FDA UDI
In Commercial Distribution
🇺🇸 United States
TempoCem®NE Automix
DI: EDMG1103020
·
Model: 110302
·
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
- TempoCem®NE Automix
- Primary DI
- EDMG1103020
- Version / Model
- 110302
- Catalog Number
- 110302
- 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
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d94a4f24-e8e8-4862-bd63-c08117ad04c1
Device Description
Temporary cement automix system, eugenol free. The temporary cement that keeps its promise. Content: 1 cartridge @ 25 ml paste, accessories.
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 |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EDMG1103028 | HIBCC | 12 | In Commercial Distribution | ||
| Package | EDMG1103021 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EDMG1103020 | HIBCC |
Customer Contacts
- Phone
- 201-894-5505
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970774 | 000 |
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