GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE

K101540 · Novocol Inc. Dba Septodont and Confi-Dental Produc · EBF · Oct 29, 2010 · Dental

Device Facts

• Record ID: K101540
• Device Name: GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
• Applicant: Novocol Inc. Dba Septodont and Confi-Dental Produc
• Product Code: EBF · Dental
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

Device Story

Granitec® Dual-Cure Core Build-Up and N'Durance Dimer Core are dental resin materials used for direct core build-up of damaged teeth. Applied by dentists in a clinical setting to restore tooth structure prior to placement of prosthetic crowns, onlays, or inlays. Materials are dual-cure, allowing for both light-curing and chemical self-curing. Used on vital or endodontically treated teeth; compatible with pins and posts. Requires use of a bonding agent to adhere to tooth structure. Provides a foundation for esthetic restorations where the core material may be visible through the veneer.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tooth shade resin material; dual-cure (light and chemical) polymerization mechanism; intended for use as a core build-up material; class II device under 21 CFR 872.3690.

Indications for Use

Indicated for direct build-up of badly broken-down teeth requiring prosthetic crowns to regain function. Suitable for vital or de-vital, endodontically treated teeth. Compatible with pins, posts, and bonding agents. Used under esthetic full porcelain/composite crowns, onlays, and inlays.

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

11:1 2 9 2010

Mr. Steve Rudolph Director of Operations Novocol Incorporated DBA Septodont and Confi-Dental Products 416 S. Taylor Avenue Louisville, Colorado 80027

Re: K101540

Trade/Device Name: Granitec® Dual-Cure Core Build-Up and N'Durance Dimer Core Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Dated: October 22, 2010 Received: October 25, 2010

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. 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. 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 vours.

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

510(k) Number (if known):

Device Name: Granitec® Dual-Cure Core Build-Up

OCT 2 9 2010

Indications for Use:

Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number: K101540

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## Indications for Use

101540 510(k) Number (if known):

Device Name: N'Durance Dimer Core

OCT 2 9 2010

Indications for Use:

N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Sumner

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

510(k) Number:

01540

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