VALO® Grand is a battery operated, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand version functions the same as the predicate, VALO® Cordless, K110582, as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand, is manufactured from the same materials (anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic), is used for the same indications, and has the same intended use as the predicate device. Both devices have three power output modes ranging from 800 – 2300 mW/cm². Both the new device and predicate cure dental composite materials in the 395 – 480 nm range using an LED light source. Differences from the predicate include an increased light head diameter to provide a larger curing area over a tooth, an additional LED activation ('power') button for better ergonomics, and the middle power mode setting has been changed from 1400 to 1600 mW/cm², which makes it more central between the Standard and Xtra Power modes.

AI/ML Overview

The provided text describes a Special 510(k) Summary for the VALO® Grand dental curing light. While it outlines the device's characteristics and its substantial equivalence to a predicate device, it does not contain detailed acceptance criteria and the comprehensive study data typically requested for proving a device meets specific performance criteria.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Verification activities included curing hardness, depth of cure per ADA Specification No. 48, maximum light intensity measurements at 2 mm for all power modes, spectral irradiance plots of all power modes, and representative user testing."

However, it does not provide a table specifying the acceptance criteria (e.g., minimum curing hardness, minimum depth of cure) for these parameters, nor does it present the actual reported device performance values against such criteria. It only states that "Based on the results of verification testing, the differences in technological characteristics did not raise different questions of safety or performance..." without showing the data.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "representative user testing" but does not specify the sample size for any of the verification activities (curing hardness, depth of cure, light intensity, spectral irradiance, or user testing).

The data provenance is also not explicitly stated (e.g., country of origin, retrospective or prospective). It simply refers to "verification testing."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies mentioned are primarily technical performance tests of the device itself (curing properties, light output), not expert-driven assessments requiring ground truth establishment in the typical sense for diagnostic or prognostic devices. "Representative user testing" is mentioned, but details about the users (experts or not, qualifications) and their role in establishing "ground truth" are absent.

4. Adjudication Method

This information is not applicable/provided. The verification activities described are objective measurements of the device's physical and curing properties, not subjective assessments requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or mentioned. The device is a dental curing light, and the studies described focus on its physical performance in curing dental materials, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance study was not performed or mentioned. The device is a physical light-emitting product, not an algorithm.

7. Type of Ground Truth Used

For the performance tests mentioned (curing hardness, depth of cure, light intensity, spectral irradiance), the "ground truth" would be established by objective laboratory measurements against predefined physical and chemical standards (e.g., ADA Specification No. 48 for depth of cure, calibrated light power meters for intensity, spectrophotometers for spectral irradiance). The document implies these standard methods were used ("per ADA Specification No. 48"), but doesn't explicitly detail the "ground truth" creation process beyond that.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The descriptions are of physical device verification.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

In summary:

The provided document is a 510(k) summary for a dental curing light, demonstrating substantial equivalence to a predicate device through engineering and performance verification. It focuses on physical and curing properties of the device. Consequently, many of the requested details, particularly those related to expert-driven ground truth, MRMC studies, or AI/ML algorithms, are not relevant or present in this type of submission. While it states that verification activities were performed, it lacks the specific quantitative results and acceptance criteria tables that would fully answer the request for "acceptance criteria and the study that proves the device meets the acceptance criteria."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2016

Ultradent Products, Inc. Mr. Corey Jaseph Regulatory Affairs Manager 505 West 10200 South South Jordan, Utah 84095

Re: K160551

Trade/Device Name: Valo® Grand Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: Mav 25, 2016 Received: June 14, 2016

Dear Ms. Jaseph:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved:50MB Not.700910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160551

Device Name VALO Grand

Indications for Use (Describe)

The VALO Grand is a source of illumination for curing photo-activated dental restorative materials and adhesives.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows a logo in brown color. The logo appears to be a stylized representation of the letters 'U' and 'A' combined. The letters are designed with rounded corners and thick lines, giving the logo a modern and bold look. There is also a registered trademark symbol in the upper right corner of the logo.

Special 510(k) Summary for VALO® Grand

This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for VALO® Grand.

l. Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Contact Person:	Ms. Marie Hess
Title:	Sr. Regulatory Affairs Associate
Telephone:	801-553-4610
FAX:	801-553-4609

Date Summary Prepared: 12 July 2016

II. Name of the Device

Trade Name:	VALO® Grand
Common Name:	Dental Curing Light
Device Classification:	Class II
Classification Product Code:	EBZ
Classification Name:	Ultraviolet Activator for Polymerization
Regulation No.	21 CFR 872.6070

lll. Device Description: VALO® Grand is a battery operated, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand version functions the same as the predicate, VALO® Cordless, K110582, as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand, is manufactured from the same materials (anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic), is used for the same indications, and has the same intended use as the predicate device. Both devices have three power output modes ranging from 800 – 2300 mW/cm². Both the new device and predicate cure dental composite materials in the 395 – 480 nm range using an LED light source. Differences from the predicate include an increased light head diameter to provide a larger curing area over a tooth, an additional LED activation ('power') button for better ergonomics, and the middle power mode setting has been changed from 1400 to 1600 mW/cm², which makes it more central between the Standard and Xtra Power modes.
IV. Indications for Use: The VALO® Grand is a source of illumination for curing photo-activated dental restorative materials and adhesives.
V. Predicate Device: The predicate device is VALO® Cordless, cleared under 510(k) K110582.

