled, light-cured, clear resin intended for use by a indications I or Goor Amanonization of a glaze and sealant 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 impart high only and restoration durability and resistance to abrasive wear. This is exportune is substantially equivalent to other FDA-certified devices (cited above) marketed in the USA. It functions in a manner similar to them and is intended for the same use as these predicate devices.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Boz DDS for Dr. Susan Runner
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040599
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§ 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.