Gelato
Prophy Paste Bubble Gum Medium Grit 100gm
25manufacturers in China registered for this device type
28catalogue numbers in this listing
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 | Keystone Industries, 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 |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
| Record revised | 2026-06-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from moisture; Special storage condition: Keep out of direct sunlight |
| Sizes | Total volume 3.5 to 14.1 Fluid Ounce; weight 100 to 400 g |
| Distribution end date | 2026-05-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 24-02377 | Total Volume 14.1 Fluid Ounce | 200 | In distribution |
| 24-02877 | Weight 400 g | 200 | In distribution |
| 24-05177 | Weight 400 g | 200 | In distribution |
| 24-02477 | Weight 400 g | 200 | In distribution |
| 24-15977 | Weight 400 g | 200 | In distribution |
| 24-03977 | Total Volume 12 Fluid Ounce | In distribution | |
| 24-08077 | Weight 340 g | In distribution | |
| 24-02977 | Weight 400 g | 200 | In distribution |
| 24-10877 | Total Volume 12 Fluid Ounce | In distribution | |
| 24-11677 | Weight 400 g | 200 | In distribution |
| 24-16577 | Total Volume 12 Fluid Ounce | In distribution | |
| 24-02677 | Total Volume 14.1 Fluid Ounce | 200 | In distribution |
| 24-02577 | Weight 400 g | 200 | In distribution |
| 24-04077 | Total Volume 12 Fluid Ounce | In distribution | |
| 24-02277 | Total Volume 14.1 Fluid Ounce | 200 | In distribution |
| 24-02777 | Weight 400 g | 200 | In distribution |
| 24-07577 | Weight 400 g | 200 | In distribution |
| 24-08177 | Weight 340 g | In distribution | |
| 24-15877 | Weight 400 g | 200 | In distribution |
| 24-11777 | Total Volume 14.1 Fluid Ounce | 200 | In distribution |
| 24-03177 | Weight 400 g | 200 | In distribution |
| 24-03077 | Total Volume 14.1 Fluid Ounce | 200 | In distribution |
| 24-09077 | Total Volume 12 Fluid Ounce | In distribution | |
| 24-05077 | Total Volume 14.1 Fluid Ounce | 200 | In distribution |
| 24-11477 | Weight 100 g | Withdrawn | |
| 24-11577 | Weight 100 g | Withdrawn | |
| 24-11277 | Weight 170 g | Withdrawn | |
| 24-11177 | Weight 170 g | 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 |
| Zooby | Young Dental Manufacturing I, LLC | 27 |
| Topex® Prophy Paste | Dentsply 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
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.