Atlas FDA

JXL

28 FDA 510(k) clearances · Product code

62 daysmedian time to decision
278 days90th percentile
28clearances measured

FDA profile

Official device name
Block, Bite
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5070
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 2 · 2006: 2 · 2008: 12 · 2009: 3 · 2010: 14 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PATI (Protector Against Tongue Injury) (K221469)Neurovice, LLC2023-02-22
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (K201309)Mecta Corporation2021-06-04
SurgeoBite (K172978)Surgovations, LLC2017-12-22
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm (K150518)Dupaco, Inc.2015-06-29
EPIGUARD (K050188)Episafe Medical Devices, Ltd.2005-04-27
VENTIL-A ORAL PROTECTOR (K992269)Somatics, Inc.1999-10-25
UNIVERSAL BITE BLOCK (K960663)B&B Medical Technologies, Inc.1996-05-17
BITE BLOCK (K954352)United States Endoscopy Group, Inc.1996-01-25
PREMIER PROMAX BITE GUARD (K941856)Premier Dental Products Co.1995-04-05
THE DAVIS DISPOSABLE PROTECTIVE SPLINT (K924333)Ora-Gard, Inc.1993-04-23
BITE BLOCK (K924304)United States Endoscopy Group, Inc.1993-04-06
TUM-E-VAC BITE BLOCK (K921946)Ethox Corp.1992-12-09
MOUTHPIECE BREATHING (K901563)Scott All-Sports, Inc.1990-06-28
JAW BLOCKER (K896745)Plastic Engineered Products Co.1989-12-14
BITE BLOCK #59430 (K890567)Medi-Source, Inc.1989-02-17
MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) (K883416)Scott All-Sports, Inc.1988-10-12
OBERTO MOUTH PROP (K864962)Medovations, Inc.1987-02-19
SOMATICS MOUTH GUARD (BITE BLOCK) (K864181)Somatics, Inc.1986-11-03
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) (K861893)Hi Chem, Inc.1986-06-05
DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE (K842788)Brimms, Inc.1984-09-11
BITESTICK BLOCK (K840789)Cherry Plastics, Inc.1984-04-05
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR (K830090)Hudson Oxygen Therapy Sales Co.1983-02-07
JACKSON BITE BLOCKS (K822018)Kelleher Corp.1982-08-03
DENTAL MOUTH PROP. (K802696)Trident Dental, Inc.1980-11-12
TRI PAC MOUTH PROP (K800369)Oxequip Health Ind.1980-02-28
DENTAL MOUTHPROP (BITE BLOCK) (K792157)Mission Dental, Inc.1979-11-13
BLACHLY BITE BLOK & CHEEK FILLER (K770090)P.H. Blachly, M.D.1977-01-31
BITE STICK, DYNA (K760258)Dyna-Med1976-07-26

Track JXL automatically

Every clearance here is in the API, with alerts when new ones post.