Atlas FDA

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

Harry J. Bosworth Co. — Predicate Candidate Screening

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

83 daysmedian FDA review time
174 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACPHarry J. Bosworth Co.2011-03-04870
K100731BOSWORTH AIR POLISHERHarry J. Bosworth Co.2010-12-032630
K061611BOSWORTH DENTIN RESINHarry J. Bosworth Co.2006-09-11940
K051224BOSWORTH SEALHarry J. Bosworth Co.2005-07-28770
K043170BOSWORTH BONDHarry J. Bosworth Co.2005-02-251010
K040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVEHarry J. Bosworth Co.2004-03-19170
K040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVEHarry J. Bosworth Co.2004-03-19170
K033751AEGIS PIT & FISSURE SEALANT WITH ACPHarry J. Bosworth Co.2004-02-05660
K031439ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)Harry J. Bosworth Co.2003-10-021490
K031811PIT & FISSURE SEALANT WITH FLUORIDEHarry J. Bosworth Co.2003-09-04840
K994027ACTIVATOR PASTEHarry J. Bosworth Co.2000-04-131390
K993716PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUEHarry J. Bosworth Co.1999-12-21490
K991492LC COMPOSITEHarry J. Bosworth Co.1999-12-022180
K991631FASTRAY LCHarry J. Bosworth Co.1999-07-26760
K991490ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)Harry J. Bosworth Co.1999-07-15780
K991489ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)Harry J. Bosworth Co.1999-07-15780
K991488SELF CURE COMPOSITEHarry J. Bosworth Co.1999-06-21540
K991491FLC COMPOSITEHarry J. Bosworth Co.1999-06-21540
K990699ORTHO-GLOW GLITTERHarry J. Bosworth Co.1999-05-17750
K981862RESIN 4Harry J. Bosworth Co.1999-02-092800
K983752ALUMINA-ZINC OXIDE POWDERS F AND RHarry J. Bosworth Co.1998-12-10480
K981691SILICONE SOFT RELINEHarry J. Bosworth Co.1998-11-031740
K981861LINER 1:HARD RELINE LIQUIDHarry J. Bosworth Co.1998-10-011410
K981618LIQUID AHarry J. Bosworth Co.1998-07-28830
K961199BOSWORTH TEMPORARY RESINHarry J. Bosworth Co.1996-06-25900
K961198BOSWORTH CH IHarry J. Bosworth Co.1996-05-24580
K961201BOSWORTH IMPRESSION MATERIAL IIHarry J. Bosworth Co.1996-05-17510
K961200BOSWORTH LIQUID RESIN IIHarry J. Bosworth Co.1996-05-17510
K960063BOSWORTH IMPRESSION MATERIAL IHarry J. Bosworth Co.1996-02-14400
K946317HARRY J. BOSWORTH RESIN I.Harry J. Bosworth Co.1995-02-16500
K940402SUPERGEL/SUPPRESSED DUSTHarry J. Bosworth Co.1994-03-28600
K933505BOSWORTH COPALIONERHarry J. Bosworth Co.1994-01-071761
K926033VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORDHarry J. Bosworth Co.1993-05-051550
K881026CONTAC, A DENTIN SEALANTHarry J. Bosworth Co.1988-06-01830
K874500GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.Harry J. Bosworth Co.1988-02-181080
K852868WUNDERSHADEHarry J. Bosworth Co.1985-09-27810
K842576CLEAR LINERHarry J. Bosworth Co.1984-09-27860
K842448BOSWORTH SUPER BOND DENTAL ADHESIVEHarry J. Bosworth Co.1984-09-27970
K841667WUNDERFILHarry J. Bosworth Co.1984-05-22290
K840405BOSWORTH DENT-ALLHarry J. Bosworth Co.1984-05-01910
K820892BOSWORTH WOODEN WEDGESHarry J. Bosworth Co.1982-05-05360
K811427SUPERFIL LIGHT & SUPERFIL BONDING SYSTEMHarry J. Bosworth Co.1981-08-20900
K800548SUPERSILHarry J. Bosworth Co.1980-03-1880
K790806PORCELITHarry J. Bosworth Co.1979-08-031010
K790807METALITHarry J. Bosworth Co.1979-08-031010

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