ZenithDental

Basic Information

• Brand Name: ZenithDental
• Primary DI: D033610551
• Version / Model: 61055
• Catalog Number: 003-61055
• Company Name: DMG AMERICA, LLC
• Labeler DUNS: 106792427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 440d6863-e199-4699-a97a-06341bf2addc

Device Description

ZenithDental Core Material 1-14g base, 1-14g Catalyst and mising pads/spatulas

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBD	Coating, Filling Material, Resin	Dental	872.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D033610551	HIBCC
Unit of Use	D033610550	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	28	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 72 Degrees Fahrenheit