(329 days)
Jet Set 4 Denture Repair Resin is intended for the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). Jet Set 4 Denture Repair Resin is for prescription use only.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "Jet Set 4 Denture Repair Resin." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies as typically found in a clinical study report or a premarket approval (PMA) application.
Therefore, I cannot provide the requested information based on the input text. The document states:
- Trade/Device Name: Jet Set 4 Denture Repair Resin
- Regulation Number: 21 CFR 872.3760
- Regulation Name: Denture relining, repairing, or rebasing resin
- Regulatory Class: Class II
- Product Code: EBI
- Intended Use: For the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). For prescription use only.
The letter explicitly states, "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...". This indicates that the device was cleared based on substantial equivalence to a predicate device, which often involves comparison to existing device performance and safety profiles rather than a new standalone clinical efficacy or performance study.
To answer your request, a different type of document, such as a summary of safety and effectiveness data (SSED) for a PMA, or a clinical study report, would be necessary.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2,2016
Lang Dental Manufacturing Company, Inc. David Lang President/Owner 175 Messner Drive Wheeling, Illinois 60090
Re: K152981
Trade/Device Name: Jet Set 4 Denture Repair Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: July 7, 2016 Received: July 8, 2016
Dear Mr. David Lang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runner DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication(s) for Use Statement 4
510(k) Number (if known): K152981 Device Name: Jet Set 4 Denture Repair Resin
Indications for Use:
Jet Set 4 Denture Repair Resin is intended for the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). Jet Set 4 Denture Repair Resin is for prescription use only.
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 OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.