ZINFOS ZINC PHOSPHATE CEMENT

K982913 · Scientific Pharmaceuticals, Inc. · EMA · Oct 19, 1998 · Dental

Device Facts

• Record ID: K982913
• Device Name: ZINFOS ZINC PHOSPHATE CEMENT
• Applicant: Scientific Pharmaceuticals, Inc.
• Product Code: EMA · Dental
• Decision Date: Oct 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.

Device Story

ZinFos is a zinc phosphate cement used by dental professionals for the permanent cementation of crowns and bridges. It is applied to non-vital teeth and vital teeth where conventional zinc phosphate cement is clinically indicated. The device functions as a luting agent to secure dental restorations in place. It is intended for professional use only in a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Zinc phosphate cement composition. Formulated for permanent dental cementation. Professional use only.

Indications for Use

Indicated for permanent cementation of crowns and bridges on non-vital teeth and vital teeth where conventional zinc phosphate cement is appropriate. For professional use only.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 1998

Dr. Jan A. Orlowski Scientific Pharmaceuticals, Incorporated 3221 Producer Way 91768 Pomona, California

K982913 Re : ZinFos Zinc Phosphate Cement Trade Name: Regulatory Class: II EMA Product Code: Dated: August 14, 1998 Received: August 19, 1998

Dear Dr. Orlowski

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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Orlowski

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 qeneral 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. 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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K982913 510(k) NUMBER (IF KNOWN):

ZinFos ZINC PHOSPHATE CEMENT DEVICE NAME:

INDICATIONS FOR USE:

For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.

(PLEASE DO NO" WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

*None of the above: FOR PROFESSIONAI USE ONIY

Susan Rumm

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