(148 days)
No
The description focuses on the hardware components, light spectrum, and basic operational modes (standard, ramp, boost, white light). There is no mention of AI, ML, or any features that would suggest adaptive learning or intelligent processing of data. The performance testing also focuses on physical properties and software functionality, not AI/ML performance metrics.
No.
The device is used to cure dental restorative materials and adhesives, not to treat a disease or condition. While dental restorations are a therapeutic intervention, the device itself is a tool used in that process, not a therapeutic device in its own right.
No
The device is primarily used to cure dental materials and illuminate dental anatomy, not to diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including a handpiece, charging base, and shield, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Source of illumination for curing photo-activated dental restorative materials and adhesives." This describes a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description details a light source used to polymerize dental materials. It does not mention any components or functions related to analyzing samples from the human body (like blood, urine, tissue, etc.) which is the core of IVD devices.
- Performance Studies: The performance studies focus on the device's ability to cure dental materials effectively and safely (heat generation, composite hardness, wavelength spectrum, optical power, software functionality, electrical safety). These are performance characteristics relevant to a therapeutic/procedural device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate a dental procedure by curing materials, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals, Dental offices and health care offices
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)
The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of the Valiant Curing Light:
- DHF 10018 TR001 Heat Generation Testing: Testing concluded that the Valiant Curing Light did not reach unsafe temperatures within typical use. No hazard or warning statement is required in the products instructions for use.
- DHF 10018 TR002 Composite Hardness Testing: Testing concluded that both the Valo and Valiant Curing Lights cure dental composite effectively. Hardness measurements obtained from cured composite pucks using the two curing lights were statistically similar. Testing confirms that the Valiant Curing Light adequately cures dental composite to depths of 2mm. This testing verifies the Valiant's efficacy and supports Valiant's substantial equivalence to the Valo.
- DHF 10018 TR003 Wavelength Spectrum Testing: Testing verified that the spectrum emitted from the Valiant matches the design criteria. Comparison testing between the Valiant and Valo curing lights supports substantial equivalence as both curing lights emits nearly identical wavelength spectrums for curing dental materials.
- DHF 10018 TR004 Optical Power Testing: Testing verified that the Valiant's optical power matches the design criteria. Comparison testing between the Valiant and Valo curing lights supports substantial equivalence as the Valiant has identical or lower optical power results. Additionally, the light attenuating shield was shown to block >99% of emitted optical power; thus, supporting safety and effectiveness of the Valiant's light attenuating shield.
- DHF 10018 TR005 Software Verification and Validation Testing: The Valiant Curing Light contains software that was developed in full compliance with the 2005 FDA Software Guidance. Testing verified that the Valiant's software functions properly.
- Electrical safety and electromagnetic compatibility testing: The Valiant Curing Light complies with IEC 60601-1 electrical safety and electromagnetic compatibility testing.
Clinical performance is not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus symbol is 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
June 8, 2017
Inter-Med / Vista Dental Products Alex Johnson Sr. Product Development Engineer 2200 South St. Ste. A Racine, Wisconsin 53404
Re: K170101
Trade/Device Name: Valiant Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: May 5, 2017 Received: Mav 8. 2017
Dear Alex Johnson:
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.
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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Mary S. Runner -A
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
2
Indications for Use
510(k) Number (if known)
K170101
Device Name Valiant Curing Light
Indications for Use (Describe)
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/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a light blue font. Below "VISTA" are the words "Dental Products" in a smaller, black font.
510(k) Summary for Valiant Curing Light
1. Applicant
| Submitter's Name: | Alex Johnson, MSc
John Baeten, MSc | Date Summary Prepared: June 7, 2017 |
|-------------------|------------------------------------------------------------------------------------|-------------------------------------|
| Address: | Inter-Med / Vista Dental Products
2200 South St. Ste A
Racine, WI, USA 53404 | Contact Person: Alex Johnson, MSc |
| Phone: | (262) 631-5306 | Email: ajohnson@vista-dental.com |
| Fax: | (262) 636-9760 | |
2. Device Name
Proprietarv Name: Valiant Curing Light Common Name: Ultraviolet activator for polymerization Classification Name: Ultraviolet activator for polymerization (21 CFR 872.6070, Product Code EBZ) Device Class: 2
3. Primary Predicate Device
Valo Cordless (K110582) by Ultradent Products
- Common Name: Ultraviolet activator for polymerization O
- Classification Name: Ultraviolet activator for polymerization (21 CFR 872.6070) O
- Product Code: EBZ O
- Device Class: 2 O
Reference Device
Sirius Max (K152936) by National Dental, Inc.
