PREMIER IMPLANT CEMENT, MODEL 3001450

K033309 · Premier Dental Products Co. · EMA · Jan 26, 2004 · Dental

Device Facts

• Record ID: K033309
• Device Name: PREMIER IMPLANT CEMENT, MODEL 3001450
• Applicant: Premier Dental Products Co.
• Product Code: EMA · Dental
• Decision Date: Jan 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Premier Implant Cement™ is a non-eugenol temporary cement for luting implant-retained crowns.

Device Story

Premier Implant Cement is a non-eugenol temporary dental cement used by dentists in clinical settings for luting implant-retained crowns. The device functions as a bonding agent to secure the crown to the implant abutment while allowing for future removal if necessary. It is applied by the clinician during the restorative phase of implant treatment to provide temporary retention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-eugenol temporary dental cement. Class II device (Product Code: EMA).

Indications for Use

Indicated for luting implant-retained crowns in patients requiring temporary cementation.

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

JAN 2 6 2004

Premier Dental Products Corporation C/O Mr. Barry Hale C.Q.E 7707 E 201 Terr Belton, Missouri 64012

Re: K033309

Trade/Device Name: Premier Implant Cement, Model 3001450 Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 14, 2004 Received: January 20, 2004

Dear Mr. Hale:

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 approvial applivines 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 WI ), I may be copy of 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. Hale

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 modi that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Aor of any I ederal banked is requirements, including, but not limited to: registration r od linting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu fishing (21 CFR Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirements us bet form in are quadiation 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) I mis letter will and A yourse 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), If you desire specification 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,

Chiu Lin, Ph.D.

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):_____________________________________________________________________________________________________________________________________________________

Device Name: Premier Implant Cement™

Indications for Use: Premier Implant Cement™ is a non-eugenol temporary cement for luting implant-retained crowns.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runor

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

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510(k) Number: _ LU33309