Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5070](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5070) → JXL — Block, Bite # JXL · Block, Bite _Neurology · 21 CFR 882.5070 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL ## Overview - **Product Code:** JXL - **Device Name:** Block, Bite - **Regulation:** [21 CFR 882.5070](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5070) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K221469.md) | PATI (Protector Against Tongue Injury) | Neurovice, LLC | Feb 22, 2023 | SESE | | [K201309](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K201309.md) | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | Jun 4, 2021 | SESE | | [K172978](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K172978.md) | SurgeoBite | Surgovations, LLC | Dec 22, 2017 | SESE | | [K150518](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K150518.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K050188.md) | EPIGUARD | Episafe Medical Devices, Ltd. | Apr 27, 2005 | SESE | | [K992269](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K992269.md) | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | Oct 25, 1999 | SESE | | [K960663](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K960663.md) | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | May 17, 1996 | SESE | | [K954352](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K954352.md) | BITE BLOCK | United States Endoscopy Group, Inc. | Jan 25, 1996 | SESE | | [K941856](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K941856.md) | PREMIER PROMAX BITE GUARD | Premier Dental Products Co. | Apr 5, 1995 | SESE | | [K924333](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K924333.md) | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | Ora-Gard, Inc. | Apr 23, 1993 | SESE | | [K924304](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K924304.md) | BITE BLOCK | United States Endoscopy Group, Inc. | Apr 6, 1993 | SESE | | [K921946](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K921946.md) | TUM-E-VAC BITE BLOCK | Ethox Corp. | Dec 9, 1992 | SESE | | [K901563](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K901563.md) | MOUTHPIECE BREATHING | Scott All-Sports, Inc. | Jun 28, 1990 | SESE | | [K896745](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K896745.md) | JAW BLOCKER | Plastic Engineered Products Co. | Dec 14, 1989 | SESE | | [K890567](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K890567.md) | BITE BLOCK #59430 | Medi-Source, Inc. | Feb 17, 1989 | SESE | | [K883416](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K883416.md) | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | Scott All-Sports, Inc. | Oct 12, 1988 | SESE | | [K864962](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K864962.md) | OBERTO MOUTH PROP | Medovations, Inc. | Feb 19, 1987 | SESE | | [K864181](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K864181.md) | SOMATICS MOUTH GUARD (BITE BLOCK) | Somatics, Inc. | Nov 3, 1986 | SESE | | [K861893](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K861893.md) | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Hi Chem, Inc. | Jun 5, 1986 | SESE | | [K842788](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL/K842788.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com