POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT

K030727 · Healex Products, Inc. · EMA · Jun 5, 2003 · Dental

Device Facts

• Record ID: K030727
• Device Name: POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
• Applicant: Healex Products, Inc.
• Product Code: EMA · Dental
• Decision Date: Jun 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For luting temporary crowns to prepared crowns.

Device Story

Preserve-Temp Plus is a dental cement used by dentists to lute temporary crowns to prepared teeth. The device functions as a bonding agent to secure temporary restorations during the interim period before permanent crown placement. It is applied in a clinical dental setting by a licensed practitioner. The device provides temporary retention, allowing for easy removal of the temporary crown when the permanent restoration is ready. It benefits the patient by maintaining tooth position and protecting the prepared tooth structure during the fabrication of the final restoration.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Dental cement classified under 21 CFR 872.3275. Product code EMA. Formulated for temporary luting applications. No specific material standards or software components described.

Indications for Use

Indicated for luting temporary crowns to prepared teeth in dental patients.

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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2003

Milton Hodosh D.M.D Healex Products, Incorporated 243 Elmwood Avenue Providence, Rhode Island 02907

Re: K030727

Trade/Device Name: Preserve - Temp Plus Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 5, 2003 Received: March 7, 2003

Dear Dr. Hodosh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Dr. Hodosh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner, DDS, MA

Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number (if known): K030727
Device Name: Preserve-Temp Plus

Indications For Use:

For luting temporary crowns to
prepared crowns.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Muly for MSR

Anesthesiolo al Hospital, ction Control. Dent

510(k) Number: 030727

Prescription Use (P =r 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)