LED Adapter 1016-001

GUDID 03760405340282

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.

DENTAL MONITORING

LED dental light, battery-powered
Primary Device ID03760405340282
NIH Device Record Key1ade66dc-d4ff-4288-ab64-6d9ffbc9fcd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLED Adapter
Version Model NumberLED Adapter
Catalog Number1016-001
Company DUNS269129881
Company NameDENTAL MONITORING
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760405340275 [Package]
Package: Shipping carton [4 Units]
In Commercial Distribution
GS103760405340282 [Primary]

FDA Product Code

EAZLight, Operating, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-25
Device Publish Date2025-12-17

Devices Manufactured by DENTAL MONITORING

03760405340282 - LED Adapter2025-12-25The 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.
03760405340282 - LED Adapter2025-12-25 The LED Adapter is battery-powered, enabling LEDs to be switched on and off by touching for 2 seconds a touch-sensitive button.
03760405340237 - DentalMonitoring - Smile Doctors 2025-06-16 Dental treatment remote monitoring
03760405340244 - DentalMonitoring - Candid 2025-06-16 Dental treatment remote monitoring
03760405340251 - DentalMonitoring - Straumann 2025-06-16 Dental treatment remote monitoring
03760405340138 - ScanBox pro Smile Doctors2025-02-24 Phone support + Cheek retractor tube ScanBoxpro M-L Pack (without box a box).The kit contains 4 elements: 2 Cheek Retractors: on
03760405340152 - ScanBox pro Smile doctors2025-02-24 Phone support + Cheek retractor tube ScanBoxpro S-M Pack (without box a box).The kit contains 4 elements: 2 Cheek Retractors: on
03760405340176 - ScanBox pro - Candid 2025-02-24 Phone support + Cheek Retractor ScanBoxpro M Pack (without box a box).The kit contains 3 elements: 1 Cheek Retractors: one Medi
03760405340213 - ScanBox pro 2025-02-24 Cheeck Retractor for photo acquisition. ScanBox pro S-M Pack (without boxabox, plastic bag only) -The kit contains 4 elements: 2

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