VALO Accessory Lenses: The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo-activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of photo-activated materials and adhesives.

Device Description

VALO Grand Corded: With its broadband spectrum, VALO Grand Corded is designed to polymerize all light cured products in the wavelength range of 385-515nm per ISO 10650. VALO has a medical grade, international power supply and is suitable for power outlets from 100 to 240 volts. The handpiece is designed to rest in a standard dental unit bracket or can be custom mounted using the bracket included with the kit.

Accessory Lenses:

. PointCure™ Lens - o Augments the VALO curing light to polymerize composite through a translucent prosthetic.
. ProxiCure™ Ball Lens - o Augments the VALO curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.
TransLume™ Green Lens - Augments the VALO curing light to aid in visualization by providing longer wavelength light to o transilluminate teeth and dental prostheses.
Black Light Lens - o Augments the VALO curing light to provide aid in visualization of fluorescing chemicals in dental resins.
Interproximal Lens - Augments the VALO curing light to aid in visualization of teeth and dental prostheses. o
White Light Lens - Augments the VALO curing light to provide a visual aid for accurate color/shade comparison or o whenever natural light is needed.

AI/ML Overview

The provided text does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving its performance. Instead, it is a 510(k) premarket notification for a dental curing light named "VALO Grand Corded and Accessory Lenses". This device is a traditional medical device, not an AI-powered one.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the non-AI device described in the document.

The document discusses the substantial equivalence of the "VALO Grand Corded and Accessory Lenses" to predicate devices based on:

Intended use: Illumination for curing photo-activated dental restorative materials and adhesives, and aid in visualization during oral procedures.
Technological characteristics: Power source, light source (LED, blue and violet wavelengths), operational modes (for curing and diagnostic purposes with accessory lenses), accessories, material composition, and technical specifications (light intensity, peak wavelength, depth of cure).
Recognized standards: ISO 10650, IEC 80601-2-60, ISO 14971, IEC 62366-1, ISO 10993-1.
Non-clinical testing: Radiant exitance and emission spectrum testing (ISO 10650:2018), illuminance and color temperature testing, beam profile testing, duty cycle testing, and disinfection validation testing.

The conclusion is that the device is substantially equivalent to the predicate devices and does not raise new concerns of safety or efficacy, which is the standard for 510(k) clearance for conventional medical devices.

Summary

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March 1, 2021

Ultradent Products, Inc % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K210550

Trade/Device Name: VALO Grand Corded and Accessory Lenses Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: Class II Product Code: EBZ,EAQ, PEQ Dated: February 19, 2021 Received: February 25, 2021

Dear Dave Yungvirt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210550

Device Name VALO Grand Corded and Accessory Lenses

Indications for Use (Describe) VALO Grand Corded: Source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO Accessory Lenses:

The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo-activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of photo-activated materials and adhesives.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K210550

Section 5: 510(k) Summary

This summary of substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for VALO™ Grand Corded and Accessory Lenses.

I. Applicant's Name and Address

Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095

Contact Person:	Mr. Adam Black
Title:	Regulatory Affairs Manager
Telephone:	801-553-4425
Fax:	801-553-4609

Date Summary Prepared: 12 February 2021

II. Name of the Device

Device:	Dental Curing Light
Trade/Device Name:	VALO™ Grand Corded and Accessory Lenses
Review Panel:	Dental
Regulation Number:	21 CFR 872.6070
Device Class:	Class II
Classification Product Code:	EBZ
Subsequent Product Code:	EAQ

III. Device Description

VALO™ Grand Corded:

With its broadband spectrum, VALO Grand Corded is designed to polymerize all light cured products in the wavelength range of 385-515nm per ISO 10650.

VALO has a medical grade, international power supply and is suitable for power outlets from 100 to 240 volts. The handpiece is designed to rest in a standard dental unit bracket or can be custom mounted using the bracket included with the kit.

Accessory Lenses:

. PointCure™ Lens
- o Augments the VALO curing light to polymerize composite through a translucent prosthetic.
. ProxiCure™ Ball Lens
- o Augments the VALO curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.

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TransLume™ Green Lens
- Augments the VALO curing light to aid in visualization by providing longer wavelength light to o transilluminate teeth and dental prostheses.
Black Light Lens
- o Augments the VALO curing light to provide aid in visualization of fluorescing chemicals in dental resins.
Interproximal Lens
- Augments the VALO curing light to aid in visualization of teeth and dental prostheses. o
White Light Lens
- Augments the VALO curing light to provide a visual aid for accurate color/shade comparison or o whenever natural light is needed.

