FDA UDI
In Commercial Distribution
🇺🇸 United States
Luxatemp® Automix Plus
DI: EDMG1104040
·
Model: 110404
·
DMG Chemisch-Pharmazeutische Fabrik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Luxatemp® Automix Plus
- Primary DI
- EDMG1104040
- Version / Model
- 110404
- Catalog Number
- 110404
- Company Name
- DMG Chemisch-Pharmazeutische Fabrik GmbH
- Labeler DUNS
- 320744915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- 4b45beb7-e09b-46fe-b588-a8573d3a65ed
Device Description
Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right away. Content: 1 cartridge @ 76 g paste, accessories. Color: B1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31783 | Temporary dental crown/bridge | A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EDMG1104048 | HIBCC | 12 | In Commercial Distribution | ||
| Package | EDMG1104041 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EDMG1104040 | HIBCC |
Customer Contacts
- Phone
- 201-894-5505
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store in the refrigerator! Protect against exposure to direct sunlight!
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit