Device
3M™ Imprint™ 4 Penta™ Putty Cartridge for Pentamix™ 3, 77786
Manufacturer
3M Deutschland GmbH
3M Deutschland GmbH
Model: 77786
Catalog: 77786
DI: 04054596736351
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
3M™ Imprint™ 4 Penta™ Putty Cartridge for Pentamix™ 3, 77786
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8968b686-67ff-4ec5-a0be-f7da247c0de3
Distribution Status:
In Commercial Distribution
DUNS Number:
315731711
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04054596736351
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38790
Name: Dental impression material mixer
Definition:
A mains electricity (AC-powered) device designed for mixing to produce a dental impression material chairside immediately before application to the oral cavity of a patient during a dental procedure. It is typically used to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material of rapid irreversible setting. The device typically consists of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer.
FDA Product Codes
EFD
AMALGAMATOR, DENTAL, AC-POWERED