(59 days)
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No
The description focuses on LED technology, battery power, and basic control switches for curing time and type. There is no mention of AI, ML, image processing, or any learning/adaptive capabilities.
No
The device is described as a curing light for dental materials, not for treating or diagnosing any medical condition in a patient.
No
Explanation: The device is described as a curing light for visible light-cured materials, which is a therapeutic function rather than a diagnostic one. It cures materials and does not aim to identify a disease, condition, or provide a diagnosis.
No
The device description clearly outlines multiple hardware components including a handpiece, LED, fiber-optic probe, battery, base unit, and transformer.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SLED CURING LIGHT is used to cure dental materials outside the body. It applies light to a material to solidify it.
- Intended Use: The intended use clearly states "Curing camphorquinone-based visible light cured (VLC) materials," which are dental restorative materials.
- Device Description: The description details a light-emitting device for curing materials, not for analyzing biological samples.
Therefore, based on the provided information, the SLED CURING LIGHT is a dental device used for curing materials, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Curing camphorquinone-based visible light cured (VLC) materials.
Product codes (comma separated list FDA assigned to the subject device)
EBT
Device Description
The SLED CURING LIGHT is a cordless battery-powered unit designed for curing VLC materials whose initiators are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation.
The SLED CURING LIGHT SYSTEM includes:
- Handpiece with an LED and control electronics
- Tapered fiber-optic probe to deliver the light to a well-defined site
- Battery for sustained electronic power
- Base unit - charges battery - stores handpiece when not in use
- Transformer to supply wall power to the base unit
- Optional amber-colored eye shield
The SLED CURING LIGHT handpiece contains three switches: one trigger to turn the curing LED on and off and two mode switches to cycle the curing time and type through several different settings. The battery in the handpiece is contained in a user-serviceable compartment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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.)
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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.
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).
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§ 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 the word "DENTSPLY" in a bold, sans-serif font. Above the word, there is a handwritten number "K031615" in black ink. The number is written diagonally across the top left corner of the image.
510(k) SUMMARY
NAME & ADDRESS:
JUL 2 1 2003
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
May 22, 2003 DATE PREPARED:
TRADE OR PROPRIETARY NAME: SLED CURING LIGHT SYSTEM visible light cure for polymerization CLASSIFICATION NAME:
| PREDICATE DEVICES: Spectrum™ 800 Curing Unit | 982318 | |
|---|---|---|
| Nova Cordless Light | 000393 |
DEVICE DESCRIPTION:
The SLED CURING LIGHT is a cordless battery-powered unit designed for curing VLC materials whose initiators are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation.
The SLED CURING LIGHT SYSTEM includes:
- . Handpiece with an LED and control electronics
- Tapered fiber-optic probe to deliver the light to a well-defined site .
- Battery for sustained electronic power ●
- . Base unit - charges battery
- stores handpiece when not in use
- Transformer to supply wall power to the base unit ●
- Optional amber-colored eye shield .
The SLED CURING LIGHT handpiece contains three switches: one trigger to turn the curing LED on and off and two mode switches to cycle the curing time and type through several different settings. The battery in the handpiece is contained in a user-serviceable compartment.
DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
(717) 845-7511
Fax (717) 849-4762
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510(k) SUMMARY (cont'd.)
. "
INTENDED USE:
. . .
Curing camphorquinone-based visible light cured (VLC) materials.
TECHNOLOGICAL CHARACTERISTICS:
The SLED CURING LIGHT SYSTEM is substantially equivalent to K982318 in intended use, appearance and design, including source placement, probe style, on-board radiometer, control circuit, handpiece style.
The SLED CURING LIGHT SYSTEM is substantially equivalent to K000393 in intended use, operation, including the range of light emitted, curing time, and cooling.
We believe the similarity of the SLED CURING LIGHT SYSTEM to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the SLED CURING LIGHT SYSTEM for the indicated use.
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Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its chest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 17405- 0872 York, Pennsylvania
Re: K031615
Trade/Device Name: SLED CURING LIGHT SYSTEM Regulation Number: 872. 6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBT Dated: May 22, 2003 Received: May 27, 2003
Dear Mr. Lehn:
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 - Mr. Lehn
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. 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 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,
fothun
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): K031615
Device Name:
SLED CURING LIGHT SYSTEM
Indications for Use:
Curing camphorquinone-based visible light cured (VLC) materials.
RS Betz DDS for Dr. K. Mulry
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
510(k) Number
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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