ClearanceBrief
510(k) K063403 ยท NHA Abutment, Implant, Dental, Endosseous

CONICAL ANGLED ABUTMENT

ApplicantImplant Innovations, Inc., Palm Beach Gardens FL, US
DecisionSubstantially Equivalent, Mar 20, 2007
ReceivedNov 9, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K063403

DateFirm and productCodeLinked 510(k)
Aug 12, 2016Biomet 3i, LLC
Conical 17 degree Angled Abutment Dental implants
Terminated
NHANone listed
Aug 12, 2016Biomet 3i, LLC
Conical 25 degree Angled Abutment Dental implants
Terminated
NHANone listed
Aug 12, 2016Biomet 3i, LLC
Certain Conical 17 degree Angled Abutment Dental implants
Terminated
NHANone listed
Aug 12, 2016Biomet 3i, LLC
Certain Conical 25 degree Angled Abutment Dental implants
Terminated
NHANone listed
Nov 3, 2011Biomet 3i, LLC
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***
Terminated
NHANone listed

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