CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

K052097 · Dentsply International · EBF · Aug 12, 2005 · Dental

Device Facts

• Record ID: K052097
• Device Name: CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE
• Applicant: Dentsply International
• Product Code: EBF · Dental
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

UNIVERSAL NANO-CERAMIC™ RESTORATIVE is indicated for direct restorations of all cavity classes in anterior and posterior teeth.

Device Story

UNIVERSAL NANO-CERAMIC™ RESTORATIVE is a light-cured, radiopaque dental restorative material. It utilizes nanotechnology combined with organically modified ceramic particles. The product features a Natural-Shade™ system, offering both a single translucency system (seven shades) and a double translucency system (four dentin shades, three enamel shades). Composition includes resin monomers, pigments, stabilizers, fillers, a fluorescing agent, activator, and accelerator. It is intended for use by dental professionals for direct restorations of all cavity classes in anterior and posterior teeth.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by the use of components previously cleared in legally marketed devices and internal test results.

Technological Characteristics

Light-cured, radiopaque dental restorative. Composition: resin monomers, pigments, stabilizers, fillers, fluorescing agent, activator, and accelerator. Utilizes nanotechnology and organically modified ceramic particles. Formulated as a multi-shade system (Natural-Shade™).

Indications for Use

Indicated for direct restorations of all cavity classes in anterior and posterior teeth.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• R-30 Aesthetic Restorative (K984387)

Submission Summary (Full Text)

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AUG 1 2 2005 K052097

# 510(k) SUMMARY

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: | July 29, 2005 |

# TRADE OR PROPRIETARY NAME: UNIVERSAL NANO-CERAMIC™ RESTORATIVE

Tooth shade resin material, 872.3690 CLASSIFICATION NAME:

R-30 Aesthetic Restorative, K984387 PREDICATE DEVICES:

### DEVICE DESCRIPTION:

The UNIVERSAL NANO-CERAMIC™ RESTORATIVE is a light-cured, radiopaque, dental restorative product for use in both anterior and posterior applications. UNIVERSAL NANO-CERAMIC" RESTORATIVE combines nanotechnology with organically modified ceramic particles resulting in a nano-ceramic restorative.

The product's Natural-Shade™ system provides two shading systems in one product. The single translucency system offers seven shades of intermediate translucency while the double translucency system offers four dentin shades with natural dentin translucencies and three enamel shades which emulate natural enamel.

UNIVERSAL NANO-CERAMIC™ RESTORATIVE is composed of resin monomers, pigments, stabilizers, fillers, a fluorescing agent, activator, and accelerator.

#### INTENDED USE:

UNIVERSAL NANO-CERAMIC™ RESTORATIVE is indicated for direct restorations of all cavity classes in anterior and posterior teeth.

# TECHNOLOGICAL CHARACTERISTICS:

All of the components in UNIVERSAL NANO-CERAMIC™ RESTORATIVE have been used in legally marketed devices or were found to be safe for dental use. We believe that the prior use of some components in legally marketed predicate devices and test results support the safety and effectiveness of UNIVERSAL NANO-CERAMIC™ RESTORATIVE for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. The logo is black and white.

AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K052097

Trade/Device Name: Ceram XTM Universal Nano-CeramicTM Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 29, 2005 Received: August 03, 2005

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 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.

Sincerely yours.

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 STATEMENT

Kò 57097

510(K) Number (if known):

UNIVERSAL NANO-CERAMIC™ RESTORATIVE Device Name:

Indications for Use:

UNIVERSAL NANO-CERAMIC™ RESTORATIVE is indicated for direct restorations of all cavity classes in anterior and posterior teeth.

Suan Runa

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

510(k) Number:

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)

Premarket Notification