Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keystone Dental, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
190 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240966 | Prima Plus Conical Implant System | Keystone Dental, Inc. | 2024-07-09 | 91 | 0 |
| K223814 | Genesis ACTIVE Implant System | Keystone Dental, Inc. | 2023-05-25 | 156 | 0 |
| K221381 | KDG Abutments | Keystone Dental, Inc. | 2022-08-10 | 89 | 0 |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental, Inc. | 2020-08-18 | 90 | 0 |
| K090397 | XPI ANGLED ABUTMENTS | Keystone Dental, Inc. | 2009-06-05 | 108 | 0 |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | Keystone Dental, Inc. | 2007-10-23 | 190 | 0 |
| K071599 | EASYGUIDE | Keystone Dental, Inc. | 2007-07-11 | 30 | 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