Luxatemp® Automix Plus 110402
GUDID EDMG1104028
Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right away. Content: 1 cartridge @ 76 g paste, accessories. Color: A2
DMG Chemisch-Pharmazeutische Fabrik GmbH
Dental crown/bridge, temporary| Primary Device ID | EDMG1104028 |
| NIH Device Record Key | 207b70e6-954a-4bf7-ac22-2991f413d241 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Luxatemp® Automix Plus |
| Version Model Number | 110402 |
| Catalog Number | 110402 |
| 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 | |
| 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
| 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 |
| 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 | EDMG1104020 [Primary] |
| HIBCC | EDMG1104021 [Package] Contains: EDMG1104020 Package: [1 Units] In Commercial Distribution |
| HIBCC | EDMG1104028 [Package] Contains: EDMG1104021 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013674
FDA Product Code
| EBG | Crown And Bridge, Temporary, 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 | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [Luxatemp® Automix Plus]
| EDMG1104061 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
| EDMG1104048 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
| EDMG1104038 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
| EDMG1104028 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
| EDMG1104018 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
| EDMG1104001 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
| EDMG1103688 | Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right aw |
Trademark Results [Luxatemp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUXATEMP 74470106 1911030 Live/Registered |
MUHLBAUER TECHNOLOGY GMBH 1993-12-14 |
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