STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150

K092912 · Danville Materials, Inc. · EBF · Dec 16, 2009 · Dental

Device Facts

• Record ID: K092912
• Device Name: STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150
• Applicant: Danville Materials, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

StarFill 2B HV and LV are dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are indicated for use as the first increment under posterior composites; for core buildups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate.

Device Story

StarFill 2B HV and LV are dual-cure polymer-based dental restorative materials. They function via auto-cure mechanism with light-cure acceleration. Used by dental professionals in clinical settings for restorative procedures, including first increment placement under posterior composites, core buildups, and luting of dental prosthetics (posts, crowns, veneers). The dual-cure property ensures polymerization in areas with limited light access. Benefits include improved clinical efficiency and reliable curing in deep or opaque restorations.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-cure (auto-cure with light-cure acceleration) polymer-based dental restorative. Material is a resin-based composite. No specific ASTM standards or software components described.

Indications for Use

Indicated for use as a dental restorative material for first increment under posterior composites, core buildups, and luting of posts, crowns, and veneers in patients requiring dental restoration where light transmission is inadequate.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Lindsay Tilton Regulatory Affairs Danville Materials, Incorporated 3420 Fostoria Way, Suite A-200 San Ramon, California 94583

DEC 1 6 2009

Re: K092912

Trade/Device Name: Starfill 2B HV, Starfill 2B LV Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 9, 2009 Received: December 9, 2009

Dear Ms. Tilton:

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 - Ms. Tilton

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 (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Wh foc

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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K092912

## Indications for Use Form

## Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

"StarFill 2B HV and LV are dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are indicated for use as the first increment under posterior composites; for core buildups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate."

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K092912