Identity
- Trade Name
- Impregum™ Soft Quick Step Light Body FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- 3M™ ESPE™ Impregum™ Soft Quick Step Light Body Polyether Impression Material Refill, 31767 FDA UDI
- Model / Reference
- 31767 FDA UDI
- Description
- 3M™ ESPE™ Impregum™ Soft Quick Step Light Body Polyether Impression Material Refill, 31767 FDA UDI
Identifiers
- Catalog Number
- 31767 FDA UDI
- Primary DI / UDI-DI
- J001702011377030 FDA UDI
- FDA Product Code
- ELW FDA UDIEID FDA UDI
- GMDN Term
- Dental material mixing nozzle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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 mixing nozzlePolyether dental impression material
Impregum™ Soft Quick Step Light Body by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyether dental impression material.
- FLEXITIME HEAVY TRAY & FLOW TRIAL KIT — Kulzer, Inc. · Class II
- SKY SELECT — DANVILLE MATERIALS, LLC · Class II
- ROYAL — DANVILLE MATERIALS, LLC · Class II
- FLEXITIME DYNAMIX HT REFILL 1X(2X380ml) — Kulzer, Inc. · Class II
- FLEXITIME DYNAMIX PUTTY REFILL1X(2X380ml — Kulzer, Inc. · Class II
- FIRST QUARTER — DANVILLE MATERIALS, LLC · Class II
- START VPS — DANVILLE MATERIALS, LLC · Class II
- FLEXITIME MEDIUM FLOW 1X50ML SAMPLE — Kulzer, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3M Deutschland GmbH
Sources (1)
- FDA UDI 37b705a8-c6f2-476e-b4ed-dfc2fd0239af 35 fields · synced May 31, 2026