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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Coltene, Inc. — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

32 daysmedian FDA review time
78 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALColtene, Inc.1990-08-28900
K882800COLTENE PRESIDENT JET REGULAR BODYColtene, Inc.1988-09-23780
K873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMColtene, Inc.1987-10-27460
K870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMColtene, Inc.1987-02-27350
K870047COLTENE RAPIDColtene, Inc.1987-01-29230
K863998COLTENE JET-MIXERColtene, Inc.1986-10-30160
K850036COLTENE PRECISEColtene, Inc.1985-02-08320
K840297COLTENE ORALLOY MAGICAPSColtene, Inc.1984-03-16520
K811666COLTENE COLTEX/COLTOFLAXColtene, Inc.1981-07-15300
K811667COLTENE PRESSURE SPOT INDICATORColtene, Inc.1981-07-15300
K811767COLTENE PRESIDENT IMPRESSION MATERIALSColtene, Inc.1981-07-15230
K811363COLTENE DRS DENTAL RESTORATIVE SYSTEMColtene, Inc.1981-06-16330
K810907COLTENE ORALLYColtene, Inc.1981-04-23200

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