(4 days)
VALO X curing light is a source of illumination for curing photo-active materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.
VALO™ X:
With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380-515 nm per ISO 10650:2018.
The VALO X curing light can be used in a corded or cordless configuration using the Ultradent VALO rechargeable batteries or provided VALO X cord adapter. The curing light is designed to rest in a standard dental unit bracket or can be custom-mounted using the VALO surface mounting bracket included with the kit.
VALO™ X Accessory Lenses:
Accessory: PointCure Lens, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite through a translucent prosthetic.
Accessory: ProxiCure Ball, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.
Accessory: Diffuser Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed.
Accessory: Diffuser Lens, Mode: Black Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins.
Accessory: Interproximal Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light in visualization of teeth and dental prostheses.
Accessory: Translume, Mode: Curing or Diagnostic Aid Modes, Description: Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses.
I am unable to provide the detailed information requested regarding the acceptance criteria and study proving device performance for the VALO X and VALO X Accessory Lenses.
The provided text is a 510(k) Summary and FDA clearance letter for a dental curing light. While it describes the device, its intended use, and a comparison to a predicate device, it does not contain the specific acceptance criteria or the detailed results of performance studies that prove the device meets those criteria.
Medical device submissions to the FDA, particularly 510(k)s seeking substantial equivalence, generally involve performance data, but the public summary (like the one provided) often only broadly states that testing was performed and confirms that the device is substantially equivalent to a predicate. It typically references standards applied and types of tests conducted (e.g., radiant exitance, biocompatibility, EMC), but does not present the granular data, acceptance criteria tables, sample sizes, or expert review details that you are asking for.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance values.
- Sample sizes used for test sets or data provenance (beyond mentioning "internal testing protocols").
- Information on ground truth establishment, including the number and qualifications of experts or adjudication methods.
- Any details about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance (as this is not an AI/software device).
- Details on training set sample sizes or how their ground truth was established.
The document states that "Device design validation and verification activities have been performed to FDA Guidance Document... and recognized standards and via internal testing protocols." It lists several ISO and IEC standards that were applied during non-clinical testing. This general statement, however, does not provide the specific performance results or acceptance thresholds.
Therefore, I cannot fulfill your request based solely on the provided text. To get such detailed information, one would typically need access to the full 510(k) submission not just the public summary or clearance letter.
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February 22, 2022
Ultradent Products, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K220471
Trade/Device Name: VALO X, VALO X Accessory Lenses Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: Class II Product Code: EBZ, EAO, PEO Dated: February 16, 2022 Received: February 18, 2022
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
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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 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 (QS) 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 and ENT 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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Indications for Use
510(k) Number (if known) K220471
Device Name VALO X; VALO X Accessory Lenses
Indications for Use (Describe)
VALO X curing light is a source of illumination for curing photo-active materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor 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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K220471
510(k) Summary
This summary of substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for VALO™ X and VALO™ X Accessory Lenses.
l. 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: 09 February 2022
II. Name of the Device
| Device: | Dental Curing Light |
|---|---|
| Trade/Device Name: | VALO™ X; VALO™ X Accessory Lenses |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.6070 |
| Device Class: | Class II |
| Classification Product Code: | EBZ |
| Subsequent Product Code: | EAQ, PEQ |
III. Device Description
VALO™ X:
With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380-515 nm per ISO 10650:2018.
The VALO X curing light can be used in a corded or cordless configuration using the Ultradent VALO rechargeable batteries or provided VALO X cord adapter. The curing light is designed to rest in a standard dental unit bracket or can be custom-mounted using the VALO surface mounting bracket included with the kit.
VALO™ X Accessory Lenses:
| Accessory | Mode | Description |
|---|---|---|
| PointCure Lens | Curing Mode | Augments the VALO X curing light to polymerize composite through a translucent prosthetic. |
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| ProxiCure Ball | Curing Mode | Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration. |
|---|---|---|
| Diffuser Lens | White Light DiagnosticAid Mode | Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed. |
| Diffuser Lens | Black Light DiagnosticAid Mode | Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins. |
| Interproximal Lens | White Light DiagnosticAid Mode | Augments the VALO X curing light in visualization of teeth and dental prostheses. |
| Translume | Curing or Diagnostic AidModes | Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses. |
IV. Statement of Intended Use
VALO X curing light is a source of illumination for curing photo-activated dental restorative materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.
V. Predicate Device
VALO X and VALO X Accessory Lenses identified predicate device: K210550 – VALO™ Grand Corded and Accessory Lenses by Ultradent Products.
VI. Comparison of Technological Characteristics
Predicate technological comparison:
The technology, delivery, and intended use of VALO™ X and VALO™ X Accessory Lenses are substantially equivalent to the identified predicate device as outlined in Table 5-1:
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| DescriptiveInformation | Devices: VALO™ X; VALO™ X AccessoryLenses | Predicate: VALO™ Grand Corded andAccessory Lenses (K210550) | Differences |
|---|---|---|---|
| Product Code/Classification | EBZ, EAQ, PEQ - Class II | EBZ, EAQ, PEQ - Class II | Identical |
| Indications forUse | VALO X curing light is a source ofillumination for curing photo-activateddental restorative materials andadhesives. It is also intended toprovide illumination to aid invisualization during oral procedures.VALO X curing light accessory/diffusorlenses are not intended for completecure of photo-activated materials andadhesives. | VALO Grand Corded:The source of illumination for curingphoto-activated dental restorativematerials and adhesives.Accessory Lenses: The VALO AccessoryLenses are multiple-use accessorylenses intended to provide illuminationto aid in visualization during oralprocedures and augment the VALOfamily of curing lights, which are asource of illumination for curing photo-activated dental restorative materialsand adhesives. VALO Accessory Lensesare not intended for complete cure ofphoto-activated materials andadhesives. | Similar |
| Intended User | Dentist or dental professional | Dentist or dental professional | Identical |
| Device Design:Power Source | VALO X curing light can be powered byan AC power supply or rechargeablebatteries.AC Power Supply: | AC Power Supply:Wall powered.Output: 9VDC, 500mA. Input: 100VAC -240VAC with adapters for internationalCapability. Ratings: Medical Grade, (UL, CE, RoHS, | Subject device can beused in a cordless modewith batteries or acorded mode with anAC power supply. Both |
| Wall powered. | WEEE) Cord: 6 ft (1.8m), 2.5mm DC connector | power supply options | |
| Output: 9VDC, 2.0A. Input: 100VAC -240VAC, 50-60 Hz with adapters forinternational capability. Ratings: MedicalGrade, (CE, RoHS, REACH) Cord: 6 ft (1.8m), 2.5mmDC connectorBattery Power:1IMR14/65 3.7V 900mAh 3.33 Wh Li-Ion rechargeable battery packPower On Button: Located on thehandle of the wand, back side and frontside | Power On Button: Located on thehandle of the wand, back side and frontsideUL Approved | result in the same lightoutput and deviceperformance. Both thebatteries and powersupply havecertifications toapplicable electricalsafety standards ontheir own. The subjectdevice was alsoevaluated for electricalsafety in both thecorded and cordlessconfigurations. | |
| Device Design:OperationalModes (CuringEBZ) | VALO X:Standard Power Mode: 1,100 mW/cm²Xtra Power Mode: 2,200mW/cm²VALO X Accessory Lenses:≥800 mW/cm² (PointCure –Recommended with High Power Mode)(ProxiCure – Recommended with modesuitable for material) | VALO Grand Corded:Standard Power Mode: 900 mW/cm²High Power Plus Mode: 1500mW/cm²Xtra Power Mode: 2100mW/cm²Accessory Lenses:≥800 mW/cm² (PointCure –Recommended with High Power Mode)(ProxiCure - Recommended with modesuitable for material) | Removal of one curingmode to provide twosimplistic curing modesfor clinical use. |
| Device Design:OperationalModes(Diagnostic EAQ,PEQ) | VALO X Accessory Lenses:≥25 mW/cm², ≤420 nm wavelength(Diffuser Lens – Black Light DiagnosticAid Mode)≥1,000 lx luminescence, 3,800-6,500 Kcolor temperature, ≥75 CRI (DiffuserLens - White Light Diagnostic AidMode) | 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 (White LightLens – Recommended with StandardCuring mode) | Similar |
