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

Applied Biomaterial Technologies — Predicate Candidate Screening

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

113 daysmedian FDA review time
602 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K935571DURALASTIC SHEETINGApplied Biomaterial Technologies1995-01-314390
K945552DURALASTIC SHEETINGApplied Biomaterial Technologies1995-01-31820
K931500THE PERMARIDGE MATRIX CHINApplied Biomaterial Technologies1994-11-176020
K913768PEC IMPLANTApplied Biomaterial Technologies1992-02-031650
K902284ZYMALAR IMPLANTApplied Biomaterial Technologies1990-09-121130
K902285THE MAGNUM CHIN IMPLANTApplied Biomaterial Technologies1990-09-121130
K902283THE NAUTILUS NASAL IMPLANTApplied Biomaterial Technologies1990-08-14840

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