ZenithDental 003-61901

GUDID D033003619011

Dental restorative material varnish

Primary Device ID	D033003619011
NIH Device Record Key	2acfe174-deed-48d4-8a51-379664486e93
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZenithDental
Version Model Number	61901
Catalog Number	003-61901
Company DUNS	106792427
Company Name	DMG AMERICA, LLC
Device Count	4
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D033003619010 [Unit of Use]
HIBCC	D033003619011 [Primary]

KLE	Agent, Tooth Bonding, Resin

Steralize Prior To Use	false
Device Is Sterile	false

D0337884100 - Kolorz Prophylaxis Paste	2025-06-12 Kolorz Prophylaxis Paste Blueberry Fine Grit (200 Unit Dose Cups)
D0337884110 - Kolorz Prophylaxis Paste	2025-06-12 Kolorz Prophylaxis Paste Blueberry Medium Grit (200 Unit Dose Cups)
D0331430200 - TEMP TABS	2025-04-28 FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS
D0331430330 - TEMP TABS	2025-04-28 FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS
D033003619011 - ZenithDental	2024-10-07ZenithDental Etch Gel 40% Phosphoric Acid Gel (4) 1.2ml syringes
D033003619011 - ZenithDental	2024-10-07 ZenithDental Etch Gel 40% Phosphoric Acid Gel (4) 1.2ml syringes
D033099550381 - Ultra Dispersed Phase High Copper	2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Fast Set 50 jar
D03309955038A1 - Ultra Dispersed Phase High Copper	2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Regular Set 50 jar
D033099550391 - Ultra Dispersed Phase High Copper	2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar

Mark Image Registration \| Serial	Company Trademark Application Date
ZENITHDENTAL 78511863 not registered Dead/Abandoned	Foremost Dental, LLC 2004-11-05