K Number
K040808
Device Name
MINI L.E.D. OEM MODULE
Manufacturer
Date Cleared
2004-04-28

(30 days)

Product Code
Regulation Number
872.6070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polymerization of light-cured dental materials Polymerization of restorative composite materials Polymerization of bonding and sealing materials.
Device Description
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).
More Information

Not Found

No
The description focuses on the physical properties and function of a light-curing device, with no mention of AI or ML.

No.
The device is described as an Ultraviolet Activator for Polymerization used for photopolymerization of dental materials, not for direct therapeutic treatment of medical conditions or diseases.

No

The device is an ultraviolet activator used for the polymerization of light-cured dental materials, not for diagnosing medical conditions.

No

The device description explicitly states it is a "Module" and a "light curing source" producing visible blue light, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the polymerization of light-cured dental materials. This is a process performed directly on the patient's teeth or dental restorations, not on samples taken from the body for diagnostic purposes.
  • Device Description: The device is described as an "Ultraviolet Activator for Polymerization" and a "photo-polymerization light curing source." This function is related to curing materials, not analyzing biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing diagnostic information about a disease or condition
    • Using reagents or assays

The device's function is clearly related to a dental procedure (curing materials) rather than an in vitro diagnostic test.

N/A

Intended Use / Indications for Use

The Satelec Mini L.E.D. OEM Module 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 to 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 materials,
  • photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) restorative composite materials, and
  • photo-polymerization in the 430-480 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.

Indications For Use:
Polymerization of light-cured dental materials
Polymerization of restorative composite materials
Polymerization of bonding and sealing materials.

Product codes

EBZ

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K032465

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.6070 Ultraviolet activator for polymerization.

(a)
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.(b)
Classification. Class II.

0

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.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

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.

2

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)

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Over-The-Counter Use_______