(14 days)
Bonding of orthodontic brackets to natural and artificial tooth surfaces
The LC BRACKET ADHESIVE SYSTEM is a two-part lightcure system (adhesive and primer) used in conjunction with a tooth conditioner.
The provided text is a 510(k) summary for the DENTSPLY International LC BRACKET ADHESIVE SYSTEM. It describes the device, its intended use, and states that it relies on substantial equivalence to predicate devices because its components have been used in legally marketed devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory filing stating substantial equivalence, not a study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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APR 6 2005
Ka50750
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | March 18, 2005 |
| TRADE OR PROPRIETARY NAME: | LC BRACKET ADHESIVE SYSTEM |
| CLASSIFICATION NAME: | Bracket adhesive resin and tooth conditioner (872.3750) |
| PREDICATE DEVICES: | Ideal® 1 Orthodontic Bracket Adhesive (K033703) |
DESCRIPTION OF DEVICE: The LC BRACKET ADHESIVE SYSTEM is a two-part lightcure system (adhesive and primer) used in conjunction with a tooth conditioner.
INTENDED USE: The LC BRACKET ADHESIVE SYSTEM is indicated for bonding of orthodontic brackets to natural and artificial tooth surfaces.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in the LC BRACKET ADHESIVE SYSTEM have been used in legally marketed devices.
We believe that the prior use of the components of the LC BRACKET ADHESIVE SYSTEM in legally marketed devices and the similarity of the modified device to the marketed device support the safety and effectiveness of the LC BRACKET ADHESIVE SYSTEM for the intended uses.
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APR 6 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K050750
Trade/Device Name: LC Bracket Adhesive System Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: March 18, 2005 Received: March 23, 2005
Dear Ms. Lewis:
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. Helen Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr i seven that your device complies with other requirements of the Act or that I Dria inade a decemination and regulations and agencies. You must comply with CEP Posts of ally I cuclar statutes and regulares and limited to: registration and listing (21 CFR Part 807); all the Act 3 requirements, moractires, was acturements as set forth in the quality labeling (21 CFR Part 801); 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) I mis letter witi anow you to organization of substantial equivalence of your device to a legally premits to medicate 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 If you desire specific 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 general information on your copyiblement Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Ching-S. Liu, Ph.D.
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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INDICATIONS FOR USE STATEMENT
11050750 510(K) Number (if known):
Device Name: LC BRACKET ADHESIVE SYSTEM
Indications for Use:
Bonding of orthodontic brackets to natural and artificial tooth surfaces
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Purr
ivision Sign-Off) vision of Anesthesiology, General Hospital, Intection Control, Dental Devices
KOSO 757 " 19('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.