Home / Device Classification / JXL

JXL — Block, Bite Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K221469neurovicePATI (Protector Against Tongue Injury)February 22, 2023
K201309mecta corporationECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumJune 4, 2021
K172978surgovationsSurgeoBiteDecember 22, 2017
K150518dupacoAirway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and ToJune 29, 2015
K050188episafe medical devicesEPIGUARDApril 27, 2005
K992269somaticsVENTIL-A ORAL PROTECTOROctober 25, 1999
K960663b and b medical technologiesUNIVERSAL BITE BLOCKMay 17, 1996
K954352united states endoscopy groupBITE BLOCKJanuary 25, 1996
K941856premier dental productsPREMIER PROMAX BITE GUARDApril 5, 1995
K924333ora-gardTHE DAVIS DISPOSABLE PROTECTIVE SPLINTApril 23, 1993
K924304united states endoscopy groupBITE BLOCKApril 6, 1993
K921946ethoxTUM-E-VAC BITE BLOCKDecember 9, 1992
K901563scott all-sportsMOUTHPIECE BREATHINGJune 28, 1990
K896745plastic engineered productsJAW BLOCKERDecember 14, 1989
K890567medi-sourceBITE BLOCK #59430February 17, 1989
K883416scott all-sportsMOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)October 12, 1988
K864962medovationsOBERTO MOUTH PROPFebruary 19, 1987
K864181somaticsSOMATICS MOUTH GUARD (BITE BLOCK)November 3, 1986
K861893hi chemGGT REAGENT CARTRIDGE (PRODUCT NO. 88204)June 5, 1986
K842788brimmsDIFFERENTIAL DIAG. OCCLUSAL APPLIANCESeptember 11, 1984