Identity
- Trade Name
- FUSION FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- FUSION,FS,HVY,BODY,ALEGRO,6PK FDA UDI
- Model / Reference
- FHA FDA UDI
- Description
- FUSION,FS,HVY,BODY,ALEGRO,6PK FDA UDI
Identifiers
- Catalog Number
- FHA FDA UDI
- Primary DI / UDI-DI
- 00816594023741 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Polyether dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyether dental impression material
Fusion by Danville Materials, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Danville Materials, Llc
Sources (1)
- FDA UDI 00dd3b70-b21b-4182-9c0b-e2c072f841f0 36 fields · synced May 31, 2026