MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT

K022025 · Milton Hodosh, M.D. · EJK · Aug 15, 2002 · Dental

Device Facts

• Record ID: K022025
• Device Name: MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
• Applicant: Milton Hodosh, M.D.
• Product Code: EJK · Dental
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOR LINING AND BASES UNDER AMALGAM AND/OR Composite RESTORATIONS AND FOR LUTING FULL CROWNS TO PREPARED TEETH.

Device Story

Preserve Cavity Liner is a dental material used by clinicians for restorative procedures. It functions as a liner and base beneath amalgam or composite restorations and as a luting agent for cementing full crowns to prepared teeth. The device is applied directly to the tooth structure during dental procedures to provide a protective barrier or adhesive interface. It aids in the restoration process by supporting filling materials and securing prosthetic crowns, thereby contributing to the structural integrity and longevity of dental repairs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Calcium hydroxide-based cavity liner. Class II device under 21 CFR 872.3250. Product code EJK.

Indications for Use

Indicated for use as a cavity liner and base under amalgam or composite restorations and for luting full crowns to prepared teeth in dental patients.

Regulatory Classification

Identification

A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 5 2002

Dr. Milton Hodosh 243 Elmwood Avenue Providence, Rhode Island 02907

Re: K022025

Trade/Device Name: Preserve Cavity Liner Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: July 12, 2002 Received: July 16, 2002

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.

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.

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Page 2 - Dr. Hodosh

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 (OS) 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

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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## Indications for Use

510(k) Number (if known): KO22Q25-m odficiation of Pornssium WIRREY's Lycon Boxy LBTF DEVITAL CEMENT Device Name: NoT NAMED YET

Indications for Use:

FOR LINING AND BASES UNDER AMALGAM AND/OR Composite RESTORATIONS AND FOR LUTING FULL CROWNS TO PREPARED TEETH.

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022025