510(k) K152243 · KLE Agent, Tooth Bonding, Resin

One Coat 7 Universal

Applicant	Coltene/Whaledent AG, Altstatten, CH
Decision	Substantially Equivalent, Dec 9, 2015
Received	Aug 10, 2015
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K152243

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.