DUCERAM PLUS CERAMIC SYSTEM

K040420 · Dentsply Intl. · EIH · Mar 18, 2004 · Dental

Device Facts

• Record ID: K040420
• Device Name: DUCERAM PLUS CERAMIC SYSTEM
• Applicant: Dentsply Intl.
• Product Code: EIH · Dental
• Decision Date: Mar 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

DUCERAM® PLUS CERAMIC SYSTEM is indicated for veneering metal framework and copings for the preparation of crowns and bridges.

Device Story

Duceram Plus Ceramic System is a dental ceramic veneering system; used by dental technicians to prepare crowns and bridges. System components include dentine, incisal, transparent, correction, opaque, margin, stain, glaze porcelains, shoulder porcelain, paste opaquers, opal masses, and lay connector paste. Applied to metal frameworks and copings to restore dental structures. Device functions as a restorative material; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Dental ceramic veneering system consisting of porcelain powders and pastes. Components include dentine, incisal, transparent, correction, opaque, margin, stain, glaze, shoulder porcelain, paste opaquers, opal masses, and lay connector paste. Materials are consistent with legally marketed dental porcelain systems.

Indications for Use

Indicated for veneering metal framework and copings for the preparation of crowns and bridges.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• DUCERAM (K871808)

Submission Summary (Full Text)

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K040420

# 510(k) SUMMARY

NAME & ADDRESS:

Image /page/0/Picture/3 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word is horizontally oriented and centered in the image. The font is stylized, with sharp angles and thick strokes.

### MAR 1 8 2004

DENTSPLY International World Headquarters Susavehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 [phone] (voice)

P. J. Lehn Telefax [phone]

www.dentsplv.com

P. Jeffery Lehn CONTACT:

February 16, 2004 DATE PREPARED:

TRADE OR PROPRIETARY NAME: DUCERAM® PLUS CERAMIC SYSTEM

Porcelain powders for clinical use (872.6660) CLASSIFICATION NAME:

DUCERAM Metal Ceramic Dental PREDICATE DEVICES: K871808 Porcelain System

DEVICE DESCRIPTION: The DUCERAM® PLUS CERAMIC SYSTEM is a dental ceramic veneering system for metal framework and copings. They are used by dental technicians for the preparation of crowns and bridges.

DUCERAM (K871808) includes Dentine, Incisal, Transparent, Correction (add-on), Opaque, Margin, Stain and Glaze Porcelains.

DUCERAM® PLUS CERAMIC SYSTEM also includes Shoulder Porcelain, Paste Opaquers, Opal Masses, and Lay Connector Paste.

INTENDED USE: DUCERAM® PLUS CERAMIC SYSTEM is indicated for veneering metal framework and copings for the preparation of crowns and bridges.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in DUCERAM® PI.US CERAMIC SYSTEM have been used in legally marketed devices.

The formulations of DUCERAM® PI.US CERAMIC SYSTEM are very similar to the legally marketed devices and have not changed in any way that would adversely affect biocompatibility. Therefore, it was determined that no additional biocompatibility testing was necessary.

We believe that the prior use of the components in legally marketed devices, the similarity in the formulations to those legally marketed devices, and the performance data provided support the safety and effectiveness of DUCERAM® PLUS CERAMIC SYSTEM for the intended use.

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Image /page/1/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" arranged 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

## MAR 1 8 2004

Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K040420

Trade/Device Name: Duceram Plus Ceramic System Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 16, 2004 Received: February 18, 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 references above and 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 the Federal F 600; Drag, and may, therefore, market the device, subject to the general approvin upportions 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 (1 Nr.), it may of budyed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routlish further announcements concerning your device in the Federal Register.

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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. of the Act of any I oderal banked as requirements, including, but not limited to: registration 1 ou inuse comply was a 807); labeling (21 CFR Part 801); good manufacturing practice alle fiscing (2) 22 republic the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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) This letter will anow your e ogni finding of substantial equivalence of your device to a premarket nothedulon. - The PDF 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 dosite specific at Compliance 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 may overn 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,

Susan Roane

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 STATEMENT

(As Required by 21 CFR 807.87(e)

KOYOYZO 510(K) Number (if known):

#### DUCERAM® PLUS CERAMIC SYSTEM Device Name:

Indications for Use:

Venecring of metal framework and copings for the preparation of crowns and bridges

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)

Kein Muluy for MSP

neral Hospital,

510(k) Number: