Anatomic Colours
GRACEY (AFTER) ANATOMIC COLOURS Dental Curette, angled, 6 3/4", (170 mm), double ended, ergonomic handle, peek handle, Fig. 13/14, 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 | 2020-06-17 |
| Record revised | 2023-08-25 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DB380R | In distribution | |
| DB381R | In distribution | |
| DB180T | In distribution | |
| DB181T | In distribution | |
| DB331R | In distribution | |
| DB382R | In distribution | |
| DB583R | In distribution | |
| DB387R | In distribution | |
| DB585R | In distribution | |
| DB593R | In distribution | |
| DB330R | In distribution | |
| DB362R | In distribution | |
| DB377R | In distribution | |
| DB389R | In distribution | |
| DB476R | In distribution | |
| DB385R | In distribution | |
| DB586R | In distribution | |
| DB344R | In distribution | |
| DB590R | In distribution | |
| DB342R | In distribution | |
| DB332R | In distribution | |
| DB471R | In distribution | |
| DB582R | In distribution | |
| DB473R | In distribution | |
| DB592R | In distribution | |
| DB182T | In distribution | |
| DB470R | In distribution | |
| DB383R | In distribution | |
| DB392R | In distribution | |
| DB596R | In distribution | |
| DB475R | In distribution | |
| DB384R | In distribution | |
| DB388R | In distribution | |
| DB472R | In distribution | |
| DB386R | In distribution | |
| DB595R | In distribution | |
| DB591R | In distribution | |
| DB368R | In distribution | |
| DB363R | In distribution |
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 |
| Zoll-Dental | Zoll-Dental | 39 |
| Aesculap | Aesculap AG | 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.