BLUEPHASE STYLE

K110756 · Ivoclar Vivadent, Inc. · EBZ · Aug 29, 2011 · Dental

Device Facts

• Record ID: K110756
• Device Name: BLUEPHASE STYLE
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBZ · Dental
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.

Device Story

Bluephase® Style is a dental curing light used by clinicians to polymerize light-cured dental materials. Device emits light in 385-515 nm range to initiate polymerization of restoratives, adhesives, and luting materials. Operated by dental professionals in clinical settings. Provides controlled light output to ensure proper hardening of dental materials, facilitating restorative procedures and indirect restorations.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultraviolet activator for polymerization; wavelength range 385-515 nm; handheld form factor; Class II device.

Indications for Use

Indicated for light curing polymerization of dental materials (restoratives, adhesives, bases, liners, sealants, temporaries, luting materials) in the 385-515 nm wavelength range.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

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

Ms. Donna Marie Hartnett Director, Quality Assurance/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

AUG 2 9 2011

Re: K110756

Trade/Device Name: Bluephase® Style Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: II Product Code: EBZ Dated: August 12, 2011 Received: August 15, 2011

Dear Ms. Hartnett:

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- Ms. Hartnett

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/ucm 115809.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/Reportal/roblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

hu 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

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## Indications for Use

510(k) Number (if known): K110756

Device Name: bluephase® style

Indications For Use:

For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

510(k) Numbe

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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