FDA UDI
In Commercial Distribution
🇺🇸 United States
crea.lign paste Dentin B1
DI: EBRECLPNDB100
·
Model: CLPNDB10
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- crea.lign paste Dentin B1
- Primary DI
- EBRECLPNDB100
- Version / Model
- CLPNDB10
- Catalog Number
- CLPNDB10
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 83526f1b-c559-4f9c-80f7-9abd10c79c4b
Device Description
crea.lign paste Dentin B1 Light curing composite nanofilled 3 g
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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38645 | Dental veneer, professional | A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBRECLPNDB109 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2016-09-20 |
| Primary | EBRECLPNDB100 | HIBCC |
Customer Contacts
- Phone
- +4907309872451
- [email protected]