FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Fresh adhäsiv
DI: E239D51141
·
Model: 1
·
Dreve Dentamid GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fresh adhäsiv
- Primary DI
- E239D51141
- Version / Model
- 1
- Catalog Number
- D5114
- Company Name
- Dreve Dentamid GmbH
- Labeler DUNS
- 388000846
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 5
- Public Version Date
- 2022-12-05
- Public Version Status
- Update
- Public Device Record Key
- 16ea9dad-4b5c-4bd7-ab22-ac76eb63bb5c
- Distribution End Date
- 2018-07-09
Device Description
For the adhesion between impression tray and silicone impression material, high adhesion and still easy cleaning of the tray. 20 ml bottle with brush insert for prefabricated metal or plastic trays. Colour: red.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E239D51141 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius