SPRING POWERLITE 2000

K992728 · Spring Health Products, Inc. · EBZ · Sep 29, 1999 · Dental

Device Facts

• Record ID: K992728
• Device Name: SPRING POWERLITE 2000
• Applicant: Spring Health Products, Inc.
• Product Code: EBZ · Dental
• Decision Date: Sep 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

High Intensity light for polymerization of dental materials and tooth whitening.

Device Story

PowerLite 2000 is a high-intensity light source used by dental professionals for the polymerization of light-cured dental materials and for tooth whitening procedures. The device emits high-intensity light to initiate chemical curing processes in dental resins or to activate whitening agents. It is intended for use in a dental office environment. The output provides the necessary energy to facilitate dental restorative or cosmetic procedures, assisting the clinician in achieving rapid material hardening or whitening results.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-intensity light source for dental applications. Device operates as a light-curing unit. Specific materials, dimensions, and software details are not provided in the source document.

Indications for Use

Indicated for polymerization of dental materials and tooth whitening 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1999

Ms. Serene O'Malley Spring Health Products, Incorporated 705 General Washington Avenue Suite 701 Norristown, Pennsylvania 19403

Re: K992728 Spring PowerLite 2000 Trade Name: Regulatory Class: II Product Code: EBZ August 23, 1999 Dated: Received: Auqust 27, 1999

Dear Ms. O'Malley:

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, Druq, 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, qood 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 Eederal Requlations, Title 21, Parts 800 to 895. A 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 obligation you might have under sections 531 through 542 of

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Page 2 -Ms. O'Malley

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
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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к992728 510(k) NUMBER (IF KNOWN):

DEVICE NAME: POwerLite 2000 ________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

High Intensity light for polymerization of dental materials and tooth whitening.

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

Concurrence of CDRH, Office of Device Evaluation (ODE

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Prescription Use y (Per 21 CFR 801.109) ાર

Over-The-Counter-(Optional Forma

Susan Russo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number .