Navigator®
Tapered Navigator® Shaping Drill 3.25MM(D) X 11.5MM(L) Short
70manufacturers in China registered for this device type
147catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous
Record
| Listed by | ZimVie US Corp LLC, United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-03-24 |
| Record revised | 2026-01-15 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 4 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SGTD19E | Diameter 1.9 mm | In distribution | |
| SGD2A | Diameter 2 mm | In distribution | |
| SGD425A | Diameter 4.25 mm | In distribution | |
| MSGTT15L | Diameter 3.25 mm | In distribution | |
| SGTCP5S | Diameter 5 mm | In distribution | |
| MSGTT85S | Diameter 3.25 mm | In distribution | |
| SGTT515L | Diameter 5 mm | In distribution | |
| SGFT24 | Length 4 mm | 25 | In distribution |
| SGTP4 | Diameter 4 mm | In distribution | |
| MSGTD85L | Length 8.5 mm | In distribution | |
| MSGTD15S | Diameter 3.25 mm | In distribution | |
| SGTAP45 | Collar Diameter 5 mm | In distribution | |
| SGTT511L | Diameter 5 mm | In distribution | |
| MSGTAP | Diameter 3.25 mm | In distribution | |
| SGD275B | Diameter 2.75 mm | In distribution | |
| SGD275D | Diameter 2.75 mm | In distribution | |
| SGTD485L | Length 8.5 mm | In distribution | |
| SGD3B | Diameter 3 mm | In distribution | |
| SGD325B | Diameter 3.25 mm | In distribution | |
| SGTD515S | Length 15 mm | In distribution | |
| MSGTD13L | Diameter 3.25 mm | In distribution | |
| SGTTAPK | In distribution | ||
| SGTD511S | Length 11.5 mm | In distribution | |
| SGMT54 | Diameter 5 mm | 25 | In distribution |
| SGD325A | Diameter 3.25 mm | In distribution | |
| SGDPH4 | In distribution | ||
| SGTD19D | Diameter 1.9 mm | In distribution | |
| SGDPH5 | In distribution | ||
| SGTP5 | Diameter 5 mm | In distribution | |
| SGTT510L | Diameter 5 mm | In distribution | |
| SGMT44 | Diameter 4.1 mm | 25 | In distribution |
| SGD385B | Diameter 3.85 mm | In distribution | |
| MSGTCDL | Diameter 3.4 mm | In distribution | |
| SGD275E | Diameter 2.75 mm | In distribution | |
| SGDPH2 | In distribution | ||
| SGTAP4 | Diameter 4.1 mm | In distribution | |
| SGTD19A | Diameter 1.9 mm | In distribution | |
| SGD425B | Diameter 4.25 mm | In distribution | |
| MSGTD10L | Length 10 mm | In distribution | |
| SGD325E | Diameter 3.25 mm | In distribution | |
| SGTT413S | Length 13 mm | In distribution | |
| SGTD510S | Diameter 5 mm | In distribution | |
| SGD275Y | Diameter 2.75 mm | In distribution | |
| SGD2Y | Diameter 2 mm | In distribution | |
| SGSD34 | Diameter 3 mm | In distribution | |
| SGD2Z | Diameter 2 mm | In distribution | |
| SGD3E | Diameter 3 mm | In distribution | |
| SGSD45 | Collar Diameter 5 mm | In distribution | |
| SGTD511L | Length 11.5 mm | In distribution | |
| MSGTT13S | Length 13 mm | In distribution | |
| SGTDPHT | In distribution | ||
| SGTD485S | Diameter 4 mm | In distribution | |
| SGTD510L | Diameter 5 mm | In distribution | |
| SGD275Z | Diameter 2.75 mm | In distribution | |
| SGD385C | Diameter 3.85 mm | In distribution | |
| SGTD513L | Length 13 mm | In distribution | |
| SGTD411S | Diameter 4 mm | In distribution | |
| SGKIT | In distribution | ||
| SGD325D | Diameter 3.25 mm | In distribution | |
| SGTLTRAY | In distribution | ||
| SGTCP4S | Diameter 4.1 mm | In distribution | |
