DUCERA ALLCERAM

K043247 · Dentsply Intl. · EIH · Dec 22, 2004 · Dental

Device Facts

• Record ID: K043247
• Device Name: DUCERA ALLCERAM
• Applicant: Dentsply Intl.
• Product Code: EIH · Dental
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.

Device Story

Ducera® AllCeram is an all-ceramic dental system used for veneering aluminum oxide cores or tooth preparations. It is intended for use by dental professionals in a clinical setting. The system consists of porcelain powders applied to the core or tooth structure to restore dental aesthetics and function. The device functions as a restorative material; it does not involve electronic processing, software, or automated analysis. Clinical benefit is derived from the material properties of the ceramic, which mimic natural tooth structure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material composition and performance data comparisons to the predicate device.

Technological Characteristics

All-ceramic system consisting of porcelain powders. Material composition is nearly equivalent to the predicate device. No electronic, software, or energy-based components.

Indications for Use

Indicated for veneering of aluminum oxide cores or tooth preparations in dental patients.

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

• VITADUR® ALPHA Porcelain (K921623)

Submission Summary (Full Text)

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## 11043247 510(k) SUMMARY

DEC 22 2004

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

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| CONTACT: | Helen Lewis |
|----------------------------|-----------------------------------------------|
| DATE PREPARED: | November 16, 2004 |
| TRADE OR PROPRIETARY NAME: | Ducera® AllCeram |
| CLASSIFICATION NAME: | Porcelain powders for clinical use (872.6660) |
| PREDICATE DEVICES: | VITADUR® ALPHA Porcelain K921623 |

DEVICE DESCRIPTION: Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.

INTENDED USE: Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in Ducera® AllCeram have been used in legally marketed devices.

Because of the nearly equivalent material composition of Ducera® AllCeram to the predicate device, no additional toxicity 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 Ducera® AllCeram for the intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 2004

Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K043247

Trade/Device Name: Ducera® AllCeram Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 16, 2004 Received: November 23, 2004

## Dear Ms. Lewis:

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.

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Page 2 -- Ms. Helen Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be duvised made a determination that your device complies with other requirements of the Act or that I Dr. I has mude a deceministered 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); an the Act 3 requirements, morading, offacturing practice requirements as set forth in the quality fabeling (21 CFR Part 801); good for 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) I mis letter with and w yourse FDA finding of substantial equivalence of your device to a legally premaince nouteation - 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 ir you don't the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other Whoolunding of Ferences on your responsibilities under the Act from the Division of Small general miorination of your of Journer Assistance at its toll-free number [phone] or 1301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

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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## INDICATIONS FOR USE

1104 3247 510(k) Number (if known):

Device Name: Ducera® AllCeram

Indications For Use:

Ducera® AllCeram is indicated for veneering of aluminum oxide cores or tooth preparations.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Runne

Division Infectio

physiology, General Hospital,
Dental Devices

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