Nobel Biocare USA, LLC
Nobel Biocare USA, LLC holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2014, with 66 FDA device recalls on record.
Top product codes for Nobel Biocare USA, LLC
FDA recalls by Nobel Biocare USA, LLC
10 most recent of 66- Z-0658-2022 — NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- Z-1851-2020 — NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
- Z-1853-2020 — Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-1855-2020 — Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-1854-2020 — Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-1857-2020 — Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-1852-2020 — Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-1856-2020 — Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-2207-2020 — NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
- Z-2250-2020 — Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nobel Biocare USA, LLC
- K132749 — NOBELPROCERA OVERDENTURE BAR
- K132746 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
- K110171 — NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
- K083100 — GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
- K073142 — NOBELREPLACE HEXAGONAL IMPLANT
- K062566 — NOBELREPLACE TAPERED CONICAL CONNECTION
- K052885 — ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
- K050641 — ZYGOMA TIUNITE
- K043312 — NOBELRONDO DENTAL CERAMIC - ZIRCONIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.