| SGTCD5S | Diameter 5 mm | In distribution | |
| SGKIT | In distribution | ||
| SGD3Z | Diameter 3 mm | In distribution | |
| SGTTRAY | In distribution | ||
| MSGTD11S | Length 11.5 mm | In distribution | |
| SGTT411L | Diameter 4 mm | In distribution | |
| SGTD415S | Diameter 4 mm | In distribution | |
| MSGSD | Diameter 3.4 mm | In distribution | |
| MSGTD11L | Diameter 3.25 mm | In distribution | |
| SGTT415S | Diameter 4 mm | In distribution | |
| SGTT511S | Length 11.5 mm | In distribution | |
| SGTT415L | Length 15 mm | In distribution | |
| SGTT513S | Diameter 5 mm | In distribution | |
| SGDPH3 | In distribution | ||
| MSGTT11L | Length 11.5 mm | In distribution | |
| SGD385Z | Diameter 3.85 mm | In distribution | |
| SGTD410S | Diameter 4 mm | In distribution | |
| MSGTT10S | Diameter 3.25 mm | In distribution | |
| SGTDPHR | In distribution | ||
| SGD2B | Diameter 2 mm | In distribution | |
| SGD3Y | Diameter 3 mm | In distribution | |
| SGTTP5 | Diameter 5 mm | In distribution | |
| SGTT510S | Length 10 mm | In distribution | |
| SGD3D | Diameter 3 mm | In distribution | |
| SGTD413S | Length 13 mm | In distribution | |
| SGTT410L | Length 10 mm | In distribution | |
| SGTD413L | Diameter 4 mm | In distribution | |
| SGD325Y | Diameter 3.25 mm | In distribution | |
| SGTT485S | Diameter 4 mm | In distribution | |
| SGTCD4L | Diameter 4.1 mm | In distribution | |
| SGTD585S | Length 8.5 mm | In distribution | |
| SGTT585S | Diameter 5 mm | In distribution | |
| SGTD19G | Diameter 1.9 mm | In distribution | |
| SGTCD4S | Diameter 4.1 mm | In distribution | |
| SGD325Z | Diameter 3.25 mm | In distribution | |
| MSGTT15S | Length 15 mm | In distribution | |
| SGD2D | Diameter 2 mm | In distribution | |
| SGLKIT | In distribution | ||
| SGTCP4L | Diameter 4.1 mm | In distribution | |
| SGD2E | Diameter 2 mm | In distribution | |
| SGTT513L | Length 13 mm | In distribution | |
| SGTAP5 | Diameter 5 mm | In distribution | |
| SGTT585L | Length 8.5 mm | In distribution | |
| SGD425C | Diameter 4.25 mm | In distribution | |
| SGTD19F | Diameter 1.9 mm | In distribution | |
| MSGTD15L | Length 15 mm | In distribution | |
| MSGTD10S | Diameter 3.25 mm | In distribution | |
| SGD2C | Diameter 2 mm | In distribution | |
| SGTTAPT | In distribution | ||
| SGTD19C | Diameter 1.9 mm | In distribution | |
| SGD425Y | Diameter 4.25 mm | In distribution | |
| SGTD585L | Diameter 5 mm | In distribution | |
| SGTD513S | Length 13 mm | In distribution | |
| SGD275A | Diameter 2.75 mm | In distribution | |
| SGD275C | Diameter 2.75 mm | In distribution | |
| MSGTCDS | Diameter 3.4 mm | In distribution | |
| MSGTT11S | Diameter 3.25 mm | In distribution | |
| SGD325C | Diameter 3.25 mm | In distribution | |
| SGTT410S | Diameter 4 mm | In distribution | |
| SGDPH1 | In distribution | ||
| MSGTT13L | Diameter 3.25 mm | In distribution | |
| SGD3A | Diameter 3 mm | In distribution | |
| SGTT515S | Length 15 mm | In distribution | |
| MSGTT85L | Length 8.5 mm | In distribution | |
| MSGTD85S | Diameter 3.25 mm | In distribution | |
| MSGTD13S | Diameter 3.25 mm | In distribution | |
| SGTT485L | Diameter 4 mm | In distribution | |
| SGTTP4 | Diameter 4.1 mm | In distribution | |
| SGSD4 | Diameter 4.1 mm | In distribution | |
| SGLKIT | In distribution | ||
| SGD385A | Diameter 3.85 mm | In distribution | |
