Zircate® Cleaning and Polishing Material – Prophy Paste
Zircate® Refill Package
25manufacturers in China registered for this device type
1catalogue number
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 | 2022-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 25 °C; Special storage condition: Keep out of direct sunlight and store in a well-ventilated place.; Special storage condition: Allow material to reach room temperature prior to use.; Special storage condition: Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.; Special storage condition: Should be stored with the original cap only.; Special storage condition: Protect from moisture. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 677001 | 1 tube (170g) | 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 |
| 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 |
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.