NobelReplace®
NOBELREPLACE® Straight Surgery Kit. The kit includes instruments to perform implant surgery for RP implants
2manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K990846 |
| Record published | 2016-09-17 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 2 to 6.5 mm |
| Distribution end date | 2021-03-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32288 | Withdrawn | |
| 3701 | Withdrawn | |
| 32284 | Withdrawn | |
| 33504 | Outer Diameter 6.500 mm | Withdrawn |
| 37178 | Withdrawn | |
| 32300 | Withdrawn | |
| 32282 | Withdrawn | |
| 32244 | Outer Diameter 2.000 mm | Withdrawn |
| 33501 | Outer Diameter 4.600 mm | Withdrawn |
| 37465 | Withdrawn | |
| 33502 | Outer Diameter 5.300 mm | Withdrawn |
| 32286 | Withdrawn | |
| 32301 | Withdrawn | |
| 32954 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
Showing 12 of 265. All products under Drill, Bone, Powered
Recalls Naming This Product
14 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 8 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | None | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 2024-02-15 | |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 473 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 346 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 260 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 154 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 264 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 59 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | None | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | None | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | None | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2019-03-14 | Class II | Packaging process control | 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. | 87 units | 2024-02-15 |
| Nobel Biocare USA, LLC | 510(k) number | 2016-07-20 | Class II | Labeling design | Incorrect drill protocol in the Instructions for Use (IFU) | 231 kits | 2016-10-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.