← Product Code [EBZ](/productcode/EBZ) · K040808

# MINI L.E.D. OEM MODULE (K040808)

_Satelec · EBZ · Apr 28, 2004 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K040808

## Device Facts

- **Applicant:** Satelec
- **Product Code:** [EBZ](/productcode/EBZ.md)
- **Decision Date:** Apr 28, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6070
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

Polymerization of light-cured dental materials Polymerization of restorative composite materials Polymerization of bonding and sealing materials.

## Device Story

Mini L.E.D. OEM Module is a universal photo-polymerization light curing source. Device emits visible blue light in the 430 to 480 nm waveband. Power density ranges between 1,000 and 2,000 W/cm2 depending on lightguide (e.g., BoosterTip 5.5 mm). Used by dental professionals in clinical settings to cure restorative composites, bonding agents, and sealing materials. Device provides sufficient energy to initiate polymerization of light-cured dental materials, facilitating dental restoration and orthodontic procedures.

## Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

## Technological Characteristics

Ultraviolet Activator for Polymerization (21 CFR 872.6070). Light-curing source utilizing LED technology. Emits visible blue light in the 430-480 nm waveband. Power density: 1,000-2,000 W/cm2. Form factor: OEM module. Standalone operation.

## Regulatory 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

- Satelec Mini L.E.D. ([K032465](/device/K032465.md))

## Submission Summary (Full Text)

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## APR 2 8 2004

K04 0408

- SMDA Summary of Safety and Effectiveness "510(k) Summary" 9.
- A. Submittor Information

SATELEC Z.I. due Phare, BP 215 17 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE Telephone: 011-33-56-34-06-07

Contact Person: Pascal Dupeyron Regulatory Affairs

March 26, 2004 Date Prepared:

- B. Device Identification

| Common/Usual Name:   | Polymerization Light-Curing Device       |
|----------------------|------------------------------------------|
| Classification Name: | Ultraviolet Activator for Polymerization |
| Proprietary Name:    | Mini L.E.D. OEM Module                   |

## C. Identification of Predicate Device(s)

The Mini L.E.D. OEM Module is substantially equivalent to the following previously cleared and currently marketing device:

Satelec Mini L.E.D. (K032465)

- D. Device Description and Intended Use
The Satelec Mini L.E.D. OEM Module is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. OEM Module is a universal photo-polymerization light curing source and producing visible blue light in the 430 to 480 nm waveband of the spectrum with a power density comprised between 1,000 400 mm Waveband of the Spottain Mar 2,000 W/cm2 (BoosterTip 5,5 mm lightguide). These power densities are sufficient for the Mini L.E.D. product intended uses, namely:

- photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) dental A materials,
- photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) 公 restorative composite materials, and
- photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) ア orthodontic brackets, and orthodontic bonding and sealing materials.
- E. Substantial Equivalence

The Satelec Mini L.E.D. OEM Module has nearly identical characteristics and intended uses as the 510(k) cleared light curing unit, the Satelec Mini L.E.D. (K032465), for the photo-polymerization of dental materials, restorative composite materials, and polymerization of bonding and sealing materials. This device is well established and has been determined to be safe and efficacious.

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2004

SATELEC C/O Ms. Jaqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02481

Re: K040808

Trade/Device Name: Mini LED OEM Module Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: March 26, 2004 Received: March 29, 2004

Dear Ms. Masse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not 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 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 (PMA), it may be subject to such additional controls. Fxisting major regulations affecting your device can be found in the Code of Federal 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 – Jaqueline E. Masse

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act mav be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Charles

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

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510(k) Number (if known):

Device Name:

Mini L.E.D. OEM Module

1040809

Indications For Use:

Polymerization of light-cured dental materials Polymerization of restorative composite materials Polymerization of bonding and sealing materials.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fichets Betz DDS d/b/a Susan Kummer

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040808

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-The-Counter Use_______

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