IV. Statement of Intended Use

VALO Grand Corded:

Source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO Accessory Lenses:

V. Predicate Device

VALO Grand Corded and Accessory Lenses identified primary predicate: K190627 – VALO™ Grand Corded by Ultradent Products, Inc and secondary predicate: K101140 – FUSION-DOE by DentLight Inc.

VII. Comparison of Technological Characteristics

Predicate technological comparison:

The technology, delivery, and intended use of VALO™ Grand Corded and Accessory Lenses are substantially equivalent to the identified predicate devices as outlined in Table 5-1:

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Table 5-1: VALO™ Grand Corded and Accessory Lenses substantial equivalence comparison

DescriptiveInformation	Device: VALO™ Grand Corded andAccessory Lenses	Primary Predicate:VALO™ Grand Corded(K190627)	Secondary Predicate:Dentlight Oral Exam Light Kit("DOE") (K101140)
Product Code/Classification	EBZ, EAQ - Class II	EBZ — Class II	EAQ — Class II
Indications forUse	VALO Grand Corded:The source of illumination for curingphoto-activated dental restorativematerials and adhesives.Accessory Lenses: The VALOAccessory Lenses are multiple-useaccessory lenses intended to provideillumination to aid in visualizationduring oral procedures and augmentthe VALO family of curing lights, whichare a source of illumination for curingphoto-activated dental restorativematerials and adhesives. VALOAccessory Lenses are not intended forcomplete cure of photo-activatedmaterials and adhesives.	The source of illumination forcuring photo-activated dentalrestorative materials andadhesives.	Dentlight Oral Exam Light Kit isindicated to be used by adentist and physician forillumination to aid invisualization during oralprocedures and an adjunct toenhance the visualization fororal examination of mucosalabnormalities and oral lesions
Intended User	Dentist or dental professional	Dentist or dental professional	Dentist or dentalprofessional
Device Design:Power Source	AC Power Supply:Wall powered.	AC Power Supply:Wall powered.	Rechargeable Li-Ion batteries
	Output: 9VDC, 500mA. Input: 100VAC -240VAC with adapters for internationalcapability. Ratings: Medical Grade, (UL, CE, RoHS,WEEE) Cord: 6 ft (1.8m), 2.5mm DC connectorPower On Button: Located on thehandle of the wand, back side and frontsideUL Approved	Output: 9VDC, 500mA. Input:100VAC - 240VAC with adaptersfor international capability.Ratings: Medical Grade, (UL, CE, RoHS,WEEE) Cord: 6 ft (1.8m), 2.5mm DC connectorPower On Button: Located onthe handle of the wand, backside and front sideUL Approved
Device Design:OperationalModes (CuringEBZ)	VALO Grand Corded:Standard Power Mode: 1000 mW/cm2High Power Plus Mode: 1600mW/cm2Xtra Power Mode: 3200mW/cm2*as measured by DemetronAccessory Lenses:≥800 mW/cm2 (PointCure –Recommened with High Power Mode)(ProxiCure – Recommended with modesuitable for material)	Standard Power Mode: 1000mW/cm2High Power Plus Mode:1600mW/cm2Xtra Power Mode: 3200mW/cm2*as measured by Demetron	N/A
Device Design:OperationalModes(Diagnostic EAQ)	Accessory Lenses:≥25 mW/cm2, ≤420 nm wavelength(Black Light Lens – Recommended withStandard Curing mode)≥1,000 lx luminescence, 5,000-6,000 Kcolor temperature, ≥85 CRI (WhiteLight Lens – Recommended withStandard Curing mode)≥15,000 lx luminescence, 500-570nmpeak wavelengths (TransLume GreenLens – Recommended with StandardCuring mode)	N/A	Violet or Blacklight: 395 – 420nm peak wavelength, ≥25mW/cm2* (Can be used in eithermode)White light: ≥1,000 lxluminescence, 5,000 - 6,000 Kcolor temperature, ≥65 CRI(Can be used in either mode)According to Manufacturermarketing material
≥15,000 lx luminescence (Interproximal Lens - Recommended with Standard Curing mode)
Device Design: Light Source	LED light, blue and violet wavelengths12mm head size	LED light, blue and violet wavelengths12mm head size	High Power LED
Device Design:Accessories	Barrier Sleeve VALO™,Blue-Light Blocking Glasses (VALO™ Grand Corded)PointCure Lens, ProxiCure Ball Lens,Translume Green Lens, Black Light Lens,Inter-proximal Lens, White Light Lens	Barrier Sleeve VALO™,Blue Light Blocking Glasses	-Light blocking safety glasses-Safety light blocking shields-Full accessories for fluorescentand transillumination oral exams-Tacking Tip-Curing Caps (3mm, 9mm, 13mm)
Composition ofMaterials	VALO Grand Corded: Aluminum, anodized blackAccessory Lenses:Lens housing - DelrinLens housing magnet – NeodymiumMolded lens – Polymethylpentene TPXRT18 (PointCure, ProxiCure, TransLume Green, Interproximal)Black Light Filter - GlassWhite Light Filter – Type 2 phosphor	Aluminum, anodized black	Solid aircraft aluminum
TechnicalSpecifications:Light Intensity	VALO Grand Corded: Standard: 900 mW/cm²High: 1,500 mW/cm²Xtra: 2,100 mW/cm²As measured by traceable Gigahertzspectrum analyzerAccessory Lenses:	Standard: 900 mW/cm²High: 1,500 mW/cm²Xtra: 2,100 mW/cm²As measured by traceableGigahertz spectrum analyzer	Curing Mode:Pulse Mode: 2,000 mW/cm²Plasma Mode: 4,000 mW/cm²Violet Light Head:

