Temple Support Disposable Cover
Catalogue number 900512-DEX, listed by Palodex Group OY, Finland, under Dental Barriers And Sleeves. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (3), Hubei (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Yueying Medical Instruments (Langfang) Co., Ltd. | Langfang | Hebei | Contract manufacturer | 9 |
| Yongqing Huaguan Dental Instruments Factory | Langfang | Hebei | Contract manufacturer | 9 |
Record
| Listed by | Palodex Group OY, Finland |
|---|---|
| FDA product code | PEM |
| Device type | Dental Barriers And Sleeves |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180947 |
| Record published | 2020-02-01 |
| Record revised | 2026-06-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900512-DEX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plasdent | Plasdent Corp. | 152 |
| Premium Plus | Premium Plus (Dongguan) Limited | 61 |
| Premium Plus | Premium Plus International Limited | 59 |
| Pac-Dent | PAC-Dent Inc. | 44 |
| JMU | JMU Dental, Inc | 42 |
| MARK3 | Cargus International, Inc | 26 |
| Rinn® | Dentsply LLC | 25 |
| iSmile | Ismile Dental Products Inc. | 19 |
| ScanX Barrier Envelopes | AIR Techniques, Inc. | 13 |
| Tidishield | Tidi Products, LLC | 12 |
| Phosphor Plate Barrier Envelopes | Maxill, Inc. | 12 |
| Benco | Benco Dental Supply Co. | 10 |
Showing 12 of 154. All products under Dental Barriers And Sleeves
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.