(74 days)
Not Found
No
The description focuses on the hardware components, light spectrum, curing modes, and basic user interface. There is no mention of any computational processing, algorithms, or learning capabilities that would indicate the presence of AI or ML.
No.
The devices are used for polymerizing dental materials, not to diagnose, cure, mitigate, treat, or prevent disease.
No
The device is described as a "dental curing light unit" intended for the "polymerization of photo-hardening dental materials." Its function is to harden materials, not to diagnose or detect medical conditions.
No
The device description explicitly details hardware components such as an LED, battery, charger unit, fiber optic, and push-buttons on a handpiece. It also mentions a light meter integrated into the charger unit. This is not a software-only 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 photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a dental curing light unit that emits light to harden dental materials. It does not analyze biological samples or provide diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on the device's ability to effectively cure dental materials (spectrum, irradiance, depth of cure), not on diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
The Starlight Pro and Silverlight are dental curing light units intended for the polymerization of photo-hardening dental materials in the oral cavity.
A light emitting diode (LED) with a wavelength between 440 nm is used in both devices as the light source.
The spectrum of the light emitted by the LED corresponds to the absorption spectrum of camphorquinone photo-initiator, which is the most common and widely used visible light photo-initiator in among available photohardening dental materials.
Camphorquinone photo-initiator has an light absorption curve ranging approx. from 400 - 500 nm, with a peak absorption at approx. 468 nm.
This range falls within the emission spectrum of the LED used in the subject devices, making the units effective for the polymerization of camphorquinone-based dental materials.
The subject devices consist of a cordless handpiece, powered by a rechargeable battery, and incorporating a LED as light source, a battery charger unit and a fiber optic that directs the light onto the material being polymerized. The devices allow the user to activate two curing modes (Fast' and 'Slow Rise') by pressing the relevant push-button on the handpiece. These two curing modes differ in the light exposure and in the mode with which the light is emitted. In particular:
The fast curing mode has an exposure time of 10 sec. at the maximum light intensity.
The slow rise exposure mode has an exposure time of 20 sec. with a gradual increase of light during the first 3 seconds up to the maximum intensity.
Acoustic signal timings are emitted by the handpiece during program execution
The charger unit allows recharging of the battery and it has an integrated light meter to check the light output. On the charger unit are three signaling LED lamps, indicating the onloff unit state, the battery charge state, and the functionality of the battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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)
Non Clinical Tests:
- Measurements of spectrum and irradiance
- Depth of cure (mm) on resin samples
- Software validation
The Starlight Pro and Silverlight comply with the electromagnetic compatibility requirements established by the standards EN IEC 60601 -1 and EN IEC 60601-1-2.
The results from these all these non-clinical tests confirm that the proposed devices are safe and effective for the polymerization of photo-hardening dental materials in the oral cavity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Translux Power Blue (K042199) - Heraeus Kulzer GmbH
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows a series of symbols or characters arranged in a row above a line with several filled circles of varying sizes connected to it. The symbols at the top appear to be stylized letters or abstract shapes, possibly forming a word or code. The line below has circles that increase in size from left to right, creating a visual progression or sequence. The contrast between the geometric shapes and the line with circles gives the image a structured yet somewhat abstract quality.
medical technology
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 1.v. mectron@mectron.com
){99295
510(k) Summary in accordance with 21 CFR 807.92
| Device Name: | Starlight Pro
Silverlight | DEC - 7 2005 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Type of 510(k) submission: | Traditional | |
| Date of Submission: | September 22, 2009 | |
| Manufacturer: | Mectron Spa
Via Loreto, 15, Carasco, GE 16042, Italy | |
| FDA Registration Number: | 3003933619 | |
| 510(k) Owner: | Mectron Spa
Via Loreto, 15, Carasco, GE 16042, Italy | |
| 510(k) Contact: | Roger Gray
Vp, Quality and Regulatory
Donawa Lifescience Consulting
Piazza Albania, 10, 00153 Rome, Italy
Tel: +39 06 578 2665
Fax: +39 06 574 3786 | |
| Trade name: | Starlight Pro
Silverlight | |
| Common Name: | Dental curing light | |
| Class: | Class II | |
| Product Codes: | EBZ | |
| Classification Regulations: | 21 CFR 872.6070:
Ultraviolet Activator for Polymerization | |
| Predicate device: | Translux Power Blue (K042199) - Heraeus Kulzer GmbH | |
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Image /page/1/Picture/0 description: The image shows a series of vertical lines, curved lines, and dots connected by a horizontal line. There are 11 vertical lines and 4 curved lines. The dots are of varying sizes, with the last dot being the largest.
medical technology
Mectron S.p. Via Loreto, 15/A 16042 Carasco - GE (Italy) Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Flsc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 i.v. mectron@mectron.com
Device Description:
The Starlight Pro and Silverlight are dental curing light units intended for the polymerization of photo-hardening dental materials in the oral cavity.
