JXL — Block, Bite Class II
FDA product code JXL covers "Block, Bite", a Class II medical device regulated under 21 CFR 882.5070. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JXL
- Device Class
- Class II
- Regulation Number
- 882.5070
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221469 | neurovice | PATI (Protector Against Tongue Injury) | February 22, 2023 |
| K201309 | mecta corporation | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | June 4, 2021 |
| K172978 | surgovations | SurgeoBite | December 22, 2017 |
| K150518 | dupaco | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and To | June 29, 2015 |
| K050188 | episafe medical devices | EPIGUARD | April 27, 2005 |
| K992269 | somatics | VENTIL-A ORAL PROTECTOR | October 25, 1999 |
| K960663 | b and b medical technologies | UNIVERSAL BITE BLOCK | May 17, 1996 |
| K954352 | united states endoscopy group | BITE BLOCK | January 25, 1996 |
| K941856 | premier dental products | PREMIER PROMAX BITE GUARD | April 5, 1995 |
| K924333 | ora-gard | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | April 23, 1993 |
| K924304 | united states endoscopy group | BITE BLOCK | April 6, 1993 |
| K921946 | ethox | TUM-E-VAC BITE BLOCK | December 9, 1992 |
| K901563 | scott all-sports | MOUTHPIECE BREATHING | June 28, 1990 |
| K896745 | plastic engineered products | JAW BLOCKER | December 14, 1989 |
| K890567 | medi-source | BITE BLOCK #59430 | February 17, 1989 |
| K883416 | scott all-sports | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | October 12, 1988 |
| K864962 | medovations | OBERTO MOUTH PROP | February 19, 1987 |
| K864181 | somatics | SOMATICS MOUTH GUARD (BITE BLOCK) | November 3, 1986 |
| K861893 | hi chem | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | June 5, 1986 |
| K842788 | brimms | DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE | September 11, 1984 |