Identity
- Trade Name
- PeriOptix® FDA UDI
- Generic Name
- LED dental light, battery-powered FDA UDI
- Device Name
- FIREFLY UNIT RED FDA UDI
- Model / Reference
- A-LED5R FDA UDI
- Description
- FIREFLY UNIT RED FDA UDI
Identifiers
- Catalog Number
- A-LED5R FDA UDI
- Primary DI / UDI-DI
- D813ALED5R0 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- LED dental light, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 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
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: LED dental light, battery-powered
PeriOptix® by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as LED dental light, battery-powered.
- PICO LED — Ecleris · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- LuM — Digital Doc LLC · Class I
- UV Minilight Battery — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- Enova Illumination — ENOVA ILLUMINATION, INC · Class I
- FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP — Hager Worldwide, Inc. · Class I
- FOCU-TIP NO.12 (SET/2) WHITE LIGHT INTENSIFYING TIP — Hager Worldwide, Inc. · Class I
- Enova Illumination — ENOVA ILLUMINATION, 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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI a2c0cf6f-a482-47b0-9360-2944879520e5 35 fields · synced Jun 9, 2026