BLUEPHASE 16I

K051782 · Ivoclar Vivadent, Inc. · EBZ · Sep 20, 2005 · Dental

Device Facts

• Record ID: K051782
• Device Name: BLUEPHASE 16I
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBZ · Dental
• Decision Date: Sep 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Device Story

Bluephase 16i is a dental curing light used by clinicians to polymerize light-cured dental materials, including composites, luting agents, and cements. The device emits high-intensity light to initiate the polymerization process. It is intended for professional use in dental clinics to facilitate restorative procedures. By providing controlled light energy, it ensures the hardening of dental materials, enabling effective tooth restoration and bonding.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultraviolet activator for polymerization; Class II device; Product Code EBZ; 21 CFR 872.6070.

Indications for Use

Indicated for light curing polymerization of dental composites, luting materials, cements, and other light-cured dental materials in a clinical setting.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted with a staff entwined by two snakes.

Public Health Service

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K051782

Trade/Device Name: Bluephase 16i Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 24, 2005 Received: July 7, 2005

Dear Ms. Hartnett:

This letter corrects our substantially equivalent letter of September 20, 2005, regarding the 510 (K) Number.

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 mensiale connineree pror to that have been reclassified in accordance with the provisions of Amendinents, on to de roos alla have - Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the vistration, 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 such additional controls. Existing major regulations affecting (FMA), it may oc subject to back adalaf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South nonements 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 Please be advised that PDA S issualled of a babeanant is vice complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and regarations, but not limited to: registration You must comply with an the Het STS Part 801); good manufacturing practice and ifsiling (21 CFR Part 607), laceming (21 CFR Part 820), regulation (21 CFR Part 820), and if requirements as set form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maticolary your device of your device to a a premarket notification. The PDF Intellig on classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de rocked in the Also, please note the regulation in entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Illay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Diviser [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clurs

Chiu Lin, Ph.D. 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

K051782_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):

Device Name: bluephase 16i

Indications For Use:

For light curing polymerization of dental composites, luting materials, cements
on and and and color and other light cured materials.

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

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) Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Susan Runne

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

510(k) Number. K051782