Atlas FDA

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

Shandong Huge Dental Material Corporation · Predicate Candidate Screening

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

100 daysmedian FDA review time
389 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260376Denture BaseShandong Huge Dental Material Corporation2026-05-06900
K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation2026-04-09900
K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation2025-08-011000
K220680Denture Base PolymersShandong Huge Dental Material Corporation2022-08-121570
K213994Flexible BlockShandong Huge Dental Material Corporation2022-03-04730
K201684A-Silicone for Bite RegistrationShandong Huge Dental Material Corporation2020-09-24940
K181747Orthodontic ApplianceShandong Huge Dental Material Corporation2019-04-182900
K160345Glass Ionomer CementShandong Huge Dental Material Corporation2017-03-033890
K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation2016-10-311170

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