Image /page/3/Picture/12 description: The image shows the logo for Ultradent Products, Inc. The logo is in a sans-serif font and is a dark orange color. The background is a lighter orange color with a geometric pattern. The logo is enclosed in a white rounded rectangle.

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VI. Indication of Risk Analysis Method:

Risk Analysis was performed on VALO® Grand utilizing processes based on ISO 14971:2012. Risks associated to patient safety and product efficacy for VALO® Grand have been identified, assessed, and controlled to level that is as low as currently feasible. Any remaining residual risks are not considered to be hazardous to patients, customers, and/or end users. Ultradent considers VALO® Grand to be substantially equivalent in its intended use as compared to the predicate device.

VII. Comparison of Technological Characteristics

VALO® Grand and VALO® Cordless have similar technological characteristics as described in Table 5.1.

Descriptive Information	Device: VALO® Granddental curing light	Predicate: VALO® Cordless dentalcuring light (K110582)
Intended Use	The source of illumination for curingphoto-activated dental restorativematerials and adhesives.	The source of illumination for curingphoto-activated dental restorativematerials and adhesives.
Intended User	Dentist or dental professional	Dentist or dental professional
Power source	Batteries: Lithium Iron Phosphate(LiFePO4) RCR123A with a workingvoltage of: 3.2VDC. Their safety ratings:CE, RoHS, WEEEPower Charger: 3.6VDC Lithium IonPhosphate smart battery chargerAC Power Supply: Connects to charger,wall powered. Output; 12VDC, 500mA.Input: 100VAC - 240VAC with adaptersfor international capability. Ratings:Medical Grade, (UL, CE, RoHS, WEEE)Cord: 6 ft (1.8m), 2.5mm DC connector	Batteries: Lithium Iron Phosphate(LiFePO4) RCR123A with a workingvoltage of: 3.2VDC. Their safety ratings:CE, RoHS, WEEEPower Charger: 3.6VDC Lithium IonPhosphate smart battery chargerAC Power Supply: Connects to charger,wall powered. Output; 12VDC, 500mA.Input: 100VAC - 240VAC with adaptersfor international capability. Ratings:Medical Grade, (UL, CE, RoHS, WEEE)Cord: 6 ft (1.8m), 2.5mm DC connector
	Power On Button: Located on thehandle of the wand, front and back side	Power On Button: Located on the handleof the wand, back side only
Operational modes	Standard Power Mode: 1000 mW/cm2High Power Plus Mode: 1600mW/cm2Xtra Power Mode: 3200mW/cm2Device indicates illumination timeselectionDevice indicates time and time selection	Standard Power Mode: 1000 mW/cm2High Power Mode: 1400mW/cm2Xtra Power Mode: 3200mW/cm2Device indicates illumination timeselectionDevice indicates time and time selection

Substantial equivalence comparison table:

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Descriptive Information	Device: VALO® Grand	Predicate: VALO® Cordless dental
	dental curing light	curing light (K110582)

Light source	LED light, blue and violet	LED light, blue and violet
	wavelengths	wavelengths
	12mm light head diameter	10 mm light head diameter
Accessories	Barrier Sleeve VALO®,	Barrier Sleeve VALO®,
	VALO® Grand Light Shield	VALO® Cordless Light Shield
Composition of	Aluminum, anodized black	Aluminum, anodized various colors
Materials

Parameters of	Chemical disinfection with approved	Chemical disinfection with approved
Disinfection	cleaning/sanitizing agents:	cleaning/sanitizing agents:

	Cavicide products	Cavicide products
	lsopropyl alcohol	lsopropyl alcohol
	Ethyl alcohol based cleaners	Ethyl alcohol based cleaners
	Lysol disinfectant (alcohol-based	Lysol disinfectant (alcohol-based
	only)	only)

Usability/Ergonomics	3 buttons – 2 power, 1 mode select	2 buttons – 1 power, 1 mode select

VALO® Grand is a similar device to the predicate, manufactured with identical materials and using the same energy source. VALO® Grand is used and cleaned in the same type of users. The differences between VALO® Grand and the predicate are the light head diameter (12 mm vs. 10 mm), the middle power mode (1600 mW/cm² vs. 1400 mW/cm²), and the addition of a second power button. These differences do not impact safety or performance as described below, and therefore do not render the device not substantially equivalent.

VALO® Grand has been designed and tested according to the FDA Guidance Document Dental Curing Lights – Premarket Notification [510(k)]. Verification activities included curing hardness, depth of cure per ADA Specification No. 48, maximum light intensity measurements at 2 mm for all power modes, spectral irradiance plots of all power modes, and representative user testing. Biocompatibility and electrical safety/EMI testing were not performed on the new device, as there were no changes from the predicate that impacted conformance to these standards.

Based on the results of verification testing, the differences in technological characteristics did not raise different questions of safety or performance of the new device when tested against the predicate according to the FDA Guidance Document, Guidance for Industry and FDA Staff: Dental Curing Lights – Premarket Notification [510(k)] Submissions. The VALO Grand is substantially equivalent to the predicate.

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.