A light emitting diode (LED) with a wavelength between 440 nm is used in both devices as the light source.
The spectrum of the light emitted by the LED corresponds to the absorption spectrum of camphorquinone photo-initiator, which is the most common and widely used visible light photo-initiator in among available photohardening dental materials.
Camphorquinone photo-initiator has an light absorption curve ranging approx. from 400 - 500 nm, with a peak absorption at approx. 468 nm.
This range falls within the emission spectrum of the LED used in the subject devices, making the units effective for the polymerization of camphorquinone-based dental materials.
The subject devices consist of a cordless handpiece, powered by a rechargeable battery, and incorporating a LED as light source, a battery charger unit and a fiber optic that directs the light onto the material being polymerized. The devices allow the user to activate two curing modes (Fast' and 'Slow Rise') by pressing the relevant push-button on the handpiece. These two curing modes differ in the light exposure and in the mode with which the light is emitted. In particular:
The fast curing mode has an exposure time of 10 sec. at the maximum light intensity.
The slow rise exposure mode has an exposure time of 20 sec. with a gradual increase of light during the first 3 seconds up to the maximum intensity.
Acoustic signal timings are emitted by the handpiece during program execution
The charger unit allows recharging of the battery and it has an integrated light meter to check the light output. On the charger unit are three signaling LED lamps, indicating the onloff unit state, the battery charge state, and the functionality of the battery.
Intended use:
The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range..
Technological Characteristics and Substantial Equivalence:
The subject devices, Starlight Pro and Silverlight, are substantially equivalent to the predicate device 'Heraeus Translux Blue, cleared for US marketing under 510(k) reference K042199. The intended use, technological characteristics, operation, light source characteristics, and wavelength range of the subject devices are identical or very similar to the predicate device.
Both the subject devices, Starlight Pro and Silverlight, and the predicate device are designed for the polvmerization of photo-hardening dental materials in the oral cavity.
All three devices consist of a battery charger unit and a cordless handpiece powered by an integral rechargeable battery, and incorporate a LED as light source and a removable fiber optic that directs the light on the material being polymerized.
2
Image /page/2/Picture/0 description: The image shows a series of vertical lines and curved shapes arranged horizontally across the top portion of the image. Below these shapes, there is a horizontal line with a series of circles of increasing size along the line. The circles start small on the left and gradually increase in size towards the right side of the image. The arrangement of shapes and circles creates a visual pattern.
medical technology
Mectron S.D.A Via Loreto, 15/A 16042 Carasco - GE (Italy) el. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc .: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 I.v. mectron@mectron.com
The operational principles of the subject devices and of the predicate device are identical. In all three devices, a monochromatic LED with identical spectral emission characteristics (wavelength 440 - 480 as light source, and all three devices can perform two different curing modes, 'Fast' and 'Slow Rise'.
Both the subject devices, Starlight, and the predicate device have a built-in light meter to measure the emitted light intensity.
Clinical Tests
್ಕೆ ಮ
No clinical testing was conducted
Non Clinical Tests
The following testing was conducted to evaluate the functionally and performance of the subject devices:
- Measurements of spectrum and irradiance
- Depth of cure (mm) on resin samples
- Software validation
The Starlight Pro and Silverlight comply with the electromagnetic compatibility requirements established by the standards EN IEC 60601 -1 and EN IEC 60601-1-2.
The results from these all these non-clinical tests confirm that the proposed devices are safe and effective for the polymerization of photo-hardening dental materials in the oral cavity.
Conclusion
The Starlight Pro. Silverlight and the predicate device share or very similar intended use, technological characteristics: operation, light source and wavelength of the emitted light.
Differences existing between the subject devices and the predicate device are minor and do not affect the safety and effectiveness of the Starlight Pro and Silverlight.
Therefore, based on the information contained in this submission, we believe that the Starlight Pro and Silverlight are both safe and effective for their intended use and substantially equivalent to the predicate device already in interstate commerce within the U.S.A.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered on the image and is the only element present.
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is used to represent the HHS and its mission to enhance the health and well-being of Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mectron S.p. A. C/O Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting SRL Piazza Albania 10 00153 Rome ITALY
DEC - 7 2009
Re: K092951
Trade/Device Name: Starlight Pro and Silverlight Regulation Number: 21. CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ Dated: September 22, 2009 Received: September 24, 2009
Dear Mr. Gray:
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 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 - Mr. Gray
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
h fo.
Susan Runner, D.D.S. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Indications for Use
510(k) Number (if known): Not known
Device Name: Starlight Pro and Silverlight devices
Indications for Use: The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range.
Image /page/5/Picture/6 description: The image shows the words "Prescription Use" in bold font. Below that, the text "(Part 21 CFR 801 Subpart D)" is written in a regular font. This text likely refers to a regulatory requirement for prescription use.
ಸ
AND/OR
Over-The-Counter Use [ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muly for HCR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092951
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