Rinn®
XCP-DS® Prosensor Kit. Contains: 8 Vertical Bitewings. XCP-DS® EVA: Plus 4 Horizontal Posterior Biteblocks, 4 Vertical Anterior Biteblocks. XCP-ORA®: Arm and Ring. XCP-DS®: Kodak 4…
XCP-DS® Prosensor Kit. Contains: 8 Vertical Bitewings. XCP-DS® EVA: Plus 4 Horizontal Posterior Biteblocks, 4 Vertical Anterior Biteblocks. XCP-ORA®: Arm and Ring. XCP-DS®: Kodak 4 Horizontal Posterior Biteblocks, 4 Vertical Anterior Biteblocks, 8 Horizontal Bitewings with Biteblock. 1 Eezee-Grip. 50 Bulk Sensor Covers.
40manufacturers in China registered for this device type
87catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (8), Jiangsu (7). 5 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 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Tianchang Jiarui Packaging Material Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Trelleborg Sealing Solutions Suzhou Company Limited | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Wenzhou Wapro Technology Co Ltd | Longgang | Zhejiang | Contract manufacturer | 1 |
| 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 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
Showing 12 of 40. All 40 manufacturers in China registered for Holder, Film, X-Ray
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EGZ |
| Device type | Holder, Film, X-Ray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.1905 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-24 |
| 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: Sterilize before each use per Instructions for Use |
| Distribution end date | 2024-02-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 540293 | In distribution | ||
| 550323 | 3 | In distribution | |
| 559921 | 10 | In distribution | |
| 550321 | In distribution | ||
| 550141 | In distribution | ||
| 552118 | 3 | In distribution | |
| 552117 | 3 | In distribution | |
| 550423 | 3 | In distribution | |
| 540867 | 6 | In distribution | |
| 556271 | In distribution | ||
| 553019 | 3 | In distribution | |
| 559913 | 6 | In distribution | |
| 540503 | 3 | In distribution | |
| 540861 | 25 | In distribution | |
| 559904 | 2 | In distribution | |
| 559923 | 10 | In distribution | |
| 559907 | 2 | In distribution | |
| 552111 | 3 | In distribution | |
| 559922 | 10 | In distribution | |
| 552115 | 3 | In distribution | |
| 552502 | 3 | In distribution | |
| 540931 | 6 | In distribution | |
| 553020 | 3 | In distribution | |
| 550624 | 3 | In distribution | |
| 540929 | 6 | In distribution | |
| 559902 | 2 | In distribution | |
| 553018 | 3 | In distribution | |
| 553015 | 3 | In distribution | |
| 559926 | 10 | In distribution | |
| 559900 | In distribution | ||
| 550626 | 3 | In distribution | |
| 550293 | In distribution | ||
| 540863 | 20 | In distribution | |
| 550055 | 50 | In distribution | |
| 540922 | 6 | In distribution | |
| 550625 | 3 | In distribution | |
| 552116 | 3 | In distribution | |
| 552113 | 3 | In distribution | |
| 550146 | In distribution | ||
| 550148 | In distribution | ||
| 540933 | 6 | In distribution | |
| 550627 | 3 | In distribution | |
| 540200 | 3 | In distribution | |
| 542045 | 5 | In distribution | |
| 559901 | 2 | In distribution | |
| 550621 | 3 | In distribution | |
| 559906 | 2 | In distribution | |
| 550619 | 3 | In distribution | |
| 552112 | 3 | In distribution | |
| 550623 | 3 | In distribution | |
| 552500 | In distribution | ||
| 553016 | 3 | In distribution | |
| 540862 | 25 | In distribution | |
| 559914 | 6 | In distribution | |
| 553014 | 3 | In distribution | |
| 552114 | 3 | In distribution | |
| 552626 | 3 | In distribution | |
| 540868 | 6 | In distribution | |
| 552501 | 3 | In distribution | |
| 550628 | 3 | In distribution | |
| 559905 | 2 | In distribution | |
| 552119 | 3 | In distribution | |
| 553712 | In distribution | ||
| 552505 | 3 | In distribution | |
| 550294 | 3 | In distribution | |
| 553017 | 3 | In distribution | |
| 550255 | 100 | In distribution | |
| 552120 | 3 | In distribution | |
| 550622 | 3 | In distribution | |
| 550521 | In distribution | ||
| 559903 | 2 | In distribution | |
| 550421 | In distribution | ||
| 552504 | 3 | In distribution | |
| 553012 | 3 | In distribution | |
| 552503 | 3 | In distribution | |
| 540935 | 3 | In distribution | |
| 540501 | In distribution | ||
| 550620 | 3 | In distribution | |
| 559924 | 10 | In distribution | |
| 552625 | 3 | In distribution | |
| 540920 | 25 | Withdrawn | |
| 553871 | Withdrawn | ||
| 554781 | Withdrawn | ||
| 552971 | Withdrawn | ||
| 549975 | Withdrawn | ||
| 552571 | Withdrawn | ||
| 559917 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrollByte | Directa AB | 181 |
| Cefla | Duphamed B.V. | 24 |
| Techno-Aide | Techno-Aide, Inc. | 23 |
| DenBite | Duphamed B.V. | 20 |
| Steri-Shield | Steri-Shield Products, Inc. | 19 |
| Henry Schein | Henry Schein, Inc. | 19 |
| Plasdent | Plasdent Corp. | 16 |
| Visionary by 3D Dental | 3D Dental Designs AND Development, LLC | 16 |
| Essentials by 3D Dental | 3D Dental Designs AND Development, LLC | 15 |
| Care Stream Dental | Duphamed B.V. | 14 |
| JMU | JMU Dental, Inc | 13 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 13 |
Showing 12 of 204. All products under Holder, Film, 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.