| ≥15,000 lx luminescence (InterproximalLens - Recommended with StandardCuring mode)≥500 nm wavelength (Translume Lens,any mode) | ≥15,000 lx luminescence, 500-570nmpeak wavelengths (TransLume GreenLens - Recommended with StandardCuring mode)≥15,000 lx luminescence (InterproximalLens - Recommended with StandardCuring mode) | ||
| Device Design:Light Source | LED light, blue and violet wavelengths(Curing mode)LED light, violet or white wavelengths(Diagnostic mode)12.5mm head size | LED light, blue and violet wavelengths12mm head size | Additional white LEDsource was added forthe White LightDiagnostic Aid Mode |
| Device Design:Accessories | -Barrier Sleeve VALO™,-Blue-Light Blocking Light Shield-PointCure Lens, ProxiCure Ball Lens,Translume Lens, Diffuser Lens, Inter-proximal Lens, | -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 | Blue-Light blocking lightshield is used in place ofblue-light blockingglasses |
| Composition ofMaterials | VALO X: Aluminum, anodized blackVALO X Accessory Lenses:Lens housing - AcetalLens housing magnet – NeodymiumMolded lens – Polymethylpentene TPXRT18 (PointCure, ProxiCure, TransLumeGreen, Interproximal)Diffuser Lens – Semi-Opaque WhiteGlass | VALO Grand Corded: Aluminum,anodized blackAccessory Lenses:Lens housing – DelrinLens housing magnet – NeodymiumMolded lens – Polymethylpentene TPXRT18 (PointCure, ProxiCure, TransLumeGreen, Interproximal)Black Light Filter - GlassWhite Light Filter – Type 2 phosphor | Similar |
| TechnicalSpecifications:Light Intensity | VALO X:Standard Power Mode: 1,100 mW/cm²Xtra Power Mode: 2,200mW/cm² | VALO Grand Corded: Standard: 900mW/cm²High: 1,500 mW/cm² | The slight difference inradiant exitance values |
| As measured by traceable Gigahertzspectrum analyzer | Xtra: 2,100 mW/ cm²As measured by traceable Gigahertzspectrum analyzer | is within the applied ISO10650 standard. | |
| VALO X Accessory Lenses: | |||
| ≥800 mW/cm² (PointCure/ProxiCure) | Accessory Lenses: | ||
| ≥25 mW/cm², ≤420 nm wavelength(Black Light Lens) | ≥800 mW/cm² (PointCure/ProxiCure) | ||
| ≥1,000 lx luminescence, 5,000-6,000 Kcolor temperature, ≥85 CRI (WhiteLight Lens) | ≥25 mW/cm², ≤420 nm wavelength(Black Light Lens) | ||
| ≥500nm peak wavelengths (TransLumeGreen Lens) | ≥1,000 lx luminescence, 5,000-6,000 Kcolor temperature, ≥85 CRI (White LightLens) | ||
| ≥15,000 lx luminescence (InterproximalLens) | ≥15,000 lx luminescence, 500-570nmpeak wavelengths (TransLume GreenLens) | ||
| ≥15,000 lx luminescence (InterproximalLens) | |||
| TechnicalSpecifications:PeakWavelength | VALO X: Nominal values: 380-420nmand 420-515nm | VALO Grand Corded: Nominal values:395-415nm and 440-480nm | Similar |
| VALO X Accessory Lenses:All lenses match the curing lights peakwavelengths except:≤420 nm wavelength (Diffuser Lens inBlack Light Diagnostic Mode)≥500 nm peak wavelength (TranslumeLens, any mode) | Accessory Lenses:All lenses match the curing lights peakwavelengths except:≤420 nm wavelength (Black Light Lens),500-570nm peak wavelengths(TransLume Green Lens) | ||
| TechnicalSpecifications:Depth of Cure | 2mm | 2mm | Identical |
| RecognizedStandards | ISO 10650:2018IEC 80601-2-60:2019ISO 14971:2019 | ISO 10650:2018IEC 80601-2-60:2019ISO 14971:2007/(R)2010 | The additional standardsused during thedevelopment of the |
| IEC 62366-1:2015ISO 10993-1:2018IEC 60601-1:2012IEC 62471:2006 | IEC 62366-1:2015ISO 10993-1:2018 | product reflect thestandards applicable forthe curing light alone. Asthe predicatesubmission, K210550,aimed at adding theadditional VALOAccessory Lenses aloneto a previously clearedVALO Grand Corded,K190627, thesestandards were notincluded in thesubmission but arecurrently applied toVALO Grand Corded. | |
