Identity
- Trade Name
- Impregum™ Penta™ Soft Medium Body FDA UDI
- Generic Name
- Dental impression material adhesive FDA UDI
- Device Name
- 3M™ ESPE™ Impregum™ Penta™ Soft Medium Body Polyether Impression Material Introkit, P31735 FDA UDI
- Model / Reference
- P31735 FDA UDI
- Description
- 3M™ ESPE™ Impregum™ Penta™ Soft Medium Body Polyether Impression Material Introkit, P31735 FDA UDI
Identifiers
- Catalog Number
- P31735 FDA UDI
- Primary DI / UDI-DI
- 04035077004404 FDA UDI
- FDA Product Code
- ELW FDA UDIEID FDA UDIEBH FDA UDIEFD FDA UDI
- GMDN Term
- Dental impression material adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI872.4565 FDA UDI872.3670 FDA UDI872.3100 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 mixing nozzlePolyether dental impression materialDental material cartridge-plunging applicator, two-component, manualDental impression material adhesive
Impregum™ Penta™ Soft Medium Body by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material adhesive.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Affinity™ Tray Adhesive — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- COE® Adhesive — Gc America Inc. · Class II
- The Orthodontic Store — Young Innovations, Inc. · Class II
- Identium Adhesive — Kettenbach GmbH & Co. KG · Class I
- Tray Adhesive for A-Silicones — DMG Chemisch-Pharmazeutische Fabrik GmbH · Class I
- ACCUDENT XD — Ivoclar Vivadent, Inc. · Class I
- IQ Dental — IQ DENTAL SUPPLY LLC · Class II
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 Deutschland GmbH
Sources (1)
- FDA UDI e22594b0-d40a-456c-b12c-43129eafa0b8 35 fields · synced May 30, 2026