DUCERAGOLD PORCELAINS

K040421 · Dentsply Intl. · EIH · Mar 18, 2004 · Dental

Device Facts

• Record ID: K040421
• Device Name: DUCERAGOLD PORCELAINS
• 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

Preparation of Crowns and Bridges: - Vencering metal framcwork and copings . - Veneering pressable ceramic .

Device Story

Duceragold Porcelains are dental ceramic powders used by dental professionals in clinical settings for the fabrication of dental restorations. The product line includes various types of porcelain, such as Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder. These materials are applied to metal frameworks, copings, or pressable ceramic substructures to create crowns and bridges. The device functions as a veneering material to restore dental aesthetics and function. It is intended for prescription use by dental clinicians.

Clinical Evidence

No clinical data provided; substantial equivalence is based on formulation similarity to legally marketed predicate devices and bench-level performance data.

Technological Characteristics

Dental ceramic powders for clinical use. Formulations are consistent with previously marketed dental porcelain products. No specific ASTM standards or energy sources are described. The device is a material-based system for dental restoration.

Indications for Use

Indicated for the preparation of crowns and bridges, specifically for veneering metal frameworks, copings, and pressable ceramics.

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

• Duccragold (K931808)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K04042|

NAME & ADDRESS:

# MAR 1 8 2004

#### DENTSPLY International

World Headquarters Susquenanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 717| 845-7511 (voice) 1767 www.dentsply.com

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

February 17, 2004 DATE PREPARED:

DUCERAGOLD® PORCELAINS TRADE OR PROPRIETARY NAME:

Porcelain powders for clinical use (872.6660) CLASSIFICATION NAME:

K931808 Duccragold PREDICATE DEVICES:

DEVICE DESCRIPTION: DUCERAGOLD® PORCELAINS are dental ceramic veneering DE VICE DESCRIPTION. preparation of crowns and bridges.

DUCERAGOLD® PORCELAINS include Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder porcelains.

INTENDED USE: Preparation of crowns and bridges - veneering metal framework and copings, and veneering pressable ceramic.

TECHNOLOGICAL CHARACTERISTICS: found רן ו DUCERAGOLD® PORCELAINS have been used in legally marketed devices.

The formulations of DUCERAGOLD® PORCELAINS are very similar to the legally marketed The Nimalatons of D 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 that the prior any marketed devices, and the performance data provided support the safety and effectiveness of DUCERAGOI.D® PORCELAINS for the intended use.

G

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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: K040421

Trade/Device Name: DUCERAGOLD® PORCELAINS Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 17, 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 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 mersule commerce prices 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, thereforc, market the device, subject to the general approvisions 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 Writ), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal Register.

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Page 2 -Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I DA mas made a december and regulations administered by other Federal agencies. of the Act of any I ederal bates and systements, including, but not limited to: registration r ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice alla fisting (21 CFR Parvov), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ajon 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) Fins letter will anow yource of substantial equivalence of your device to a premiarked predicated. - 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 desire speoffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral information on your responsibilities under the Act from the may outant outer generational and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runnos

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)

510(K) Number (if known): K040421

#### DUCERAGOLD® PORCELAINS Device Name:

Indications for Use:

Preparation of Crowns and Bridges:

- Vencering metal framcwork and copings .
- Veneering pressable ceramic .

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kari Murby for WSR

esthesiology, General Hospital, Control. Dental De

510(k) Number:***_****_*