Nobel Biocare N1™
OsseoShaper 2 Nobel Biocare N1™ 4.0x13mm
1manufacturer
48catalogue numbers in this listing
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Xiang JI Precision Machinery Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
Record
| Listed by | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | QRQ |
| Device type | Non-Irrigation Endosseous Dental Implant Drill Bits |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2023-05-08 |
| Record revised | 2024-05-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry |
| Sizes | Outer diameter 3.5 to 4.8 mm; length 7 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300888 | Outer Diameter 4.800 mm | In distribution |
| 300889 | Length 9.000 mm | In distribution |
| 300898 | Outer Diameter 4.000 mm | In distribution |
| 300889 | Outer Diameter 4.800 mm | In distribution |
| 300886 | Outer Diameter 4.000 mm | In distribution |
| 300901 | Outer Diameter 4.800 mm | In distribution |
| 300897 | Outer Diameter 4.000 mm | In distribution |
| 301175 | Outer Diameter 3.500 mm | In distribution |
| 301176 | Outer Diameter 4.000 mm | In distribution |
| 300901 | Length 11.000 mm | In distribution |
| 300884 | Outer Diameter 4.000 mm | In distribution |
| 300890 | Length 11.000 mm | In distribution |
| 300881 | Outer Diameter 3.500 mm | In distribution |
| 300888 | Outer Diameter 4.800 mm | In distribution |
| 301179 | Length 15.000 mm | In distribution |
| 300883 | Outer Diameter 3.500 mm | In distribution |
| 300900 | Length 9.000 mm | In distribution |
| 300897 | Outer Diameter 4.000 mm | In distribution |
| 300898 | Length 13.000 mm | In distribution |
| 300899 | Length 7.000 mm | In distribution |
| 300896 | Length 9.000 mm | In distribution |
| 300886 | Length 11.000 mm | In distribution |
| 300900 | Outer Diameter 4.800 mm | In distribution |
| 300892 | Outer Diameter 3.500 mm | In distribution |
| 300892 | Outer Diameter 3.500 mm | In distribution |
| 300899 | Outer Diameter 4.800 mm | In distribution |
| 301175 | Outer Diameter 3.500 mm | In distribution |
| 300893 | Outer Diameter 3.500 mm | In distribution |
| 301178 | Length 15.000 mm | In distribution |
| 300887 | Outer Diameter 4.000 mm | In distribution |
| 301176 | Outer Diameter 4.000 mm | In distribution |
| 300881 | Length 9.000 mm | In distribution |
| 300887 | Outer Diameter 4.000 mm | In distribution |
| 300882 | Length 11.000 mm | In distribution |
| 300885 | Length 9.000 mm | In distribution |
| 300885 | Length 9.000 mm | In distribution |
| 300882 | Length 11.000 mm | In distribution |
| 300893 | Length 11.000 mm | In distribution |
| 300894 | Length 13.000 mm | In distribution |
| 300895 | Length 7.000 mm | In distribution |
| 300884 | Length 7.000 mm | In distribution |
| 301178 | Length 15.000 mm | In distribution |
| 300895 | Outer Diameter 4.000 mm | In distribution |
| 301179 | Outer Diameter 4.000 mm | In distribution |
| 300894 | Length 13.000 mm | In distribution |
| 300883 | Length 13.000 mm | In distribution |
| 300896 | Outer Diameter 4.000 mm | In distribution |
| 300890 | Length 11.000 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guided Surgery Drill | Bioline Dental Implant Systems Ltd | 25 |
| Zygomatic Implant Drill | Bioline Dental Implant Systems Ltd | 8 |
| Step Drill | Bioline Dental Implant Systems Ltd | 8 |
| Crestal Drill | Paragon Implant MFG., LLC | 6 |
| MK Drill Bit | MK medical GmbH | 5 |
| Cortical Drill | Bioline Dental Implant Systems Ltd | 4 |
| Trephine Drill | Bioline Dental Implant Systems Ltd | 4 |
| Ruby Hex Drill | Paragon Implant MFG., LLC | 4 |
| Pterygoid Implant Drill | Bioline Dental Implant Systems Ltd | 3 |
| Countersink Drill | Bioline Dental Implant Systems Ltd | 2 |
| Double diameter drill D2,8/2,4x13mm RealGUIDE Z3D Kit | 3DIEMME SRL | 2 |
| Double diameter drill D2,8/2,4x10mm RealGUIDE Z3D Kit | 3DIEMME SRL | 1 |
Showing 12 of 49. All products under Non-Irrigation Endosseous Dental Implant Drill Bits
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.