FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
visio.lign color, visio.lign shield
K Number: K240735
·
Decision Dec 12, 2024
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
51
Applicant Total
3
Review Days
269
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Basic Information
- Device Name
- visio.lign color, visio.lign shield
- K Number
- K240735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3310
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bredent GmbH & Co. KG
- Date Received
- March 18, 2024
- Decision Date
- December 12, 2024
- Product Code
- EBD
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBD | Coating, Filling Material, Resin | FDA class 2 | Dental |
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