FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
V-Print c&b temp
K Number: K231591
·
Decision Jul 31, 2023
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
0
Applicant Total
119
Review Days
60
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Basic Information
- Device Name
- V-Print c&b temp
- K Number
- K231591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voco GmbH
- Date Received
- June 1, 2023
- Decision Date
- July 31, 2023
- Product Code
- POW
- 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 |
|---|---|---|---|
| POW | Crown And Bridge, Long-Term Temporary, Resin | FDA class 2 | Dental |
Other Clearances by Voco GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | May 1, 2026 | Substantially Equivalent |
| K261357 | Grandio disc multicolor | Apr 27, 2026 | Substantially Equivalent |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Mar 20, 2026 | Substantially Equivalent |
| K251390 | MTA vpt | Jul 3, 2025 | Substantially Equivalent |
| K251239 | GrandioSO Unlimited | May 21, 2025 | Substantially Equivalent |
| K231817 | AlignerFlow LC | Dec 1, 2023 | Substantially Equivalent |
| K230877 | Admira Fusion 5 | Jul 13, 2023 | Substantially Equivalent |
| K220236 | V-Print dentbase | Sep 21, 2022 | Substantially Equivalent |
| K220640 | Bifix Hybrid Abutment Cement | Aug 23, 2022 | Substantially Equivalent |
| K220743 | CediTEC | Jul 5, 2022 | Substantially Equivalent |