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Unit, X-Ray, Extraoral With Timer

FDA product code EHD · 187 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.1800
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-12-02 – 2026-09-14

EHD 2002-05-03

DEGOTZEN SYNCHRO

Applicant The Gotzen Group, Inc.

K number K021245

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EHD 2002-02-15

CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)

Applicant Cavitat Medical Technologies, Inc.

K number K011147

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EHD 2002-02-04

VERAVIEWEPOCS, MODEL VE

Applicant J. Morita USA, Inc.

K number K013955

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EHD 2002-02-01

JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002

Applicant Progeny, Inc.

K number K020070

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EHD 2001-10-16

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE

Applicant Afp Imaging Corp.

K number K013176

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EHD 2001-08-09

IMAGE-X SYSTEM

Applicant Tg Group, Inc.

K number K012355

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EHD 2001-06-29

PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT

Applicant Planmeca Oy

K number K011619

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EHD 2000-11-09

SAMSUNG 10DR IMPLANT SYSTEM

Applicant Samsung Sds Co., Ltd.

K number K002062

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EHD 2000-09-01

STRATO X

Applicant Villa Sistemi Medicali S.P.A.

K number K002432

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EHD 2000-07-13

FOCUS

Applicant Instrumentarium Corp.

K number K001729

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EHD 2000-05-04

MULTI-PULSE 2000

Applicant Imaging Sciences Intl., Inc.

K number K001248

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EHD 2000-05-03

DIMAX 2

Applicant Planmeca Oy

K number K000771

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EHD 2000-05-02

HELIODENT VARIO

Applicant Sirona Dental Systems GmbH

K number K000672

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EHD 2000-04-28

DIXI 2

Applicant Planmeca Oy

K number K000428

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EHD 2000-04-18

PM 2002 PROLINE/AEC

Applicant Planmeca Oy

K number K000163

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EHD 2000-04-07

MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT

Applicant Minxray, Inc.

K number K000061

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EHD 2000-03-16

IMAGE X-70 PLUS DENTAL X-RAY UNIT

Applicant Medical Device Consultants, Inc.

K number K000551

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EHD 2000-03-14

ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH

Applicant Dentsply Intl.

K number K994285

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EHD 1999-09-07

GENDEX 765DC, MODEL 110-0154

Applicant Dentsply Intl.

K number K992610

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EHD 1999-06-25

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,

Applicant Trophy Radiologie

K number K991455

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EHD 1999-06-22

MODIFICATION TO DIGIPAN

Applicant Trophy Radiologie

K number K991912

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EHD 1999-06-18

PANATOME

Applicant Imaging Sciences Intl., Inc.

K number K991518

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EHD 1999-06-18

EXPLOR-X 70

Applicant Villa Sistemi Medicali S.P.A.

K number K991310

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EHD 1999-02-10

VIPERSOFT

Applicant Integra Medical

K number K984030

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EHD 1999-01-14

AZTECH 70

Applicant Villa Sistemi Medicali S.P.A.

K number K984524

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EHD 1998-04-17

PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM

Applicant Planmeca Oy

K number K980581

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EHD 1998-04-14

DENOPTIX BARRIER ENVELOPE (SIZE 0-4)

Applicant Dentsply Intl.

K number K980543

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EHD 1998-03-27

CRANEX TOME CEPH, OR CRANEX TOME

Applicant Orion Corporation Soredex

K number K974877

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EHD 1998-01-20

VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.

Applicant J. Morita USA, Inc.

K number K974077

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EHD 1998-01-06

SANKO INTRAORAL DENTAL X-RAY

Applicant Sanko X-Ray Manufacturing Co., Ltd.

K number K972921

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EHD 1997-11-21

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100

Applicant Instrumentarium Imaging, Inc.

K number K973642

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EHD 1997-11-10

KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER

Applicant Eastman Kodak Company

K number K973476

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EHD 1997-10-08

ROTOGRAPH PLUS

Applicant Chicago X-Ray Systems, Inc.

K number K972968

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EHD 1997-09-15

SIEMENS ORTHOPHOS DS/DS CEPH

Applicant Siemens AG

K number K972312

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EHD 1997-09-12

ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD

Applicant Pelton & Crane Co.

K number K972249

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EHD 1997-09-11

INFIMED DENTAL SYSTEM

Applicant Infimed, Inc.

K number K962422

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EHD 1997-09-05

SIDEXIS DIGITAL RADIOGRAPHY SYSTEM

Applicant Pelton & Crane Co.

K number K972168

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EHD 1997-08-05

PM 2002 CC PROLINE

Applicant Planmeca Oy

K number K970812

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EHD 1997-05-14

SCANRITE DFS

Applicant Scanrite Systems

K number K970850

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EHD 1997-04-01

PROSTYLE INTRA

Applicant Planmeca Oy

K number K970975

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EHD 1997-03-17

RADX SYSTEM

Applicant Electro Medical Systems, Inc.

K number K965203

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EHD 1997-02-26

PM 2002 CC PROLINE

Applicant Planmeca Oy

K number K970263

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EHD 1997-01-27

PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT

Applicant Kaycor Intl., Ltd.

K number K965072

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EHD 1997-01-02

ACURAY DIGITAL X-RAY

Applicant New Image Industries, Inc.

K number K963403

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EHD 1996-12-23

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

Applicant Dentsply Intl.

K number K964659

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EHD 1996-12-23

BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY

Applicant Belmont Equipment Corp.

K number K963699

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EHD 1996-11-26

DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM

Applicant Fair Image, Inc.

K number K962631

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EHD 1996-10-02

ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER

Applicant Electronic Control Concepts

K number K963185

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EHD 1996-09-23

DIGIPAN

Applicant Trophy Radiologie

K number K961826

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EHD 1996-07-25

ELITYS OR ELITYS-E

Applicant Trophy Radiologie

K number K962337

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EHD 1996-07-25

TOMOGRAPH ACCESSORIES

Applicant Steri-Oss, Inc.

K number K962120

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EHD 1995-12-11

PROSTYLE INTRA

Applicant Planmeca Oy

K number K955429

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EHD 1995-10-07

PANORAMIC X-RAY UNIT (MODIFICATION)

Applicant Planmeca Oy

K number K952763

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EHD 1994-03-21

FLASH DENT

Applicant Chicago X-Ray Systems, Inc.

K number K931300

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EHD 1994-02-18

GX-770 X-RAY CONTROL, MODEL 46-404600G4

Applicant Gendex Corp.

K number K935046

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EHD 1994-01-25

DENTAL X-RAY UNIT

Applicant Castellini S.P.A.

K number K932111

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EHD 1993-12-15

PANORAMIC X-RAY UNITS, MODIFICATION

Applicant Planmeca Oy

K number K934063

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EHD 1993-09-29

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS

Applicant Gendex Corp.

K number K925094

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EHD 1993-09-14

ORALIX DC

Applicant Gendex Corp.

K number K931001

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EHD 1993-07-14

ALPHA II

Applicant Dynarad Corp.

K number K931725

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EHD 1993-04-27

ORTHOCEPH OC100

Applicant Instrumentarium Corp.

K number K930338

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EHD 1993-03-30

MAMMOTEST PRODUCT, MODIFICATION

Applicant Fischer Imaging Corp.

K number K926575

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EHD 1993-03-30

PORT-XD

Applicant Mobile Dental Equipment Corp.

K number K923360

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EHD 1992-11-27

COFFMAN IMPLANT TOMOGRAPH

Applicant Coffman Dental

K number K924130

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EHD 1992-11-27

SENS-A-RAY

Applicant Regam Medical Systems

K number K923067

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EHD 1991-11-05

ORTHOPANTOMOGRAPH 100

Applicant Instrumentarium Corp.

K number K912893

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EHD 1991-10-30

COFFMAN TOMOGRAPH

Applicant Coffman Dental

K number K913652

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EHD 1990-04-25

S-70 PORTABLE DENTAL X-RAY SYSTEM

Applicant Lorad Medical Systems, Inc.

K number K894935

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EHD 1989-11-17

ORTHOPHOS AND ORTHOPHOS C

Applicant Siemens Medical Solutions USA, Inc.

K number K895467

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EHD 1988-08-04

LASER - 1000

Applicant Panoramic Corp.

K number K882436

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EHD 1988-06-17

PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE

Applicant Kevex Corp.

K number K875212

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EHD 1988-03-31

AXIAL TOME, 60, FLUORO AND TOMAX

Applicant Axialtome Corp.

K number K872825

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EHD 1987-12-07

MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY

Applicant Belmont Equipment Corp.

K number K874238

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EHD 1987-07-16

PORTABLE DENTAL X-RAY UNIT MODEL 4000

Applicant Home/Office Dental, Inc.

K number K872240

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EHD 1987-05-04

FIAD EXPLOR-X; MODEL 70 KVP

Applicant United States Dental

K number K871051

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EHD 1987-02-13

PANORAMIC X-RAY MODEL PC-1000

Applicant Panoramic Corp.

K number K870236

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EHD 1986-11-26

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC

Applicant Planmeca USA, Inc.

K number K864474

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EHD 1986-07-01

CEPHALOSTAT

Applicant Dallas Dental Co.

K number K860835

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EHD 1986-03-06

X-RANGE 65

Applicant Alpine Dental Equipment Co.

K number K854741

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EHD 1985-09-03

INTRAORAL DENTAL X-RAY SYSTEM 70-X

Applicant Trophy Radiologie

K number K851095

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EHD 1981-06-09

GE 900

Applicant General Electric Co.

K number K811103

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EHD 1980-03-03

PANOREX II DENTAL X-RAY UNIT

Applicant Pennwalt Corp.

K number K800133

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EHD 1980-01-16

GENERAL ELECTRIC PANELIPSE LD

Applicant General Electric Co.

K number K792581

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EHD 1978-09-11

DENTAL X-RAY UNIT HELIODENT 70

Applicant Siemens Corp.

K number K781288

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EHD 1978-09-11

DENTAL X-RAY UNIT

Applicant Siemens Corp.

K number K781286

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EHD 1978-04-10

PANORAMIC X-RAY, DENTAL

Applicant Den-Tal-Ez Mfg Co., Inc.

K number K780469

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EHD 1977-12-02

PANORAMIC X-RAY SYSTEM MODEL A

Applicant Sybron Corp.

K number K772164

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