	≥800 mW/cm² (PointCure/ProxiCure)≥25 mW/cm², ≤420 nm wavelength(Black Light Lens)≥1,000 lx luminescence, 5,000-6,000 Kcolor temperature, ≥85 CRI (WhiteLight Lens)≥15,000 lx luminescence, 500-570nmpeak wavelengths (TransLume GreenLens)≥15,000 lx luminescence (InterproximalLens)		≥25 mW/cm²* (Can be used ineither mode)White Light Head:≥1,000 lx luminescence**According to Manufacturermarketing material
TechnicalSpecifications:PeakWavelength	VALO Grand Corded: Nominal values:395-415nm and 440-480nmAccessory Lenses:All lenses match the curing lights peakwavelengths except:≤420 nm wavelength (Black Light Lens),500-570nm peak wavelengths(TransLume Green Lens)	Nominal values: 395-415nm and440-480nm	Nominal values for curing lightsource and White Light Head:440-480nmViolet Light Head: 395-420nm
TechnicalSpecifications:Depth of Cure	2mm	2mm	2mm
RecognizedStandards	ISO 10650:2018IEC 80601-2-60:2019ISO 14971:2007/(R)2010IEC 62366-1:2015ISO 10993-1:2018	ISO 10650:2015IEC 80601-2-60:2012IEC 60601-1 Ed. 3.1ISO 14971:2007/(R)2010IEC 62366-1:2015	ADA 48:2004ISO 10650:2007IEC 60601-1:2007ISO 14971:2007
Parameters ofDisinfection	VALO Grand Corded:Acceptable Cleaners -Lysol Brand III Disinfectant Spray(Recommended)Cavicide products (non-bleach)	Acceptable Cleaners:Lysol Brand III Disinfectant Spray(Recommended)Cavicide products (non-bleach)Isopropyl alcohol	Acceptable Cleaners:Lysol Brand III Disinfectant Spray(Recommended)Cavicide products (non-bleach)Isopropyl alcohol
Isopropyl alcohol	Ethyl alcohol-based cleaners	Ethyl alcohol-based cleaners
Ethyl alcohol-based cleaners	Lysol Concentrate (alcohol-	Lysol Concentrate (alcohol-
Lysol Concentrate (alcohol-based only)	based only)	based only)
Accessory Lenses:Cleaners – Henry Schein General
Purpose Cleaner or equivalent product
Disinfectant - Cidex® OPA Solution or
equivalent product

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As outlined in the comparison tables above, the VALO™ Grand Corded and Accessory Lenses are similar to the identified primary and secondary predicate devices with respect to intended use, power sources, light sources, principal of operation, intended user, and biocompatibility.

As this submission is to declare a significant change of introducing new accessories to a previously cleared device, the testing completed to demonstrate equivalence with the predicate included compatibility and functionality with the proposed new accessories. These tests show that the proposed VALO™ Accessory Lenses supplement the use of parent device of VALO™ Grand Corded. The proposed VALO™ Accessory Lenses supplement the VALO™ Grand Corded curing light as outlined above.

Device design validation and verification activities have been performed to FDA Guidance Document Dental Curing Lights – Premarket Notification [510(k)] and recognized standards and via internal testing protocols.

Non-clinical tests performed to establish substantial equivalence to identified predicate devices included radiant exitance and emission spectrum testing according to ISO 10650:2018, illuminance and color temperature testing, beam profile testing, duty cycle testing, and disinfection validation testing.

Conclusion: Based on these comparisons to the predicate device, we believe that VALO™ Grand Corded and Accessory Lenses are substantially equivalent to the predicate devices, in that they augment the use of the already cleared predicate, and do not raise new concerns of safety or efficacy.

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.