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Unit, X-Ray, Intraoral

FDA product code EAP · 42 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.1810
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-03 – 2012-02-07

EAP 2012-02-07

MEDICAL IMAGE PROCESSING UNIT

Applicant Humanray Co,Ltd

K number K113360

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EAP 2011-06-30

PROVU (TM) DENTAL X-RAY SYSTEM

Applicant Advanced Image Science, Inc.

K number K102573

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EAP 2009-11-30

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

Applicant Schick Technologies, Inc.

K number K093453

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EAP 2008-05-13

DENTRON SENSOR

Applicant Dentron Systems, LLC

K number K080738

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EAP 2005-09-27

THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)

Applicant Flow X-Ray Corp.

K number K052422

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EAP 2004-06-07

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

Applicant Schick Technologies, Inc.

K number K041385

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EAP 1996-03-29

HELIODENT DS

Applicant Pelton & Crane Co.

K number K960819

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EAP 1996-03-01

ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM

Applicant Dentsply Intl.

K number K960028

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EAP 1995-12-28

ATLANTIS

Applicant Trophy Radiologie

K number K953936

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EAP 1995-10-27

EXPLOR-X (AZTEH) HF

Applicant Chicago X-Ray Systems, Inc.

K number K954565

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EAP 1995-07-20

LUMIX 70B

Applicant Emix U.S.A., Inc.

K number K951734

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EAP 1995-06-30

TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY

Applicant Trophy Radiologie

K number K950533

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EAP 1995-04-19

TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY

Applicant Trophy Radiologie

K number K950532

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EAP 1995-04-06

AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER

Applicant Chicago X-Ray Systems, Inc.

K number K950667

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EAP 1995-02-03

HELIODENT MD

Applicant Pelton & Crane Co.

K number K950030

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EAP 1994-08-17

RADWORKS

Applicant Radworks Corp.

K number K934645

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EAP 1994-07-29

ORTHOPHOS 3/ ORTHOPHOS 3C

Applicant Pelton & Crane Co.

K number K936068

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EAP 1994-01-31

COMPUTED ORAL RADIOLOGY SYSTEM

Applicant Schick Technologies, Inc.

K number K933455

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EAP 1993-11-23

INTREX VSK INTERORAL DENTAL X-RAY UNIT

Applicant Keystone X-Ray, Inc.

K number K931486

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EAP 1993-09-20

YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY

Applicant Kaycor Intl., Ltd.

K number K931717

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EAP 1993-07-13

INTREX INTERORAL DENTAL X-RAY UNIT

Applicant Keystone X-Ray, Inc.

K number K930925

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EAP 1993-05-25

IMAGE-X 70 INTRAORAL X-RAY SYSTEM

Applicant Afp Imaging Corp.

K number K930761

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EAP 1993-01-21

HEALTHPAK X-RAY SOX BARRIERS

Applicant Healthpak, Inc.

K number K923307

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EAP 1990-05-23

PANORAMIC MODEL X-CALIBER X-RAY

Applicant Belmont Equipment Corp.

K number K900681

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EAP 1990-01-22

TRIMODE SP DENTAL INTRA ORAL X-RAY

Applicant Tempo Technology, Inc.

K number K896963

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EAP 1990-01-22

MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE

Applicant Mdt Diagnostic Co.

K number K896024

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EAP 1988-12-21

VARIABLE KV INTREX VSK 60 - 90 KVP

Applicant Keystone X-Ray, Inc.

K number K883354

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EAP 1988-09-09

MINIM-X 2001-CIAS & MINIM-X 2002-CIAS

Applicant Dentomar, Inc.

K number K882379

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EAP 1986-04-24

NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY

Applicant Belmont Equipment Corp.

K number K861328

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EAP 1985-06-05

BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD

Applicant Belmont Equipment Corp.

K number K852019

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EAP 1983-12-29

ACURAY 071A DENTAL INTRAORAL X-RAY

Applicant Belmont Equipment Corp.

K number K834279

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EAP 1983-10-28

INTREX

Applicant Pennwalt Corp.

K number K833241

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EAP 1983-09-12

ACURACY 071, DENTAL, INTRAORAL-X-RAY

Applicant Belmont Equipment Corp.

K number K832065

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EAP 1980-03-03

XR-710

Applicant Pennwalt Corp.

K number K800063

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EAP 1980-01-28

PORTARAY

Applicant Siemens Corp.

K number K792535

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EAP 1980-01-09

RAFLEX 70

Applicant Mdt Corp., Inc.

K number K792437

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EAP 1980-01-09

DENTIX DENTAL X-RAY UNIT

Applicant Precise Optics

K number K792307

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EAP 1979-09-04

DENTAL XERORADIOGRAPHY

Applicant Xerox Medical Systems

K number K791014

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EAP 1978-12-04

GE-700 INTRA ORAL X-RAY SYSTEM

Applicant General Electric Co.

K number K781630

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EAP 1977-12-22

X-RAY SYSTEM FOR DENTAL APPLICATION

Applicant General Electric Co.

K number K772184

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EAP 1977-03-08

X-RAY TUBE - PANOBEAM

Applicant Thoro-Ray, Inc.

K number K770345

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EAP 1976-08-03

X-RAY UNIT, DENTAL DIAGNOSTIC

Applicant The S. S. White Co.

K number K760323

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