MODIFICATION OF PARAPOST CEMENT

K993710 · Coltene/Whaledent, Inc. · EMA · Dec 21, 1999 · Dental

Device Facts

• Record ID: K993710
• Device Name: MODIFICATION OF PARAPOST CEMENT
• Applicant: Coltene/Whaledent, Inc.
• Product Code: EMA · Dental
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ParaCem cement is for the discretionary use by dentists for the permanent cementation of endodontic posts into root canals after endodontic therapy has been completed.

Device Story

ParaCem cement is a dental material used by dentists for permanent cementation of endodontic posts into root canals post-endodontic therapy. The device functions as a bonding/cementing agent to secure posts within the tooth structure. It is applied in a clinical dental setting by a licensed dentist. The output is a physical bond between the post and the root canal, providing structural support for subsequent dental restorations. The device benefits the patient by ensuring the stability and retention of endodontic posts, which are essential for restoring teeth that have undergone root canal treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement for endodontic post fixation. Chemical composition and physical properties are consistent with established dental cement standards for permanent restoration.

Indications for Use

Indicated for permanent cementation of endodontic posts into root canals following endodontic therapy. For use by dentists.

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.

Predicate Devices

• Para Post Cement (K945366)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Mr. H.J. Vogelstein Official Correspondent Coltene Whaledent Incorporated 750 Corporate Drive Mahwah, New Jersey 07430

Re : K993710 Trade Name: Modification of Parapost Cement Regulatory Class: II Product Code: EMA Dated : November 1, 1999 Received: November 3, 1999

## Dear Mr. Vogelstein:

Wc 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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMF, regulation (21 CFR Part 820) and that, through periodic GMF inspections, the Food and Drug Administration (FDA) will verily such assumptions. Failure to comply with the GMP . Gulation may result in regulatory 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 through 542 of the Act for devices under the Electronic Product Radiation

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Mr. Vogelstein Page 2

Control provisions, or other Federal laws or regulations. 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" (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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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## Coltène/Whaledent Inc.

## Amended Submission to K945366 Para Post Cement Indications for Use

ParaCem cement is for the discretionary use by dentists for the permanent cementation

of endodontic posts into root canals after endodontic therapy has been completed.

Prescription Use
(Per 21 CFR 801.109)

Susan Runyon

(Division Sign-Off) Division of Dental, Infection Con and General Hospital D 510(k) Number

529c

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