VALO Grand

K160551 · Ultradent Products, Inc. · EBZ · Jul 13, 2016 · Dental

Device Facts

• Record ID: K160551
• Device Name: VALO Grand
• Applicant: Ultradent Products, Inc.
• Product Code: EBZ · Dental
• Decision Date: Jul 13, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VALO Grand is a battery-operated, handheld, LED-based dental curing light used by dentists or dental professionals in clinical settings. It emits blue and violet light (395–480 nm) to polymerize photo-initiated dental resins and adhesives. The device features three power output modes (Standard, High Power Plus, Xtra Power) ranging from 800–2300 mW/cm². Input consists of user-selected power and time settings via buttons on the wand; output is a focused light beam delivered through a 12mm diameter head. The device is powered by rechargeable Lithium Iron Phosphate batteries. Compared to the predicate, it features an increased light head diameter, an additional activation button for improved ergonomics, and an adjusted middle power mode. The device aids in the restoration of teeth by hardening dental materials, directly impacting the efficiency and success of restorative dental procedures.

Clinical Evidence

Bench testing only. 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, and representative user testing. No clinical data was required or provided.

Technological Characteristics

Handheld LED curing light. Materials: anodized aluminum, rubber, silicone adhesive, plastic. Energy: 3.2VDC LiFePO4 battery, 12VDC/500mA AC power supply. Wavelength: 395–480 nm. Light head diameter: 12mm. Connectivity: None. Sterilization: Chemical disinfection (Cavicide, isopropyl/ethyl alcohol, Lysol). Compliance: ADA Specification No. 48.

Indications for Use

Indicated for curing photo-activated dental restorative materials and adhesives in dental patients.

Regulatory Classification

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.

Predicate Devices

• VALO® Cordless (K110582)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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<br>dental curing light | Predicate: VALO® Cordless dental<br>curing light (K110582) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The source of illumination for curing<br>photo-activated dental restorative<br>materials and adhesives. | The source of illumination for curing<br>photo-activated dental restorative<br>materials and adhesives. |
| Intended User | Dentist or dental professional | Dentist or dental professional |
| Power source | Batteries: Lithium Iron Phosphate<br>(LiFePO4) RCR123A with a working<br>voltage of: 3.2VDC. Their safety ratings:<br>CE, RoHS, WEEE<br><br>Power Charger: 3.6VDC Lithium Ion<br>Phosphate smart battery charger<br><br>AC Power Supply: Connects to charger,<br>wall powered. Output; 12VDC, 500mA.<br>Input: 100VAC - 240VAC with adapters<br>for international capability. Ratings:<br>Medical Grade, (UL, CE, RoHS, WEEE)<br>Cord: 6 ft (1.8m), 2.5mm DC connector | Batteries: Lithium Iron Phosphate<br>(LiFePO4) RCR123A with a working<br>voltage of: 3.2VDC. Their safety ratings:<br>CE, RoHS, WEEE<br><br>Power Charger: 3.6VDC Lithium Ion<br>Phosphate smart battery charger<br><br>AC Power Supply: Connects to charger,<br>wall powered. Output; 12VDC, 500mA.<br>Input: 100VAC - 240VAC with adapters<br>for international capability. Ratings:<br>Medical Grade, (UL, CE, RoHS, WEEE)<br>Cord: 6 ft (1.8m), 2.5mm DC connector |
| | Power On Button: Located on the<br>handle of the wand, front and back side | Power On Button: Located on the handle<br>of the wand, back side only |
| Operational modes | Standard Power Mode: 1000 mW/cm2<br>High Power Plus Mode: 1600mW/cm2<br>Xtra Power Mode: 3200mW/cm2<br>Device indicates illumination time<br>selection<br>Device indicates time and time selection | Standard Power Mode: 1000 mW/cm2<br>High Power Mode: 1400mW/cm2<br>Xtra Power Mode: 3200mW/cm2<br>Device indicates illumination time<br>selection<br>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.