Identity
- Trade Name
- Dentacenter Operative Dental Unit FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories. FDA UDI
- Model / Reference
- SAF-500-M4 FDA UDI
- Description
- Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D104SAF500M4 FDA UDI
- 510(k) Number
- K100212 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system instrument unit, electric
Dentacenter Operative Dental Unit by Safari Dentaire Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Posterior CleanFlow Procedure Instrument with Matrices — SONENDO, INC. · Class II
- SCALEX — Dentamerica · Class II
- DCI Edge — DCI International, LLC · Class I
- SCALEX — Dentamerica · Class II
- Standard Triton Self-Contained Delivery Systems — ASI MEDICAL, INC. · Class I
Cleared under the same submission
K100212 also covers:
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
- Dentacenter Operative Dental Unit — Safari Dentaire Inc
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
- Safari Dentaire Inc
Sources (1)
- FDA UDI b8bfccf0-cf74-472a-a629-fa411d254366 34 fields · synced May 30, 2026