- O Common Name: Ultraviolet activator for polymerization
- Classification Name: Ultraviolet activator for polymerization (21 CFR 872.6070) O
- Product Code: EBZ O
- Device Class: 2 O
4
Image /page/4/Picture/0 description: The image contains the text "Mountains Above The Rest" in a bold, sans-serif font. The text is horizontally oriented and appears to be the main subject of the image. The background is plain and white, which makes the text stand out.
Image /page/4/Picture/1 description: The image is a logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below the word "VISTA" is the phrase "Dental Products" in a smaller, bolder font. The color of the logo is a light blue.
4. Device Description
The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.
This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.
ട. Intended Use / Indication for Use
Source of illumination for curing photo-activated dental restorative materials and adhesives.
6. Technological Characteristics and Substantial Equivalence
| | Predicate Device:
Valo Cordless
(Ultradent Products) | Valiant Curing Light
(Inter-Med / Vista Dental
Products) | Reference Device:
Sirius Max
(National Dental, Inc.) |
|-------------|------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------|
| Common name | Activator, ultraviolet for
polymerization | Activator, ultraviolet for
polymerization | Activator, ultraviolet for
polymerization |
Vista Dental Products , Racine, WI 53404 ● 2200 South St. Ste A Toll Free 1.877.418.4782 ● 262.636.9755 ● Fax 262.636.9760
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Image /page/5/Picture/0 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a stylized font, with a mountain range graphic above it. Below the word "VISTA" is the text "Dental Products" in a smaller font. The logo is simple and clean, and the mountain range graphic suggests a connection to nature or the outdoors.
| Predicate Device: Valo Cordless (Ultradent Products) | Valiant Curing Light (Inter-Med / Vista Dental Products) | Reference Device: Sirius Max (National Dental, Inc.) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| FDA classification name and number | 872.6070 Ultraviolet activator for polymerization | 872.6070 Ultraviolet activator for polymerization | 872.6070 Ultraviolet activator for polymerization | ||||||
| 510(k) number | K110582 | K170101 (pending) | K152936 | ||||||
| Product code | EBZ | EBZ | EBZ | ||||||
| Indication for use / intended use | Source of illumination for curing photo-activated dental restorative materials and adhesives. | Source of illumination for curing photo-activated dental restorative materials and adhesives. | The Sirius Max Diode Curing Light is intended for use as a source of illumination for photo initiated curing and/or activation/polymerization of dental restorative materials and adhesives. | ||||||
| Where used | Dental offices and health care offices | Dental offices and health care offices | Dental offices and health care offices | ||||||
| Target population | Health care professionals | Health care professionals | Health care professionals | ||||||
| Anatomical site | Oral cavity | Oral cavity | Oral cavity | ||||||
| Light source | 4 broad blue LEDs for photo-initiated curing of dental materials | 4 broad blue LEDs for photo-initiated curing of dental materials | |||||||
| 1 white light LED for transillumination | 1 broad blue LED for photo-initiated curing of dental materials | ||||||||
| 1 white light LED for transillumination | |||||||||
| Curing settings (light intensity and pulse characteristics) | Mode | Power (mW/cm²) | Duration (s) | Mode | Power (mW/cm²) | Duration (s) | Mode | Power (mW/cm²) | Duration (s) |
| Standard | 1000 | 5, 10, 15, 20 | Standard | 1200 | 20 (beep at 10s) | Normal | 1200 | 10, 20 | |
| Ramp | 1200 | 20 (beep at | Soft Start | 1400 | 15 | ||||
| Predicate Device: | |||||||||
| Valo Cordless | |||||||||
| (Ultradent Products) | Valiant Curing Light | ||||||||
| (Inter-Med / Vista Dental | |||||||||
| Products) | Reference Device: | ||||||||
| Sirius Max | |||||||||
| (National Dental, Inc.) | |||||||||
| 10s) | |||||||||
| High | |||||||||
| power | 1400 | 1, 2, 3, 4 | Boost | 1700 | 5 | High | |||
| Power | 1300 | 5 | |||||||
| Pulse | 1400 | 5, 10 | |||||||
| Xtra | |||||||||
| power | 3200 | 3 | N/A | N/A | N/A | Xtra | |||
| Power | 3000 | 1, 3 | |||||||
| Orthodo | |||||||||
| ntics | 1400 | 10x3 | |||||||
| Curing | |||||||||
| wavelengths | Broad spectrum blue light | ||||||||
| (395nm-480nm) | |||||||||
| Peaks at 465nm and 400nm | Broad spectrum blue light | ||||||||
| (400nm-500nm) | |||||||||
| Peaks at 475nm and 410nm | Broad spectrum blue light | ||||||||
