Luxatemp® Automix Solar 110360
GUDID EDMG1103608
Dual cure temporary crown and bridge material automix system; bis acrylic composite. Content: 1 cartridge @ 76 g paste, accessories. Color: A2.
DMG Chemisch-Pharmazeutische Fabrik GmbH
Dental crown/bridge, temporary| Primary Device ID | EDMG1103608 |
| NIH Device Record Key | 07457ac6-9a06-4ef5-b8c1-7a7a01da1e24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Luxatemp® Automix Solar |
| Version Model Number | 110360 |
| Catalog Number | 110360 |
| 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 | EDMG1103600 [Primary] |
| HIBCC | EDMG1103601 [Package] Contains: EDMG1103600 Package: [1 Units] In Commercial Distribution |
| HIBCC | EDMG1103608 [Package] Contains: EDMG1103601 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 |
Devices Manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH
| EDMG2240081 - LuxaFlow® Ultra BL | 2024-12-09 Flowable light cure provisional add-on material Refill Content: 2 Syringes @ 1.5 g, 10 Luer-Lock-Tips. Color: BL |
| EDMG2228291 - Safetip Dispenser Pro | 2024-07-22 Dispenser for direct application with all commercially available composite tips. e. g. suitable for Ecosite Elements. |
| EDMG2229010 - Ecosite One | 2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region. |
| 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. |
| EDMG2229001 - Ecosite One | 2023-11-29 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region. |
| 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 |
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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