(58 days)
Not Found
No
The description focuses on the device's function as a light source with different power modes and does not mention any AI/ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device cures dental restorative materials and adhesives, which is a functional process rather than a direct therapeutic intervention on a patient.
No
This device is a dental curing light used to polymerize dental resins and materials, which is a treatment function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a wand, batteries, and a battery charger, indicating it is a physical device, not software-only.
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 device used directly on a patient's teeth to cure materials, not a device used to test samples in vitro (outside the body).
- Device Description: The description details a "dental curing light used for polymerization of all photo-initiated dental materials." This further reinforces its use in a clinical dental setting for treating patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely therapeutic/restorative in a dental context.
N/A
Intended Use / Indications for Use
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes
EBZ
Device Description
Valo® Cordless is a visible light activator for polymerization of dental resins. In other words, it is a dental curing light used for polymerization of all photo-initiated dental materials. The VALO Cordless is shipped as a system with the VALO Cordless wand, 4 rechargeable batteries, 2 for initial use and 2 for later use, a battery charger and 50 VALO Cordless Barrier Sleeves. An Instruction for Use is also included inside the packaging. The Instructions for Use details the function of the device and describes the modes for the VALO Cordless. VALO Cordless has three operating modes. They are Standard Power Mode: 1000mW/cm², High Power Mode: 1400mW/cm² and Xtra Power Mode: 3200mW/cm².
The VALO CORDLESS curing light uses a custom, multi-wavelength Light Emitting Diode (LED) for producing the high intensity light (395 - 480 nm) capable of polymerizing all light cure dental materials. This intensity will also penetrate porcelain and is capable of curing underlying resin cements similarly to a quality halogen light.
The VALO CORDLESS curing light uses safe Ultradent VALO rechargeable batteries and battery charger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 three tests were conducted along with bench tests described in the 510(k); depth of cure, software verification and validation and IEC 60601-1 Electrical Safety.
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.
0
SPECIAL 510(K) PREMARKET SUMMARY
VALO® Cordless
This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for VALO® Cordless.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Contact Person: Title: Telephone: FAX: Date Summary Prepared:
Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 April 1, 2011
Name of the Device
| Trade Name: | VALO® Cordless |
|---|---|
| Common Name: | Activator, ultraviolet for polymerization |
| Device Classification: | II |
| Classification Product Code: | EBZ |
Legally Marketed Predicate Device to Which Equivalence is Claimed
The predicate device is VALO® {K083647}. This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095.
Product Description: Valo® Cordless is a visible light activator for polymerization of dental resins. In other words, it is a dental curing light used for polymerization of all photo-initiated dental materials. The VALO Cordless is shipped as a system with the VALO Cordless wand, 4 rechargeable batteries, 2 for initial use and 2 for later use, a battery charger and 50 VALO Cordless Barrier Sleeves. An Instruction for Use is also included inside the packaging. The Instructions for Use details the function of the device and describes the modes for the VALO Cordless. VALO Cordless has three operating modes. They are Standard Power Mode: 1000mW/cm², High Power Mode: 1400mW/cm² and Xtra Power Mode: 3200mW/cm².
1
110582
Source of illumination for curing photo-activated dental restorative Indications for Use: materials and adhesives.
Technological Summary: The VALO CORDLESS curing light uses a custom, multi-wavelength Light Emitting Diode (LED) for producing the high intensity light (395 - 480 nm) capable of polymerizing all light cure dental materials. This intensity will also penetrate porcelain and is capable of curing underlying resin cements similarly to a quality halogen light.
The VALO CORDLESS curing light uses safe Ultradent VALO rechargeable batteries and battery charger.
| VALO CORDLESS Curing Light | |
|---|---|
| Wavelength range | 395nm – 480nm (see qualification below) |
| Effective output Power of VALO CORDLESS falls within the following wavelength range: | |
| 395nm |