(79 days)
PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel to adhere orthodontic brackets to tooth surfaces.
PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel.
The provided text is a 510(k) clearance letter from the FDA for a dental adhesive. It does not contain any information about acceptance criteria or a study proving device performance.
Therefore, I cannot fulfill your request for the specific details you've asked for. The document is strictly a regulatory clearance and does not include scientific study results or performance metrics.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern around the edge. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K014059
Trade/Device Name: Pulpdent Trans OBA Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: December 4, 2001 Received: December 10, 2001
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 You must contint with an the Fict b requirements (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lacelity 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 310(K) premiation nonfloate 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 II you desire specific ad 1100 100 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Comphance wease contact the Office of Compliance at (301) 594-4639. advertising or your arranged, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (11 CF 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 the Act may be obtained from and Boumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy
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
Ko14059
PULPDENT TRANS OBA Orthodontic Bracket Adhesive Device Name
Indications for Use:
510 (k) Number
(if known)
PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel 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 (Per 21 CFR 801.109)
or
Over-The-Counter Use
Susan Runns
(Division Sign-Off) Division of Dental, Infection Control, േർ General Hospital Devi F : O(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.