Block, Bite
FDA product code JXL · Class II (moderate risk) · 21 CFR 882.5070 · Neurology
28510(k) clearances
0PMA approvals
0recalls
Manufacturers
- United States Endoscopy Group, Inc. 2
- Scott All-Sports, Inc. 2
- Somatics, Inc. 2
- Neurovice, LLC 1
- Dyna-Med 1
- B&B Medical Technologies, Inc. 1
- Premier Dental Products Co. 1
- Ora-Gard, Inc. 1
- Ethox Corp. 1
- Plastic Engineered Products Co. 1
- Medi-Source, Inc. 1
- Medovations, Inc. 1
- Hi Chem, Inc. 1
- Brimms, Inc. 1
- Cherry Plastics, Inc. 1
- Hudson Oxygen Therapy Sales Co. 1
- Kelleher Corp. 1
- Trident Dental, Inc. 1
- Oxequip Health Ind. 1
- Mission Dental, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury)JXL · Traditional | Neurovice, LLC | 02/22/2023SE |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumJXL · Traditional | Mecta Corporation | 06/04/2021SE |
| K172978 | SurgeoBiteJXL · Traditional | Surgovations, LLC | 12/22/2017SE |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…JXL · Traditional | Dupaco, Inc. | 06/29/2015SE |
| K050188 | EpiguardJXL · Traditional | Episafe Medical Devices, Ltd. | 04/27/2005SE |
| K992269 | Ventil-A Oral ProtectorJXL · Traditional | Somatics, Inc. | 10/25/1999SE |
| K960663 | Universal Bite BlockJXL · Traditional | B&B Medical Technologies, Inc. | 05/17/1996SE |
| K954352 | Bite BlockJXL · Traditional | United States Endoscopy Group, Inc. | 01/25/1996SE |
| K941856 | Premier Promax Bite GuardJXL · Traditional | Premier Dental Products Co. | 04/05/1995SE |
| K924333 | The Davis Disposable Protective SplintJXL · Traditional | Ora-Gard, Inc. | 04/23/1993SE |
| K924304 | Bite BlockJXL · Traditional | United States Endoscopy Group, Inc. | 04/06/1993SE |
| K921946 | Tum-E-Vac Bite BlockJXL · Traditional | Ethox Corp. | 12/09/1992SE |
| K901563 | Mouthpiece BreathingJXL · Traditional | Scott All-Sports, Inc. | 06/28/1990SE |
| K896745 | Jaw BlockerJXL · Traditional | Plastic Engineered Products Co. | 12/14/1989SE |
| K890567 | Bite Block #59430JXL · Traditional | Medi-Source, Inc. | 02/17/1989SE |
| K883416 | Mouthpiece Breathing (Performance Mouthguard)JXL · Traditional | Scott All-Sports, Inc. | 10/12/1988SE |
| K864962 | Oberto Mouth PropJXL · Traditional | Medovations, Inc. | 02/19/1987SE |
| K864181 | Somatics Mouth Guard (Bite Block)JXL · Traditional | Somatics, Inc. | 11/03/1986SE |
| K861893 | GGT Reagent Cartridge (Product No. 88204)JXL · Traditional | Hi Chem, Inc. | 06/05/1986SE |
| K842788 | Differential Diag. Occlusal ApplianceJXL · Traditional | Brimms, Inc. | 09/11/1984SE |
| K840789 | Bitestick BlockJXL · Traditional | Cherry Plastics, Inc. | 04/05/1984SE |
| K830090 | Disposable Bite Block/Tongue DepressorJXL · Traditional | Hudson Oxygen Therapy Sales Co. | 02/07/1983SE |
| K822018 | Jackson Bite BlocksJXL · Traditional | Kelleher Corp. | 08/03/1982SE |
| K802696 | Dental Mouth Prop.JXL · Traditional | Trident Dental, Inc. | 11/12/1980SE |
| K800369 | Tri Pac Mouth PropJXL · Traditional | Oxequip Health Ind. | 02/28/1980SE |
| K792157 | Dental Mouthprop (Bite Block)JXL · Traditional | Mission Dental, Inc. | 11/13/1979SE |
| K770090 | Blachly Bite Blok & Cheek FillerJXL · Traditional | P.H. Blachly, M.D. | 01/31/1977SE |
| K760258 | Bite Stick, DynaJXL · Traditional | Dyna-Med | 07/26/1976SE |