Atlas FDA

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

Belport Company, Inc., Gingi-Pak · Predicate Candidate Screening

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

152 daysmedian FDA review time
311 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak2026-04-10590
K251775RODIN CementBelport Company, Inc., Gingi-Pak2025-09-02840
K250279RC-SwiftPrepBelport Company, Inc., Gingi-Pak2025-07-021520
K250222SDF ProBelport Company, Inc., Gingi-Pak2025-05-071000
K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak2024-06-20990
K231060ProMin Dental Desensitizing GelBelport Company, Inc., Gingi-Pak2024-06-134270
K231793RODIN 3D Resin SPLINT, Hard/FlexBelport Company, Inc., Gingi-Pak2024-03-262800
K223365RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-Pak2023-03-271440
K211420Stasis GelBelport Company, Inc., Gingi-Pak2022-03-143110
K211419Gingi-Aid GelBelport Company, Inc., Gingi-Pak2022-01-102480
K200462EtchPro Etching GelBelport Company, Inc., Gingi-Pak2020-09-021900

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