(306 days)
For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to seal canal walls, to promote healing effects and to help preserve the sealer and sealer / gutta percha interface.
MCS - Martin's Canal Sealer
This is a 510(k) clearance letter for a dental device, not a study report for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth cannot be extracted from this document.
The document discusses the regulatory clearance of "MCS - Martin's Canal Sealer" and states its intended use for sealing root canals. It confirms that the device is substantially equivalent to a legally marketed predicate device, indicating it meets the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
No information regarding AI/ML performance, acceptance criteria, or studies proving such criteria are met is present in this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 1998
Dr. Howard Martin, DMD, P.A. C/O Kyle H. Sibinovic, Ph.D. Agent for Dr. Howard Martin, DMD, P.A. Shaldra, Incorporated 4327 Reels Mill Road Frederick, Maryland 21704-7759
Re : K973636 Mcs-Martin's Canal Sealer Trade Name: Requlatory Class: II Product Code: EMA April 29, 1998 Dated: April 29, 1998 Received:
Dear Dr. Sibinovic:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 - Dr. Sibinovic
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 requlation (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,
Patricio Cucurella for
Timothy A. Ulatowski 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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510 (k) Number (if known): Original # 973636
Device Name: MCS - Martin's Canal Sealer
Indications for Use: For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to seal canal walls, to promote healing effects and to help preserve the sealer and sealer / gutta percha interface.
(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 CFR801 109)
Over-The-Counter Use (Optional Fomat 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. 15973636
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.