Atlas FDA

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

DiaDent Group International · Predicate Candidate Screening

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

169 daysmedian FDA review time
266 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261166DIA-CEMDiaDent Group International2026-07-09910
K261093DIAFILDiaDent Group International2026-06-02610
K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (RefillDiaDent Group International2026-05-19480
K254112Dia-X Sil BiteDiaDent Group International2026-03-19900
K231552Dia-CemDiaDent Group International2023-07-28590
K220804Dia-X Bond UniversalDiaDent Group International2022-06-15890
K213401DIAPLUS UniversalDiaDent Group International2022-01-311050
K210421Diafil & Diafil CapsuleDiaDent Group International2021-06-281370
K210333DiaPasteDiaDent Group International2021-03-25480
K200174DIA-ROOT BIO MTADiaDent Group International2020-09-182390
K200809D-LUX+DiaDent Group International2020-08-071330
K200175DIA-ROOT BIO SealerDiaDent Group International2020-06-251540
K192392DiaPlusDiaDent Group International2020-05-262660
K190091DiapasteDiaDent Group International2020-03-274340
K192284DiaFil FlowDiaDent Group International2020-03-252160
K192510DIAFIL & DIAFIL CapsuleDiaDent Group International2020-03-201900
K192022DiaTemp FlowDiaDent Group International2020-02-131990
K192158DiaTempDiaDent Group International2020-02-131880
K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIDiaDent Group International2020-02-071690
K182009Dia-ProsealDiaDent Group International2019-09-264260
K182625Diapex PlusDiaDent Group International2019-06-032520
K130163D-LUXDiaDent Group International2013-08-162050

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