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)
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Terminated
NHAK072642
Aug 9, 2019Nobel Biocare Usa Llc
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are inte
Terminated
NHAK161435
Aug 9, 2019Nobel Biocare Usa Llc
Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be us
Terminated
NHAK071370
Aug 9, 2019Nobel Biocare Usa Llc
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used
Terminated
NHAK071370
Aug 9, 2019Nobel Biocare Usa Llc
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be
Terminated
NHAK974150
Aug 9, 2019Nobel Biocare Usa Llc
Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to b
Terminated
NHAK974150
Jul 19, 2019Nobel Biocare Usa Llc
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Terminated
NHAK071370
Feb 26, 2019Biomet 3i, LLC
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the
Terminated
NHAK052648
K102209
Feb 26, 2019Biomet 3i, LLC
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max
Terminated
NHAK052648
K102209
Feb 26, 2019Biomet 3i, LLC
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th
Terminated
NHAK052648
K102209
Feb 26, 2019Biomet 3i, LLC
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th
Terminated
NHAK052648
K102209
Feb 26, 2019Biomet 3i, LLC
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max
Terminated
NHAK052648
K102209
Jul 23, 2018Nobel Biocare Usa Llc
Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore che
Terminated
NHAK072570
Mar 8, 2018Southern Implants, (Pty.) Ltd.
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or
Terminated
NHAK163634
Jan 23, 2018Implant Direct Sybron Manufacturing, LLC
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Terminated
NHAK130572
Jan 19, 2018Implant Direct Sybron Manufacturing, LLC
SwishPlus Implant Intended for use in support for fixed bridgework.
Terminated
NHAK081396
Jul 21, 2017Implant Direct Sybron Manufacturing, LLC
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Terminated
NHAK090234
Jun 20, 2017Keystone Dental Inc
Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-
Terminated
NHAK051614
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341
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
NHAK092341

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