Identity
- Trade Name
- LUVIS-C300 Series FDA UDI
- Generic Name
- LED dental light, line-powered FDA UDI
- Device Name
- AC 100-240 V 1.5 A, 50-60 Hz FDA UDI
- Model / Reference
- C300 WALL FDA UDI
- Description
- AC 100-240 V 1.5 A, 50-60 Hz FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053083881 FDA UDI
- FDA Product Code
- EAZ FDA UDI
- GMDN Term
- LED dental light, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: LED dental light, line-powered
LUVIS-C300 Series by Dentis Co. , Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as LED dental light, line-powered.
- Midmark — Midmark Corporation · Class I
- Midmark — Midmark Corporation · Class I
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
- Dental Operating Light — Medfruition Electronics Technology Co., Ltd · Class I
- Midmark — Midmark Corporation · Class I
- Midmark — Midmark Corporation · Class I
- Forest — Ls Enterprises, Inc. · Class I
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
- Dentis Co. , Ltd
Sources (1)
- FDA UDI f0682964-f342-4ae4-96a6-a0d2bed4bcb5 33 fields · synced May 30, 2026