Straumann CARES Visual and Nova Dental CAD
FDA 510(k) clearance K233252 · decided 2024-12-26
Clearance details
- K-number
- K233252
- Device name
- Straumann CARES Visual and Nova Dental CAD
- Applicant
- Institut Straumann AG
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-12-26
- Days to decision
- 455 days
- Clearance type
- Traditional
- Product code
- PNP
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Basel, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CloudPoint FastDesign Chairside (K231529) | Prismatik Dentalcraft, Inc. | 2024-03-14 |
| TRUST (K221107) | Rgorithm Korea | 2023-07-18 |
| AbutmentCAD (K193352) | Exocad GmbH | 2021-07-21 |
| Abutment Design (K200100) | 3Shape A/S | 2020-10-07 |
| Sirona Dental CAD/CAM System with InLab Software (K200191) | Dentsply Sirona | 2020-08-19 |
| DTX Studio design (K181932) | Nobel Biocare AB | 2019-03-01 |
| 3Shape Abutment Designer Software (K151455) | 3Shape A/S | 2016-09-06 |
Recalls involving this device
No recalls on record reference this clearance.