DYRACT® CEM PLUS CEMENT is indicated for: 1) Cementation of conventional metal or porcelain-fused-to-metal inlays, crowns, bridges, posts and post-core units: 2) Adhesive cementation of porcelain, composite, or all-ceranic inlays, onlays and crowns; and 3) Cementation of all-zirconia bridges.

Device Description

DYRACT® CEM PLUS CEMENT is a dental luting cement (powder/liquid system) that combines the major benefits of glass ionomer cements--adhesion to tooth substance and fluoride release--with the mechanical strength of a luting composite.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental luting cement called DYRACT® CEM PLUS CEMENT. It establishes substantial equivalence to predicate devices and outlines the intended uses and technological characteristics. However, it does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert involvement, or any form of clinical or performance study details relevant to the questions asked.

Therefore, I cannot extract the requested information from the provided text. The document is primarily an FDA communication approving market access based on substantial equivalence, not a detailed study report.

Summary

{0}------------------------------------------------

510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the text "K0412-72" in a handwritten style. The characters are bold and slightly uneven, giving it a casual appearance. The numbers and letters are clearly distinguishable, although the handwriting is not perfectly neat.

OCT 18 2004

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17404 P. J. Lehn Telefax (717) 849-4343

CONTACT:	P. Jeffery Lehn
DATE PREPARED:	May 11, 2004
TRADE OR PROPRIETARY NAME:	DYRACT® CEM PLUS CEMENT
CLASSIFICATION NAME:	Dental Cement (872.3275)
PREDICATE DEVICES:	RelyX Luting Cement K933139
	Dyract® Flow Restorative K982395

DYRACT® CEM PLUS CEMENT is a dental luting cement DEVICE DESCRIPTION: (powder/liquid system) that combines the major benefits of glass ionomer cements--adhesion to tooth substance and fluoride release--with the mechanical strength of a luting composite.

DYRACT® CEM PLUS CEMENT is indicated for: 1) Cementation of INTENDED USE: conventional metal or porcelain-fused-to-metal inlays, crowns, bridges, posts and post-core units: 2) Adhesive cementation of porcelain, composite, or all-ceranic inlays, onlays and crowns; and 3) Cementation of all-zirconia bridges.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in DYRACT® CEM PLUS CEMENT have been used in legally marketed devices or were found safe for dental use.

DYRACT® CEM PLUS CEMENT was evaluated for biocompatibility. The cured material was tested for cytotoxicity and found to be acceptable.

We believe that the prior use of the components of DYRACT® CEM PLUS CEMENT in legally marketed devices, the performance data, and the biocompatibility data provided support the safety and effectiveness of DYRACT® CEM PLUS CEMENT for the intended uses.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes extending from its head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

DENTSPLY International C/O Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, Pensylvania 17405-0872

Re: K041272

Trade/Device Name: DYRACT® CEM PLUS CEMENT Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 29, 2004 Received: September 30, 2004

Dear Mr. Lehn:

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.

{2}------------------------------------------------

Page 2 - Mr. Lehn

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Ronyu

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

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

K041272 510(K) Number (if known):

DYRACT® CEM PLUS CEMENT Device Name:

Indications for Use:

.. . . . . . .

Cementation of conventional metal or porcelain-fused-to-metal inlays, onlays, 1. crowns, bridges, posts and post-core units
Adhesive cementation of porcelain, composite, or all-ceramic inlays, onlays 2. and crowns
Cementation of all-zirconia bridges ని.

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

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)

Suan Runne

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

510(k) Number: K641272

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.