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)
Top companies in NHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet 3i | 19 | 174 |
| Nobel Biocare AB | 49 | 7 |
| Institut Straumann AG | 47 | 0 |
| Straumann USA | 32 | 7 |
| Dentsply Sirona | 23 | 0 |
| Terrats Medical SL | 21 | 0 |
| Zimmer Dental, Inc. | 21 | 0 |
| Prismatik Dentalcraft, Inc. | 19 | 1 |
| Osstem Implant Co., Ltd. | 18 | 0 |
| Atlantis Components, Inc. | 17 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H)
Item: IMPAP32G
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H)
Item: IWTH564
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H)
Item: IWTH54
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H)
Item: IWTH52
Dental implants Terminated |
NHA | K072642 |
| Dec 8, 2015 | Implant 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 |
NHA | K081396 |
| Sep 11, 2015 | Biomet 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 |
NHA | K072642 |
| Sep 5, 2014 | Biomet 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 |
NHA | K072642 |
| Mar 17, 2014 | Biomet 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 |
NHA | K032263 K052648 |
| Nov 22, 2013 | Southern 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 |
NHA | K070905 |
| Sep 16, 2013 | Camlog 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 |
NHA | None listed |
| Sep 16, 2013 | Camlog 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 |
NHA | None listed |
| Sep 16, 2013 | Camlog 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 |
NHA | None listed |
| Sep 16, 2013 | Camlog 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 |
NHA | None listed |
| Mar 8, 2013 | Keystone 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 |
NHA | K101545 |
| Mar 8, 2013 | Keystone 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 |
NHA | K101545 |
| Aug 24, 2012 | Biomet 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 |
NHA | None listed |
| Aug 8, 2012 | Straumann 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 |
NHA | K081005 |
| Aug 8, 2012 | Biomet 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 |
NHA | K063341 |
| Apr 25, 2012 | Biomet 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 |
NHA | K092341 |
| Nov 3, 2011 | Biomet 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 |
NHA | K072642 |
| Nov 3, 2011 | Biomet 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 |
NHA | K063403 |
| Jul 26, 2011 | Biomet 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 |
NHA | K092341 |
| Mar 29, 2008 | Biomet 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 |
NHA | K072642 |
| Mar 28, 2008 | Biomet 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 |
NHA | K072642 |
| Jan 17, 2008 | Biomet 3i Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410 Terminated |
NHA | K060291 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.