RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT

K042215 · Premier Dental Products Co. · EMA · Sep 21, 2004 · Dental

Device Facts

• Record ID: K042215
• Device Name: RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
• Applicant: Premier Dental Products Co.
• Product Code: EMA · Dental
• Decision Date: Sep 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cementation of Gutta-Percha in root canal using the single cone technique.

Device Story

Premier EndoCem is a glass ionomer cement used by dental professionals for the cementation of Gutta-Percha points during root canal procedures. The device is applied within the root canal to secure the Gutta-Percha cone, facilitating the sealing of the canal. It functions as a restorative dental material to ensure proper obturation. The device is intended for prescription use only.

Clinical Evidence

bench testing only

Technological Characteristics

Glass ionomer cement; dental restorative material; 21 CFR 872.3275(b) classification; product code EMA.

Indications for Use

Indicated for the cementation of Gutta-Percha points in root canals using the single cone technique.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2004

Mr. Vince D'Alessandro Regulatory Manager Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462

Re: K042215

Trade/Device Name: Premier EndoCem Glass Ionomer Cement Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 11, 2004 Received: August 16, 2004

Dear Mr. D'Alessandro:

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 arior 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. Vince D'Alessandro

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issuance of a substance or and other requirements of the Act or
that FDA has made a determination that your device attemption of our must comply that FDA has made a determination into your dee a compless. You must comply with
any Federal statutes and regulations administered by other Federal and listing (21 CFR Part 8 any Federal statutes and regulations administered by other resustation and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration all the Act's requirements, Including proctice requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as est orth in th labeling (21 CFR Part 801); good manufacturing interests absorbed the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni systems (QS) regulation (21 OFR 120086), Act); 21 CFR 1000-1050.
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) This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of th premarket notification. The FDA finding of substantial equilter of 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 If you desire specific advice for your device on our and the results on the promotions on the promotion
contact the Office of Compliance at [phone]. Additionally, for contact the Office of Compliance at [phone] for and contact [phone]. Also,
and advertising of your device, please contact the Office of Compliance at (311 FFR and advertising of your device, prease comact as onemarket notification" (21CFR)
please note the regulation entitled, "Misbranding by references researchilities under the Act please note the regulation entitled, "Misuralion on your responsibilities under the Act may
Part 807.97) you may obtain. Other general information on Consumer Assistance any Part 807.97) you may obtain. Other getter informational Consumer Assistance at its
be obtained from the Division of Small Manufacturers, International Consumer Assistance at be obtained from the Dryiston or chiaon of chian its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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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## Statement of Indications for Use

510(k) Number (If known): __

K042215

Device Name: Premier Endo Cem

Indications for use: Cementation of Gutta-Percha in root canal using the single cone technique.

> Please do not write below this line Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-the-Counter Use Prescription Use Per 21 CFR 801.109

Optional Format 1-2-96

Sirsen Quorr

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiclogy, General Hospital, Division Control, Dental Devices

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510(k) Number: Kauai15