FDA UDI
In Commercial Distribution
🇺🇸 United States
visio.lign color Grey-Blue
DI: EBREVLCOLGREYBL0
·
Model: VLCOLGREYBL
·
bredent GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- visio.lign color Grey-Blue
- Primary DI
- EBREVLCOLGREYBL0
- Version / Model
- VLCOLGREYBL
- Catalog Number
- VLCOLGREYBL
- 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
- e98ba66b-b095-4da1-8f7a-8cbec53fd713
Device Description
visio.lign color Grey-Blue 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 | EBREVLCOLGREYBL9 | HIBCC | dummy | 1 | Not in Commercial Distribution | 2025-03-10 |
| Primary | EBREVLCOLGREYBL0 | HIBCC |
Customer Contacts
- Phone
- +4907309872531
- [email protected]
- Phone
- +4907309872451
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240735 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep out of sunlight