(35 days)
Not Found
No
The description focuses on the hardware components and basic light-emitting function, with no mention of AI/ML terms or capabilities.
No
The device is used for photopolymerization of dental resins, which is a process to harden dental materials, not to directly treat a disease or condition in a patient.
No
The device is described as a dental curing light intended for the photopolymerization of dental resins, a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components (handpiece, fiber optic end tip, cradle, LED light source, transformer) and the performance studies include hardware verification and validation.
Based on the provided information, the DVI Curing Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for the photopolymerization of dental resins." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a device that emits light to cure materials in the patient's mouth. This is an in vivo application, not in vitro (meaning "in glass" or outside of the body).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DVI Curing Light's function is to solidify dental materials directly within the patient's mouth.
N/A
Intended Use / Indications for Use
The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.
Product codes
EBZ
Device Description
The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.
The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted to evaluate the functional performance and safety of the proposed DVI Curing Light:
- Software and hardware verification and validation .
- . Electrical safety and electromagnetic compatibility
- . Resin polymerization times
The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JAN 2 5 2005
510(k) Summary for Designs for Vision Inc. Curing Light
1. SPONSOR
Designs for Vision, Inc. 760 Koehler Avenue Ronkonkoma, NY 11779
Contact Person: Richard Feinbloom Telephone: 631-585-3300
Date Prepared: December 20, 2004
2. Device Name
Proprietary Name: DVI Curing Light Common/Usual Name: dental curing light ultraviolet activator for polymerization Classification Name:
3. PREDICATE DEVICES
Dentsply SmartLite (IQ) LED Curing Light (K041372)
Sybron Dental L.E. Demetron (K021797).
4. DEVICE DESCRIPTION
The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.
The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of
1
between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.
ડ. INTENDED USE
The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed and predicate devices consist of a handpiece with a fiberoptic tip. The handpiece of the proposed DVI Curing Light and the predicate devices sit in a cradle. The handpiece is removed from the cradle during operation. The cradles of both the proposed and predicate devices serve as a charging base for the handpieces.
The operational principles of the proposed and predicate devices are identical in that they are LED devices used for photopolymerization of dental resins. The tip of the handpiece is oriented appropriately relative to the material being photopolymerized and the selected treatment time is initiated. In all devices, the light source is an LED light source located in the handpiece.
7. PERFORMANCE TESTING
The following testing was conducted to evaluate the functional performance and safety of the proposed DVI Curing Light:
- Software and hardware verification and validation .
- . Electrical safety and electromagnetic compatibility
- . Resin polymerization times
The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2005
Designs for Vision, Incorporated C/O Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K043530
Trade/Device Name: DVI Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: December 20, 2004 Received: December 21, 2004
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate commerce
use stated in the enclosure) to legally market of predicate or to devices that use stated in the enclosure) to regally man keep preadinents, or to devices that prior to May 28, 1976, the enachient with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (PMA have been reclassified in accordance with the provisions of the Act. The may, a Act (Act) that do not require approval of a promatico provisions of the Act. The general therefore, market the device, subject to me general registration, listing of devices, good
controls provisions of the Act include requirements for annual regular and adultera controls provisions of the Act merace requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more in the regulations affecting your device can be
may be subject to such additional controls. Existing may of anddition, EDA may p may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Featur reserving your device in the Federal Register.
3
Page 2 - Mary McNamara-Cullinane, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DX 3 Issualled of a volence complies with other requirements of the Act or that FDA nas made a determination and regulations and reactions. You must comply with CEP Page of C ally redular statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); all the Act s requirements; morading, base manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 807), good bart 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) I mis icher with anow you to begin mailing of substantial equivalence of your device to a legally premaired notification: "The PDF interior 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 If you desire specific admission 900 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your of your er 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,
Clive S. Liu, Ph.D.
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
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Indications for Use
1043530 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ DVI Curing Light
Indications for Use:
The DVI Curing Light is a dental curing light that is intended for photopolymerization of dental resins.
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)
Sina Runner
(Division Sign-Off) Urvision of Anesthesiology, General Hospital, Intection Control, Dental Devices
K(k) Number: K0413530
Designs for Vision, Inc. 510(k) Curing Light
December 20, 2004