FDA Product Code
FDA Product Code JXL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5070
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | 2023-02-22 | Traditional | PDF ↗ |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | 2021-06-04 | Traditional | PDF ↗ |
| K172978 | SurgeoBite | Surgovations, LLC | 2017-12-22 | Traditional | PDF ↗ |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | Dupaco, Inc. | 2015-06-29 | Traditional | PDF ↗ |
| K050188 | EPIGUARD | Episafe Medical Devices, Ltd. | 2005-04-27 | Traditional | PDF ↗ |
| K992269 | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K960663 | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K954352 | BITE BLOCK | United States Endoscopy Group, Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K941856 | PREMIER PROMAX BITE GUARD | Premier Dental Products Co. | 1995-04-05 | Traditional | PDF ↗ |
| K924333 | THE DAVIS DISPOSABLE PROTECTIVE SPLINT | Ora-Gard, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K924304 | BITE BLOCK | United States Endoscopy Group, Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K921946 | TUM-E-VAC BITE BLOCK | Ethox Corp. | 1992-12-09 | Traditional | PDF ↗ |
| K901563 | MOUTHPIECE BREATHING | Scott All-Sports, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K896745 | JAW BLOCKER | Plastic Engineered Products Co. | 1989-12-14 | Traditional | PDF ↗ |
| K890567 | BITE BLOCK #59430 | Medi-Source, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K883416 | MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) | Scott All-Sports, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K864962 | OBERTO MOUTH PROP | Medovations, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Somatics, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Hi Chem, Inc. | 1986-06-05 | Traditional | PDF ↗ |
| K842788 | DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE | Brimms, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K840789 | BITESTICK BLOCK | Cherry Plastics, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K830090 | DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR | Hudson Oxygen Therapy Sales Co. | 1983-02-07 | Traditional | PDF ↗ |
| K822018 | JACKSON BITE BLOCKS | Kelleher Corp. | 1982-08-03 | Traditional | PDF ↗ |
| K802696 | DENTAL MOUTH PROP. | Trident Dental, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K800369 | TRI PAC MOUTH PROP | Oxequip Health Ind. | 1980-02-28 | Traditional | PDF ↗ |
| K792157 | DENTAL MOUTHPROP (BITE BLOCK) | Mission Dental, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K770090 | BLACHLY BITE BLOK & CHEEK FILLER | P.H. Blachly, M.D. | 1977-01-31 | Traditional | PDF ↗ |
| K760258 | BITE STICK, DYNA | Dyna-Med | 1976-07-26 | Traditional | PDF ↗ |
Product code JXL · Class II · Neurology. Data: openFDA.