House Brand Dentistry
HSB - FL2 FG White Mounted Stone,12/Pk. Flame finishing stones. Aluminum Oxide for fine finishing of composites
13manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Guangdong Okay Technology Co., Ltd. | Zhong Shan | Guangdong | Manufacturer | 10 |
| Shurcon Manufacturing Company | Jia Shan | Zhejiang | Manufacturer | 10 |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | Weihai | Shandong | Manufacturer | 10 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Shenzhen Samo Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 9 |
Showing 12 of 13. All 13 manufacturers in China registered for Instrument, Hand, Calculus Removal
Record
| Listed by | Frontier Dental Supply Inc, Canada |
|---|---|
| FDA product code | ELA |
| Device type | Instrument, Hand, Calculus Removal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Exporter |
| Premarket notification | Exempt |
| Record published | 2026-02-10 |
| Record revised | 2025-06-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HSB-411301 | 12 | In distribution | |
| HSB-411303 | 12 | In distribution | |
| HSB-411300 | 12 | In distribution | |
| HSB-411302 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 1,041 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 47 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 42 |
| Burkhart Dental | Nordent Manufacturing Inc | 21 |
| Henry Schein Acclean | Henry Schein, Inc. | 18 |
| Karl Hammacher Gmbh | Nordent Manufacturing Inc | 17 |
| Blue AND Green | Nordent Manufacturing Inc | 13 |
| Nordent Manufacturing | Nordent Manufacturing Inc | 9 |
| Safco | Nordent Manufacturing Inc | 8 |
| zumax | Zumax Medical Co., Ltd. | 3 |
| Stoma® | Storz AM Mark Gmbh | 3 |
| Benco | Benco Dental Supply Co. | 2 |
Showing 12 of 16. All products under Instrument, Hand, Calculus Removal
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.