Topex® Prophy Paste
Topex® Prophy Paste Non-Fluoride Cherry Medium Cups - Box of 200
25manufacturers in China registered for this device type
27catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Guangxi (4), Hebei (3). 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 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
Showing 12 of 25. All 25 manufacturers in China registered for Agent, Polishing, Abrasive, Oral Cavity
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EJR |
| Device type | Agent, Polishing, Abrasive, Oral Cavity |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2024-06-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at normal room temperature. |
| Packaging | Case of 24, box of 6, box of 24, pack of 24, pack of 6 |
| Sizes | Weight 34 g |
| Distribution end date | 2024-06-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AD30012FG | Box of 200 Cups | 200 | In distribution |
| AD30019FG | Box of 200 Cups | 200 | In distribution |
| AD30017FG | Box of 200 Cups | 200 | In distribution |
| AD30008FG | Box of 200 Cups | 200 | In distribution |
| AD30000FG | Box of 200 Cups | 200 | In distribution |
| AD30014FG | Box of 200 Cups | 200 | In distribution |
| AD30004FG | Box of 200 Cups | 200 | In distribution |
| AD30022FG | 6 Jars (12 oz/34 g each) | In distribution | |
| AD30015FG | Box of 200 Cups | 200 | In distribution |
| AD30001FG | 24 Cartons of 200 Cups | 200 | In distribution |
| AD30041FG | Box of 200 Cups | 200 | In distribution |
| AD30018FG | Box of 200 Cups | 200 | In distribution |
| AD30032FG | 6 Jars (12 oz/34 g each) | In distribution | |
| AD30002FG | Box of 200 Cups | 200 | In distribution |
| AD30009FG | Box of 200 Cups | 200 | In distribution |
| AD30025FG | Box of 200 Cups | 200 | In distribution |
| AD60002FG | Box of 200 Cups | 200 | In distribution |
| AD30011FG | 200 cups, 1 prophy grip, 1 ring, 1 DFU | 200 | In distribution |
| AD30042FG | Box of 200 Cups | 200 | In distribution |
| AD30029FG | Box of 200 Cups | 200 | Withdrawn |
| AD30040FG | 6 Jars (12 oz/34 g each) | Withdrawn | |
| AD60011FG | Box of 200 Cups | 200 | Withdrawn |
| AD30007FG | Box of 200 Cups | 200 | Withdrawn |
| AD30034FG | Weight 34 g | Withdrawn | |
| AD30021FG | Weight 34 g | Withdrawn | |
| AD30024FG | 6 Jars (12 oz/34 g each) | Withdrawn | |
| AD30031FG | 6 Jars (12 oz/34 g each) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Strauss Diamond | Diamond Strauss Instruments Inc | 319 |
| Henry Schein | Henry Schein, Inc. | 56 |
| Nupro® Prophylaxis Paste with Fluoride | Dentsply LLC | 44 |
| Waterpik Prophy Paste | Water PIK, Inc. | 38 |
| D-Lish | Young Dental Manufacturing I, LLC | 32 |
| Gelato | Keystone Industries | 28 |
| Zooby | Young Dental Manufacturing I, LLC | 27 |
| Enamel Pro® Prophy Paste | Premier Dental Products Co. | 26 |
| AIR-Flow | E.M.S. Electro Medical Systems S.A. | 24 |
| Sparkle Prophylaxis Paste | Crosstex International | 22 |
| CleanJoy | Voco Gmbh | 21 |
| Ena Shiny | Micerium SPA | 20 |
Showing 12 of 341. All products under Agent, Polishing, Abrasive, Oral Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121698 | 2012-08-06 |
| K000169 | 2000-03-24 |
| K983966 | 1999-01-29 |
| K912945 | 1991-09-16 |
| K901580 | 1990-09-06 |
| K872251 | 1987-07-02 |
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.