(44 days)
Not Found
No
The summary describes a standard dental curing light and does not mention any AI or ML capabilities.
Yes
The device is used for curing dental composites, which is a therapeutic process.
No
The device is a dental curing light, which is used for polymerization of dental composites, not for diagnosing medical conditions.
No
The device description explicitly states it is a "hand-held polymerization light" and uses a "rechargeable Li-ion Battery for cordless operation," indicating it is a physical 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 "Curing of dental composites using visible light." This describes a physical process applied to a material (dental composite) outside of the body, not a diagnostic test performed on biological samples.
- Device Description: The description confirms it's a "hand-held polymerization light intended for use in curing dental composites." This aligns with the intended use and does not suggest any diagnostic function.
- Lack of IVD Indicators: The document 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 patient's health status
- Using reagents or assays
Therefore, the Doctor's Light LED Dental Curing Light is a therapeutic or procedural device used in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Curing of dental composites using visible light.
Product codes
EBZ
Device Description
Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
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)
This device meets consensus standards IEC 60601-1 for electrical safety and IEC 60601-1-2. Bench testing was also conducted to demonstrate performance specifications.
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information: Emergo Group Inc. 1705 S Capital of Texas Hwy Suite 500 Austin, TX 78746
AUG 2 3 2007
Date Summary Prepared: July 9, 2007
Contact Persons: Ian P Gordon igordon@emergogroup.com
Device Name:
Trade Name(s): Doctor's Light LED Dental Curing Light Classification Name: Ultraviolet Activator for Polymerization Panel: Dental Product Code: EBZ
Predicate Device Information:
Bluephase® marketed by Ivclar Vivodent, Incoporated, under K033520; and Turbo-Pen marketed by Apoza Enterprize Co., Ltd.
Device Description:
Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
Intended Use:
This device is intended for curing dental composites using visible light.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in intended use and technological characteristics, including:
- Light source .
- Power source .
- Wavelength .
- Materials .
- Light intensity .
- Peak wavelength .
- Depth of cure .
Performance Test Data and Conclusions:
This device meets consensus standards IEC 60601-1 for electrical safety and IEC 60601-1-2. Bench testing was also conducted to demonstrate performance specifications.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail. The logo is black and white.
AUG 2 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Good Doctors Company, Limited C/O Mr. Ian P. Gordon Senior Vice President Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin. Texas 78746
Re: K071908
Trade/Device Name: Doctor's Light LED Dental Curing Light Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: July 05, 2007 Received: July 10, 2007
Dear Mr. Gordon:
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.
2
Page 2 - Mr. Gordon
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Sudite Y. Michael Ours
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known):
Device Name: Doctor's Light LED Dental Curing Light
Indications for Use:
Curing of dental composites using visible light.
Prescription Use XX (Part 21 CFR 801 Subpart D) 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 Marley for MSR
Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
(10(k) Nur