Product code JXL
- Device name
- Block, Bite
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5070
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | 2023-02-22 |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | 2021-06-04 |
| K172978 | SurgeoBite | Surgovations, LLC | 2017-12-22 |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | Dupaco, Inc. | 2015-06-29 |
| K050188 | EPIGUARD | Episafe Medical Devices, Ltd. | 2005-04-27 |
| K992269 | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | 1999-10-25 |
| K960663 | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | 1996-05-17 |
| K954352 | BITE BLOCK | United States Endoscopy Group, Inc. | 1996-01-25 |
| K941856 | PREMIER PROMAX BITE GUARD | Premier Dental Products Co. | 1995-04-05 |
| K924333 | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | Ora-Gard, Inc. | 1993-04-23 |
| K924304 | BITE BLOCK | United States Endoscopy Group, Inc. | 1993-04-06 |
| K921946 | TUM-E-VAC BITE BLOCK | Ethox Corp. | 1992-12-09 |
| K901563 | MOUTHPIECE BREATHING | Scott All-Sports, Inc. | 1990-06-28 |
| K896745 | JAW BLOCKER | Plastic Engineered Products Co. | 1989-12-14 |
| K890567 | BITE BLOCK #59430 | Medi-Source, Inc. | 1989-02-17 |
| K883416 | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | Scott All-Sports, Inc. | 1988-10-12 |
| K864962 | OBERTO MOUTH PROP | Medovations, Inc. | 1987-02-19 |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Somatics, Inc. | 1986-11-03 |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Hi Chem, Inc. | 1986-06-05 |
| K842788 | DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE | Brimms, Inc. | 1984-09-11 |
| K840789 | BITESTICK BLOCK | Cherry Plastics, Inc. | 1984-04-05 |
| K830090 | DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR | Hudson Oxygen Therapy Sales Co. | 1983-02-07 |
| K822018 | JACKSON BITE BLOCKS | Kelleher Corp. | 1982-08-03 |
| K802696 | DENTAL MOUTH PROP. | Trident Dental, Inc. | 1980-11-12 |
| K800369 | TRI PAC MOUTH PROP | Oxequip Health Ind. | 1980-02-28 |
| K792157 | DENTAL MOUTHPROP (BITE BLOCK) | Mission Dental, Inc. | 1979-11-13 |
| K770090 | BLACHLY BITE BLOK & CHEEK FILLER | P.H. Blachly, M.D. | 1977-01-31 |
| K760258 | BITE STICK, DYNA | Dyna-Med | 1976-07-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850298007058 | MouthGuard | SOMATICS, LLC | 2026-05-28 |
| 00850298007034 | VENTIL-A Oral Protector | SOMATICS, LLC | 2026-05-27 |
| 00850298007041 | MouthGuard | SOMATICS, LLC | 2026-05-27 |
| 00860015137906 | PATI | NEUROVICE, L.L.C. | 2025-12-19 |
| 10850045508071 | Cotton Bite Block | SIGMASTIM DOMESTIC, LLC | 2025-01-27 |
| 10850045508088 | Cotton Bite Block | SIGMASTIM DOMESTIC, LLC | 2025-01-27 |
| 14026704646545 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-04-24 |
| 24026704646542 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-04-24 |
| 14026704580221 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704580224 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 34026704580225 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 10889483150030 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-27 |
| 20889483150037 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-27 |
| M36837891 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |