Nobel Biocare Usa Llc
FDA Regulatory Profile
Nobel Biocare Usa Llc has 66 FDA recalls, 7 inspections, 9 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0658-2022 · Class II · Dec 17, 2021
- Latest inspection
- Aug 8, 2025 · NAI
- Latest 510(k)
- Jul 24, 2014
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 66 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 7 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0658-2022 | Class II | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Dec 17, 2021 |
| Z-1851-2020 | Class II | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI… | Aug 28, 2019 |
| Z-1853-2020 | Class II | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the… | Aug 9, 2019 |
| Z-1852-2020 | Class II | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to… | Aug 9, 2019 |
| Z-1854-2020 | Class II | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the… | Aug 9, 2019 |
| Z-1855-2020 | Class II | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the… | Aug 9, 2019 |
| Z-1856-2020 | Class II | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end… | Aug 9, 2019 |
| Z-1857-2020 | Class II | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly… | Aug 9, 2019 |
| Z-2207-2020 | Class II | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI… | Jul 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-1307-2020 | Class II | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills… | Mar 14, 2019 |
| Z-1303-2020 | Class II | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided… | Mar 14, 2019 |
| Z-1322-2020 | Class II | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw… | Mar 14, 2019 |
| Z-1302-2020 | Class II | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills… | Mar 14, 2019 |
| Z-1315-2020 | Class II | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper… | Mar 14, 2019 |
| Z-1310-2020 | Class II | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills… | Mar 14, 2019 |
| Z-1304-2020 | Class II | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills… | Mar 14, 2019 |
| Z-1320-2020 | Class II | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to… | Mar 14, 2019 |
| Z-1316-2020 | Class II | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove… | Mar 14, 2019 |
| Z-1317-2020 | Class II | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove… | Mar 14, 2019 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 8, 2025 | Pomona, CA | Biologics | No Action Indicated (NAI) | 1000125598 |
| Sep 26, 2017 | Pomona, CA | Biologics | No Action Indicated (NAI) | 1000125598 |
| Oct 15, 2015 | Pomona, CA | Devices | Voluntary Action Indicated (VAI) | 1000125598 |
| Jun 2, 2015 | Pomona, CA | Biologics | No Action Indicated (NAI) | 1000125598 |
| Apr 1, 2015 | Pomona, CA | Devices | No Action Indicated (NAI) | 1000125598 |
| Jun 15, 2011 | Pomona, CA | Devices | No Action Indicated (NAI) | 1000125598 |
| May 14, 2010 | Pomona, CA | Devices | Voluntary Action Indicated (VAI) | 1000125598 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1000125598 | Pomona, CA | 7 | Aug 8, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132749 | NOBELPROCERA OVERDENTURE BAR | Jul 24, 2014 |
| K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | Jan 30, 2014 |
| K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS | Jun 15, 2011 |
| K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | Nov 19, 2008 |
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT | Jan 11, 2008 |
| K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | Dec 6, 2006 |
| K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | Dec 23, 2005 |
| K050641 | ZYGOMA TIUNITE | Apr 7, 2005 |
| K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA | Feb 1, 2005 |