Atlas FDA

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

Jedental Co., Inc. · Predicate Candidate Screening

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

104 daysmedian FDA review time
220 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933612JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)Jedental Co., Inc.1994-02-242200
K935718JEDENTAL VLC DENTAL CURING LIGHTJedental Co., Inc.1994-01-26570
K934073JEDENTAL GLASS IONOMER CEMENT AND LINERJedental Co., Inc.1994-01-261590
K935727P&FS PIT AND FISSURE SEALANTJedental Co., Inc.1994-01-21510
K933656JEDENTAL PSROFILL SELF-CURE COMPOSITEJedental Co., Inc.1993-11-171130
K933543ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)Jedental Co., Inc.1993-11-011040
K933554JEDENTAL ZINC CEMENT IMPROVEDJedental Co., Inc.1993-11-011030
K931880PROFILL LC COMPOSITEJedental Co., Inc.1993-07-08850

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