Luxatemp® Ultra 110909
GUDID EDMG1109098
Temporary crown and bridge material automix system; bis acrylic composite. For a look that is hard to beat. Content: 1 cartridge @ 76 g paste, accessories. Color: A 3.5.
DMG Chemisch-Pharmazeutische Fabrik GmbH
Dental crown/bridge, temporary| Primary Device ID | EDMG1109098 |
| NIH Device Record Key | c9b24fd6-b9c6-45c5-a73b-43edc1abd35b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Luxatemp® Ultra |
| Version Model Number | 110909 |
| Catalog Number | 110909 |
| 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 | EDMG1109090 [Primary] |
| HIBCC | EDMG1109091 [Package] Contains: EDMG1109090 Package: [1 Units] In Commercial Distribution |
| HIBCC | EDMG1109098 [Package] Contains: EDMG1109091 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101710
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® Ultra]
| EDMG1109118 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109108 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109098 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109088 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109078 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109068 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109051 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109041 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
| EDMG1109011 | Temporary crown and bridge material automix system; bis acrylic composite. For a look that is ha |
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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