(42 days)
Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.
Not Found
This is a letter from the FDA to a medical device manufacturer, indicating that their device, "Adhesive 1," has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance for marketing the device.
Therefore, I cannot extract the requested information regarding the acceptance criteria and the study that proves the device meets them from the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Ms. Samantha J. Cheetham Director, Sales and Marketing Southern Dental Industries, Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106
Re: K050331
Trade/Device Name: Adhesive 1 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and LBH Dated: March 10, 2005 Received: March 14, 2005
Dear Ms. Cheetham:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 910(t) program is substantially equivalent (for the indications for relerenced above and nave decemined are esseed predicate devices marketed in interstate commerce use stated in the encreated to togent date of the Medical Device Amendments, or to devices that proof to May 26, 1970, the enactions and the provisions of the Federal Food, Drug, and Cosmetic liave been teclassified in accordants with a premarket approval application (PMA). You may, Act (Act) that ao not require applovar othe general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good controls provisions of the rist in, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see ao rol) ... Existing major regulations affecting your device can be may be subject to such additional controller. Title 21, Parts 800 to 898. In addition, FDA may publish fourther announcements concerning your device in the Federal Register.
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Page 2 – Ms. Samantha J. Cheetham
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Syrita Michael Davis
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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510(k) Number (if known): K (05033 |
Device Name:
Indications For Use:
Adhesive 1
ﮩﺮ ﮨﮯ
Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: $\checkmark$
(Per 21 CFR 801.109)
Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1-2-96)
of Anesthesiology, General Hospital, ion Control, Dental Devices
ber K05033)
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.