Ethox Medical
Catalogue number 950094201, listed by Ethox Corp., United States, under Block, Bite. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Yangdong Honghai Plastics Production Company | Yangjiang | Guangdong | Contract manufacturer | 3 |
| Yangjiang Junchang Trading Co., Ltd. | Yangjiang | Guangdong | Exporter | 3 |
Record
| Listed by | Ethox Corp., United States |
|---|---|
| FDA product code | JXL |
| Device type | Block, Bite |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5070 |
| 510(k) | K921946 |
| Record published | 2016-09-27 |
| Record revised | 2026-01-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: General Warehouse. Do not get wet. |
| Packaging | Box of 20 |
| Distribution end date | 2025-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 950094201 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 3 |
| Cotton Bite Block | Sigmastim Domestic LLC | 2 |
| MouthGuard | Somatics, LLC | 2 |
| Ventil-A Oral Protector | Somatics, LLC | 1 |
| Pati | Neurovice, L.L.C. | 1 |
| Grafco | GF Health Products, Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K921946 | 1992-12-09 |
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.