MCS-MEDICATED CANAL SEALER

K973636 · Dr. Howard Martin, P.A. · EMA · Jul 27, 1998 · Dental

Device Facts

• Record ID: K973636
• Device Name: MCS-MEDICATED CANAL SEALER
• Applicant: Dr. Howard Martin, P.A.
• Product Code: EMA · Dental
• Decision Date: Jul 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

MCS-Martin's Canal Sealer is a dental material used by dentists during endodontic procedures. It is applied to the walls of prepared root canals to create a seal before the final placement of gutta-percha or other root canal filling materials. The sealer functions to promote healing and maintain the integrity of the interface between the canal wall and the filling material. It is intended for professional use in a clinical setting.

Technological Characteristics

Dental root canal sealer material. Formulated for application to canal walls to interface with gutta-percha. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for sealing prepared root canals in adult or deciduous teeth prior to final filling with gutta percha or other root canal fillers.

Regulatory Classification

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. 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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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