(208 days)
- An adjunct device to be used for short-term pain relief from muscle spasm pain due to occlusal interference.
- Prescription device.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "BEST BITE™ Discluder". This document is a regulatory approval, and it does not contain any information regarding acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to the device's efficacy or performance characteristics.
The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices, meaning it has similar intended use, technological characteristics, and safety and effectiveness. This determination is based on the information provided in the 510(k) premarket notification, which would have included data to support substantial equivalence. However, the details of that supporting data are not present in this letter.
Therefore, I cannot extract the requested information from the provided document.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
JUL 1 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jerome M. Simon, D.D.S. 1500 Summer Street Stamford, Connecticut 06905
Re: K980953
Trade/Device Name: BEST BITE™ Discluder Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: August 27, 1998 Received: September 4, 1998
Dear Dr. Simon:
This letter corrects our substantially equivalent letter of October 7, 1998.
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 (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 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. Simon
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 continue 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 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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 tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Smith Y. Michael David.
Chiú 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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K980953 510(k) Number:
Device Name: BEST-BITE™ Discluder
Indications for use:
- · An adjunct device to be used for short-term pain relief from muscle spasm pain due to occlusal interference.
- · Prescription device.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH, Office of Device Education (ODE)
Prescription Use
Or
Over-the-Counter Use _ (optional form 1-2-96)
Gerald Shupack
(Division Sign-Off)
Division of Dental, Infection Control. and General Hospital Devices 510(k) Number
N/A