Nobel Biocare Usa Llc

FDA Regulatory Profile

Summary

Total Recalls
66
510(k) Clearances
9
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0658-2022Class IINobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE RDecember 17, 2021
Z-1851-2020Class IINobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)0733August 28, 2019
Z-1855-2020Class IISnappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endAugust 9, 2019
Z-1857-2020Class IITemporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly conneAugust 9, 2019
Z-1852-2020Class IITemporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to tAugust 9, 2019
Z-1853-2020Class IITemporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the eAugust 9, 2019
Z-1856-2020Class IIUniversal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseoAugust 9, 2019
Z-1854-2020Class IIEsthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endoAugust 9, 2019
Z-2207-2020Class IINobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: July 19, 2019
Z-2250-2020Class IIHealing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage:May 28, 2019
Z-1319-2020Class IIImplant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove imMarch 14, 2019
Z-1307-2020Class IIDrill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, GuiMarch 14, 2019
Z-1323-2020Class IIImplant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but incMarch 14, 2019
Z-1308-2020Class IIDrill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, GuideMarch 14, 2019
Z-1314-2020Class IIDense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the uppeMarch 14, 2019
Z-1321-2020Class IIImplant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implaMarch 14, 2019
Z-1318-2020Class IIImplant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if thMarch 14, 2019
Z-1306-2020Class IIDrill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, GuideMarch 14, 2019
Z-1309-2020Class IIDrill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, GuiMarch 14, 2019
Z-1305-2020Class IIScrew Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided TapeMarch 14, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K132749NOBELPROCERA OVERDENTURE BARJuly 24, 2014
K132746NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTIONJanuary 30, 2014
K110171NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMSJune 15, 2011
K083100GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RPNovember 19, 2008
K073142NOBELREPLACE HEXAGONAL IMPLANTJanuary 11, 2008
K062566NOBELREPLACE TAPERED CONICAL CONNECTIONDecember 6, 2006
K052885ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315December 23, 2005
K050641ZYGOMA TIUNITEApril 7, 2005
K043312NOBELRONDO DENTAL CERAMIC - ZIRCONIAFebruary 1, 2005