FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NanoVarnish
DI: E239D389001
·
Model: D38900
·
Dreve Dentamid GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NanoVarnish
- Primary DI
- E239D389001
- Version / Model
- D38900
- Catalog Number
- D38900
- Company Name
- Dreve Dentamid GmbH
- Labeler DUNS
- 388000846
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-12
- Public Version
- 5
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 6f726388-545e-425a-bc94-9eb735b1d702
- Distribution End Date
- 2023-10-17
Device Description
No.
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
- 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 |
|---|---|---|---|---|
| EBD | Coating, Filling Material, Resin | Dental | 872.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45294 | Dental restorative material varnish | A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E239D389001 | HIBCC |
Customer Contacts
- Phone
- +49230388070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162408 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 28 Degrees Celsius