Nobel Biocare Usa Llc
FDA Regulatory Profile
Nobel Biocare Usa Llc appears in FDA public data with 66 recalls, 9 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0658-2022, Class II) was initiated on December 17, 2021. Its most recent 510(k) clearance was granted on July 24, 2014.
Summary
- Total Recalls
- 66
- 510(k) Clearances
- 9
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0658-2022 | Class II | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | December 17, 2021 |
| Z-1851-2020 | Class II | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)0733 | August 28, 2019 |
| Z-1853-2020 | Class II | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the e | August 9, 2019 |
| Z-1856-2020 | Class II | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseo | August 9, 2019 |
| Z-1854-2020 | Class II | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endo | August 9, 2019 |
| Z-1855-2020 | Class II | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the end | August 9, 2019 |
| Z-1857-2020 | Class II | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly conne | August 9, 2019 |
| Z-1852-2020 | Class II | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to t | August 9, 2019 |
| Z-2207-2020 | Class II | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: | July 19, 2019 |
| Z-2250-2020 | Class II | Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: | May 28, 2019 |
| Z-1314-2020 | Class II | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the uppe | March 14, 2019 |
| Z-1317-2020 | Class II | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove im | March 14, 2019 |
| Z-1313-2020 | Class II | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and | March 14, 2019 |
| Z-1311-2020 | Class II | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and | March 14, 2019 |
| Z-1308-2020 | Class II | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guide | March 14, 2019 |
| Z-1319-2020 | Class II | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove im | March 14, 2019 |
| Z-1321-2020 | Class II | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove impla | March 14, 2019 |
| Z-1307-2020 | Class II | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Gui | March 14, 2019 |
| Z-1316-2020 | Class II | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove imp | March 14, 2019 |
| Z-1323-2020 | Class II | Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but inc | March 14, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132749 | NOBELPROCERA OVERDENTURE BAR | July 24, 2014 |
| K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | January 30, 2014 |
| K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS | June 15, 2011 |
| K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | November 19, 2008 |
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT | January 11, 2008 |
| K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | December 6, 2006 |
| K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | December 23, 2005 |
| K050641 | ZYGOMA TIUNITE | April 7, 2005 |
| K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA | February 1, 2005 |