Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentsply Interntional — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
98 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092614 | X-SMART EASY | Dentsply Interntional | 2009-12-02 | 98 | 0 |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | 2009-07-24 | 18 | 0 |
| K090454 | ALLURE MB CERAMIC BRACKETS | Dentsply Interntional | 2009-03-20 | 25 | 0 |
| K082973 | STER-MATE STERILE LAVAGE KIT | Dentsply Interntional | 2009-01-29 | 115 | 0 |
| K082974 | MYSTIQUE MB CERAMIC BRACKETS | Dentsply Interntional | 2008-11-07 | 32 | 0 |
| K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | Dentsply Interntional | 2008-05-22 | 15 | 0 |
| K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | Dentsply Interntional | 2008-04-18 | 72 | 0 |
| K080246 | COMPOSITE ALIGNER BUTTON | Dentsply Interntional | 2008-04-11 | 71 | 0 |
| K080203 | MTA ROOT CANAL SEALER | Dentsply Interntional | 2008-03-26 | 58 | 0 |
| K073173 | SELF-ADHESIVE RESIN CEMENT | Dentsply Interntional | 2008-01-23 | 71 | 0 |
| K073218 | MTA ADVANCED MATERIAL | Dentsply Interntional | 2008-01-07 | 53 | 0 |
| K071817 | OSTEOGRAF/N-300 | Dentsply Interntional | 2007-09-04 | 63 | 0 |
| K072058 | MODIFICATION TO: OSTEOGRAF/N-700 | Dentsply Interntional | 2007-08-03 | 8 | 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