(94 days)
The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials.
The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a product called "Bosworth Dentin Resin," dated September 1, 2006.
It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the specified indications for use. This letter is an official notification of market clearance based on substantial equivalence, not a detailed report of performance testing against specific acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a staff with two snakes entwined around it, which is a symbol often associated with medicine and healthcare. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2006
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Re: K061611
Trade/Device Name: Bosworth Dentin Resin Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 27, 2006 Received: July 31, 2006
Dear Ms. Goldstein:
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 – Ms. Mildred M. Goldstein
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
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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Page 1 of 1
510(K) Number: K061611
Device Name: Bosworth Dentin Resin
INDICATIONS FOR USE:
The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials.
The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.
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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1/2/96) Jun-Off) on of Anesthesiology, General Hospital, ion Control, Dental Devices foumber
§ 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.