(48 days)
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
The provided text is a 510(k) premarket notification for a dental adhesive system. It does not contain information about acceptance criteria, study design, or performance metrics in the way one would describe for an AI/ML medical device. This document is for a traditional physical medical device (Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System) and therefore the questions in the prompt, which are tailored for AI/ML device evaluations, are not applicable.
Here's why the questions are not relevant and what information is provided:
- Acceptance Criteria/Reported Device Performance: The document states the device is "substantially equivalent in composition and intended use to the products listed above." This is the primary "acceptance criterion" for a 510(k) submission for a non-AI device – demonstrating substantial equivalence to a legally marketed predicate device. There are no specific performance metrics (like sensitivity, specificity, AUC) reported because it's a materials science question rather than an diagnostic/AI performance question.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (for test/training sets): These concepts are fundamental to evaluating AI/ML models. They are entirely absent and irrelevant for a physical adhesive product. The "safety and effectiveness" section refers to general usage of dental restorative materials over 20 years, indicating a high benefit-to-risk ratio, and mentions that predicate products have received 510(k) approval. This is not a study in the context of AI/ML validation but rather a statement supporting general safety based on historical use of similar materials.
- Training Set Sample Size/Ground Truth: Not applicable for a physical device.
In summary, the provided text describes a 510(k) submission for a traditional dental adhesive and does not contain the information required to answer your specific questions related to AI/ML device evaluation.
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Pulpdent Sealant / Paste Orthodontic Bracket Adhesive System
EXHIBIT 2
K02013
FEB 2 8 2002
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
RESPONSE TO SMDA OF 1990
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: Fax: 617-926-6262
DEVICE
TRADE NAME: PULPDENT Sealant/ Paste Orthodontic Bracket Adhesive System CLASSIFICATION NAME: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: 76 DYH, 21 CFR Part 872.3750
PREDICATE DEVICES:
GAC AccuBond Sealant/Paste Bonding System GAC ExactaBond Sealant/Paste Bonding System Reliance Excel Bonding Adhesive Reliance Phase 11 Sealant/Paste System 3M Concise Orthodontic Bond System
DESCRIPTION AND INTENDED USE:
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is substantially equivalent in composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS:
According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States. In addition, the predicate products listed above have been given 510 (k) premarket approval as Class II Dental Devices under CFR 872.3750.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K020115
Trade/Device Name: Pulpdent Sealant/Paste Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: January 04, 2002 Received: January 11, 2002
Dear Mr. Berk:
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.
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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/dsmarnain.html
Sincerely yours,
Tim A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510 (k) Number (if known)
Device Name: PULPDENT Sealant / Paste Orthodontic Bracket Adhesive System
KO20115
Indications for Use:
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
or
Over-The-Counter Use
Susan Rinn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 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.