Identity
- Trade Name
- Avalon Biomed NeoSEALER Flo 2.2 g w/ 20 Flex Flo Tips FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- For use in obturating root canals as part of orthograde root canal therapy with gutta percha. FDA UDI
- Model / Reference
- ANSFK FDA UDI
- Description
- For use in obturating root canals as part of orthograde root canal therapy with gutta percha. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810092938620 FDA UDI
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 2.2 Gram FDA UDI
Avalon Biomed NeoSEALER Flo 2.2 g w/ 20 Flex Flo Tips by Nusmile, Ltd — 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
- Nusmile, Ltd
Sources (1)
- FDA UDI 15bf23a2-ffda-48a9-8d4b-b3444e28cbde 37 fields · synced May 29, 2026