Atlas FDA

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

Innovative Bioceramix, Inc. · Predicate Candidate Screening

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

55 daysmedian FDA review time
588 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231259iRoot SP PlusInnovative Bioceramix, Inc.2023-05-31300
K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS FaInnovative Bioceramix, Inc.2022-11-22550
K130312IROOT FMInnovative Bioceramix, Inc.2014-09-185880
K102867IROOT FSInnovative Bioceramix, Inc.2010-12-03640
K092715IROOT BP PLUSInnovative Bioceramix, Inc.2009-09-28250
K082943IROOT BP, MODEL IRBP 4609Innovative Bioceramix, Inc.2009-01-06960
K080917IROOT SPInnovative Bioceramix, Inc.2008-04-0980
K063422BIOAGGREGATEInnovative Bioceramix, Inc.2006-11-2180

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