Identity
- Trade Name
- Beautifil II FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- Beautifil II Refill Tips Shade A3 BurButler Kit . Contains DI: E23517540 FDA UDI
- Model / Reference
- 001 FDA UDI
- Description
- Beautifil II Refill Tips Shade A3 BurButler Kit . Contains DI: E23517540 FDA UDI
Identifiers
- Catalog Number
- BIIK2 FDA UDI
- Primary DI / UDI-DI
- E235BIIK20 FDA UDI
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Beautifil II by Shofu Dental Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA UDI c5a2b18a-7cb8-4227-99f0-883ce5033d5b 37 fields · synced Jun 8, 2026