TRANSLUX ENERGY

K012341 · Heraeus Kulzer, Inc. · EBZ · Aug 30, 2001 · Dental

Device Facts

• Record ID: K012341
• Device Name: TRANSLUX ENERGY
• Applicant: Heraeus Kulzer, Inc.
• Product Code: EBZ · Dental
• Decision Date: Aug 30, 2001
• 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® Energy is a light-curing unit used by dental professionals to polymerize resin-based dental materials. It functions as an ultraviolet activator for polymerization. The device is a development of the predicate Translux® EC, designed to provide improved handling and more favorable properties for the user and patient. It is used intraorally to cure sealants, restoratives, bonding, and luting materials, facilitating dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Classified as an ultraviolet activator for polymerization (21 CFR 872.6070). The device is a light-curing unit designed for intraoral use. Technical specifications and material compositions are not detailed beyond its function as a light source for resin polymerization.

Indications for Use

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

Predicate Devices

• Translux EC by Kulzer (K892456)

Submission Summary (Full Text)

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AUG 3 0 2001

K012341

Heraeus Kulzer, Inc. Translux® Energy 510(K) Submission

# Summary of Safety and Effectiveness

### Submitter:

| Company Name: | Heraeus Kulzer, Inc. |
|----------------|---------------------------------------------------------|
| Address: | 4315 South Lafayette Blvd.<br>South Bend, Indiana 46614 |
| Telephone No.: | 219-299-6662 |
| Fax No.: | 219-299-6616 |
| Date: | July 19, 2001 |

## Name of Device

Date:

Classification Name: Ultraviolet activator for polymerization

Proprietary Name: Translux® Energy

Light-curing unit Common Name:

Predicate Device

Translux EC by Kulzer [K892456]

Description for the Premarket Notification

Translux Energy Light Curing Unit which is classified as an Ultraviolet Activator for Polymerization (21C.F.R. § 872.607).

Translux® Energy has the same intended use and is substantially equivalent to Kulzer's already 510(K)-cleared light-curing unit Translux® EC [K892456]. The Translux ® Energy is a further development of the Translux® EC light source to provide the patient and user with more comfortable handling and more favorable properties.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 3 0 2001

Ms. Cheryl V. Zimmerman Manager of Quality Operations & Complaince Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, India 46614-2517

Re : K012341 Trade/Device Name: Translux® Enerqy Requlation Number: 872.6070 Regulatory Class: II Product Code: EBZ Dated: July 20, 2001 Received: July 24, 2001

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 — Ms. Zimmerman

concerning your device in the Eederal Register. Please note: concerning your device in enter in entification submission does chis response co your pro you might have under sections 531 not arrect any obrigation you miggs under the Electronic Chrough 542 of the Act 101 acress or other Federal laws or requlations.

This letter will allow you to begin marketing your device as a Inis receer will areas for market notification. The FDA described in your SIU(K) prematice of your device to a legally marketed predicate device results in a classification for your marketed predicate device rubals. In alle to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpccirie add additionally 809.10 for in regulation (21 chi rares), please contact the Office of Compliance at [phone]. Additionally, for questions on Compilance at (301) wertising of your device, please contact che Dfomotion and adversion [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other qeneral premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibion on immand [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
K. Lilacrist

Timothy|A. Ulatowski Director Division of Dental, Infection Control

and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 长创 234 |

Device Name: Translux® Energy

Indications for Use:

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

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Concurrence of CDRH, Office of Device evaluation (ODE)

| Prescription Use | <span></span> |
|----------------------|---------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | <span></span> |
|--------------------------|---------------|
| (Optional Format 1-2-96) | |

(Division Sign-Off) Pamela Scott for Susan Runner

Dental Infection Control

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_1001233