NUANCE

K101215 · Discus Dental, LLC · EBF · May 12, 2010 · Dental

Device Facts

• Record ID: K101215
• Device Name: NUANCE
• Applicant: Discus Dental, LLC
• Product Code: EBF · Dental
• Decision Date: May 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Nuance Universal Composite: - Direct restorations of anterior or posterior teeth (Class I Class V) . - Diastema closures . - Intraoral repairs of fractured crowns/bridges . Nuance Posterior Composite: - Direct restorations of Class I and Class II cavities . Nuance Flowable Composite: - Direct restorations of anterior or posterior teeth . - Cavity base/liner . - Intraoral repairs of fractured crowns/bridges .

Device Story

Nuance Dental Composite Materials (Universal, Posterior, and Flowable) are light-cured, resin-based dental restorative materials. Used by dental professionals in clinical settings for direct tooth restorations, cavity lining, and repair of fractured dental prosthetics. Materials are applied directly to the tooth structure and cured using a dental curing light. These composites function as restorative agents to replace lost tooth structure, restore function, and improve aesthetics. No complex electronics, software, or algorithms are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, resin-based dental composite material. Formulated for direct placement in dental cavities. No electronic components, software, or connectivity. Sterilization is not applicable as the material is intended for direct clinical application.

Indications for Use

Indicated for direct dental restorations (Class I-V), diastema closures, cavity base/liner applications, and intraoral repair of fractured crowns/bridges in patients requiring restorative dental treatment.

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Discus Dental, LLC C/O Mr. Casey Conry Responsible Third Party official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747

## MAY 1 2 2010

Re: K101215

Trade/Device Names: Nuance Universal Composite, Nuance Posterior Composite, and Nuance Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 28, 2010 Received: April 30, 2010

Dear Mr. Conry:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Conry

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nn for

Anthony D. Watson, B.S., M.S., M.B.A. 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

### 510(k) Number:

Device Name: Nuance Dental Composite Material

### Indications For Use:

Nuance Universal Composite:

- Direct restorations of anterior or posterior teeth (Class I Class V) .
- Diastema closures .
- Intraoral repairs of fractured crowns/bridges ●

Nuance Posterior Composite:

- Direct restorations of Class I and Class II cavities .
Nuance Flowable Composite:

- Direct restorations of anterior or posterior teeth .
- Cavity base/liner .
- Intraoral repairs of fractured crowns/bridges .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <b>X</b> | AND/OR | Over-The-Counter Use |
|-----------------------------|----------------------------------------------|---------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |
| | <i>Kei Muliy for MSR</i> | | |
| | (Division Sign-Off) | | |
| | Division of Anesthesiology, General Hospital | | |
| | Infection Control, Dental Devices | | |
| | 10(k) Number: | K101215 | |