Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Denterprise International, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231202 | QuickRayPRO | Denterprise International, Inc. | 2023-06-22 | 56 | 0 |
| K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | 2018-04-04 | 30 | 0 |
| K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015-12-14 | 153 | 0 |
| K122582 | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 | Denterprise International, Inc. | 2012-12-07 | 106 | 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