(31 days)
Not Found
No
The description focuses on LED technology for light curing and does not mention any AI or ML components or functionalities.
No
The device is used for curing dental materials, not for treating a disease or condition in a patient.
No
Explanation: A diagnostic device identifies or characterizes a disease or condition. This device is a curing light used to harden dental materials, which is a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a cordless, battery-powered unit with a handpiece, probe with an LED, and a base/recharger unit, 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 "curing camphorquinone-based visible light cured (VLC) dental materials." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a light-emitting device used to solidify dental materials. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body, specifically the mouth) to perform a physical action (curing).
N/A
Intended Use / Indications for Use
The SmartLite™ PS Pen-Style LED Curing Light is indicated for curing camphorquinone-based visible light cured (VLC) dental materials.
Product codes
EBZ
Device Description
The SmartLite™ PS Pen-Style LED Curing Light is a cordless, battery-powered unit designed for curing VLC materials whose initiator systems are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The unit is based ion LED (light emitting diode) technology for light generation.
The SmartLite™ PS Pen-Style LED Curing Light includes:
- A handpiece with control electronics and an inductively-recharged battery .
- . A probe with a single LED at the tip
- A base/recharger unit that plugs directly into main power .
- . An optional eye shield
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
SmartLite™ iQ LED Curing Light K031615, Spectrum™ 800 Curing Unit K982318
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 2 4 2004
510(k) SUMMARY
DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872
P. Jeffery Lehn CONTACT:
DATE PREPARED:
| TRADE OR PROPRIETARY NAME: | SmartLite™ PS Pen-Style LED Curing Light |
|---|---|
| CLASSIFICATION NAME: | Ultraviolet Activator for Polymerization (872.6070) |
| PREDICATE DEVICES: | SmartLite™ iQ LED Curing Light K031615 |
| Spectrum™ 800 Curing Unit K982318 |
DEVICE DESCRIPTION:
The SmartLite™ PS Pen-Style LED Curing Light is a cordless, battery-powered unit designed for curing VLC materials whose initiator systems are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The unit is based ion LED (light emitting diode) technology for light generation.
The SmartLite™ PS Pen-Style LED Curing Light includes:
- A handpiece with control electronics and an inductively-recharged battery .
- . A probe with a single LED at the tip
- A base/recharger unit that plugs directly into main power .
- . An optional eye shield
INTENDED USE:
The SmartLite™ PS Pen-Style LED Curing Light is indicated for curing camphorquinone-based visible light cured (VLC) dental materials.
TECHNOLOGICAL CHARACTERISTICS:
The SmartLite™ PS Pen-Style LED Curing Light is substantially equivalent to K031615 in intended use, operation, wavelength range, and light source.
The SmartLite™ PS Pen-Style LED Curing Light is substantially equivalent to K982318 in intended use, operation.
We believe the similarity of the SmartLite™ PS Pen-Style LED Curing Light to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the SmartLite™ PS Pen-Style LED Curing Light for the indicated use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle or bird-like figure with three stylized lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2004
Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872
Re: K041372
Trade/Device Name: SmartLite™ PS Pen-Style LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 19, 2004 Received: May 24, 2004
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have love and have determined the device is substantially equivalent (for the indications for relected in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enorouses of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic If to been recentive in are areas of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manker the devices, backed requirements for annual registration, listing of devices, good controls provisions or abeling, and prohibitions against misbranding and adulteration.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may publish forther announcements concerning your device in the Eederal Register.
2
Page 2 – Mr. P. Jeffery 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 of that FDA has made a delectimination mat your ceviler Federal agencies. You must comply with any Federal Statules and regulations administered of Sacreesstration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration an an the Act STequirements, metuding, but novine requirements as set forth in the quality labeling (21 CFR Part 801), good manatates and if applicable, the electronic product radiation systems (QB) regalation (2s 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) I his letter will anow you to begin maneling of substantial equivalence of your device to a legally premarket notification. The PDA mainly of sassamal on our 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 If you desire specific auvice for your actively, for questions on the promotions on the promotion comact the Office of Compinance at (301) 594-4639 Compliance at (301) 594-4639. Also, ASS, STOR and advertising of your do free, prease ossirance to premarket notification" (21CFR please note the regulation childer, "Internation on your responsibilities under the Act may Patt 807.97) you they obtain. Other generational and Consumer Assistance at its be obtained from are (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
Enclosure
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
1041372 510(K) Number (if known):
SmartLite™ PS Pen-Style LED Curing Light Device Name:
Indications for Use:
The SmartLite™ PS Pen-Style LED Curing Light is indicated for curing camphorquinone-based visible light cured (VLC) dental materials
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punne
nesthestology, Infection Control, Der
510(k) Number: