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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a dental curing light called Valo™. It describes the device, its indications for use, and claims substantial equivalence to a predicate device (Palmlight). However, it does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance.

The document is a declaration of substantial equivalence based on the device being similar to an already legally marketed device, not a report of a new clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Number and qualifications of experts.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document is a regulatory filing stating that the Valo™ device is an ultraviolet activator for polymerization, intended as a source of illumination for curing photo-activated dental restorative materials and adhesives, and that it is substantially equivalent to a predicate device. It does not include the detailed performance study information you are asking for.

Summary

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K083647

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

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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

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

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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

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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:

Page_1 of 1

(Posted November 13, 2003)

Regulation Number and Section

§ 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.