Identity
- Trade Name
- 3M™ Impregum™ Penta™ FDA UDI
- Generic Name
- Dental impression material mixer FDA UDI
- Device Name
- 3M™ Impregum™ Penta™ Soft Quick Step Medium Body Cartridge for Pentamix™ 3 - Medium Purple, P3776 FDA UDI
- Model / Reference
- P3776 FDA UDI
- Description
- 3M™ Impregum™ Penta™ Soft Quick Step Medium Body Cartridge for Pentamix™ 3 - Medium Purple, P3776 FDA UDI
Identifiers
- Catalog Number
- P3776 FDA UDI
- Primary DI / UDI-DI
- 04054596736382 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Dental impression material mixer 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: Dental impression material mixer
3M™ Impregum™ Penta™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental impression material mixer.
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Imprint™ 4 Penta™ Super Quick Heavy — 3M Deutschland GmbH · Class I
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 0fd47295-57a1-40de-9808-c62284f1a0b8 35 fields · synced Jun 6, 2026