| Primary Device ID | EDMG1102661 |
| NIH Device Record Key | 07d732d3-80fb-44cd-baa7-903971839250 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Automix-Tips Blue 1:1 |
| Version Model Number | 110266 |
| Catalog Number | 110266 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG1102660 [Unit of Use] |
| HIBCC | EDMG1102661 [Primary] |
| EID | Syringe, Restorative And Impression Material |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-09 |
| Device Publish Date | 2022-09-01 |
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| EDMG2229020 - Ecosite One | 2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region. |
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| EDMG5400050 - DeltaFil | 2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de |
| EDMG5400060 - DeltaFil | 2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de |
| EDMG5400100 - DeltaFil | 2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de |
| EDMG1102661 - Automix-Tips Blue 1:1 | 2022-09-09Automix-Tips Blue 1:1. Suitable for: PermaCem Automix, PermaCem Automix Dual, TempoCem Automix, TempoCem NE Automix. Content: 50 tips. |
| EDMG1102661 - Automix-Tips Blue 1:1 | 2022-09-09 Automix-Tips Blue 1:1. Suitable for: PermaCem Automix, PermaCem Automix Dual, TempoCem Automix, TempoCem NE Automix. Content: 50 |
| EDMG1103511 - Automix-Tips Blue 10:1 | 2022-09-09 Automix-Tips Blue 10:1. Suitable for: Luxatemp Ultra, Luxatemp Fluorescence, Luxatemp Plus, Luxatemp Solar. |