GTC®
GTC Bent Dental Plate - 10 Degrees Down (Medium)
8manufacturers in China registered for this device type
15catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Elekta Beijing Medical Systems Co., Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Jiangsu Rayer Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K962155 |
| Record published | 2016-07-26 |
| Record revised | 2024-03-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2023-12-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GTCSVS | 5 | In distribution | |
| GTCDTSS | 5 | Withdrawn | |
| GTCOCP | Withdrawn | ||
| GTCDDU | Withdrawn | ||
| GTCDPS10U | Withdrawn | ||
| GTCDPM | Withdrawn | ||
| GTCDPS10D | Withdrawn | ||
| GTCDIMU | Withdrawn | ||
| GTCDTSM | 5 | Withdrawn | |
| GTCDPS | Withdrawn | ||
| GTCDPM10U | Withdrawn | ||
| OP | Withdrawn | ||
| GTCDPL | Withdrawn | ||
| GTCDPM10D | Withdrawn | ||
| GTCDTSL | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| Orfit Industries | Orfit Industries NV | 680 |
| Aquaplast RT™ | Qfix | 569 |
| Fibreplast® | Qfix | 271 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 115 |
| Vac-Lok™ Cushion | Medtec LLC | 100 |
| Visicoil | IZI Medical Products LLC | 86 |
| BodyFIX | 3C-Medical Intelligence GmbH | 84 |
| AlignRT Plus | Vision RT Limited | 72 |
| Fibreplast® Assure™ Open View | Qfix | 72 |
| Accelerator, Linear, Medical | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 71 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-01-23 | Not classified | Device Design | Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a t | 33 units | 2012-10-01 |
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.