Hahn
Hahn Tapered Implant Guided Shaping Drill for Dense Bone - Ø5.0 x 11.5 mm
70manufacturers in China registered for this device type
188catalogue numbers in this listing
1recall
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 | Prismatik Dentalcraft, Inc., 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 |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2023-08-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 11 mm |
| Distribution end date | 2024-11-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70-1071-SRG0177 | In distribution | ||
| 70-1071-SRG0079 | In distribution | ||
| 70-1071-SRG0085 | In distribution | ||
| 70-1153-PRC0030 | In distribution | ||
| 70-1153-PRC0051 | In distribution | ||
| 70-1153-PRC0021 | Height 11 mm | In distribution | |
| 70-1071-SRG0221 | In distribution | ||
| 70-1174-SRG0020 | In distribution | ||
| 70-1071-SRG0056 | In distribution | ||
| 70-1071-SRG0196 | In distribution | ||
| 70-1071-SRG0071 | In distribution | ||
| 70-1153-PRC0061 | Height 11 mm | In distribution | |
| 70-1071-SRG0222 | In distribution | ||
| 70-1071-SRG0184 | In distribution | ||
| 70-1071-SRG0089 | In distribution | ||
| 70-1153-PRA0109 | In distribution | ||
| 70-1071-SRG0224 | In distribution | ||
| 70-1153-PRA0066 | Post Height, 13mm | In distribution | |
| 70-1071-SRG0219 | In distribution | ||
| 70-1153-PRC0070 | In distribution | ||
| 70-1071-SRG0214 | In distribution | ||
| 70-1071-SRG0081 | In distribution | ||
| 70-1153-PRC0032 | In distribution | ||
| 70-1153-PRC0017 | Height 11 mm | In distribution | |
| 70-1153-PRC0060 | Height 11 mm | In distribution | |
| 70-1071-SRG0165 | In distribution | ||
| 70-1071-SRG0063 | In distribution | ||
| 70-1071-SRG0200 | In distribution | ||
| 70-1071-SRG0091 | In distribution | ||
| 70-1071-SRG0229 | In distribution | ||
| 70-1071-SRG0061 | In distribution | ||
| 70-1071-SRG0215 | In distribution | ||
| 70-1071-SRG0172 | In distribution | ||
| 70-1071-SRG0090 | In distribution | ||
| 70-1174-SRG0022 | In distribution | ||
| 70-1071-SRG0226 | In distribution | ||
| 70-1153-PRC0056 | In distribution | ||
| 70-1071-SRG0073 | In distribution | ||
| 70-1153-PRC0019 | Height 11 mm | In distribution | |
| 70-1153-PRC0048 | In distribution | ||
| 70-1071-SRG0207 | In distribution | ||
| 70-1071-SRG0179 | In distribution | ||
| 70-1153-PRC0042 | In distribution | ||
| 70-1071-SRG0182 | In distribution | ||
| 70-1153-PRA0069 | Post Height, 13mm | In distribution | |
| 70-1153-PRC0078 | In distribution | ||
| 70-1071-SRG0220 | In distribution | ||
| 70-1153-PRA0110 | In distribution | ||
| 70-1153-PRC0071 | In distribution | ||
| 70-1153-PRC0035 | 5 | In distribution | |
| 70-1153-PRC0050 | In distribution | ||
| 70-1071-SRG0169 | In distribution | ||
| 70-1071-SRG0181 | In distribution | ||
| 70-1071-SRG0083 | In distribution | ||
| 70-1071-SRG0164 | In distribution | ||
| 70-1071-SRG0170 | In distribution | ||
| 70-1071-SRG0193 | In distribution | ||
| 70-1153-PRC0058 | Height 11 mm | In distribution | |
| 70-1174-SRG0019 | In distribution | ||
| 70-1071-SRG0192 | In distribution | ||
| 70-1071-SRG0175 | In distribution | ||
| 70-1071-SRG0077 | In distribution | ||
| 70-1153-PRC0038 | In distribution | ||
| 70-1174-SRG0021 | In distribution | ||
| 70-1071-SRG0054 | In distribution | ||
| 70-1153-PRA0068 | Post Height, 13mm | In distribution | |
| 70-1071-SRG0168 | In distribution | ||
| 70-1071-SRG0218 | In distribution | ||
| 70-1071-SRG0227 | In distribution | ||
| 70-1071-SRG0082 | In distribution | ||
| 70-1071-SRG0068 | In distribution | ||
| 70-1153-PRC0073 | In distribution | ||
| 70-1071-SRG0231 | In distribution | ||
| 70-1071-SRG0213 | In distribution | ||
| 70-1071-SRG0066 | In distribution | ||
| 70-1071-SRG0064 | In distribution | ||
| 70-1074-PRS0051 | In distribution | ||
| 70-1071-SRG0065 | In distribution | ||
| 70-1153-PRC0024 | In distribution | ||
| 70-1071-SRG0198 | In distribution | ||
| 70-1071-SRG0190 | In distribution | ||
| 70-1071-SRG0084 | In distribution | ||
| 70-1071-SRG0174 | In distribution | ||
| 70-1153-PRC0018 | Height 11 mm | 5 | In distribution |
| 70-1153-PRA0108 | In distribution | ||
| 70-1153-PRC0059 | Height 11 mm | In distribution | |
| 70-1071-SRG0080 | In distribution | ||
| 70-1071-SRG0086 | In distribution | ||
| 70-1071-SRG0167 | In distribution | ||
| 70-1153-PRC0076 | In distribution | ||
| 70-1071-SRG0171 | In distribution | ||
