Identity
- Trade Name
- Flashlite® FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- FL MAGNA/1401 LIGHT SHIELD FDA UDI
- Model / Reference
- CR1077 FDA UDI
- Description
- FL MAGNA/1401 LIGHT SHIELD FDA UDI
Identifiers
- Catalog Number
- CR1077 FDA UDI
- Primary DI / UDI-DI
- D813CR10770 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental/surgical polymerization lamp
Flashlite® by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/surgical polymerization lamp.
- LEDEX — Dentmate Technology Co. , Ltd. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- VALO — ULTRADENT PRODUCTS, INC. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- VALO — ULTRADENT PRODUCTS, INC. · Class II
- Coltolux — Coltene/Whaledent Inc. · Class II
- Ascent PX Charging Station — CAO GROUP, INC. · Class II
- VALO — ULTRADENT PRODUCTS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI a6a4d44f-b249-4f51-be74-e4527387e822 35 fields · synced Jun 9, 2026