Identity
- Trade Name
- visio.lign color Starter Kit FDA UDI
- Generic Name
- Dental prosthesis veneer resin FDA UDI
- Device Name
- visio.lign color Starter Kit 8 pieces FDA UDI
- Model / Reference
- VLCOLSKIT FDA UDI
- Description
- visio.lign color Starter Kit 8 pieces FDA UDI
Identifiers
- Catalog Number
- VLCOLSKIT FDA UDI
- Primary DI / UDI-DI
- EBREVLCOLSKIT0 FDA UDI
- 510(k) Number
- K240735 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental prosthesis veneer resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Dental prosthesis veneer resin
visio.lign color Starter Kit by bredent GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis veneer resin.
- Defend — Young Innovations, Inc. · Class II
- Ceramage — SHOFU DENTAL CORP. · Class II
- CERAMAGE — SHOFU DENTAL CORP. · Class II
- Ceramill — Vertex-Dental B.V. · Class I
- Signum composite flow — Kulzer, Inc. · Class II
- Solidex — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
Cleared under the same submission
K240735 also covers:
- visio.lign color Black — bredent GmbH & Co. KG
- visio.lign color Blue — bredent GmbH & Co. KG
- visio.lign color Body A — bredent GmbH & Co. KG
- visio.lign color Body B — bredent GmbH & Co. KG
- visio.lign color Body C — bredent GmbH & Co. KG
- visio.lign color Body D — bredent GmbH & Co. KG
- visio.lign color Brown — bredent GmbH & Co. KG
- visio.lign color Creme — bredent GmbH & Co. KG
- visio.lign color Grey-Blue — bredent GmbH & Co. KG
- visio.lign color Gum Light — bredent GmbH & Co. KG
- visio.lign color Gum Pink — bredent GmbH & Co. KG
- visio.lign color Gum Red — bredent GmbH & Co. KG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI 26348103-24b3-4349-8ee4-084fcaf0522b 37 fields · synced Jun 1, 2026