Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PNP · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
455 daysmedian FDA review time
595 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | 2024-12-26 | 455 | 0 |
| K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | 2024-03-14 | 293 | 0 |
| K221107 | TRUST | Rgorithm Korea | 2023-07-18 | 459 | 0 |
| K193352 | AbutmentCAD | Exocad GmbH | 2021-07-21 | 595 | 0 |
| K200100 | Abutment Design | 3Shape A/S | 2020-10-07 | 265 | 0 |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | 2020-08-19 | 205 | 0 |
| K181932 | DTX Studio design | Nobel Biocare AB | 2019-03-01 | 225 | 0 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016-09-06 | 463 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda