Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Block Drug Company, Inc. · Predicate Candidate Screening

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

69 daysmedian FDA review time
166 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945462SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.1994-12-20430
K935925VISION PROPHY PASTE WITH FLUORIDEBlock Drug Company, Inc.1994-01-26440
K933893VISION PROPHY PASTE WITHOUT FLUORIDEBlock Drug Company, Inc.1993-11-16980
K884533SENSODYNE SEALANT DENTIN CONDITIONING SYSTEMBlock Drug Company, Inc.1989-04-121660
K881974PROFICIENT(TM) PROPHYLAXIS ANGLEBlock Drug Company, Inc.1988-07-25750
K872225SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDERBlock Drug Company, Inc.1987-06-30210
K862876NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.1986-08-29300
K800831PY-CO-PROX TM DENTAL BRUSHBlock Drug Company, Inc.1980-05-08240
K791064DUO TWO LAYER DENTURE CLEANSERBlock Drug Company, Inc.1979-10-091200
K780849DENTROL LIQUID DENTURE ADHESIVEBlock Drug Company, Inc.1978-07-31690

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