(186 days)
Desensitizing dentin surfaces by occluding dentin tubules with A mixture of 2 Liquids, Use under crowns And Gridges before cementation, OR for treating cervical Class V erosiono.
Not Found
I am sorry, but based on the provided document, I cannot answer questions about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "GREEN-OR Dentin Desensitizer," indicating that the device has been found substantially equivalent to a legally marketed predicate device.
This type of document primarily confirms regulatory clearance for marketing based on substantial equivalence, rather than detailing specific performance acceptance criteria or the results of a stand-alone clinical study that proved those criteria were met. The letter does not contain information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or ground truth establishment for any studies.
- Details about expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
- Information on standalone algorithm performance or training set details.
To obtain such information, one would typically need to review the original 510(k) submission summary or other supporting documentation, which is not included in this extract.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH &" are vertically oriented on the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 DEC
Mr. John Discko Executive Vice President Centrix, Incorporated 770 River Road 06484-5458 Shelton, Court
Re : K981972 Green-OR Dentin Desensitizer Trade Name: Requlatory Class: II Product Code: LBH September 17, 1998 Dated: September 21, 1998 Received:
Dear Mr. Discko:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Discko
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN):
DEVICE NAME: GREEN-OR Desensitizer
INDICATIONS FOR USE:
Desensitizing dentin surfaces
by occluding dentin tubules with A
mixture of 2 Liquids, Use under
crowns And Gridges before cementation,
OR for treating cervical Class V
erosiono.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation
Over-The-Counter-Use OR Prescription Use Optional Format 1-2-96) (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.