Rinn®
XCP-ORA® Toshiba #2. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus: 2 Horizontal Posterior Biteblocks, 2 Vertical Anterior Biteblocks, XCP-DS® Kodak: 2 Horizontal Bitewings with…
XCP-ORA® Toshiba #2. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus: 2 Horizontal Posterior Biteblocks, 2 Vertical Anterior Biteblocks, XCP-DS® Kodak: 2 Horizontal Bitewings with Biteblock, 2 Vertical Bitewings with Biteblock, Schick Elite: 2 Vertical Bitewings, 50 Bulk Sensor Covers.
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 | Dentsply LLC, United States |
|---|---|
| FDA product code | PEM |
| Device type | Dental Barriers And Sleeves |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at room temperature. |
| Distribution end date | 2024-02-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 559910 | In distribution | ||
| 559908 | In distribution | ||
| 550143 | 300 | In distribution | |
| 550140 | In distribution | ||
| 550200 | 200 | In distribution | |
| 550051B | In distribution | ||
| 550252 | In distribution | ||
| 556071 | In distribution | ||
| 554782 | In distribution | ||
| 550147 | In distribution | ||
| 556171 | In distribution | ||
| 550149 | 300 | In distribution | |
| 559909 | In distribution | ||
| 550500 | 500 | In distribution | |
| 550052 | In distribution | ||
| 559912 | Withdrawn | ||
| 554916 | Withdrawn | ||
| 553071 | Withdrawn | ||
| 559911 | Withdrawn | ||
| 554912 | Withdrawn | ||
| MK-0500 | 5 | Withdrawn | |
| 554900 | Withdrawn | ||
| 552160 | Withdrawn | ||
| 551971 | Withdrawn | ||
| 549971 | Withdrawn |
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 |
| 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 |
| Patient Armor Barriers | American Hospital Supply | 10 |
Showing 12 of 154. All products under Dental Barriers And Sleeves
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160232 | 2016-06-07 |
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.