AccessGUDID - DEVICE: 3M™ Pentamix™ (04054596735729)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ Pentamix™
Version or Model: 77876
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 77876
Company Name: 3M Deutschland GmbH

Primary DI Number: 04054596735729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731711 *Terms of Use

Device Description: 3M™ Pentamix™ 3 Automatic Mixing Unit, 77876

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38790	Dental impression material mixer	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFD	AMALGAMATOR, DENTAL, AC-POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: abfc2300-d560-4a4f-b2e5-a948163d6b44
Public Version Date: September 06, 2022
Public Version Number: 1
DI Record Publish Date: August 29, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)228-3957
Email: 3Mhealthcarecompliance@mmm.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES