Bite Blocks 10pcs OP 3d
Catalogue number 901013, listed by Palodex Group OY, Finland, under Aligner, Beam, X-Ray. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Palodex Group OY, Finland |
|---|---|
| FDA product code | EHA |
| Device type | Aligner, Beam, X-Ray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.1820 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180947 |
| Record published | 2021-05-26 |
| Record revised | 2025-12-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rinn® | Dentsply LLC | 37 |
| 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 |
| 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.