(4 days)
This document does not list any Reference Device(s) K/DEN numbers. The section for "Reference Device(s)" explicitly states "Not Found".
No
The device description and performance studies focus on the light-emitting and curing properties of the device and its accessories, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
No
A therapeutic device is one that treats or heals a disease or medical condition. This device is a curing light for dental materials and adhesives, and aids in visualization; it does not directly treat or heal.
No
The device is described as a light source for curing dental materials and aiding in visualization. While some accessory lenses aid in visualization, the text does not indicate that the visualization is for the purpose of diagnosis. There is no mention of the device being used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines hardware components (handpiece, power supply, lenses) and physical performance testing (radiant exitance, emission spectrum, illuminance, etc.), indicating it is a hardware device with accessories, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for curing dental restorative materials and adhesives, and for aiding in visualization during oral procedures. This is a direct interaction with the patient's oral cavity and materials applied to the teeth, not the examination of specimens derived from the human body.
- Device Description: The device is a light source and accessory lenses used within the mouth. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The device is clearly intended for use in vivo (within the living body) for dental procedures, not in vitro (in glass/outside the body) for diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
EBZ, EAQ, PEQ
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 - Augments the VALO curing light to polymerize composite through a translucent prosthetic.
. ProxiCure™ Ball Lens - 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 transilluminate teeth and dental prostheses.
. Black Light Lens - 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.
. White Light Lens - Augments the VALO curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed.
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
Dentist or dental professional
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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:
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.
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
| Descriptive
Information | Device: VALO™ Grand Corded and
Accessory 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 for
Use | VALO Grand Corded:
The source of illumination for curing
photo-activated dental restorative
materials and adhesives.
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. | The source of illumination for
curing photo-activated dental
restorative materials and
adhesives. | Dentlight Oral Exam Light Kit is
indicated to be used by a
dentist and physician for
illumination to aid in
visualization during oral
procedures and an adjunct to
enhance the visualization for
oral examination of mucosal
abnormalities and oral lesions |
| Intended User | Dentist or dental professional | Dentist or dental professional | Dentist or dental
professional |
| 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 international
capability. Ratings: Medical Grade, (UL, CE, RoHS,
WEEE) Cord: 6 ft (1.8m), 2.5mm DC connector
Power On Button: Located on the
handle of the wand, back side and front
side
UL Approved | Output: 9VDC, 500mA. Input:
100VAC - 240VAC with adapters
for international capability.
Ratings: Medical Grade, (UL, CE, RoHS,
WEEE) Cord: 6 ft (1.8m), 2.5mm DC connector
Power On Button: Located on
the handle of the wand, back
side and front side
UL Approved | |
| Device Design:
Operational
Modes (Curing
EBZ) | VALO Grand Corded:
*Standard Power Mode: 1000 mW/cm2
*High Power Plus Mode: 1600mW/cm2
Xtra Power Mode: 3200mW/cm2
*as measured by Demetron
Accessory Lenses:
≥800 mW/cm2 (PointCure –
Recommened with High Power Mode)
(ProxiCure – Recommended with mode
suitable for material) | *Standard Power Mode: 1000
mW/cm2
*High Power Plus Mode:
1600mW/cm2
Xtra Power Mode: 3200mW/cm2
*as measured by Demetron | N/A |
| Device Design:
Operational
Modes
(Diagnostic EAQ) | Accessory Lenses:
≥25 mW/cm2, ≤420 nm wavelength
(Black Light Lens – Recommended with
Standard Curing mode)
≥1,000 lx luminescence, 5,000-6,000 K
color temperature, ≥85 CRI (White
Light Lens – Recommended with
Standard Curing mode)
≥15,000 lx luminescence, 500-570nm
peak wavelengths (TransLume Green
Lens – Recommended with Standard
Curing mode) | N/A | Violet or Blacklight: 395 – 420
nm peak wavelength, ≥25
mW/cm2* (Can be used in either
mode)
White light: ≥1,000 lx
luminescence*, 5,000 - 6,000 K
color temperature*, ≥65 CRI*
(Can be used in either mode)
*According to Manufacturer
marketing material |
| ≥15,000 lx luminescence (Interproximal Lens - Recommended with Standard Curing mode) | | | |
| Device Design: Light Source | LED light, blue and violet wavelengths
12mm head size | LED light, blue and violet wavelengths
12mm 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 fluorescent
and transillumination oral exams
-Tacking Tip
-Curing Caps (3mm, 9mm, 13mm) |
| Composition of
Materials | VALO Grand Corded: Aluminum, anodized black
Accessory Lenses:
Lens housing - Delrin
Lens housing magnet – Neodymium
Molded lens – Polymethylpentene TPX
RT18 (PointCure, ProxiCure, TransLume Green, Interproximal)
Black Light Filter - Glass
White Light Filter – Type 2 phosphor | Aluminum, anodized black | Solid aircraft aluminum |
| Technical
Specifications:
Light Intensity | VALO Grand Corded: Standard: 900 mW/cm²
High: 1,500 mW/cm²
Xtra: 2,100 mW/cm²
As measured by traceable Gigahertz
spectrum analyzer
Accessory Lenses: | Standard: 900 mW/cm²
High: 1,500 mW/cm²
Xtra: 2,100 mW/cm²
As measured by traceable
Gigahertz spectrum analyzer | Curing Mode:
Pulse Mode: 2,000 mW/cm²
Plasma Mode: 4,000 mW/cm²
Violet Light Head: |
| | | | |
| | ≥800 mW/cm² (PointCure/ProxiCure)
≥25 mW/cm², ≤420 nm wavelength
(Black Light Lens)
≥1,000 lx luminescence, 5,000-6,000 K
color temperature, ≥85 CRI (White
Light Lens)
≥15,000 lx luminescence, 500-570nm
peak wavelengths (TransLume Green
Lens)
≥15,000 lx luminescence (Interproximal
Lens) | | ≥25 mW/cm²* (Can be used in
either mode)
White Light Head:
≥1,000 lx luminescence*
*According to Manufacturer
marketing material |
| Technical
Specifications:
Peak
Wavelength | VALO Grand Corded: Nominal values:
395-415nm and 440-480nm
Accessory Lenses:
All lenses match the curing lights peak
wavelengths except:
≤420 nm wavelength (Black Light Lens),
500-570nm peak wavelengths
(TransLume Green Lens) | Nominal values: 395-415nm and
440-480nm | Nominal values for curing light
source and White Light Head:
440-480nm
Violet Light Head: 395-420nm |
| Technical
Specifications:
Depth of Cure | 2mm | 2mm | 2mm |
| Recognized
Standards | ISO 10650:2018
IEC 80601-2-60:2019
ISO 14971:2007/(R)2010
IEC 62366-1:2015
ISO 10993-1:2018 | ISO 10650:2015
IEC 80601-2-60:2012
IEC 60601-1 Ed. 3.1
ISO 14971:2007/(R)2010
IEC 62366-1:2015 | ADA 48:2004
ISO 10650:2007
IEC 60601-1:2007
ISO 14971:2007 |
| Parameters of
Disinfection | 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.