LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL

K092501 · Novocol, Inc. · EBF · Nov 12, 2009 · Dental

Device Facts

• Record ID: K092501
• Device Name: LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
• Applicant: Novocol, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 12, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Light-Activated Low-Stress Thiol-Ene Composite Restorative Material is a light Cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides easy esthetics since it is formulated in shades matching the VITA Lumin® Shade guide. This low stress nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V. It may also be used for dental core build-ups

Device Story

Light-activated nanohybrid composite restorative material; used by dentists for direct restoration of anterior and posterior teeth (Classes I-V) and core build-ups. Material utilizes thiol-ene chemistry to provide low-stress polymerization. Applied by clinician to tooth cavity; cured using standard dental light-curing units. Matches VITA Lumin shade guide for esthetic outcomes. Benefits include reduced polymerization stress compared to traditional methacrylates, potentially improving marginal integrity and reducing post-operative sensitivity.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Nanohybrid composite restorative material; thiol-ene based chemistry; light-activated polymerization; shade-matched to VITA Lumin guide; intended for direct dental restorations.

Indications for Use

Indicated for direct esthetic restoration of anterior and posterior teeth (Class I, II, III, IV, and V) and dental core build-ups in patients requiring dental restorative procedures.

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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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Steve Rudolph Quality Assurance/Regulatory Affairs Manager Novocol, Incorporated 416 South Taylor Avenue Louisville, Colorado 80027

NOV 12 2009

Re: K092501

Trade/Device Name: Light-Activated Low-Stress Thiol-Ene Composite Restorative Material

Regulation Number: 21CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 11, 2009 Received: August 14, 2009

Dear Mr. Rudolph:

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 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. Rudolph

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 yours,

Susan Runner, D.D.S., M.A. Acting 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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Novocol Inc. dba Septodont Confi-Dental Division Abbreviated 510(k) Premarket Notification

Light-Activated Low- Stress Thiol-Ene Composite

R092501

# INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Light-Activated Low-Stress Thiol-Ene Composite Restorative Material

# Indications for Use:

"Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" is a light Cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides easy esthetics since it is formulated in shades matching the VITA Lumin® Shade guide. This low stress nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V. It may also be used for dental core build-ups

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

Over-The-Counter Use (21 CFR Part 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 Muhly for MSR

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

510(k) Number: K092501

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