Identity
- Trade Name
- Dental Operating Light FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas. FDA UDI
- Model / Reference
- SAF-302-01 FDA UDI
- Description
- A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas. FDA UDI
Identifiers
- Catalog Number
- SAF-302-01 FDA UDI
- Primary DI / UDI-DI
- D104SAF30201 FDA UDI
- FDA Product Code
- EAZ FDA UDI
- GMDN Term
- Fixed examination/treatment room light 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixed examination/treatment room light
Dental Operating Light by Safari Dentaire Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed examination/treatment room light.
- Chromophare F300 — Berchtold Holding GmbH · Class I
- Celestial Star — Sunnex, Inc. · Class I
- Celestial Star — Sunnex, Inc. · Class I
- Tri Star — Sunnex, Inc. · Class I
- Sim.LED 350 3p — S.I.M.E.O.N. Medical GmbH & Co. KG · Class I
- MIRA Minor Surgery Light — Amico Lights Corporation · Class II
- StarTrol — HUOT INSTRUMENTS, LLC · Class II
- HexaLux — STERIS CORPORATION · 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 |
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Manufacturer
- Manufacturer
- Safari Dentaire Inc
Sources (1)
- FDA UDI 49af9f07-eae7-481b-bd8c-2ab193ec0d9c 34 fields · synced Jun 8, 2026