Tatum Surgical/Hand Tool
Hand Tool #30 Integrity .050 Hex driver with handle for Integrity abutments, healing cuffs, cover screws, and 2mm screws
70manufacturers in China registered for this device type
34catalogue numbers in this listing
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 | Suncoast Dental, Inc., United States |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-15 |
| Record revised | 2020-12-07 (version 4) |
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, manufacturing date |
| Distribution end date | 2019-05-14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Hand Tool / HT.09 | Hand Tool #9 ADA shank 4x2mm male driver to fit Tapered, Screw and Integrity 3.7-5.0 Implants | In distribution |
| Hand Tool / HT.10 | Hand Tool #10 ADA hex driver 1mm to fit Unipost abutments and unipost healing screws | In distribution |
| Hand Tool / HT.27 | Hand Tool #27 Adapter for Tatum ratchet to fit standard 4mm square drive | In distribution |
| Hand Tool / HT.08 | Hand Tool #8 ADA shank extender to fit drills and taps | In distribution |
| Hand Tool / HT.13 | Hand Tool #13 Driver for 3.0mm angled one piece Implant (CBA) | In distribution |
| Hand Tool / HT.07 | Hand Tool #7 Long ratchet extension 3.5mm to fit Tapered, Screw and Integrity 3.7-5.0 Implants. | In distribution |
| Hand Tool / HT.06 | Hand Tool #6 Short ratchet extension 3.5mm to fit Tapered, Screw and Integrity 3.7-5.0 Implants. | In distribution |
| Hand Tool / HT.30 | Hand Tool #30 Integrity.050 Hex driver with handle for Integrity abutments, healing cuffs, cover screws, and 2-2.5mm screws | In distribution |
| Hand Tool / HT.24 | Hand Tool #24 Driver for 7.0mm one piece Implant (CB) | In distribution |
| Hand Tool / HT.17 | Hand tool #17 Driver for 4.0-4.5mm one piece Implants (CB) | In distribution |
| Hand Tool / HT.14 | Hand Tool #14 Driver for 3.0mm and 3.5mm one piece ball post Implant (SB) and 3.5-4.0mm two-piece small ball abutment. | In distribution |
| Hand Tool / HT.15 | Hand tool #15 Driver for 3.5mm one piece Implants (CB) | In distribution |
| Hand Tool / HT.12 | Hand tool #12 Driver for 3.0mm one piece Implants (CB) | In distribution |
| HT.07U | 4.0mm Square Head & 2.5mm pentagon | In distribution |
| Hand Tool / HT.16 | Hand Tool #16 Driver for 4.0 and 4.5mm one piece Implant (SB) and Small Ball abutment | In distribution |
| Hand Tool / HT.22 | Hand Tool #22 Driver for 5.0mm one piece ball post Implant (SB) | In distribution |
| Hand Tool / HT.23 | Hand Tool #23 Driver for 6.0mm one piece Implant (CB) | In distribution |
| Hand Tool / HT.29 | Hand Tool #29 Integrity.050 lach grip driver for Integrity abutments, healing cuffs, cover screws, and 2-2.5mm screws | In distribution |
| Hand Tool / HT.31A | Hand Tool #31A Driver for 3.5mm angled one piece Implant (CBA) | In distribution |
| Hand Tool / HT.07L | Hand Tool #7L Long ratchet extension 3.5mm to fit Integrity 6.0-8.0 Implants. | In distribution |
| HT.07D | Duel Head, 3.5mm Hex & 2.5mm Pentagon | In distribution |
| Hand Tool / HT.32A | Hand Tool #32A Driver for 4.0mm angled one piece Implant (CBA) | In distribution |
| Hand Tool / HT.05 | Hand Tool #5 Female socket extension 4mm to fit drivers HT.09/9L | In distribution |
| Hand Tool / HT.25 | Hand Tool #25 Driver for 8.0mm one piece Implant (CB) | In distribution |
| HT.06U | 4.0mm Square Head | In distribution |
| Hand Tool / HT.26 | Hand Tool #26 Adapter for standard 4mm square drive ratchet to fit Tatum drivers | In distribution |
| Hand Tool / HT.11 | Hand Tool #11 hex driver 1mm with handle to fit Unipost abutments and unipost healing screws | In distribution |
| Hand Tool / HT.19 | Hand Tool #19 Small Ball post driver (non-hex) | In distribution |
| Hand Tool / HT.20 | Hand Tool #20 One piece Implant driver socket extension | In distribution |
| Hand Tool / HT.21 | Hand Tool #21 One piece Implant Latch-grip extension for Handpiece and EZ driver Handle | In distribution |
| Hand Tool / HT.09L | Hand Tool #9L ADA shank 4x2mm male driver to fit Integrity 6.0-8.0 Implants | In distribution |
| Hand Tool / HT.18 | Hand tool #18 Driver for 5.0mm one piece Implants (CB) | In distribution |
| Hand Tool / HT.06L | Hand Tool #6L Short ratchet extension 3.5mm to fit Integrity 6.0-8.0 Implants. | In distribution |
| Hand Tool / HT.28 | Hand Tool #28 thumb screw driver for 4mm square | 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
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.