PDT, Inc.
CSS-7 Composite Sculpting System
5manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Shandong (1). 2 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EKJ |
| Device type | Burnisher, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-30 |
| Record revised | 2022-05-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R336 Calcium Hydroxide Placement | In distribution | |
| R530 CSS-6 Composite System | In distribution | |
| R526 CSS-5 Composite System | In distribution | |
| R330 2/29 Burnisher | In distribution | |
| R332 26/27S Burnisher | In distribution | |
| R331 Hollenback 6 | In distribution | |
| R337 Norton CP | In distribution | |
| R334 Ladmore 3 | In distribution | |
| R335 Acorn 21B | In distribution | |
| R329 Burnisher 18 | In distribution | |
| R333 27/29 Burnisher | In distribution | |
| R522 CSS-4 Composite System | In distribution | |
| R338 21B-27 Burnisher | In distribution | |
| R528 CSS-7 Composite System | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 157 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 58 |
| Power Dental USA | Power Dental U.S.A. Inc. | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 24 |
| J & J Instruments Inc | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 21 |
| Zoll-Dental | Zoll-Dental | 16 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 14 |
| Henry Schein | Henry Schein, Inc. | 7 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 5 |
| Burkhart Dental | Nordent Manufacturing Inc | 5 |
Showing 12 of 54. All products under Burnisher, Operative
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.