Identity
- Trade Name
- ROBOT POINT FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- FG ROBOT COURSE 1 PIECE FDA UDI
- Model / Reference
- 883C-1 FDA UDI
- Description
- FG ROBOT COURSE 1 PIECE FDA UDI
Identifiers
- Catalog Number
- 883C-1 FDA UDI
- Primary DI / UDI-DI
- E235883C10 FDA UDI
- FDA Product Code
- DZP FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4535 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
Robot Point by Shofu Dental Corp. — 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
- Shofu Dental Corp.
Sources (1)
- FDA UDI d5485a47-b8da-47ff-a676-f35a323c4826 35 fields · synced May 30, 2026