ClearanceBrief
510(k) K180947 ยท OAS X-Ray, Tomography, Computed, Dental

Orthopantomograph OP 3D

ApplicantPalodex Group OY, Tuusula, FI
DecisionSubstantially Equivalent, Jun 7, 2018
ReceivedApr 11, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180947

DateFirm and productCodeLinked 510(k)
Dec 31, 2018KaVo Dental Technologies LLC
cone-beam CT system
Open, Classified
OASNone listed

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