ACE
Handle Double Blade Flat 1.5MM Width W/Metric Marking 5" 13CM
29manufacturers in China registered for this device type
28catalogue 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 | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | EJB |
| Device type | Handle, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2019-10-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Sizes | Length 10 to 16.5 cm; length 80 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16901001 | Length 15 cm | In distribution |
| 4418035 | In distribution | |
| 0039356 | Length 13 cm | In distribution |
| 7861320 | Length 15.5 cm | In distribution |
| 7861330 | Length 10 cm | In distribution |
| 4541501 | In distribution | |
| 4419051 | In distribution | |
| 0039364 | Length 14.5 cm | In distribution |
| 4413002 | In distribution | |
| 4414029 | In distribution | |
| 4418043 | In distribution | |
| 0039362 | Length 13 cm | In distribution |
| 0030995 | Length 16 cm | In distribution |
| 6500014 | In distribution | |
| 16901002 | Length 15 cm | In distribution |
| 0030993 | Length 13 cm | In distribution |
| 20169901 | Length 80 mm | In distribution |
| 0030992 | Length 13 cm | In distribution |
| 9700030 | Length 13 cm | In distribution |
| 20155001 | In distribution | |
| 0039372 | Length 14.5 cm | In distribution |
| 7861350 | Length 13 cm | In distribution |
| 0039360 | Length 13 cm | In distribution |
| 0030997 | Length 16.5 cm | In distribution |
| 9700031 | Length 11.5 cm | In distribution |
| 4423050 | In distribution | |
| 0039358 | Length 14.5 cm | In distribution |
| 4413031 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 121 |
| 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 |
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.