| 70-1071-SRG0203 | In distribution | ||
| 70-1071-SRG0202 | In distribution | ||
| 70-1071-SRG0060 | In distribution | ||
| 70-1153-PRC0054 | In distribution | ||
| 70-1071-SRG0185 | In distribution | ||
| 70-1071-SRG0194 | In distribution | ||
| 70-1071-SRG0067 | In distribution | ||
| 70-1071-SRG0178 | In distribution | ||
| 70-1071-SRG0191 | In distribution | ||
| 70-1071-SRG0187 | In distribution | ||
| 70-1153-PRC0031 | In distribution | ||
| 70-1071-SRG0078 | In distribution | ||
| 70-1071-SRG0173 | In distribution | ||
| 70-1153-PRA0063 | Post Height, 13mm | In distribution | |
| 70-1071-SRG0201 | In distribution | ||
| 70-1071-SRG0217 | In distribution | ||
| 70-1071-SRG0212 | In distribution | ||
| 70-1153-PRA0067 | Post Height, 13mm | In distribution | |
| 70-1071-SRG0223 | In distribution | ||
| 70-1153-PRC0068 | In distribution | ||
| 70-1153-PRC0055 | In distribution | ||
| 70-1153-PRC0047 | In distribution | ||
| 70-1153-PRC0039 | In distribution | ||
| 70-1153-PRC0041 | In distribution | ||
| 70-1071-SRG0062 | In distribution | ||
| 70-1071-SRG0216 | In distribution | ||
| 70-1071-SRG0166 | In distribution | ||
| 70-1153-PRA0062 | Post Height, 13mm | In distribution | |
| 70-1071-SRG0195 | In distribution | ||
| 70-1071-SRG0180 | In distribution | ||
| 70-1071-SRG0074 | In distribution | ||
| 70-1153-PRC0066 | In distribution | ||
| 70-1071-SRG0076 | In distribution | ||
| 70-1153-PRC0025 | In distribution | ||
| 70-1071-SRG0197 | In distribution | ||
| 70-1153-PRC0040 | In distribution | ||
| 70-1071-SRG0058 | In distribution | ||
| 70-1071-SRG0204 | In distribution | ||
| 70-1071-SRG0230 | In distribution | ||
| 70-1071-SRG0053 | In distribution | ||
| 70-1071-SRG0055 | In distribution | ||
| 70-1071-SRG0209 | In distribution | ||
| 70-1071-SRG0069 | In distribution | ||
| 70-1153-PRC0057 | In distribution | ||
| 70-1153-PRC0049 | In distribution | ||
| 70-1153-PRC0013 | Height 11 mm | In distribution | |
| 70-1153-PRA0111 | In distribution | ||
| 70-1153-PRA0064 | Post Height, 13mm | In distribution | |
| 70-1153-PRC0015 | Height 11 mm | In distribution | |
| 70-1153-PRC0026 | In distribution | ||
| 70-1153-PRC0052 | In distribution | ||
| 70-1153-PRC0029 | In distribution | ||
| 70-1153-PRC0037 | 5 | In distribution | |
| 70-1153-PRC0027 | In distribution | ||
| 70-1153-PRC0077 | In distribution | ||
| 70-1071-SRG0208 | In distribution | ||
| 70-1071-SRG0228 | In distribution | ||
| 70-1071-SRG0075 | In distribution | ||
| 70-1153-PRC0064 | In distribution | ||
| 70-1071-SRG0088 | In distribution | ||
| 70-1071-SRG0206 | In distribution | ||
| 70-1153-PRC0045 | In distribution | ||
| 70-1153-PRC0063 | In distribution | ||
| 70-1153-PRC0067 | In distribution | ||
| 70-1153-PRC0023 | In distribution | ||
| 70-1153-PRC0014 | Height 11 mm | 5 | In distribution |
| 70-1071-SRG0057 | In distribution | ||
| 70-1071-SRG0211 | In distribution | ||
| 70-1071-SRG0183 | In distribution | ||
| 70-1153-PRC0074 | In distribution | ||
| 70-1071-SRG0225 | In distribution | ||
| 70-1071-SRG0070 | In distribution | ||
| 70-1153-PRC0044 | In distribution | ||
| 70-1153-PRC0062 | Height 11 mm | In distribution | |
| 70-1153-PRC0028 | In distribution | ||
| 70-1153-PRC0036 | 5 | In distribution | |
| 70-1153-PRC0075 | In distribution | ||
| 70-1071-SRG0176 | In distribution | ||
| 70-1071-SRG0189 | In distribution | ||
| 70-1153-PRC0053 | In distribution | ||
| 70-1071-SRG0059 | In distribution | ||
| 70-1071-SRG0188 | In distribution | ||
| 70-1153-PRC0065 | In distribution | ||
| 70-1153-PRC0072 | In distribution | ||
| 70-1071-SRG0087 | In distribution | ||
| 70-1071-SRG0205 | In distribution | ||
| 70-1153-PRC0046 | In distribution | ||
| 70-1071-SRG0199 | In distribution | ||
| 70-1153-PRC0069 | In distribution | ||
| 70-1153-PRC0043 | In distribution | ||
| 70-1071-SRG0072 | In distribution | ||
| 70-1071-SRG0186 | In distribution | ||
| 70-1153-PRA0065 | Post Height, 13mm | In distribution | |
| 70-1071-SRG0210 | In distribution | ||
| 70-1153-PRC0020 | Height 11 mm | 5 | Withdrawn |
| 70-1153-PRC0016 | Height 11 mm | 5 | Withdrawn |
| 70-1153-PRC0022 | Height 11 mm | 5 | 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
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 |
|---|---|---|---|---|
| 2025-04-14 | Class II | Process control | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. | 15 units |
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.