FDA UDI
In Commercial Distribution
🇺🇸 United States
LED Adapter
DI: 03760405340282
·
Model: LED Adapter
·
DENTAL MONITORING
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LED Adapter
- Primary DI
- 03760405340282
- Version / Model
- LED Adapter
- Catalog Number
- 1016-001
- Company Name
- DENTAL MONITORING
- Labeler DUNS
- 269129881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-17
- Public Version
- 1
- Public Version Date
- 2025-12-25
- Public Version Status
- New
- Public Device Record Key
- 1ade66dc-d4ff-4288-ab64-6d9ffbc9fcd9
Device Description
The LED Adapter is battery-powered, enabling LEDs to be switched on and off by touching for 2 seconds a touch-sensitive button. The battery of the LED Adapter can be reloaded using a Type-C charger which is not provided in the LED Adapter pack. The LED Adapter is intended to be used as an accessory of the ScanBoxpro to provide illumination of the mouth to take pictures of the intraoral cavity using a smartphone.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EAZ | Light, Operating, Dental | Dental | 872.4630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56318 | LED dental light, battery-powered | A battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760405340282 | GS1 | ||||
| Package | 03760405340275 | GS1 | Shipping carton | 4 | In Commercial Distribution |