Star+ VPS Scannable Impression Material

K152349 · Danville Materials, LLC · ELW · Nov 23, 2015 · Dental

Device Facts

• Record ID: K152349
• Device Name: Star+ VPS Scannable Impression Material
• Applicant: Danville Materials, LLC
• Product Code: ELW · Dental
• Decision Date: Nov 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, and implant techniques. The impression material can also be scanned by dental impression scanners

Device Story

Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane (VPS) dental impression material. It is used by dental professionals in clinical settings to capture anatomical details for crown, bridge, edentulous, and implant procedures. The material is designed to be compatible with dental impression scanners, allowing the physical impression to be digitized for CAD/CAM workflows. It functions as a traditional dental impression material, providing high-accuracy negative replicas of oral structures. The resulting scan facilitates the design and fabrication of dental restorations or prosthetics, potentially improving fit and reducing chair time for the patient.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Addition-cured vinyl polysiloxane (VPS) dental impression material. Formulated for compatibility with optical dental impression scanners. Supplied as a multi-component system for mixing. Physical properties consistent with standard dental impression materials (ISO 4823).

Indications for Use

Indicated for dental patients requiring crown, bridge, edentulous, or implant impression procedures. For professional use only.

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).

Predicate Devices

• Star VPS Impression Material (K062656)

Submission Summary (Full Text)

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Public Health Service

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

November 23, 2015

Danville Materials LLC Dong Hua Regulatory Affairs Director 3420 Fostoria Way Suite A-200 San Ramon, California 94583

Re: K152349

Trade/Device Name: Star+ VPS Scannable Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: August 31, 2015 Received: September 3, 2015

Dear Dong Hua:

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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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 of medical devicerelated 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, 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) K152349

Device Name

Star+ VPS Scannable Impression Material

Indications for Use (Describe)

Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, and implant techniques. The impression material can also be scanned by dental impression scanners

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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