ZenithDental 003-61901
GUDID D033003619011
ZenithDental Etch Gel 40% Phosphoric Acid Gel (4) 1.2ml syringes
DMG AMERICA, LLC
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 |
Customer Support Contacts
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com | |
| Phone | 201-894-5505 |
| eanagnostos@dmg-america.com |
Device Dimensions
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D033003619010 [Unit of Use] |
| HIBCC | D033003619011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131248
FDA Product Code
| KLE | Agent, Tooth Bonding, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-10-07 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by DMG AMERICA, LLC
| 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 |
| D03309955039A1 - Ultra Dispersed Phase High Copper | 2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Regular Set 50 jar |
| D033099550441 - Ultra Dispersed Phase High Copper | 2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Fast Set 50 jar |
| D03309955044A1 - Ultra Dispersed Phase High Copper | 2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Regular Set 50 jar |
| D033099550621 - Ultra Dispersed Phase High Copper | 2022-10-03 Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Fast Set 500 jar |
Trademark Results [ZenithDental]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZENITHDENTAL 78511863 not registered Dead/Abandoned |
Foremost Dental, LLC 2004-11-05 |
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