Identity
- Trade Name
- Imprint™ II Garant™ FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- 3M™ ESPE™ Imprint™ II Light Body Refill Pack, 9378 FDA UDI
- Model / Reference
- 9378 FDA UDI
- Description
- 3M™ ESPE™ Imprint™ II Light Body Refill Pack, 9378 FDA UDI
Identifiers
- Catalog Number
- 9378 FDA UDI
- Primary DI / UDI-DI
- 30605861011991 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone 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
No
FDA UDI
Category: Silicone dental impression material
A comprehensive medical device directory listing the Imprint II Garant, a 3M ESPE silicone dental impression material. This device is used for creating impressions of teeth and gums, and is suitable for implantable applications.
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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
- 3m Company
Sources (1)
- FDA UDI a5e76624-84aa-4287-b664-13e36e4e0cab 35 fields · synced Jun 20, 2026