Atlas FDA

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

Aidite (Qinhuangdao) Technology Co., Ltd. — Predicate Candidate Screening

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

85 daysmedian FDA review time
327 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253036Light-curing Coloring Materials (ALCM)Aidite (Qinhuangdao) Technology Co., Ltd.2026-04-061960
K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.2025-08-271120
K250534Biomic Color OpaqueAidite (Qinhuangdao) Technology Co., Ltd.2025-05-20850
K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd.2025-04-30690
K250811Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.2025-04-11250
K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-AAidite (Qinhuangdao) Technology Co., Ltd.2025-03-14670
K242884Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd.2024-11-22600
K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd.2024-07-12280
K230115Denture Base ResinAidite (Qinhuangdao) Technology Co., Ltd.2023-03-17590
K223742Dental Ceramic BlocksAidite (Qinhuangdao) Technology Co., Ltd.2023-03-08840
K223477PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd.2023-02-16900
K222626Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.2022-12-06970
K213570Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.2022-01-07580
K190217Aidite PMMAAidite (Qinhuangdao) Technology Co., Ltd.2020-12-176820
K192723Coloring LiquidAidite (Qinhuangdao) Technology Co., Ltd.2020-08-183260
K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd.2020-07-083270

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