3Shape Abutment Designer Software
FDA 510(k) clearance K151455 · decided 2016-09-06
Clearance details
- K-number
- K151455
- Device name
- 3Shape Abutment Designer Software
- Applicant
- 3Shape A/S
- Decision
- Substantially Equivalent
- Date received
- 2015-06-01
- Decision date
- 2016-09-06
- Days to decision
- 463 days
- Clearance type
- Traditional
- Product code
- PNP
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Copenhagen, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch 3Shape A/S
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Straumann CARES Visual and Nova Dental CAD (K233252) | Institut Straumann AG | 2024-12-26 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.