| (430nm-490nm) | |||||||||
| Peak at 460nm | |||||||||
| Cooling system | Convection cooled | Convection cooled | Convection cooled | ||||||
| Materials | Aluminum body, glass lens, | ||||||||
| plastic controls / elements | Aluminum body, glass lens, | ||||||||
| plastic controls / elements | Aluminum body, glass lens, | ||||||||
| plastic controls / elements | |||||||||
| Sterility | Non sterile | Non sterile | Non sterile | ||||||
| Radiation safety | Complies with ADA 48 | Complies with ADA 48 | Complies with ADA 48 | ||||||
| Electrical safety | IEC 60601-1 | IEC 60601-1 | |||||||
| IEC 62133 | IEC 60601-1 |
Vista Dental Products • 2200 South St. Ste A , Racine, WI 53404
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Image /page/6/Picture/0 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a blue sans-serif font. Below the word "VISTA" is the text "Dental Products" in a smaller, black sans-serif font.
Vista Dental Products Toll Free 1.877.418.4782 • 262.636.9755 • Fax 262.636.9760
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Image /page/7/Picture/0 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a blue sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller, black sans-serif font. The logo is clean and professional, suggesting a company that is reliable and trustworthy.
| | Predicate Device:
Valo Cordless
(Ultradent Products) | Valiant Curing Light
(Inter-Med / Vista Dental
Products) | Reference Device:
Sirius Max
(National Dental, Inc.) |
|---------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Standards met | IEC 60601-1
Complies with ADA 48 | IEC 60601-1
IEC 62133
Complies with ADA 48 / ISO
10650-2
ISO 14971
ISO 10993-1
IEC 62471 | IEC 60601-1
Complies with ADA 48 |
Similarities between the Valiant Curing Light and Valo Cordless
- The Valiant Curing Light has identical indications for use as the predicate device, the Valo Cordless.
- . The Valiant Curing Light has the same mode of action as the predicate device, the Valo Cordless (i.e. photo-polymerization of monomers and oligomers to polymers via activation of photoinitiators).
- . The Valiant Curing Light has equivalent performance characteristics as the predicate device (Valo Cordless) as both products use the same light source (LED).
- The Valiant Curing Light uses a combination of LEDs to activate CO and TPO photoinitiators, similarly to the predicate device (Valo Cordless).
- The Valiant Curing Light is substantially equivalent to the predicate device (Valo Cordless) as both devices shown compliance with IEC 60601-1 and ADA 48 (i.e. ISO 10650-1).
- The Valiant Curing Light and the Valo Cordless are both equivalent in their design; both ● medical devices are Li-ion battery operated cordless with an aluminum body construction.
Differences between the Valiant Curing Light and Valo Cordless
- Although the Valiant Curing Light and Valo Cordless have different light intensity results ● and curing wavelengths, these differences do not raise any substantial equivalence concerns as the Valiant Curing Light and Valo Cordless curing dental materials equally
- o See DHF10018 TR002: No statistical difference in microhardness was measured from the investigated dental materials post-cure using the Valiant Curing Light or Valo Cordless. Because the Valiant Curing Light has a lower optical power than the Valo, yet cures dental materials equivalently, safety of the Valiant Curing Light is further supported.
- The Valiant Curing Light and Valo Cordless have slightly different curing settings ●
- The Valiant Curing Light provides standard, ramp, and boost curing modes while O the Valo Cordless provides standard, high power, and xtra power modes.
- The Valiant Curing Light was designed for simplicity, i.e. there is not an option to O change the duration during the various curing modes.
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Image /page/8/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a trademark symbol next to it. Below "VISTA" is the text "Dental Products" in a smaller, sans-serif font.
- This difference does not raise any substantial equivalence concerns as the Valiant O Curing Light and Valo Cordless cure dental materials equally.
- o It should be noted that other 510(k) cleared dental curing lights also contain a ramp curing mode. Please reference Sirius Max Diode Curing Light 510(k) K152936, which utilizes a "soft start" mode where the optical power of curing LEDs is ramped over a set period of time. This product is only provided here for reference. Inter-Med / Vista Dental Products is not claiming substantial equivalence to the Sirius Max Diode Curing Light.
