Atlas FDA

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

E&D Dental Manufacturing Co. — Predicate Candidate Screening

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

66 daysmedian FDA review time
174 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883698ZINC OXIDE EUGENOL TEMPORARY CEMENTE&D Dental Manufacturing Co.1988-11-29910
K873739ACRYLIC IMPRESSION TRAY MATERIALSE&D Dental Manufacturing Co.1988-03-071740
K873738ACRYLIC BASE DENTURE MATERIALSE&D Dental Manufacturing Co.1987-11-20660
K871639DENTAL DIAMOND BURSE&D Dental Manufacturing Co.1987-05-18210
K864922DENTAL HANDPIECES AND ATTACHMENTE&D Dental Manufacturing Co.1987-02-19650
K862745EUGENOL USPE&D Dental Manufacturing Co.1986-07-31100

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