MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI

K032465 · Satelec · EBZ · Oct 21, 2003 · Dental

Device Facts

• Record ID: K032465
• Device Name: MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
• Applicant: Satelec
• Product Code: EBZ · Dental
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Satelec Mini L.E.D. product 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. is a universal photopolymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490 nm waveband of the spectrum with a power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-quide). These power densities are sufficient for the Mini L.E.D. product intended uses, namely: photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental A materials, photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.

Device Story

Cordless, handheld polymerization light-curing device; used by dental professionals in clinical settings. Emits visible blue light (430-490 nm) via light-guide tips. Power density ranges from 1,000 W/cm² (7.5 mm guide) to 2,000 W/cm² (5.5 mm BoosterTip). Operates as a light source to initiate polymerization of dental composites, bonding agents, and orthodontic adhesives. Enables clinicians to harden restorative materials during dental procedures; improves efficiency and material curing performance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cordless, handheld polymerization light-curing unit. Emits visible blue light (430-490 nm). Power density: 1,000-2,000 W/cm² depending on light-guide tip (7.5 mm or 5.5 mm). Class II device (21 CFR 872.6070).

Indications for Use

Indicated for the photopolymerization of visible light-cured (VLC) dental materials, restorative composite materials, orthodontic brackets, and orthodontic bonding and sealing materials in the 430-490 nm waveband.

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

• Satelec ACTA (K961735)
• 3M ESPE Epilar Freelight (K011154)
• GC America GC E-Light (K012134)

Submission Summary (Full Text)

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K032465

## OCT 2 1 2003

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

SATELEC Z.I. due Phare, BP 215 17 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE 011-33-56-34-06-07 Telephone: Pascal Dupeyron Contact Person: Requlatory Affairs August 8, 2003 Date Prepared:

## B. Device Identification

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

## C. Identification of Predicate Device(s)

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

> Satelec ACTA (K961735) 3M ESPE Epilar Freelight (K011154) GC America GC E-Light (K012134) i

- D. Device Description and Intended Use
The Satelec Mini L.E.D. product 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. is a universal photopolymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490 nm waveband of the spectrum with a power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-quide). These power densities are sufficient for the Mini L.E.D. product intended uses, namely:

- photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental A materials,
- ア photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
- > photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.
- E. Substantial Equivalence

The Satelec Mini L.E.D. product has nearly identical characteristics and intended uses as the 510(k) cleared light curing units, the Satelec ACTA (K961735), the 3M ESPE Epilar Freelight (K011154) and the GC America GC E-Light (K012134) for the photo-polymerization of dental materials, restorative composite materials, and polymerization of bonding and sealing materials. These devices are well established and determined to be safe and effective.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2003

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

Re: K032465

Trade/Device Name(s): Mini LED and Smartlite Mini Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: August 08, 2003 Received: August 16, 2003

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. Existing 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 [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Patricia Lucente/foe

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:

Satelec Mini L.E.D. Polymerization Light-Curing Device Model: Mini L.E.D. Model: Smartlite Mini

Indications For Use:

- > photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials,
- > photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
- > photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic 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) (Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital,

Division of Anesthesiology, General.
Infection Control, Dental Devices

ICO 32468

510(k) Number:

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)