DENTALIS KEZ ENDODONITC SEALER

K971642 · Neodental Chemical Products Co., Ltd. · EMA · Jul 24, 1997 · Dental

Device Facts

• Record ID: K971642
• Device Name: DENTALIS KEZ ENDODONITC SEALER
• Applicant: Neodental Chemical Products Co., Ltd.
• Product Code: EMA · Dental
• Decision Date: Jul 24, 1997
• 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 promote healing effects and to help prevent bacterial contamination of the canal.

Device Story

Dentalis Kez Endodontic Sealer is a dental material used by dentists during endodontic procedures. It is applied to prepared root canals to seal the space between the canal wall and the filling material (e.g., gutta percha). The sealer acts as a barrier to prevent bacterial contamination and is intended to promote healing within the canal. It is used in a clinical setting by dental professionals.

Technological Characteristics

Endodontic sealer material; chemical composition for sealing root canals.

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; intended to promote healing and prevent bacterial contamination.

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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kyle H. Sibinovic, Ph.D. ·Agent Neodental Chemical Company, Ltd. C/O Shaldra, Incorporated 7613 Carteret Road Bethesda, Maryland 20817

JUL 2 4 1997

Re : K971642 Trade Name: Dentalis Kez Endodontic Sealer Requlatory Class: II Product Code: EMA Dated: May 2, 1997 Received: May 2, 1997

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 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. ਪ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory action. In addition, FDA may publish further announcements 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 diaqnostic 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Time A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510 (k) Number (if known): K971642

Device Name: Dentalis Kez Endodontic 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 promote healing effects and to help prevent bacterial contamination of the canal.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|---------------------------------------|
| (Division Sign-Off) | Gerald Shipp |
| Division of Dental, infection Control, and General Hospital Devices | |
| 510(k) Number | K971642 |
| Prescription Use<br>(Per 21 CFR801 109) | <div> <span>✓</span> </div> |
| | OR |
| | Over-The-Counter Use<br>(Optional For |

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> Over-The-Counter Use (Optional Fomat 1-2-96)