ClearanceBrief
510(k) K100145 ยท EIH Powder, Porcelain

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06

ApplicantA&E Bioceramic Co., Ltd., Taoyuan County, TW
DecisionSubstantially Equivalent, Apr 13, 2010
ReceivedJan 19, 2010
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K100145

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.