CEMENT-IT ALL PURPOSE, MODEL N97

K060698 · Pentron Clinical Technologies · EMA · May 10, 2006 · Dental

Device Facts

• Record ID: K060698
• Device Name: CEMENT-IT ALL PURPOSE, MODEL N97
• Applicant: Pentron Clinical Technologies
• Product Code: EMA · Dental
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.

Device Story

Cement-It All Purpose is a self-etching, dual-cure adhesive resin cement used by dentists for luting dental restorations. Supplied in automix dual-barrel syringes for direct application to the restorative site. Eliminates need for separate etchant, primer, or adhesive. Provides strength and radiopacity via barium borosilicate glass filler. Used in clinical dental settings to secure inlays, onlays, crowns, bridges, and posts.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Dual-cure luting agent; self-etching adhesive resin cement. Composition: ~65% filler by weight (barium borosilicate glass, particle size <2 microns). Delivery: Automix dual-barrel syringe. Radiopaque.

Indications for Use

Indicated for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. Not indicated for veneer restorations.

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

• MaxCem (K041474)

Submission Summary (Full Text)

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cing dentistry one Innovation at a time."

MAY 10 2006

#### 6.0 510(K) SUMMARY

Pentron Clinical Technologies, LLC, 68 North Plains Industrial Road Wallingford, CT 06492 Tel: [phone] Fax: [phone] Contact: Greg Moreau =============================================================================================================================================================================

Trade Name: Cement-It All Purpose Common Name: Dental resin cement Classification Name: Dental Cement, 21CFR 872.3275, EMA ==============================================================================================================================================================================

Cement-It All Purpose product performs the same intended function as its predicate device, MaxCem (reference K041474). Both devices are intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. Both devices are not recommended for use on veneer restorations.

The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive.

Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features.

Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.

A review for safety and effectiveness was performed and found not to have been affected.

510(k) Submission for Cement-It All Purpose

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 10 2006

Mr. Greg Moreau Director, Quality Systems Pentron Clinical Technologies, LLC 68 North Plains Industrial Road Wallingford, Connecticut 06492

Re: K060698

Trade/Device Name: Cement-It All Purpose Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 28, 2006 Received: May 03, 2006

Dear Mr. Moreau:

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 - Mr. Greg Moreau

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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Chu S. Lin, PhD

Chiu S. Lin, PhD 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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5.0 INDICATION FOR USE STATEMENT

510(k) NUMBER (if KNOWN):

DEVICE NAME: Cement-It All Purpose

# INDICATION FOR USE:

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Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.

# (PLEASE DO NOT 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) | <div> <span style="font-size: 2em;">✓</span> </div> |
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OR

| Over-The-Counter-Use (Optional Format 1-2-96) | |
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510(k) Submission for Cement-It All Purpose

(Signature Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

K060698