ClearanceBrief
Panels › Dental › Product code NHA · Class 2

Abutment, Implant, Dental, Endosseous

Regulation 872.3630

30510(k)s in 12 months (716 all time)
5recalls in 12 months (225 all time)
194recalls that name a 510(k)
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Top companies in NHA

DateFirm and productCodeLinked 510(k)
Aug 12, 2016Biomet 3i, LLC
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
Terminated
NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants
Terminated
NHANone listed
Aug 12, 2016Biomet 3i, LLC
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
Terminated
NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
Terminated
NHAK072642
Dec 8, 2015Implant Direct Sybron Manufacturing, LLC
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patie
Terminated
NHAK081396
Sep 11, 2015Biomet 3i, LLC
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
Terminated
NHAK072642
Sep 5, 2014Biomet 3i, LLC
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior t
Terminated
NHAK072642
Mar 17, 2014Biomet 3i, LLC
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Ab
Terminated
NHAK032263
K052648
Nov 22, 2013Southern Implants, Inc
Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable
Terminated
NHAK070905
Sep 16, 2013Camlog Usa
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricat
Terminated
NHANone listed
Sep 16, 2013Camlog Usa
C2244.4308 CONELOG Titanium Base CC 4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction
Terminated
NHANone listed
Sep 16, 2013Camlog Usa
C2244.3820;, CONELOG Titanium Base CC 3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction
Terminated
NHANone listed
Sep 16, 2013Camlog Usa
C2244.3808, CONELOG Titanium Base CC 3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction w
Terminated
NHANone listed
Mar 8, 2013Keystone Dental Inc
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandib
Terminated
NHAK101545
Mar 8, 2013Keystone Dental Inc
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandible
Terminated
NHAK101545
Aug 24, 2012Biomet 3i, LLC
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Ci
Terminated
NHANone listed
Aug 8, 2012Straumann USA, LLC
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/o
Terminated
NHAK081005
Aug 8, 2012Biomet 3i, LLC
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de
Terminated
NHAK063341
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
NHAK092341
Nov 3, 2011Biomet 3i, LLC
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX On
Terminated
NHAK072642
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
NHAK063403
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
NHAK092341
Mar 29, 2008Biomet 3i, Inc.
BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
Terminated
NHAK072642
Mar 28, 2008Biomet 3i, Inc.
BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.
Terminated
NHAK072642
Jan 17, 2008Biomet 3i
Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
Terminated
NHAK060291

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