STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387

K092319 · Danville Materials, Inc. · ELW · Sep 16, 2009 · Dental

Device Facts

• Record ID: K092319
• Device Name: STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
• Applicant: Danville Materials, Inc.
• Product Code: ELW · Dental
• Decision Date: Sep 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

The device is an additional-cure vinyl polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques.

Device Story

Star VPS (First Half, First Quarter) is an addition-cure vinyl polysiloxane (VPS) dental impression material. Used by dental professionals to create accurate impressions of oral structures for crown, bridge, edentulous, and implant restorative procedures. Material is applied to dental trays, placed in the patient's mouth, and allowed to set to capture detailed anatomical geometry. Output is a physical negative mold used by dental laboratories to fabricate dental prosthetics. Benefits include high dimensional stability and detail reproduction for clinical restorative workflows.

Clinical Evidence

Bench testing only.

Technological Characteristics

Addition-cure vinyl polysiloxane (VPS) elastomer. Supplied as a multi-component system for mixing. Exhibits high dimensional stability and detail reproduction typical of silicone-based dental impression materials. Non-sterile, professional use dental device.

Indications for Use

Indicated for dental impression procedures including crown and bridge, edentulous, and implant techniques.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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

## SEP 1 6 2009

Mr. Craig R. Bruns President Danville Materials, Incorporated 3420 Fostoria Way, Suite A-200 San Ramon, California 94583

Re: K092319

Trade/Device Name: Star VPS, First Half, First Quarter Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 22, 2009 Received: August 4, 2009

Dear Mr. Bruns:

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. Bruns

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 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 for

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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## Indications for Use

510(k) Number (if known): K092319

Device Name: Star VPS, First Half, First Quarter

Indications For Use: The device is an additional-cure
viny| polysiloxane dental impression material
that is used for all crown and bridges,
edentulous and Implant techniques.

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)

Supan Punx

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

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510(k) Number: K092819