Identity
- Trade Name
- Impregum™ Penta™ Soft Heavy Body FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- 3M™ ESPE™ Impregum™ Penta™ Soft Heavy Body Polyether Impression Material Intro Kit, P31739 FDA UDI
- Model / Reference
- P31739 FDA UDI
- Description
- 3M™ ESPE™ Impregum™ Penta™ Soft Heavy Body Polyether Impression Material Intro Kit, P31739 FDA UDI
Identifiers
- Catalog Number
- P31739 FDA UDI
- Primary DI / UDI-DI
- J001702011379760 FDA UDI
- FDA Product Code
- EBH FDA UDIELW FDA UDIEFD FDA UDIEID FDA UDI
- GMDN Term
- Polyether dental impression material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 FDA UDI872.3660 FDA UDI872.3100 FDA UDI872.4565 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: Dental material injection cannula, single-useDental material mixing nozzlePolyether dental impression materialDental impression material adhesive
Impregum™ Penta™ Soft Heavy Body by 3M Deutschland GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- 3M Deutschland GmbH
Sources (1)
- FDA UDI 2452c2b5-3f9c-4ff8-b719-df7d11d042f2 35 fields · synced Jun 8, 2026