| SGTT411S | Diameter 4 mm | In distribution | |
| SGTD410L | Diameter 4 mm | In distribution | |
| SGD3C | Diameter 3 mm | In distribution | |
| MSGTT10L | Length 10 mm | In distribution | |
| SGD425Z | Diameter 4.25 mm | In distribution | |
| SGTD415L | Diameter 4 mm | In distribution | |
| SGD385Y | Diameter 3.85 mm | In distribution | |
| SGTD515L | Length 15 mm | In distribution | |
| SGTCP5L | Diameter 5 mm | In distribution | |
| SGTD411L | Length 11.5 mm | In distribution | |
| SGTT413L | Diameter 4 mm | In distribution | |
| SGLTRAY | In distribution | ||
| SGTCD5L | Diameter 5 mm | In distribution | |
| SGTRAY | In distribution | ||
| SGTD19B | Diameter 1.9 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accessories, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,379 |
| Accessories, Implant, Dental, Endosseous | Institut Straumann AG | 1,320 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 1,112 |
| Inclusive | Prismatik Dentalcraft, Inc. | 1,045 |
| Medentika | Medentika GmbH | 1,042 |
| BioHorizons | Biohorizons Implant Systems Inc. | 1,008 |
| IPD | Implant Protesis Dental 2004 SL | 998 |
| Klockner | Soadco, S.L. | 995 |
| Dynamic Abutment Solutions | Talladium España, SL | 877 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 738 |
| Nobel Biocare® | Nobel Biocare AB | 703 |
| MIS | MIS Implants Technologies Ltd. | 615 |
Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous
Recalls
14 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-10-11 | Class II | Employee error | The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant. | 356 units | 2019-03-13 |
| 2017-10-11 | Class II | Employee error | The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant. | 891 kits | 2019-03-13 |
| 2017-10-11 | Class II | Employee error | The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant. | 166 kits | 2019-03-13 |
| 2017-10-11 | Class II | Employee error | The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant. | 30 kits | 2019-03-13 |
| 2017-07-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | 76 products | 2019-08-05 |
| 2017-07-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | 86 products | 2019-08-05 |
| 2017-07-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | 423 products | 2019-08-05 |
| 2017-07-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | 349 products | 2019-08-05 |
| 2015-11-16 | Class II | Software design (manufacturing process) | Images contained within radiographic transparency ART 1036 are undersized. | 686 | 2016-12-14 |
| 2015-09-21 | Class II | Process control | Inadequate biocompatibility testing. | 30,111 devices. | 2016-10-12 |
| 2015-09-21 | Class II | Process control | Inadequate biocompatibility testing. | 30,111 devices. | 2016-10-12 |
| 2015-08-10 | Class II | Labeling mix-ups | RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N’s laser marking “RASH3N” during manufacturing. | 103 pieces | 2016-10-12 |
| 2015-08-10 | Class II | Labeling mix-ups | The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N’s laser marking “RASH3N” during manufacturing. | 96 pieces | 2016-10-12 |
| 2015-01-22 | Class II | Device Design | The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant. | 627 units | 2015-08-03 |
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.