PNP
8 FDA 510(k) clearances · Product code
455 daysmedian time to decision
595 days90th percentile
8clearances measured
FDA profile
- Official device name
- Dental Abutment Design Software For Dental Laboratory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3630
- Medical specialty
- Dental
- Flags
- Implant
- FDA definition
- The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| 3Shape Abutment Designer Software (K151455) | 3Shape A/S | 2016-09-06 |
Track PNP automatically
Every clearance here is in the API, with alerts when new ones post.