(45 days)
Not Found
No
The summary describes a dental curing light, which is a simple illumination device. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies.
No
The device is used for curing dental materials, which is a supportive function in a dental procedure, not directly for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device is described as an "activator" or "dental curing light" used for "curing photo-activated dental restorative materials and adhesives" and "polymerization of all photo-mitiated dental materials." This indicates it is a therapeutic or treatment device, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description explicitly states it is a "dental curing light," which is a hardware device used for polymerization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Source of illumination for curing photo-activated dental restorative materials and adhesives." This describes a device used externally to polymerize materials within the patient's mouth.
- Device Description: The description confirms it's a "dental curing light used for polymerization of all photo-mitiated dental materials." This further reinforces its function as an external device acting on materials.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention any analysis of biological specimens.
Therefore, the Valo™ device, as described, is a therapeutic or procedural device used in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes
EBZ
Device Description
Valo™ is an activator, ultraviolet for polymerization. In other words, it is a dental curing light used for polymerization of all photo-mitiated dental materials.
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)
Not Found
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
SPECIAL 510(K) PREMARKET SUMMARY
Valo™
JAN 2 3 2009
This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Valo™
Applicant's Name and Address
Ultradent Products, Inc 505 West 10200 South South Jordan, UT 84095
| Contact Person | Diane Rogers |
|---|---|
| Title | Regulatory Affairs Manager |
| Telephone | 800-552-5512 x4491, 801-553-4491 |
| FAX | 801-553-4609 |
| Date Summary Prepared | December 11, 2008 |
Name of the Device
| Trade Name | Valo™ |
|---|---|
| Common Name | Activator, ultraviolet for polymerization |
| Device Classification | II |
| Classification Product Code | EBZ |
Legally Marketed Predicate Device to Which Equivalence is Claimed
The predicate device is Palmlight (K003383) This device is manufactured and distributed by Ultradent Products, Inc , 505 West, 10200 South, South Jordan, Utah 84095
Product Description Valo™ is an activator, ultraviolet for polymerization In other words, it is a dental curing light used for polymerization of all photo-mitiated dental materials
Indications for Use: Source of illumination for curing photo-activated dental restorative materials and adhesives
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 stylized eagle with three stripes representing the department's mission. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
JAN 2 3 2009
K083647 Trade/Device Name Valo™ Regulation Number 21 CFR 872 6070 Regulation Name Ultraviolet Activator for Polymerization Regulatory Class II Product Code EBZ Dated January 14, 2009 Received January 14, 2009
Dear Ms Rogers
Re
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
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 regustration 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index.html
Sincerely yours.
Chattanooga, morton for
Ginette Y Michaud, M D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Statement of Indications for Use
K083647 510(k) Number (if known)
Valo™ Device Name
Indications for Use
1 1
Source of illumination for curung photo-activated dental restorative materials and adhesives.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruase
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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(Posted November 13, 2003)