FLIPO XENON CURING LIGHT

K994028 · Lokki · EBZ · Jan 12, 2000 · Dental

Device Facts

• Record ID: K994028
• Device Name: FLIPO XENON CURING LIGHT
• Applicant: Lokki
• Product Code: EBZ · Dental
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flipo Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Story

The Flipo Curing Light is a dental device used by clinicians to provide light energy for curing restorative materials and facilitating tooth whitening. It functions as an illumination source. The device is operated by dental professionals in a clinical setting. By providing specific light output, it enables the hardening of dental composites and supports whitening treatments, thereby assisting in restorative and cosmetic dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental curing light; illumination source for polymerization and whitening; class II device.

Indications for Use

Indicated for use by dental professionals for the polymerization of dental restorative materials and as an illumination source for tooth whitening procedures.

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 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Mr. Hillard W. Welch U.S. Representative for LOKKI (France) 344 Annabelle Point Road 02632-2402 Centerville, MA

Re : K994028 Flipo Curing Light Trade Name: Requlatory Class: II Product Code: EBZ Dated: November 22, 1999 Received: November 26, 1999

Dear Mr. Welch:

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 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 The general controls provisions of the Act 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. ਖੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Welch

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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K994028

510(k) Number (if known): K994028

"Flipo" Curing Light Device Name: __

Indications For Use:

"The Flipo Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry."

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801,109) | |

510(k) Number

Susan Kinne (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D

99 41838

OR

Over-The-Counter Use

Optional Formal 1-2-96)