(107 days)
- Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets.
- Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets.
- One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.
Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets. Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for S & C Polymer's Bracket Adhesives, detailing contact information, device names, descriptions, intended use, and claims of substantial equivalence to predicate devices. It also includes the FDA's clearance letter acknowledging substantial equivalence.
Therefore, I cannot provide the requested table and study details.
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S & C Polymer
AUG 2 0 2003
S & C-BRACKET ADHESIVES - Premarket Notification 510(k) Submission - page 7
510(k) Summary of Safety and Effectiveness
Submitter
S & C Polymer GmbH Robert-Bosch-Strasse 5 D-25335 Elmshorn (0049) (0) 4121-4830 (Phone) (0049) (0) 4121-483 181 (Fax)
Dr. Christian Boettcher (Contact Person)
Date Summary Prepared: April 2003
Device Name:
- S & C-Bracket Adhesives · Tride Name
- Bracket Adhesives • Common Name
- Adhesive, Bracket and tooth conditioner, Resin · Classification Name (per 21 CFR § 872.3750):
Devices for which Substantial Equivalence is claimed:
IVOCLAR VIVADENT (Manufacturer) LC BRACKET ADHESIVE: Heliosit Orthodontic (Product) RELIANCE ORTHODONTICS PRODUCTS DC BRACKET ADHESIVE: (Manufacturer) NO MIX BRACKET ADHESIVE: Rely a Bond (Product) Device Description: Light cure bracket adhesive for the direct bonding LC Bracket Adhesive: of transparent glass ceramic brackets, plastic brackets and metal brackets. Dual cure bracket adhesive for the direct bonding D( Bracket Adhesive: of glass ceramic brackets, plastic brackets and metal brackets One step bracket adhesive for the direct bonding No Mix Bracket Adhesive: of metal-, ceramic and plastic brackets.
Intended Jse of the Device:
The Bracket Adhesives are used for the bonding of brackets.
Substantial Equivalence:
The products are substantially equivalent to other legally marketed devices in the United States.
The Light Cure Bracket Adhesive marketed by Ivoclar Vivadent (Heliosit Orthodontic) functions in a m inner similar to and is intended for the same use as the product marketed by S & C Polymer (LC Bracket Adhesive).
The No Mix Bracket Adhesive marketed by Reliance Orthodontic Products (Rely a Bond) functions in a manner similar to and is intended for the same use as the product marketed by S & C Polymer (DC Bracket Adhesive, No Mix Bracket Adhesive).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2003
Dr. Christian Boettcher Regulatory Compliance Officer S & C Polymer Robert-Bosh-Strasse 5 D-25335 Elmshorn GERMANY
Re: K031420
Trade/ Device Name: S&C- Bracket Adhesives Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and tooth Conditioner Regulatory Class: II Product Code: DYH Dated: April 29, 2003 Received: May 5, 2003
Dear Dr. Boettcher:
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. Bottcher
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Susan Runner, DDS, MA, Interim 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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9. Statement of Indications for Use
510 k) Number (if known):
Device Name:
Ind cations for Use:
5031420
-
- LC Bracket Adhesive
-
- DC Bracket Adhesive
- No Mix Bracket Adhesive 3.
- Light cure bracket adhesive for the direct 1. bonding of transparent glass ceramic brackets, plastic brackets and metal brackets.
- Dual cure bracket adhesive for the direct 2. bonding of glass ceramic brackets, plastic brackets and metal brackets.
- One step bracket adhesive for the direct bonding 3. of metal-, ceramic and plastic brackets.
Kein Mulay for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K 031420
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescrintion Use:
§ 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.