Atlas FDA

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

Geistlich-Pharma — Predicate Candidate Screening

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

236 daysmedian FDA review time
595 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033815BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGENGeistlich-Pharma2004-01-15370
K014289ORTHOSS RESORBABLE BONE VOID FILLERGeistlich-Pharma2002-03-28900
K970569BIO-BLOCKSGeistlich-Pharma2000-08-1412940
K974399BIO-OSS COLLAGENGeistlich-Pharma1998-09-162990
K970321BIO-OSS ANORGANIC BOVINE BONEGeistlich-Pharma1998-09-155950
K972817RESOR-PIN RESORBABLE MEMBRANE PINGeistlich-Pharma1998-07-243600
K960724BIO-GIDE RESORBABLE BILAYER MEMBRANEGeistlich-Pharma1997-06-114750
K952618BIO-OSSGeistlich-Pharma1995-08-28830
K952619BIO-OSS CERAMICGeistlich-Pharma1995-08-28830
K952617BIO-OSSGeistlich-Pharma1995-08-07620
K920508BIO-OSS BLOCKSGeistlich-Pharma1992-11-242930
K874943SONAR-AID(R) ULTRASOUND STANDOFF PADGeistlich-Pharma1988-07-252360
K873763BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITEGeistlich-Pharma1987-12-08830
K871773BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANTGeistlich-Pharma1987-08-241100
K850819GELIPERM ABSORBIND GRANULATED GELGeistlich-Pharma1985-05-07680
K823225GELIPERM GRANULESGeistlich-Pharma1983-08-122870

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