Certain®
Certain® NON-Hexed Implant Pick-UP Coping 4.1MM(D) X 4.1MM(P)
70manufacturers in China registered for this device type
68catalogue 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 9) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 10 mm |
| Distribution end date | 2020-10-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| QNTSK40 | In distribution | ||
| IIPDTUS | In distribution | ||
| IRE200U | In distribution | ||
| IUNITS | Diameter 3.4 mm | 5 | In distribution |
| IIPDTL | Diameter 6 mm | In distribution | |
| IRH600 | In distribution | ||
| IDIM01 | Length 10 mm | In distribution | |
| IWIP57 | Diameter 5 mm | In distribution | |
| IIPDTUL | In distribution | ||
| IMMBP | Diameter 3.4 mm | In distribution | |
| ILPCMBP3 | Diameter 3.4 mm | In distribution | |
| IPPMM1 | Diameter 3.4 mm | In distribution | |
| IILA20 | Diameter 4.1 mm | In distribution | |
| IIIC41 | Diameter 4.1 mm | In distribution | |
| ILT150 | In distribution | ||
| ISRT05N | In distribution | ||
| ISRT06N | In distribution | ||
| IPPIA5 | Diameter 5 mm | In distribution | |
| ILTAH57 | In distribution | ||
| IWIP56 | Diameter 5 mm | In distribution | |
| PSKT35 | In distribution | ||
| IMIC30 | Diameter 3.4 mm | In distribution | |
| IMIC33 | Diameter 3.4 mm | In distribution | |
| IBPGP | Diameter 6 mm | 3 | In distribution |
| IIIC12 | Diameter 4.1 mm | In distribution | |
| IMPDTL | Diameter 3.4 mm | In distribution | |
| ILPCMBP5 | Diameter 5 mm | In distribution | |
| IWIP60 | Diameter 6 mm | In distribution | |
| IILAW6 | Diameter 6 mm | In distribution | |
| IWSU30 | In distribution | ||
| IMPDTS | Diameter 3.4 mm | In distribution | |
| IDIKT | In distribution | ||
| IIIC75 | Diameter 4.1 mm | In distribution | |
| IRORDR | 10 | In distribution | |
| NCATD0C | In distribution | ||
| SLIMKT | In distribution | ||
| ISC3 | Diameter 3.4 mm | In distribution | |
| IWIP66 | Diameter 6 mm | In distribution | |
| IIIC60 | Diameter 4.1 mm | In distribution | |
| ISRT10N | In distribution | ||
| ILPCMBP4 | Diameter 4.1 mm | In distribution | |
| PSKT30U | In distribution | ||
| PTT300I | In distribution | ||
| IBPMGP | Diameter 3.4 mm | 3 | In distribution |
| IPPIA3 | Diameter 4.1 mm | In distribution | |
| IPPIA6 | Diameter 6 mm | In distribution | |
| IIPDTS | Diameter 4 mm | In distribution | |
| IRE100U | In distribution | ||
| IDI001 | Length 10 mm | In distribution | |
| IMBP4 | Diameter 4.1 mm | In distribution | |
| IMMILA | Diameter 3.4 mm | In distribution | |
| ISC4 | Diameter 4.1 mm | In distribution | |
| SRT10N | In distribution | ||
| IMMBP35 | Diameter 3.4 mm | In distribution | |
| IWIP67 | Diameter 6 mm | In distribution | |
| IMBP5 | Diameter 5 mm | In distribution | |
| ISRT06 | In distribution | ||
| IIIC42 | Diameter 4.1 mm | In distribution | |
| IWIP55 | Diameter 5 mm | In distribution | |
| IWIP50 | Diameter 5 mm | In distribution | |
| PSKT40 | In distribution | ||
| IMLT150 | Diameter 3.4 mm | In distribution | |
| ICD100 | Diameter 4 mm | In distribution | |
| PTT300UI | In distribution | ||
| IILAW5 | Diameter 5 mm | In distribution | |
| ISRT10 | Withdrawn | ||
| ISRT01 | Withdrawn | ||
| ISRT05 | Withdrawn |
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.