Helmut Zepf
Handle, Universal, Zepf-Bionik, Peek, FOR Exchangeable Inserts M2,5X0,5 Single-Ended,lightred-Magenta,conesocket
29manufacturers in China registered for this device type
121catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (6), Shanghai (3). 6 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 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Instrument, Dental
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EJB |
| Device type | Handle, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
| Record revised | 2024-01-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 26.194.68 | In distribution | |
| 26.197.02 | In distribution | |
| 26.193.16 | In distribution | |
| 24.080.01 | In distribution | |
| 26.194.16 | In distribution | |
| 24.087.00 | In distribution | |
| 26.193.06 | In distribution | |
| 19.199.00 | In distribution | |
| 26.180.06 | In distribution | |
| 26.193.04 | In distribution | |
| 26.010.09OX | In distribution | |
| 26.010.21OX | In distribution | |
| 26.193.09 | In distribution | |
| 17.700.00 | In distribution | |
| 26.195.05 | In distribution | |
| 26.197.09 | In distribution | |
| 24.086.01 | In distribution | |
| 26.197.07 | In distribution | |
| 26.195.02 | In distribution | |
| 26.193.11 | In distribution | |
| 26.179.51 | In distribution | |
| 64021.19.003 | In distribution | |
| 26.194.01 | In distribution | |
| 26.179.59 | In distribution | |
| 26.193.15 | In distribution | |
| 26.193.19 | In distribution | |
| 26.193.02 | In distribution | |
| 26.179.50 | In distribution | |
| 26.197.01 | In distribution | |
| 26.010.06OX | In distribution | |
| 24.080.02 | In distribution | |
| 26.195.10 | In distribution | |
| 47.502.15 | In distribution | |
| 26.030.03 | In distribution | |
| 26.194.10 | In distribution | |
| 26.030.01 | In distribution | |
| 26.179.58 | In distribution | |
| 26.010.05OX | In distribution | |
| 26.194.05 | In distribution | |
| 26.197.05 | In distribution | |
| 26.195.08 | In distribution | |
| 26.030.09 | In distribution | |
| 26.181.03 | In distribution | |
| 26.181.04 | In distribution | |
| 26.182.00 | In distribution | |
| 26.010.01OX | In distribution | |
| 26.194.14 | In distribution | |
| 26.010.11OX | In distribution | |
| 26.191.02 | In distribution | |
| 26.010.02OX | In distribution | |
| 26.194.18 | In distribution | |
| 17.700.01 | In distribution | |
| 26.010.07OX | In distribution | |
| 26.191.03 | In distribution | |
| 26.195.04 | In distribution | |
| 26.197.04 | In distribution | |
| 26.030.08 | In distribution | |
| 26.191.01 | In distribution | |
| 26.195.01 | In distribution | |
| 26.193.05 | In distribution | |
| 26.193.01 | In distribution | |
| 26.179.57 | In distribution | |
| 26.193.17 | In distribution | |
| 26.193.10 | In distribution | |
| 26.194.07 | In distribution | |
| 26.180.07CS | In distribution | |
| 26.193.18 | In distribution | |
| 19.200.00 | In distribution | |
| 26.194.02 | In distribution | |
| 26.030.06 | In distribution | |
| 26.194.08 | In distribution | |
| 64021.19.002 | In distribution | |
| 26.194.19 | In distribution | |
| 26.179.55 | In distribution | |
| 26.195.09 | In distribution | |
| 26.180.13 | In distribution | |
| 26.030.04 | In distribution | |
| 26.193.12 | In distribution | |
| 24.089.12 | In distribution | |
| 24.089.02 | In distribution | |
| 26.010.03OX | In distribution | |
| 26.030.10 | In distribution | |
| 26.197.06 | In distribution | |
| 26.195.03 | In distribution | |
| 26.194.09 | In distribution | |
| 26.193.13 | In distribution | |
| 26.197.10 | In distribution | |
| 17.700.40 | In distribution | |
| 26.195.06 | In distribution | |
| 26.194.15 | In distribution | |
| 26.194.20 | In distribution | |
| 24.085.00HZU | In distribution | |
| 26.010.10OX | In distribution | |
| 26.179.56 | In distribution | |
| 26.193.07 | In distribution | |
| 26.194.13 | In distribution | |
| 26.193.14 | In distribution | |
| 26.197.08 | In distribution | |
| 24.087.02 | In distribution | |
| 26.195.07 | In distribution | |
| 26.180.07 | In distribution | |
| 26.197.03 | In distribution | |
| 64021.19.001 | In distribution | |
| 26.010.08OX | In distribution | |
| 26.194.11 | In distribution | |
| 19.200.30 | In distribution | |
| 26.181.01 | In distribution | |
| 26.030.02 | In distribution | |
| 17.710.00 | In distribution | |
| 26.193.20 | In distribution | |
| 26.010.04OX | In distribution | |
| 26.194.03 | In distribution | |
| 26.030.07 | In distribution | |
| 26.193.08 | In distribution | |
| 26.194.06 | In distribution | |
| 26.194.17 | In distribution | |
| 26.194.12 | In distribution | |
| 26.194.04 | In distribution | |
| 26.030.05 | In distribution | |
| 26.193.03 | In distribution | |
| 26.191.04 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 89 |
| Premium Plus | Premium Plus International Limited | 83 |
| Surgical Kit | Shinhung MST Co., Ltd. | 78 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 59 |
| Bioclear Diamond Wedge | Bioclear Matrix Systems, LLC | 50 |
| Hygitech | Hygitech | 47 |
| Plasdent | Plasdent Corp. | 37 |
| Stoma® | Storz AM Mark Gmbh | 34 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 34 |
| LMDental | LM-Dental | 33 |
| Henry Schein | Henry Schein, Inc. | 32 |
| ACE | Ace Surgical Supply Co., Inc. | 28 |
Showing 12 of 221. All products under Handle, Instrument, Dental
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.