Identity
- Trade Name
- NeoSEALER EZFlo (0.5 g Syringe + 4 Tips) Mini Kit 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
- ANSEZFM 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
- 00810118105593 FDA UDI
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Commercial Distribution
- 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 — 0.5 Gram FDA UDI
Category: Hygroscopic dental cement
NeoSEALER EZFlo (0.5 g Syringe + 4 Tips) Mini Kit by Nusmile, Ltd — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Nusmile, Ltd
Sources (1)
- FDA UDI fbefbd25-fc55-4dba-8add-7daf0009b0bb 35 fields · synced May 30, 2026