FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VITA Akzent LC
K Number: K211854
·
Decision Nov 22, 2021
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
51
Applicant Total
3
Review Days
159
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Basic Information
- Device Name
- VITA Akzent LC
- K Number
- K211854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3310
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vita Zahnfabrik GmbH H Rauter & CO
- Date Received
- June 16, 2021
- Decision Date
- November 22, 2021
- 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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