JXL · Class II · 21 CFR 882.5070

FDA Product Code JXL: Block, Bite

Leading manufacturers include United States Endoscopy Group, Inc., Hi Chem, Inc. and Medovations, Inc..

28
Total
28
Cleared
100d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Block, Bite Devices (Product Code JXL)

28 devices
1–24 of 28
Cleared Feb 22, 2023
PATI (Protector Against Tongue Injury)
K221469
Neurovice, LLC
Neurology · 278d
Cleared Jun 04, 2021
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309
Mecta Corporation
Neurology · 385d
Cleared May 17, 1996
UNIVERSAL BITE BLOCK
K960663
B&B Medical Technologies, Inc.
Neurology · 91d
Cleared Jan 25, 1996
BITE BLOCK
K954352
United States Endoscopy Group, Inc.
Neurology · 129d
Cleared Apr 05, 1995
PREMIER PROMAX BITE GUARD
K941856
Premier Dental Products Co.
Neurology · 355d
Cleared Apr 06, 1993
BITE BLOCK
K924304
United States Endoscopy Group, Inc.
Neurology · 223d
Cleared Feb 19, 1987
OBERTO MOUTH PROP
K864962
Medovations, Inc.
Neurology · 59d
Cleared Jun 05, 1986
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893
Hi Chem, Inc.
Chemistry · 20d
Cleared Feb 07, 1983
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
K830090
Hudson Oxygen Therapy Sales Co.
Neurology · 27d
Cleared Aug 03, 1982
JACKSON BITE BLOCKS
K822018
Kelleher Corp.
Neurology · 26d

About Product Code JXL - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code JXL since 1976, with 28 receiving FDA clearance (average review time: 100 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.