(17 days)
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket.
The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands.
The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental adhesive device, Aegis® ORTHO Dual-Cured Orthodontic Adhesive. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.
The document primarily addresses the substantial equivalence of the device to existing predicate devices under the FDA's 510(k) pathway. This pathway is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically involve the detailed performance studies, acceptance criteria, or ground truth establishment that would be associated with AI/ML devices.
Therefore, for your request, I cannot provide the information as it relates to an AI/ML device study because:
- No acceptance criteria are mentioned for an AI/ML device. The document discusses regulatory compliance for a physical dental adhesive.
- No study proving device performance in the context of AI/ML is detailed. The letter acknowledges the device's substantial equivalence to predicate devices, but this is a regulatory determination, not a performance study for an AI/ML algorithm.
- None of the requested specific categories (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) are present in the document. These are relevant to AI/ML device evaluation, not a physical dental adhesive.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2004
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Rc: K040547
Trade/Device Name: Aegis® ORTHO Dual-Cured Orthodontic Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH and EMA Dated: February 27, 2004 Received: March 09, 2004
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 approvisions 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 Please be advised that I DA 3 issualled of a sassamming with other requirements mean that ITDA has made a decemmand regulations administered by other Federal agencies. of the Act of ally rederal statutes and registeredts, including, but not limited to: registration You must contint an the Her Her Prece Proq.21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirents as set form in the quality by sections (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) This letter will anow you to begin mained of substantial equivalence of your device to a premarket nothleation. THC FDA mainly or salessification 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), If you desire specific advice for your as at (301) 594-4613. Additionally, for questions on please contact the Office of Compliance at ( s o) , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , the promotion and the regulation entitled, "Misbranding by reference to (201) 594-4059. Also, please note are are not obtain. Other general information on premarket notification (21 Cr Act may be obtained from the Division of Small your responsibilities ander the 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
Sincercly yours,
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
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Page 1 of 1
510(K) Number:
Device Name: Aegis-ORTHO Dual-Cured Orthodontic Adhesive
INDICATIONS FOR USE:
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket.
The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands.
The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use OR (Optional Format 1/2/96)
Susa Russo
ction Control Dental
510(k) Number:
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.