TempoCem® Automix 212129
GUDID EDMG2121291
Temporary cement automix system. The temporary cement that keeps its promise. Content: 2 syringes @ 5 ml paste, accessories.
DMG Chemisch-Pharmazeutische Fabrik GmbH
Zinc oxide eugenol dental cement| Primary Device ID | EDMG2121291 |
| NIH Device Record Key | b97f0724-2dc7-4ce1-ab67-7c1f9224e3fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TempoCem® Automix |
| Version Model Number | 212129 |
| Catalog Number | 212129 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in the refrigerator! Protect against exposure to direct sunlight! |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG2121290 [Primary] |
| HIBCC | EDMG2121291 [Package] Contains: EDMG2121290 Package: [2 Units] In Commercial Distribution |
| HIBCC | EDMG2121298 [Package] Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110759
FDA Product Code
| EMB | Zinc Oxide Eugenol |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-03-18 |
| Device Publish Date | 2020-11-09 |
On-Brand Devices [TempoCem® Automix]
| EDMG2121291 | Temporary cement automix system. The temporary cement that keeps its promise. Content: 2 syringe |
| EDMG1103001 | Temporary cement automix system. The temporary cement that keeps its promise. Content: 1 cartrid |
Trademark Results [TempoCem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMPOCEM 75106484 2155450 Live/Registered |
MUHLBAUER TECHNOLOGY GMBH 1996-05-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.