FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Vittra APS Unique Flow
K Number: K232994
·
Decision Oct 18, 2024
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
10
Review Days
392
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Basic Information
- Device Name
- Vittra APS Unique Flow
- K Number
- K232994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentscare Ltda
- Date Received
- September 22, 2023
- Decision Date
- October 18, 2024
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Dentscare Ltda
| K Number | Device Name | ||
|---|---|---|---|
| K231859 | PrimmaArt | Nov 26, 2024 | Substantially Equivalent |
| K210231 | Vittra APS Unique | Oct 14, 2021 | Substantially Equivalent |
| K201707 | Opallis, Opallis Flow | Dec 22, 2020 | Substantially Equivalent |
| K192682 | Orthocem, Ortho Bite | Aug 14, 2020 | Substantially Equivalent |
| K191389 | Allcem Veneer APS | Feb 25, 2020 | Substantially Equivalent |
| K191306 | Llis, Vittra APS | Dec 16, 2019 | Substantially Equivalent |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | Dec 13, 2019 | Substantially Equivalent |
| K183465 | Allcem, Allcem Core | Nov 2, 2019 | Substantially Equivalent |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Sep 4, 2019 | Substantially Equivalent |