Identity
- Trade Name
- PeriOptix FDA UDI
- Generic Name
- LED dental light, battery-powered FDA UDI
- Device Name
- Firefly Cordless Headlight System International FDA UDI
- Model / Reference
- A-LED5-99 FDA UDI
- Description
- Firefly Cordless Headlight System International FDA UDI
Identifiers
- Primary DI / UDI-DI
- D813ALED5990 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- LED dental light, battery-powered 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
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
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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 |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 0c2d5067-d5ed-4815-b44c-ba229163e7a5 34 fields · synced Jun 9, 2026