Nobel Biocare USA LLC
Yorba Linda, CA, US
NOBEL BIOCARE USA, LLC appears in FDA device records in Yorba Linda, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 68 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Nobel Biocare USA LLC between 2005 and 2014. The busiest year on record is 2005, with 3. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2006 | 1 |
| 2008 | 2 |
| 2011 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132749 | NOBELPROCERA OVERDENTURE BAR | NHA | Substantially Equivalent | |
| K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | NHA | Substantially Equivalent | |
| K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS | NHA | Substantially Equivalent | |
| K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | NHA | Substantially Equivalent | |
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT | DZE | Substantially Equivalent | |
| K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | DZE | Substantially Equivalent | |
| K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | NHA | Substantially Equivalent | |
| K050641 | ZYGOMA TIUNITE | NHA | Substantially Equivalent | |
| K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA | EIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2027971 | 1000125598 | NOBEL BIOCARE USA, LLC | 22715 Savi Ranch Parkway, YORBA LINDA, CA 92887 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 68| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0658-2022 | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure. | Class II | Terminated | |
| 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. | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm). | Class II | Terminated | |
| 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. | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. | Class II | Terminated | |
| 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. | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. | Class II | Terminated | |
| 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. | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. | Class II | Terminated | |
| 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. | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. | Class II | Terminated | |
| 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. | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. | Class II | Terminated | |
| 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. | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. | Class II | Terminated | |
| Z-2207-2020 | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 | The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery. | Class II | Terminated | |
| 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. | Packaged dental implant healing abutments were found to contain the wrong size device. | Class II | Terminated | |
| Z-1325-2020 | Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1324-2020 | Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1323-2020 | Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1322-2020 | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1321-2020 | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1320-2020 | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1319-2020 | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1318-2020 | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1317-2020 | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1316-2020 | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1315-2020 | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1314-2020 | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1313-2020 | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1312-2020 | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated | |
| Z-1311-2020 | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain