ClearanceBrief
510(k) K092341 ยท NHA Abutment, Implant, Dental, Endosseous

LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION

ApplicantBiomet 3i, Inc., Palm Beach Gardens FL, US
DecisionSubstantially Equivalent, Nov 30, 2009
ReceivedAug 4, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K092341

DateFirm and productCodeLinked 510(k)
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 30 ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 30 ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE 30 ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE 30 ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE 30 ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE 17 ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE 30 ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implan
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental imp
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use a
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental impla
Terminated
NHANone listed
Sep 14, 2016Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inten
Terminated
NHANone listed
Aug 12, 2016Biomet 3i, LLC
EP Healing Abutment Dental implants
Terminated
NHANone listed
Apr 25, 2012Biomet 3i, LLC
Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Ce
Terminated
NHANone listed
Jul 26, 2011Biomet 3i, LLC
LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then b
Terminated
NHANone listed

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