- The Valiant Curing Light contains a white light mode (white light LED) which is operated independently from the curing light LEDs: the Valo Cordless does not contain a white light mode option.
- The white light can be used for intraoral illumination to aid in the visualization of O dental anatomy.
- This difference does not raise any substantial equivalence concerns as the Valiant O Curing Light's white light mode is a class I dental operating light (CFR 872.4630).
- It should be noted that other 510(k) cleared dental curing lights also contain a white o light mode. Please reference Sirius Max Diode Curing Light 510(k) K152936 which includes a white light option for transillumination and visualization of dental anatomy. This product is only provided here for reference. Inter-Med / Vista Dental Products is not claiming substantial equivalence to the Sirius Max Diode Curing Light.
- The Valiant Curing Light and predicate curing light (Valo Cordless) share similar intended ● uses, technical characteristics, features, and specifications. The dental curing characteristics of Valiant Curing Light are statistically significantly similar to the cleared medical / predicate device: Valo Cordless (510(k) K110582). Therefore, the Valiant Curing Light is substantially equivalent to the predicate device.
Applicable Standards
- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance (3td Edition)
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for ● basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (4th Edition)
- IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid ● electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications (2nd Edition)
- ADA48-2-2010 ANSI/ADA Standard No. 48-2 LED Curing Lights ●
- ISO 14971:2007 Application of Risk Management to Medical Devices ●
- ISO 14971:2012 Application of Risk Management to Medical Devices ●
- ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1 Evaluation and . Testing
- IEC 62741 Photobiological Safety of Lamps and Lamp Systems
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Image /page/9/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a trademark symbol to the right. Below the word "VISTA" are the words "Dental Products".
Non-Clinical Performance Testing and Compliance 7.
The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of the Valiant Curing Light as suggested by the FDA's guidance for industry and FDA staff titled "Dental Curing Lights - Premarket Notification [510(k)] Submissions'' issued on March 27, 2006:
- DHF 10018 TR001 Heat Generation Testing ●
- Testing concluded that the Valiant Curing Light did not reach unsafe temperatures O within typical use.
- No hazard or warning statement is required in the products instructions for use. o
- DHF 10018 TR002 Composite Hardness Testing ●
- Testing concluded that both the Valo and Valiant Curing Lights cure dental O composite effectively. Hardness measurements obtained from cured composite pucks using the two curing lights were statistically similar. Testing confirms that the Valiant Curing Light adequately cures dental composite to depths of 2mm. This testing verifies the Valiant's efficacy and supports Valiant's substantial equivalence to the Valo.
- DHF 10018 TR003 Wavelength Spectrum Testing ●
- Testing verified that the spectrum emitted from the Valiant matches the design O criteria. Comparison testing between the Valiant and Valo curing lights supports substantial equivalence as both curing lights emits nearly identical wavelength spectrums for curing dental materials.
- DHF 10018 TR004 Optical Power Testing ●
- Testing verified that the Valiant's optical power matches the design criteria. O Comparison testing between the Valiant and Valo curing lights supports substantial equivalence as the Valiant has identical or lower optical power results.
- Additionally, the light attenuating shield was shown to block >99% of emitted O optical power; thus, supporting safety and effectiveness of the Valiant's light attenuating shield.
- DHF 10018 TR005 Software Verification and Validation Testing ●
- The Valiant Curing Light contains software that was developed in full compliance O with the 2005 FDA Software Guidance (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11th, 2005.
- Testing verified that the Valiant's software functions properly. O
- Electrical safety and electromagnetic compatibility testing ●
- The Valiant Curing Light complies with IEC 60601-1 electrical safety and O electromagnetic compatibility testing.
Clinical Performance Testing and Compliance 8.
Clinical performance is not deemed necessary.
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Image /page/10/Picture/0 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a light blue sans-serif font, with the letters slightly spaced apart. Above the word "VISTA" is a stylized mountain range, also in light blue. Below "VISTA" are the words "Dental Products" in a smaller, black sans-serif font.
9. Conclusion
The Valiant Curing Light is substantially equivalent to Valo Cordless (K110582) in intended use and operation; both medical devices use LEDs as the source of light for curing dental materials. Benchtop testing supports substantial equivalence of the Valiant to the Valo Cordless.