LUMA LIGHT 2000 CURE LIGHT

K992102 · Lumalite, Inc. · EBF · Aug 31, 1999 · Dental

Device Facts

• Record ID: K992102
• Device Name: LUMA LIGHT 2000 CURE LIGHT
• Applicant: Lumalite, Inc.
• Product Code: EBF · Dental
• Decision Date: Aug 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental composites or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.

Device Story

High-intensity filtered light source and optical delivery system; used in dental clinics by practitioners. Device emits light to accelerate curing of photo-activated dental composites, sealants, bonding agents, primers, and bleaching formulations. Operates at four times the rate of conventional light systems. Benefits include faster procedure times and increased reliability/adaptability for various dental practice situations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-intensity filtered light source with optical delivery system. Device is a Class II dental curing light. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for curing photo-activated dental materials (direct restorations, sealants, bonding agents, primers) and photo-activated bleaching formulations in dental patients.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Kuring and Bleaching Light (K962376)
• Apollo 95E (K981948)
• Pac Light (K952333)

Submission Summary (Full Text)

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AUG 3 | 1999

に

## 510K Summary

Regulatory Authority: Safe Medical Devices Act of 1990. CFR 807.87

| Company Name: | | |
|----------------------------------------------------------------------------------------------------|---------|------------------------------|
| Luma Lite, Inc.<br>477 Marina Pkwy #400<br>Chula Vista, CA 91910 | | |
| Company Contact: | | |
| Joe Forehand<br>Luma Lite, Inc.<br>477 Marina Pkwy #400<br>Chula Vista, CA 91910<br>[phone] | | |
| Device Name: | | |
| Luma Light 2000 Cure Light | | |
| Predicate Devices: | | |
| Kuring and Bleaching Light | K962376 | Kreativ, Inc. |
| Apollo 95E | K981948 | DMD |
| Pac Light | K952333 | American Dental Technologies |

Device and indications for use:

The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.

### Discussion:

Since the intended use and technical specifications of the Luma Light 2000 Cure Light are virtually identical to the predicate devices and the differences in the device only make it easier to use, more reliable and more adaptable to a variety of dental practice situations, we believe that the Luma Light 2000 Cure Light is substantially equivalent to the predicate devices and can be marketed under Section 510 (k) of the FD&C Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 1999

Mr. Joseph M. Forehand Vice President of Operations Luma Lite, Incorporated 477 Marina Parkway #400 Chula Vista, California 91910

Re: K992102 Luma Light 2000 Cure Light Trade Name: Requlatory Class: II Product Code: EBF June 16, 1999 Dated: Received: June 21, 1999

Dear Mr. Forehand:

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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulation 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 obligation you might have under sections 531 through 542 of

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## Page 2 - Mr. Forehand

This letter will allow you to begin marketing your device as Inis receir will arion (k) premarket notification. The FDA described in your 510\n, promience of your device to a legally Finding of Subscancial Squr.
marketed predicate device results in a classification for your marketed predicate device rusatevice to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpcorre additionally 809.10 for in regulation (21 crk rares), please contact the Office of Compliance at [phone]. Additionally, for questions on ebmpriance as (30 advertising of your device, please contact the Dffice of Compliance at [phone]. Also, please note the Orrice Or Compiland, "Misbranding by reference to the regaración Chouses, (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance oblained from cho mumber [phone] or [phone] or at at ICS COII-Tree namber (000)- 050 Eda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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# Indications Statement

11992102 510(k) Number:

Device Name:

Luma Light 2000 Cure Light

Indication for Use:

The Luma Light 2000 Cure Light is a high intensity filtered light The Luma Light 2000 Cure Light is a high induces curing of photosource, and optical centery system, castivated bleaching activated dental composites or proto-activersional light systems.
formulations at four (4) times the rate of conventional light systems. formulations at four (4) lines the rate of on on on on one of the material The Luma Light 2000 Cure Light Caros an phones
materials such as those used in direct restorations, sealants, matoling agents and primers.

Su
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number

(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