TRANSLUX POWER BLUE

K042199 · Heraeus Kulzer,GmbH · EBZ · Sep 8, 2004 · Dental

Device Facts

• Record ID: K042199
• Device Name: TRANSLUX POWER BLUE
• Applicant: Heraeus Kulzer,GmbH
• Product Code: EBZ · Dental
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.

Device Story

Translux® Power Blue is a dental curing light used by dental professionals in clinical settings. It emits light to trigger polymerization of light-cured resin materials, including pit and fissure sealants, restorative composites, bonding agents, and luting cements. The device functions as an activator for these materials, facilitating the hardening process necessary for dental procedures. It is operated by dentists or dental staff to ensure proper setting of restorative materials, directly impacting the structural integrity and success of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultraviolet/visible light activator for polymerization. Class II device (21 CFR 872.6070). Product code: EBZ. Handheld dental curing light form factor.

Indications for Use

Indicated for light-induced intraoral polymerization of resin dental pit and fissure sealants, restorative materials, bonding agents, or luting materials in dental patients.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Heraeus Kulzer GmbH & Company KG C/O Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614

Re: K042199

Trade/Device Names: Translux® Power Blue Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: August 12, 2004 Received: August 13, 2004

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for referenced above and nove to legally marketed predicate devices marketed in interstate commerce use stated in the encreated to the Medical Device Amendments, or to devices that provision way 20, 1770, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nuve boon roomseries and 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 thereone, manker the act include requirements for annual registration, listing of devices, good Controls provisions of a.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 If your de nee to such additional controls. Existing major regulations affecting your device can be finay of subject to bearn adam 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. Cheryl V. Zimmerman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 27x 5 tookine of our device complies with other requirements of the Act or that FDA hade a decemination administered by other Federal agencies. You must comply with CFFD Box 900 ally redular statutes and regularene, but not limited to: registration and listing (21 CFR Part 807); an the Act s requirements, morading, oractice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation systems (QB) regarts (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) I mis letter with anow you to ough finding of substantial equivalence of your device to a legally prematics nouried.com - The suits in a 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), please 11 you dosire specific ad rior of Compliance at [phone]. Additionally, for questions on the promotion connact the Office of Your device, please contact the Office of Compliance at [phone]. Also, and advertising of your avers, preference to premarket notification" (21CFR please note the regalation in. Other general information on your responsibilities under the Act may I all 007:77) you the Division of Small Manufacturers, International and Consumer Assistance at its oo obained in and the more [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu S. Lin, PhD

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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K04299 510(k) Number (if known):

Device Name: Translux® Power Blue

Indications for Use:

Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.

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

Concurrence of CDRH, Office of Device evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042199