(89 days)
GC OPB-100 is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns (e.g., Herbst or expansion appliances).
Not Found
I am sorry, but the provided text from K080724 is a 510(k) clearance letter from the FDA for a dental bonding agent (GC OPB-100). This type of document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way you've requested.
Specifically, this document is a notification of substantial equivalence to a predicate device, which means the FDA determined it is as safe and effective as a legally marketed device. It does not elaborate on the specific performance studies, acceptance criteria, or statistical details often found in performance reports or clinical trial summaries.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: This letter focuses on regulatory clearance, not on presenting performance metrics against specific acceptance criteria.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, and Training Set Ground Truth: These details are part of the underlying technical data and studies submitted by the manufacturer to the FDA, but they are not included in this summary clearance letter.
To answer your questions, one would need access to the full 510(k) submission, which is typically not publicly available in this level of detail. The provided document only serves as confirmation of regulatory clearance based on a determination of substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 2008
Dr. Mark Heiss Director - Professional Relations and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K080724
Trade/Device Name: GC OPB-100 Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: June 4, 2008 Received: June 4, 2008
Dear Dr. Heiss:
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.
{1}------------------------------------------------
Page 2- Dr. Heiss
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,
Chris
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K080724
Device Name: GC OPB-100
Indications For Use: GC OPB-100 is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns (e.g., Herbst or expansion appliances).
Prescription Use
(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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kim Hauley for MSA
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
10(k) Number: K080724
Page ી
§ 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.