Driva™
72 catalogue numbers from SP4D, listed by ZimVie US Corp LLC, United States, under Drill, Dental, Intraoral. 20 manufacturers in China are registered for this product code.
20manufacturers in China registered for this device type
72catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (5), Anhui (2). 4 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
Showing 12 of 20. All 20 manufacturers in China registered for Drill, Dental, Intraoral
Record
| Listed by | ZimVie US Corp LLC, United States |
|---|---|
| FDA product code | DZA |
| Device type | Drill, Dental, Intraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-08-18 |
| Record revised | 2026-01-15 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP4D | Ø4.4mm/Ø3.8mm, x 17mm | In distribution |
| TSV6DSN | Ø5.7mm/Ø5.1mm, x 16mm | In distribution |
| 1207A | Ø3.25mm x 14mm | In distribution |
| TSV3DN | Ø3.4mm/Ø2.8mm, x 22mm | In distribution |
| STP28D19 | Ø2.8mm/Ø2.4mm, x 19mm | In distribution |
| SPD6DSN | Ø5.7mm/Ø5.1mm x 16mm | In distribution |
| STR23D25 | Ø2.3mm x 25mm | In distribution |
| SPD51DN | Ø5.1mm x 22mm | In distribution |
| 1208A | Ø3.25mm x 19mm | In distribution |
| SPD5DSN | Ø5.1mm/Ø4.4mm x 16mm | In distribution |
| SP3D | Ø3.4mm/Ø2.8mm, x 17mm | In distribution |
| SPD28DN | Ø2.8mm x 22mm | In distribution |
| SV5.1DSN | Ø5.1mm x 16mm | In distribution |
| SPD41DN | Ø3.8mm x 22mm | In distribution |
| 1210A | Ø4.0mm x 14mm | In distribution |
| STR23D19 | Ø2.3mm x 19mm | In distribution |
| 1212A | Ø4.5mm x 14mm | In distribution |
| SV2.3DN | Ø2.3mm x 22mm | In distribution |
| OP4.2D | In distribution | |
| SPD5DN | Ø5.1mm/Ø4.4mm x 22mm | In distribution |
| SV3.4DN | Ø3.4mm x 22mm | In distribution |
| SPD3DSN | Ø3.4mm/Ø2.8mm x 16mm | In distribution |
| 1213A | Ø4.5mm x 16mm | In distribution |
| OP2.3D | In distribution | |
| 1211A | Ø4.0mm x 19mm | In distribution |
| SPD23DSN | Ø2.3mm x 16mm | In distribution |
| 1215A | Ø5.0mm x 14mm | In distribution |
| OP2.8D | In distribution | |
| STR34D25 | Ø3.4mm x 25mm | In distribution |
| SPD44DN | Ø4.4mm/Ø3.8mm x 22mm | In distribution |
| 1293 | Ø2.75mm x 14mm | In distribution |
| SPD38DSN | Ø3.8mm/Ø3.4mm x 16mm | In distribution |
| TSV3.8DSN | Ø3.8mm/Ø3.4mm, x 16mm | In distribution |
| 1298 | Ø2.75mm x 19mm | In distribution |
| SPD51DSN | Ø5.1mm x 16mm | In distribution |
| 1205A | Ø3.0mm x 19mm | In distribution |
| 1216A | Ø5.0mm x 16mm | In distribution |
| SPD34DSN | Ø3.4mm x 16mm | In distribution |
| SPD28DSN | Ø2.8mm x 16mm | In distribution |
| SPD23DN | Ø2.3mm x 22mm | In distribution |
| ZOP2.8DN | Ø2.8mm/Ø2.4mm, x 22mm | In distribution |
| SV3.4DSN | Ø3.4mm x 16mm | In distribution |
| STR28D19 | Ø2.8mm x 19mm | In distribution |
| SV2.3DSN | Ø2.3mm x 16mm | In distribution |
| STP38D19 | Ø3.8mm/Ø3.4mm, x 19mm | In distribution |
| TSV4DN | Ø4.4mm/Ø3.8mm, x 22mm | In distribution |
| STP34D19 | Ø3.4mm/Ø2.8mm, x 19mm | In distribution |
| TSV3DSN | Ø3.4mm/Ø2.8mm, x 16mm | In distribution |
| SPD41DSN | Ø3.8mm x 16mm | In distribution |
| 1201A | Ø2.3mm x 14mm | In distribution |
| SV2.8DSN | Ø2.8mm x 16mm | In distribution |
| SV3.8DSN | Ø3.8mm x 16mm | In distribution |
| STP34D25 | Ø3.4mm/Ø2.8mm, x 25mm | In distribution |
| OP3.5D | In distribution | |
| SPD34DN | Ø3.4mm x 22mm | In distribution |
| STP44D19 | Ø4.4mm/Ø3.8mm, x 19mm | In distribution |
| TSV4DSN | Ø4.4mm/Ø3.8mm, x 16mm | In distribution |
| STR34D19 | Ø3.4mm x 19mm | In distribution |
| SPD38DN | Ø3.8mm/Ø3.4mm x 22mm | In distribution |
| STR38D19 | Ø3.8mm x 19mm | In distribution |
| STP28D25 | Ø2.8mm/Ø2.4mm, x 25mm | In distribution |
| SPD6DN | Ø5.7mm/Ø5.1mmx 22mm | In distribution |
| 1202A | Ø2.3mm x 19mm | In distribution |
| STR28D25 | Ø2.8mm x 25mm | In distribution |
| TLSDS | Ø3.5mm x 11mm | In distribution |
| TSV3.8DN | Ø3.8mm/Ø3.4mm, x 22mm | In distribution |
| STR38D25 | Ø3.8mm x 25mm | In distribution |
| SV5.1DN | Ø5.1mm x 22mm | In distribution |
| SV3.8DN | Ø3.8mm x 22mm | In distribution |
| SPD3DN | Ø3.4mm/Ø2.8mm x 22mm | In distribution |
| 1204A | Ø3.0mm x 14mm | In distribution |
| SPD44DSN | Ø4.4mm/Ø3.8mm x 16mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neobiotech Implant System | Neobiotech Co., Ltd. | 685 |
| Jota | Jota AG | 307 |
| OneGuide Taper Drill | Osstem Implant Co., Ltd. | 291 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 286 |
| 122 Taper Drill | Osstem Implant Co., Ltd. | 285 |
| Taper Drill | Osstem Implant Co., Ltd. | 279 |
| Edenta | Edenta Etablissement | 275 |
| Bone Compaction Drill | Osstem Implant Co., Ltd. | 200 |
| Dental Surgical Drill | Cowellmedi Co., Ltd. | 195 |
| Twist Drill | Osstem Implant Co., Ltd. | 169 |
| Bondent | United Dental Changzhou | 166 |
| Ritter Implants Dental System | Ritter Implants GmbH & Co. KG | 156 |
Showing 12 of 875. All products under Drill, Dental, Intraoral
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2017-07-10 | 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. | 237 products | 2019-08-05 |
| 2009-06-29 | Not classified | Mixed-up of materials/components | Some of the packages of ACT3020, drills may actually contain an ACT3220 drill. | 29 units | 2010-01-05 |
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.