Aesculap
Dental Curette, angled, 7", (175 mm), spoon shaped, double ended, ergonomic handle, peek handle, dark blue, non-sterile, reusable
4manufacturers in China registered for this device type
39catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | EMK |
| Device type | Curette, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-07 |
| Record revised | 2023-08-22 (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 |
| Distribution end date | 2025-02-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MB416R | In distribution | |
| DO655R | In distribution | |
| FK584R | In distribution | |
| DO671R | In distribution | |
| FK595R | In distribution | |
| FK597R | In distribution | |
| FK598R | In distribution | |
| FK585R | In distribution | |
| DB409R | In distribution | |
| FK582R | In distribution | |
| FK592R | In distribution | |
| MB417R | In distribution | |
| DO606R | In distribution | |
| MG331R | In distribution | |
| DO674R | In distribution | |
| DB406R | In distribution | |
| DO673R | In distribution | |
| DB407R | In distribution | |
| FK593R | In distribution | |
| DO672R | In distribution | |
| FK586R | In distribution | |
| MB415R | In distribution | |
| FK581R | In distribution | |
| DO651R | In distribution | |
| FK599R | In distribution | |
| FK583R | In distribution | |
| DO670R | In distribution | |
| DB411R | In distribution | |
| FK588R | In distribution | |
| FK589R | In distribution | |
| FK587R | In distribution | |
| DO650R | In distribution | |
| FK594R | In distribution | |
| DB658T | In distribution | |
| FK596R | In distribution | |
| FK591R | In distribution | |
| DB660T | Withdrawn | |
| DB659T | Withdrawn | |
| DB657T | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 693 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 170 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 112 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 85 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 72 |
| Paul Banditt | Terlain Enterprises, Inc. | 52 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 45 |
| Sklar® | Sklar Corporation | 40 |
| Anatomic Colours | Aesculap AG | 39 |
| Zoll-Dental | Zoll-Dental | 39 |
| devemed | Devemed Gmbh | 33 |
| Reicodent | Devemed Gmbh | 30 |
Showing 12 of 107. All products under Curette, Surgical, 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.