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Block, Bite

FDA product code JXL · 27 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5070
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-26 – 2023-02-22

JXL 2023-02-22

PATI (Protector Against Tongue Injury)

Applicant Neurovice, LLC

K number K221469

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JXL 2021-06-04

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium

Applicant Mecta Corporation

K number K201309

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JXL 2017-12-22

SurgeoBite

Applicant Surgovations, LLC

K number K172978

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JXL 2005-04-27

EPIGUARD

Applicant Episafe Medical Devices, Ltd.

K number K050188

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JXL 1999-10-25

VENTIL-A ORAL PROTECTOR

Applicant Somatics, Inc.

K number K992269

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JXL 1996-05-17

UNIVERSAL BITE BLOCK

Applicant B&B Medical Technologies, Inc.

K number K960663

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JXL 1996-01-25

BITE BLOCK

Applicant United States Endoscopy Group, Inc.

K number K954352

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JXL 1995-04-05

PREMIER PROMAX BITE GUARD

Applicant Premier Dental Products Co.

K number K941856

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JXL 1993-04-23

THE DAVIS DISPOSABLE PROTECTIVE SPLINT

Applicant Ora-Gard, Inc.

K number K924333

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JXL 1993-04-06

BITE BLOCK

Applicant United States Endoscopy Group, Inc.

K number K924304

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JXL 1992-12-09

TUM-E-VAC BITE BLOCK

Applicant Ethox Corp.

K number K921946

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JXL 1990-06-28

MOUTHPIECE BREATHING

Applicant Scott All-Sports, Inc.

K number K901563

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JXL 1989-12-14

JAW BLOCKER

Applicant Plastic Engineered Products Co.

K number K896745

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JXL 1989-02-17

BITE BLOCK #59430

Applicant Medi-Source, Inc.

K number K890567

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JXL 1988-10-12

MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)

Applicant Scott All-Sports, Inc.

K number K883416

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JXL 1987-02-19

OBERTO MOUTH PROP

Applicant Medovations, Inc.

K number K864962

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JXL 1986-11-03

SOMATICS MOUTH GUARD (BITE BLOCK)

Applicant Somatics, Inc.

K number K864181

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JXL 1986-06-05

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

Applicant Hi Chem, Inc.

K number K861893

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JXL 1984-09-11

DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE

Applicant Brimms, Inc.

K number K842788

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JXL 1984-04-05

BITESTICK BLOCK

Applicant Cherry Plastics, Inc.

K number K840789

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JXL 1983-02-07

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

Applicant Hudson Oxygen Therapy Sales Co.

K number K830090

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JXL 1982-08-03

JACKSON BITE BLOCKS

Applicant Kelleher Corp.

K number K822018

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JXL 1980-11-12

DENTAL MOUTH PROP.

Applicant Trident Dental, Inc.

K number K802696

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JXL 1980-02-28

TRI PAC MOUTH PROP

Applicant Oxequip Health Ind.

K number K800369

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JXL 1979-11-13

DENTAL MOUTHPROP (BITE BLOCK)

Applicant Mission Dental, Inc.

K number K792157

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JXL 1977-01-31

BLACHLY BITE BLOK & CHEEK FILLER

Applicant P.H. Blachly, M.D.

K number K770090

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JXL 1976-07-26

BITE STICK, DYNA

Applicant Dyna-Med

K number K760258

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