(135 days)
No
The device description and performance studies focus solely on the physical characteristics and light curing capabilities of a dental light curing device, with no mention of AI or ML.
No
The device is described as a light source for curing dental restorative materials, implying it changes the state of these materials rather than directly diagnosing, treating, or preventing disease in a patient.
No.
The device is described as a "visible light activator for polymerization of dental resins," indicating it is used for curing materials, not for diagnosing conditions.
No
The device description clearly states it is a battery-operated, hand-held, LED-based visible light curing device manufactured from physical materials like anodized aluminum, rubber buttons, and an LED light source. This indicates it is a hardware device, not software-only.
Based on the provided information, the VALO® Grand is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "a source of illumination for curing photo-activated dental restorative materials and adhesives." This describes a device used to treat or process materials in situ within the patient's mouth, not a device used to perform tests on samples taken from the body.
- Device Description: The description focuses on the physical characteristics and function of a light curing device used in dental procedures. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring analytes
The VALO® Grand is a therapeutic device used in dentistry to polymerize dental materials.
N/A
Intended Use / Indications for Use
The VALO® Grand is a source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes
EBZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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/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)
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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® Grand
dental curing light | Predicate: VALO® Cordless dental
curing light (K110582) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The source of illumination for curing
photo-activated dental restorative
materials and adhesives. | The source of illumination for curing
photo-activated dental restorative
materials and adhesives. |
| Intended User | Dentist or dental professional | Dentist or dental professional |
| Power source | Batteries: Lithium Iron Phosphate
(LiFePO4) RCR123A with a working
voltage of: 3.2VDC. Their safety ratings:
CE, RoHS, WEEE
Power Charger: 3.6VDC Lithium Ion
Phosphate smart battery charger
AC Power Supply: Connects to charger,
wall powered. Output; 12VDC, 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 | Batteries: Lithium Iron Phosphate
(LiFePO4) RCR123A with a working
voltage of: 3.2VDC. Their safety ratings:
CE, RoHS, WEEE
Power Charger: 3.6VDC Lithium Ion
Phosphate smart battery charger
AC Power Supply: Connects to charger,
wall powered. Output; 12VDC, 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, front and back side | Power On Button: Located on the handle
of the wand, back side only |
| Operational modes | Standard Power Mode: 1000 mW/cm2
High Power Plus Mode: 1600mW/cm2
Xtra Power Mode: 3200mW/cm2
Device indicates illumination time
selection
Device indicates time and time selection | Standard Power Mode: 1000 mW/cm2
High Power Mode: 1400mW/cm2
Xtra Power Mode: 3200mW/cm2
Device indicates illumination time
selection
Device 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.