Premier Curettes
BIG Easy Ultralite Gracey 11/14
3manufacturers in China registered for this device type
41catalogue numbers in this listing
1510(k) clearance
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 |
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EMS |
| Device type | Curette, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-04-10 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8100255 | In distribution | |
| 05601 | In distribution | |
| 1004665 | In distribution | |
| 05611 | In distribution | |
| 1004651 | In distribution | |
| 1004652 | In distribution | |
| 1004663 | In distribution | |
| 1004660 | In distribution | |
| 05637 | In distribution | |
| 05607 | In distribution | |
| 05643 | In distribution | |
| 05667 | In distribution | |
| 05655 | In distribution | |
| 05641 | In distribution | |
| 8100267 | In distribution | |
| 1004661 | In distribution | |
| 05661 | In distribution | |
| 1004666 | In distribution | |
| 1004671 | In distribution | |
| 05676 | In distribution | |
| 05639 | In distribution | |
| 05675 | In distribution | |
| 05693 | In distribution | |
| 05605 | In distribution | |
| 1004662 | In distribution | |
| 8100239 | In distribution | |
| 1004679 | In distribution | |
| 05653 | In distribution | |
| 05670 | In distribution | |
| 8100254 | In distribution | |
| 05617 | In distribution | |
| 05603 | In distribution | |
| 1004672 | In distribution | |
| 05665 | In distribution | |
| 05613 | In distribution | |
| 05673 | In distribution | |
| 05615 | In distribution | |
| 05635 | In distribution | |
| 8100268 | In distribution | |
| 05666 | In distribution | |
| 05677 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 1,276 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 1,032 |
| American Eagle Instruments | American Eagle Instruments | 681 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 301 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 185 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 145 |
| Stoma® | Storz AM Mark Gmbh | 121 |
| PDT, Inc. | PDT, Inc. | 120 |
| Henry Schein | Henry Schein, Inc. | 112 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 108 |
| Pomee | Pomee Corporation | 69 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 63 |
Showing 12 of 321. All products under Curette, Periodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K841011 | 1984-06-15 |
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.