AccessGUDID - DEVICE: ZenithDenatl (D033610501)

GUDID

Device Identifier (DI) Information

Brand Name: ZenithDenatl
Version or Model: 61050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 003-61050
Company Name: DMG AMERICA, LLC

Primary DI Number: D033610501
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 106792427 *Terms of Use

Device Description: ZenithDental Natural Cure Composite 1-14g base, 1-14g Catalyst with mixing pads and spatulas

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):	No
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?
45294	Dental restorative material varnish	A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBD	Coating, Filling Material, Resin

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
Storage Environment Temperature: less than 75 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 28 Gram

Device Record Status

Public Device Record Key: c47c5634-1ddc-41db-9ca3-ce344808d364
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016