| Parameters ofDisinfection | VALO X:Disinfectant: 70% isopropyl alcohol(IPA)VALO X Accessory Lenses:Cleaners – Henry Schein GeneralPurpose Cleaner or equivalent productDisinfectant - Cidex® OPA Solution orequivalent product | VALO Grand Corded:Acceptable Cleaners -Lysol Brand III Disinfectant Spray(Recommended)Cavicide products (non-bleach)Isopropyl alcoholEthyl alcohol-based cleanersLysol Concentrate (alcohol-based only)Accessory Lenses:Cleaners – Henry Schein GeneralPurpose Cleaner or equivalent productDisinfectant - Cidex® OPA Solution orequivalent product | Validated disinfectant isused in place ofacceptable cleaners |
| User Interface | |||
| VALO X has minimal user interfaceitems, two buttons with visualindicators and an accelerometerfunction allowing mode changes by adrum tap and wave motion. | VALO Grand Corded has a moderateuser interface system. On the deviceitself there are three buttons and avisual indicator system. | Both the subject andpredicate devices usedifferent button pressesto control functions,audible cues toacknowledge modechange, and indicatorlights to identify currentmode selected andother state/ functions.The addition of theaccelerometer functionto the subject deviceaims to enhance theuser interface byallowing a simplifiedmethod to changemodes. |
Table 5-1: VALO™ X and VALO™ X Accessory Lenses substantial equivalence comparison
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As outlined in the comparison tables above, VALO™ X and VALO™ X Accessory Lenses are similar to the identified predicate device with respect to intended user, materials, light intensity, depth of cure, utilized consensus standards, peak wavelength and biocompatibility.
Primary differences between the subject device and predicate device are the option of using VALO X by means of batteries (cordless version) or AC power supply (corded version), the different operating modes (two curing modes and two diagnostic modes), the use of a bluelight blocking shield in place of blue-light blocking glasses, updated user interface with fewer buttons and the addition of an accelerometer function, the addition of a fourth whitewavelength LED, and the reliance on a validated disinfectant process rather than a list of acceptable cleaners.
VII. Performance Data
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. Software verification and validation of the device were conducted in accordance with the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Non-clinical tests performed to establish substantial equivalence to the identified predicate device included radiant exitance, illuminance and color temperature, beam profile, duty cycle, EMC, electromagnetic disturbance, photobiological safety and disinfection validation testing. See the table below for standards used during non-clinical testing.
| ISO 10650:2018 | Dentistry - Powered polymerization activators |
|---|---|
| IEC 80601-2-60:2019 | Particular requirements for basic safety and essential performance ofdental equipment |
| ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation andtesting within risk management process |
| IEC 60601-1:2012 | Medical Electrical Equipment – Part 1: General Requirements forBasic Safety and Essential Performance |
| IEC 60601-1-2:2014 | Medical Electrical Equipment – Part 1: General Requirements forBasic Safety and Essential Performance – Collateral Standard:Electromagnetic disturbances - Requirements and tests |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
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Conclusion: Based on these comparisons to the predicate device, we believe that VALO™ X and VALO™ X Accessory Lenses are substantially equivalent to the predicate device, in that they achieve the same intended use by similar technologies that do not raise new concerns of safety or efficacy.
§ 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.