Rinn®
XCP-QT® Universal Disposable Sensor Holder. Contains: 2 XCP-ORA® Arms and Rings, XCP-QT 100 Bitetabs, 50 Universal Sensor Covers.
2manufacturers in China registered for this device type
37catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EHA |
| Device type | Aligner, Beam, X-Ray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.1820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-27 |
| Record revised | 2024-09-11 (version 7) |
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, manufacturing date |
| Storage | Special storage condition: Store at room temperature. |
| Distribution end date | 2024-02-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 540860 | In distribution | ||
| 550322 | 3 | In distribution | |
| 540858 | In distribution | ||
| 550771 | In distribution | ||
| 542050 | 6 | In distribution | |
| 550100 | 2 | In distribution | |
| 550777 | 12 | In distribution | |
| 540874 | In distribution | ||
| 540927 | In distribution | ||
| 540871 | In distribution | ||
| 540873 | In distribution | ||
| 550598 | In distribution | ||
| 542071 | In distribution | ||
| 550661 | 2 | In distribution | |
| 540934B | 500 | In distribution | |
| 540857 | In distribution | ||
| 540865 | In distribution | ||
| 550775 | In distribution | ||
| 550774 | In distribution | ||
| 550773 | In distribution | ||
| 540872 | In distribution | ||
| 550597 | In distribution | ||
| 550772 | 4 | In distribution | |
| 540934 | In distribution | ||
| 554903 | 150 | Withdrawn | |
| 540310 | Withdrawn | ||
| 554901 | 150 | Withdrawn | |
| 550071 | 2 | Withdrawn | |
| 554906 | 150 | Withdrawn | |
| 554904 | 150 | Withdrawn | |
| 551046 | 2 | Withdrawn | |
| 554911 | Withdrawn | ||
| 554905 | Withdrawn | ||
| 554902 | 150 | Withdrawn | |
| 540312 | Withdrawn | ||
| 554913 | Withdrawn | ||
| 550776 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dispos-a-Bite | Metrex Research | 12 |
| Schick | Dentsply LLC | 5 |
| Bar, Alignment, Universal | Dental Imaging Technologies Corporation | 2 |
| Endodontic Bar – Alignment Bar | Dental Imaging Technologies Corporation | 1 |
| Cranex 3D PAT Posit Accessories | Palodex Group OY | 1 |
| Bite blocks 10pcs OP 3D | Palodex Group OY | 1 |
| Intraoral Sensor Holders Arms and Rings | Sirona Dental, Inc. | 1 |
| Cranex 3D PAN Accessories | Palodex Group OY | 1 |
| Bite Block (SET OF 10 PCS) | Palodex Group OY | 1 |
| Intraoral Sensor Holder Arms and Rings | Sirona Dental, Inc. | 1 |
| Bar, Alignment, Bitewing, Dexis | Dental Imaging Technologies Corporation | 1 |
| Bar, Alignment, Bitewing, Short | Dental Imaging Technologies Corporation | 1 |
Showing 12 of 20. All products under Aligner, Beam, X-Ray
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.