AccessGUDID - DEVICE: ZenithDental Premium Dispersed Phase (D033099610011)

GUDID

Device Identifier (DI) Information

Brand Name: ZenithDental Premium Dispersed Phase
Version or Model: 61001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 099-61001
Company Name: DMG AMERICA, LLC

Primary DI Number: D033099610011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 106792427 *Terms of Use

Device Description: ZenithDental Premium Dispersed Phase Dental Alloy Powder Fast Set 5Toz

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:	Yes
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?
16367	Dental amalgam	A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJJ	Alloy, Amalgam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K820617	000

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
Storage Environment Temperature: between -4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 5 Gram

Device Record Status

Public Device Record Key: 9c25ba0e-f087-409c-bfae-22e8fd8c92ad
Public Version Date: September 19, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2016