(284 days)
The Pre-Cemented Orthodontic Bracket System is indicated for use in bonding orthodontic appliances for orthodontic treatment.
The Pre-Cemented Orthodontic Bracket System consists of precemented orthodontic brackets and an optional bonding tray. The orthodontic brackets and component used in the application are currently marketed medical devices.
The provided text describes a 510(k) premarket notification for a "Pre-Cemented Orthodontic Bracket System." However, it is not a study that proves the device meets acceptance criteria.
The document is a notification from the FDA confirming that the agency has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that based on the provided information, the FDA believes the new device has the same intended use and technological characteristics as a device already on the market, and therefore does not require a premarket approval application (PMA).
The document does NOT contain:
- Acceptance criteria for performance.
- Results from any studies (clinical or bench) comparing the device's performance against specific metrics.
- Information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The 510(k) summary explicitly states: "All of the components found in the Pre-Cemented Orthodontic Bracket System are legally marketed devices or are found in legally marketed devices. As there are no changes in formulation from the predicate devices, we believe that additional biocompatibility testing is not required." This suggests that the substantial equivalence argument relies on the existing safety and effectiveness of the predicate devices and their components, rather than new, independent performance testing of the combined system against defined acceptance criteria.
Therefore, I cannot populate the requested table and information as the provided text does not contain the necessary details about acceptance criteria or a study proving the device meets them.
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FEB 1 2 2007
510(k) SUMMARY
| Owner/Contact Information: | ||
|---|---|---|
| Dr. Carolyn PrimusPrimus Consulting7046 Owl's Nest TerraceBradenton, FL 34203 | 941-753-9737 |
| Date Summary Prepared: | May 1, 2006 |
|---|---|
| ------------------------ | ------------- |
Pre-Cemented Orthodontic Bracket System Draft Trade Name:
FDA Classification Name and Number: Bracket adhesive resin and tooth conditioner, 872.3750 Resin impression tray material, 872.3670
APC™ Plus Adhesive K020394 Legally Marketed Predicate Devices
Description of the Device: The Pre-Cemented Orthodontic Bracket System consists of precemented orthodontic brackets and an optional bonding tray. The orthodontic brackets and component used in the application are currently marketed medical devices.
Intended use: The Pre-Cemented Orthodontic Bracket System is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Technological Characteristics: All of the components found in the Pre-Cemented Orthodontic Bracket System are legally marketed devices or are found in legally marketed devices. As there are no changes in formulation from the predicate devices, we believe that additional biocompatibility testing is not required.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The overall design is simple and professional, conveying a sense of authority and trustworthiness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Carolyn M. Primus Official Correspondent Primus Consulting 7046 Owl's Nest Terrace Bradenton, Florida 34203
FEB 1 % 2007
Re: K061252
Trade/Device Name: Pre-Cemented Orthodontic Bracket System Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: January 4, 2007 Received: January 22, 2007
Dear Dr. Primus:
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 - Dr. Primus
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" (21CFR 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,
Clare
Chiu Lin, Ph.D. 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): K061252
Device Name: Pre-Cemented Orthodontic Bracket System
Indications for Use:
Indicated for use in bonding orthodontic appliances for orthodontic treatment
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clare
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ingina Sign, Oif) Obision of Agesthestology. General Hospital, Infortion Control, Disnial De
§ 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.