(48 days)
No
The description focuses on the device's function as a light source for curing dental materials and details hardware modifications. There is no mention of AI or ML capabilities.
No
The device is used to cure dental restorative materials, which is a functional process rather than directly treating a disease or condition in a therapeutic manner.
No
The device is a light curing device used to polymerize dental restorative materials and adhesives, not to diagnose a condition or disease.
No
The device description explicitly states it is a "mains-powered, visible light activator" and is manufactured from physical materials like "anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic". It is a hardware device with a light source for curing dental materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The source of illumination for curing photo-activated dental restorative materials and adhesives." This describes a device used in the mouth to cure dental materials, not a device used to test samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description details a "visible light activator for polymerization of dental resins." This further reinforces its function in a dental procedure, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a dental curing light, which is a therapeutic/procedural device used in dentistry.
N/A
Intended Use / Indications for Use
The source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes
EBZ
Device Description
VALO® Grand Corded is a mains-powered, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand Corded version functions the same as the predicate, VALO® (K083647), as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand Corded, 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 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, and the middle power mode setting has been increased to make it more central between the Standard and Xtra Power modes. Additionally, VALO Grand Corded will include one pair of Blue Light Blocking Glasses, which will replace the Light Shield.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible light
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
Not Found
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, including ADA , where available, and via internal testing protocols. Results confirm that VALO® Grand Corded performs equivalently to the predicate VALO® with the modifications that have been made.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2019
Ultradent Products, Inc. Karen Kakunes Regulatory Affairs Manager 505 West Ultradent Drive (10200 South) South Jordan, Utah 84095
Re: K190627
Trade/Device Name: VALO Grand Corded Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: March 8, 2019 Received: March 12, 2019
Dear Karen Kakunes:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tina Kiang, Ph.D. Acting 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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VALO® Grand Corded Special 510(K)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name VALO Grand Corded
Indications for Use (Describe)
The 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 is a stylized design that resembles the letters 'U' and 'E' connected together. The symbol '®' is located at the top right corner of the logo. Below the logo, the text 'K190627' is displayed.
Special 510(k) Summary for VALO® Grand Corded
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 Corded.
l. Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095 FDA Establishment Registration #: 1718912
| Contact Person: | Ms. Karen Kakunes |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | 801-553-4366 |
| FAX: | 801-553-4609 |
Date Summary Prepared: 22 April 2019
II. Name of the Device
| Trade Name: | VALO® Grand Corded |
|---|---|
| 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 |
III. Device Description:
VALO® Grand Corded is a mains-powered, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand Corded version functions the same as the predicate, VALO® (K083647), as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand Corded, 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 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, and the middle power mode setting has been increased to make it more central between the Standard and Xtra Power modes. Additionally, VALO Grand Corded will include one pair of Blue Light Blocking Glasses, which will replace the Light Shield.
Image /page/3/Picture/11 description: The image shows the text '1 of 4' in black font. The text is positioned against a white background at the top, with a brown or orange color filling the lower portion of the image. The text indicates that this is the first image in a series of four.
505 West 10200 South
South Jordan, Utah 84095, USA
www.ultradent.com
800.552.5512
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IV. Indications for Use:
The source of illumination for curing photo-activated dental restorative materials and adhesives.
V. Predicate Device:
The primary predicate device, VALO®, K083647, 23 Jan 2009 and reference device VALO Grand, K160551, 13 Jul 2016.
VI. ldentification of Risk Analysis Method:
Risk Analysis was performed on VALO® Grand Corded utilizing processes based on ISO 14971. Risks associated to patient safety and product efficacy for VALO® Grand Corded have been identified, assessed, and mitigated to a substantially equivalent level.
Comparison of Technological Characteristics VII.
VALO® Grand Corded and VALO® have similar technological characteristics as described in Table 5.1.
| Descriptive Information | Device: VALO® Grand Corded
dental curing light | Predicate: VALO® dental curing light
(K083647) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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. |
| Principle of Operation | Hand-held professional dental
curing light which emanates light
energy with peak wavelengths
between 395 - 480 nm range from
an LED light source which cures
photocurable, polymer resin-based
dental restorative materials | Hand-held professional dental curing
light which emanates light energy
with peak wavelengths between 395
- 480 nm range from an LED light
source which cures photocurable,
polymer resin-based dental
restorative materials |
| Intended User | Dentist or dental professional | Dentist or dental professional |
| Power source | Wall powered, 9VDC, medical grade
with adapters for international
capability
UL Approved | Wall powered, 9VDC, medical grade
with adapters for international
capability
UL Approved |
| Operational modes | *Standard Power Mode: 1000 mW/cm2 | *Standard Power Mode: 1000 mW/cm2 |
Table 5.1: Substantial equivalence comparison
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| Descriptive Information | Device: VALO® Grand Corded
dental curing light | Predicate: VALO® dental curing light
(K083647) |
|-----------------------------|------------------------------------------------------|-------------------------------------------------------------------|
| | *High Power Plus Mode: 1600mW/cm² | *High Power Mode: 1400mW/cm² |
| | Xtra Power Mode: 3200mW/cm² | Xtra Power Mode: 3200mW/cm² |
| | Device indicates illumination time
selection | Device indicates illumination time
selection |
| | Device indicates time and time selection | Device indicates time and time selection |
| | *as measured by Demetron | *as measured by Demetron |
| Light source | LED light, blue and violet wavelengths | LED light, blue and violet wavelengths |
| | 12mm head size | 10 mm head size |
| Accessories | Barrier Sleeve VALO®,
Blue-Light Blocking Glasses | Barrier Sleeve VALO®,
VALO® Light Shield |
| Composition of
Materials | Aluminum, anodized black | Aluminum, anodized black |
| Acceptable Cleaners | Acceptable Cleaners: | Anti-microbial surface disinfectant |
| | Lysol Brand III Disinfectant Spray
(Recommended) | DO NOT autoclave. |
| | Cavicide products (non-bleach) | DO NOT immerse in any kind of
ultrasonic batch or any liquids. |
| | Isopropyl alcohol | |
| | Ethyl alcohol-based cleaners | |
| | Lysol Concentrate (alcohol-based only) | |
| Usability/Ergonomics | 3 buttons – 2 power, 1 mode select | 2 buttons – 1 power, 1 mode select |
As outlined in the comparison tables above, VALO® Grand Corded is similar to the primary predicate, VALO® (K083647), in technology and identical in indications for use, power source, depth of cure, peak wavelength, and similar light source (LED). VALO® Grand Corded is used and cleaned in the same way by the same type of users. VALO Grand (K160551) is included as a reference device for the difference in head size between the subject device and the primary predicate.
The major functional changes between the submitted device, VALO® Grand Corded and the predicate device VALO® is in the light head diameter (12 mm vs 10 mm), an additional LED activation button, and the change in intensity of the High Power Plus (middle) mode setting (1600 mW/cm²). The VALO® Blue-Light Blocking Glasses were not included as part of the original VALO® submission. However, the original submission included a recommended light shield attachment as an accessory during use. VALO® Grand Corded is replacing the light shield supplied with the device to instead include Blue-Light Blocking Glasses. These differences do not impact safety and effectiveness based on validation and verification activities described below.
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Device design validation and verification activities have been performed to FDA Guidance Document Dental Curing Lights – Premarket Notification [510(k)] and recognized standards, including ADA , where available, and via internal testing protocols. Results confirm that VALO® Grand Corded performs equivalently to the predicate VALO® with the modifications that have been made.
Based on these comparisons to already-cleared predicate device, we believe that VALO® Grand Corded is substantially equivalent to VALO®.