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

Company510(k)sRecalls
Biomet 3i19174
Nobel Biocare AB497
Institut Straumann AG470
Straumann USA327
Dentsply Sirona230
Terrats Medical SL210
Zimmer Dental, Inc.210
Prismatik Dentalcraft, Inc.191
Osstem Implant Co., Ltd.180
Atlantis Components, Inc.170
DateFirm and productCodeLinked 510(k)
Aug 12, 2016Biomet 3i, LLC
IOL Titanium Temporary Cylinder Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
IOL Pick-Up Impression Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
IOL Healing Cap Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
IOL Distal Extension Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
IOL Abutment and Screw Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Index Coping Surgical Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Implant Twist Lock TM Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Implant EP Twist Lock TM Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Implant EP Pick-Up Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Healing Abutment Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Gold -Tite Hexed Retaining Screw Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Gold Slotted Screw Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Gingihue Post Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Gingihue 15 Degree Pre-Angled Post Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
EP Healing Abutment Dental implants
Terminated		 NHAK092341
Aug 12, 2016Biomet 3i, LLC
Drill Stop Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Conical Healing Cap Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Conical EP Twist Lock TM Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Conical EP Pick-Up Coping (Non-Hexed) Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Conical EP Pick-Up Coping (Hexed) Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Conical EP Healing Cap Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Titanium Square Uniscrew Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Titanium Hexed Uniscrew Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Temporary Non-Hexed Cylinder Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Temporary Hexed Cylinder Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Temporary Healing Retention Cylinder Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Standard Abutment Transfer Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Standard Abutment Temporary Screw Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Standard Abutment Pick -Up Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Standard Abutment Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Quickbridge TM Cap Dental implants
Terminated		 NHAK071551
Aug 12, 2016Biomet 3i, LLC
Provide Impression Coping Dental implants
Terminated		 NHANone listed
Aug 12, 2016Biomet 3i, LLC
Prep-Tite Post Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Preformance Temporary Cylinder Dental implants
Terminated		 NHAK061969
Aug 12, 2016Biomet 3i, LLC
Preformance Post Dental implants
Terminated		 NHAK061969
Aug 12, 2016Biomet 3i, LLC
Preformance 15 degrees pre-angled post Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
Terminated		 NHAK112730
Aug 12, 2016Biomet 3i, LLC
LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants
Terminated		 NHAK112730
Aug 12, 2016Biomet 3i, LLC
Gold-Tite Square Uniscrew Item: UNISG Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
Terminated		 NHAK060291
Aug 12, 2016Biomet 3i, LLC
Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
Terminated		 NHAK053170
Aug 12, 2016Biomet 3i, LLC
Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
Terminated		 NHAK072642
Aug 12, 2016Biomet 3i, LLC
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
Terminated		 NHAK072642

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