Enamel Pro® Prophy Paste
Enamel Pro® Prophy Paste Raspberry Mint-Coarse (Box of 200)
25manufacturers in China registered for this device type
26catalogue numbers in this listing
2510(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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EJR |
| Device type | Agent, Polishing, Abrasive, Oral Cavity |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K062166 |
| Record published | 2022-06-29 |
| Record revised | 2025-07-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9007618 | In distribution | |
| 9007627 | In distribution | |
| 9007631 | In distribution | |
| 9007622 | In distribution | |
| 9007609 | In distribution | |
| 9007621 | In distribution | |
| 9007605 | In distribution | |
| 9007600 | In distribution | |
| 9007603 | In distribution | |
| 9007601 | In distribution | |
| 9007602 | In distribution | |
| 9007611 | In distribution | |
| 9007607 | In distribution | |
| 9007612 | In distribution | |
| 9007606 | In distribution | |
| 9007615 | In distribution | |
| 9007630 | In distribution | |
| 9007619 | In distribution | |
| 9007613 | In distribution | |
| 9007617 | In distribution | |
| 9007614 | In distribution | |
| 9007608 | In distribution | |
| 9007616 | In distribution | |
| 9007620 | In distribution | |
| 9007604 | In distribution | |
| 9007610 | In distribution |
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 |
| Topex® Prophy Paste | Dentsply LLC | 27 |
| 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 |
|---|---|
| K062166 | 2006-11-21 |
| K891536 | 1989-06-09 |
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.