JXL · Block, Bite
Neurology · 21 CFR 882.5070 · Class 2
Overview
| Product Code | JXL |
|---|---|
| Device Name | Block, Bite |
| Regulation | 21 CFR 882.5070 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | Feb 22, 2023 | SESE |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | Jun 4, 2021 | SESE |
| K172978 | SurgeoBite | Surgovations, LLC | Dec 22, 2017 | SESE |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | Dupaco, Inc. | Jun 29, 2015 | SESE |
| K050188 | EPIGUARD | Episafe Medical Devices, Ltd. | Apr 27, 2005 | SESE |
| K992269 | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | Oct 25, 1999 | SESE |
| K960663 | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | May 17, 1996 | SESE |
| K954352 | BITE BLOCK | United States Endoscopy Group, Inc. | Jan 25, 1996 | SESE |
| K941856 | PREMIER PROMAX BITE GUARD | Premier Dental Products Co. | Apr 5, 1995 | SESE |
| K924333 | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | Ora-Gard, Inc. | Apr 23, 1993 | SESE |
| K924304 | BITE BLOCK | United States Endoscopy Group, Inc. | Apr 6, 1993 | SESE |
| K921946 | TUM-E-VAC BITE BLOCK | Ethox Corp. | Dec 9, 1992 | SESE |
| K901563 | MOUTHPIECE BREATHING | Scott All-Sports, Inc. | Jun 28, 1990 | SESE |
| K896745 | JAW BLOCKER | Plastic Engineered Products Co. | Dec 14, 1989 | SESE |
| K890567 | BITE BLOCK #59430 | Medi-Source, Inc. | Feb 17, 1989 | SESE |
| K883416 | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | Scott All-Sports, Inc. | Oct 12, 1988 | SESE |
| K864962 | OBERTO MOUTH PROP | Medovations, Inc. | Feb 19, 1987 | SESE |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Somatics, Inc. | Nov 3, 1986 | SESE |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Hi Chem, Inc. | Jun 5, 1986 | SESE |
| K842788 | DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE | Brimms, Inc. | Sep 11, 1984 | SESE |
Top Applicants
- Scott All-Sports, Inc. — 2 clearances
- Somatics, Inc. — 2 clearances
- United States Endoscopy Group, Inc. — 2 clearances
- B&B Medical Technologies, Inc. — 1 clearance
- Brimms, Inc. — 1 clearance
