AccessGUDID - DEVICE: PowerMix™ Automatic Impression Material Dispenser (00359883000608)

GUDID

Device Identifier (DI) Information

Brand Name: PowerMix™ Automatic Impression Material Dispenser
Version or Model: 031121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 031121
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883000608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Two-component dental material applicator, electric

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:	Yes
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?
62681	Dental material cartridge-plunging applicator, two-component, electric	An electrically-powered device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is a handpiece with an electric cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.	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: Yes 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
Special Storage Condition, Specify: Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 765 Gram

Device Record Status

Public Device Record Key: f09543de-6758-44da-b1ed-45c92644f69f
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025