(13 days)
Not Found
Not Found
No
The summary describes a dental curing light, which uses light to polymerize materials. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device's intended use is for the polymerization (a chemical process often used in dentistry to harden materials) of dental restorations and adhesives, which is a manufacturing or preparation step for dental materials rather than a direct therapeutic intervention on a patient. It facilitates the creation of a restoration, not directly treats a condition.
No
The device is indicated for the polymerization of dental restorations, which is a treatment process, not a diagnostic one. It cures materials rather than identifying a condition or disease.
No
The intended use describes a device for the polymerization of dental materials, which strongly suggests a hardware component (a light source) is involved in the polymerization process. The lack of a device description prevents confirmation, but the function described is not typically performed by software alone.
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 dental restorative materials. This is a physical process applied to materials outside the body (or applied to materials in the mouth, but not analyzing biological samples).
- Lack of Biological Sample Analysis: IVDs are defined by their use in examining specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not mention any interaction with or analysis of biological samples.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Other Sections: The absence of information about image processing, AI/ML, input imaging modality, anatomical site (in the context of biological samples), patient age range (relevant for diagnostic tests), user/care setting (often specified for diagnostic labs or clinical settings), and performance studies related to diagnostic accuracy further supports that it's not an IVD.
This device appears to be a dental light curing unit, which is a medical device used in dentistry, but not an IVD.
N/A
Intended Use / Indications for Use
This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.
Product codes
EBZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra oral and extra oral
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.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2004
Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128
Re: K040551
Trade/Device Name: Coltolux® LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ Dated: February 29, 2004 Received: March 02, 2004
Dear Mr. Vogelstein:
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.
1
Page 2 - Mr. Henry J. Vogelstein
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/clsma/dsmamain.html
Sincerely vours.
Keir Muly
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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Image /page/2/Picture/0 description: The image shows the words "coltene" and "whaledent" stacked on top of each other. The word "coltene" is in a bold, sans-serif font, and there are three diagonal lines after the word. The word "whaledent" is in a similar font and is located directly below "coltene."
Coltène/Whaledent Inc. 510(k) Submission
| Indications for Use | ||
|---|---|---|
| 510(k) Number (if known): | Not known | K040551 |
Device Name: Coltolux LED Curing Light
Indications for Use:
This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.
Prescription Use
(21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 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 Russo
Clivision Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesental Devices
Confrol, Dontrol, Devices (Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign of Anesiology, Golf
Division of Anesthesiology, Dental Devicess
Infection Control, Dentrol, Devices
510(k) Number.