Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maruchi — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
242 daysmedian FDA review time
441 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213757 | Endocem MTA Premixed Regular | Maruchi | 2023-02-14 | 441 | 0 |
| K212229 | White Endoseal MTA | Maruchi | 2021-08-13 | 28 | 0 |
| K202015 | White ENDOSEAL MTA | Maruchi | 2021-03-24 | 246 | 0 |
| K201799 | CleaniCal | Maruchi | 2021-02-12 | 227 | 0 |
| K170175 | ENDOSEAL MTA | Maruchi | 2018-02-26 | 403 | 0 |
| K133054 | ENDOSEAL | Maruchi | 2014-05-12 | 227 | 0 |
| K133042 | ENDOCEM ZR | Maruchi | 2014-05-12 | 227 | 0 |
| K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | Maruchi | 2012-03-19 | 242 | 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