Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sybron Dental Specialties — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
279 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182826 | Ormco Spark Aligner System | Sybron Dental Specialties | 2018-10-11 | 6 | 0 |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | Sybron Dental Specialties | 2017-04-21 | 269 | 0 |
| K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | 2016-08-05 | 199 | 0 |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT | Sybron Dental Specialties | 2016-07-27 | 279 | 0 |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | Sybron Dental Specialties | 2016-05-06 | 212 | 0 |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual- | Sybron Dental Specialties | 2016-04-14 | 190 | 0 |
| K151526 | Zone, ZoneFree, Zone A1 | Sybron Dental Specialties | 2015-09-10 | 94 | 0 |
| K151332 | Nexus Universal, Nexus Universal Chroma | Sybron Dental Specialties | 2015-08-17 | 90 | 0 |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | 2015-06-19 | 105 | 0 |
| K143209 | SonicFill 2 | Sybron Dental Specialties | 2015-02-05 | 87 | 0 |
| K130869 | TAKE 1 ADVANCE | Sybron Dental Specialties | 2013-05-30 | 62 | 0 |
| K082671 | HERCULITE ULTRA | Sybron Dental Specialties | 2008-12-11 | 87 | 1 |
| K061042 | LINGLOCK | Sybron Dental Specialties | 2007-01-19 | 280 | 0 |
| K063116 | DEMETRON A.2 | Sybron Dental Specialties | 2006-12-05 | 54 | 0 |
| K061230 | VECTORS TEMPORARY ANCHORAGE SYSTEM | Sybron Dental Specialties | 2006-08-03 | 93 | 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