FDA UDI
In Commercial Distribution
🇺🇸 United States
visio.lign color Yellow
DI: EBREVLCOLYELLOW0
·
Model: VLCOLYELLOW
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- visio.lign color Yellow
- Primary DI
- EBREVLCOLYELLOW0
- Version / Model
- VLCOLYELLOW
- Catalog Number
- VLCOLYELLOW
- Company Name
- bredent GmbH & Co. KG
- Labeler DUNS
- 341086190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-10
- Public Version
- 1
- Public Version Date
- 2025-03-18
- Public Version Status
- New
- Public Device Record Key
- 90164caf-8152-441d-beab-9129010b38e3
Device Description
visio.lign color Yellow 2.6 ml
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 38781 | Dental prosthesis veneer resin | A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EBREVLCOLYELLOW9 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2025-03-10 |
| Primary | EBREVLCOLYELLOW0 | HIBCC |
Customer Contacts
- Phone
- +4907309872451
- [email protected]
- Phone
- +4907309872531
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240735 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep out of sunlight