FDA Product Code
FDA Product Code MUH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.1800
510(k) Clearances — 207 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K120318 | VIVI ERGON-X HF | Vivi S.R.L. | 2012-03-06 | Traditional | PDF ↗ |
| K113497 | HYPERION | Cefla S.C. Cefla Dental Group | 2012-01-17 | Traditional | PDF ↗ |
| K111103 | DIGITAL X-RAY IMAGING SYSTEM | Rf Co., Ltd. | 2012-01-05 | Traditional | PDF ↗ |
| K102456 | INTRAORAL BELSENSOR GOLD | Takara Belmont USA, Inc. | 2011-12-15 | Traditional | PDF ↗ |
| K112380 | CLEARVISION | Midmark Corp. | 2011-11-22 | Traditional | PDF ↗ |
| K111649 | CS 7600 | Carestream Health, Inc. | 2011-09-23 | Traditional | PDF ↗ |
| K103290 | EDLEN IMAGING - GEMINI DUSB | Edlen Imaging, LLC | 2011-09-19 | Abbreviated | PDF ↗ |
| K111152 | ROTOGRAPH EVO 3D | Villa Sistemi Medicali S.P.A. | 2011-07-22 | Abbreviated | PDF ↗ |
| K111231 | PANOURA 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011-07-13 | Traditional | PDF ↗ |
| K110768 | COMPUTED DENTAL RADIOGRAPHY | Schick Technologies, Inc. | 2011-04-20 | Special | PDF ↗ |
| K103689 | PLANMECA PROMAX 3D MID | Planmeca Oy | 2011-03-17 | Traditional | PDF ↗ |
| K110371 | ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY | Panoramic Corp. | 2011-03-17 | Traditional | PDF ↗ |
| K110160 | BEL-CYPHER N | Takara Belmont Corporation | 2011-02-17 | Special | PDF ↗ |
| K102124 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM | VATECH Co., Ltd. | 2010-10-22 | Traditional | PDF ↗ |
| K100960 | WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS | Cefla Dental Group | 2010-10-21 | Traditional | PDF ↗ |
| K093683 | ORTHOPANTOMOGRAPH OP300 | Instrumentarium Dental, Palodex Group OY | 2010-10-06 | Traditional | PDF ↗ |
| K101661 | MYRAY HYPERION | Cefla Dental Group | 2010-09-16 | Traditional | PDF ↗ |
| K092329 | SOPIX 2 | Sopro | 2010-07-20 | Traditional | PDF ↗ |
| K093590 | PLANMECA PROMAX 3D MAX | Planmeca Oy | 2010-05-12 | Traditional | PDF ↗ |
| K092171 | VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2010-04-26 | Traditional | PDF ↗ |
| K093478 | KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM | Trophy | 2010-04-26 | Traditional | PDF ↗ |
| K100317 | DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO | VATECH Co., Ltd. | 2010-03-24 | Traditional | PDF ↗ |
| K090526 | MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR | E-Woo Technology | 2009-12-02 | Traditional | PDF ↗ |
| K092591 | ORTHOPANTOMOGRAPH OP30 | Instrumentarium Dental, Palodex Group OY | 2009-11-20 | Traditional | PDF ↗ |
| K092547 | DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX | Dentimax | 2009-10-30 | Traditional | PDF ↗ |
| K092537 | DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 | Toshiba America Electronic Components, Inc. | 2009-08-27 | Traditional | PDF ↗ |
| K091866 | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM | Midmark | 2009-07-20 | Traditional | PDF ↗ |
| K083057 | I-MAX TOUCH | Owandy | 2009-06-02 | Traditional | PDF ↗ |
| K090458 | DEXIS SENSOR | Dexis, LLC | 2009-05-28 | Traditional | PDF ↗ |
| K090020 | BEL-CYPHER, MODEL Y977 | Takara-Belmont Co., Ltd. | 2009-03-13 | Traditional | PDF ↗ |
| K083532 | ADX4000-L, DX3000-L | Dexcowin Co., Ltd. | 2009-03-10 | Traditional | PDF ↗ |
| K082972 | KODAK 9500 | Trophy | 2008-12-05 | Traditional | PDF ↗ |
| K081088 | MYRAY SKYVIEW | Cefla S.C. | 2008-11-06 | Abbreviated | PDF ↗ |
| K081925 | SNAPSHOT | Instrumentarium Dental, Palodex Group OY | 2008-09-02 | Traditional | PDF ↗ |
| K081903 | XIOS PLUS WALL-MODULE | Sirona Dental Systems GmbH | 2008-08-26 | Traditional | PDF ↗ |
| K080889 | KODAK 9000C EXTRAORAL IMAGING SYSTEM | Trophy | 2008-04-29 | Special | PDF ↗ |
| K073365 | DENTAL DIGITAL X-RAY IMAGING SYSTEM | VATECH Co., Ltd. | 2008-04-08 | Traditional | PDF ↗ |
| K073696 | VERAVIEWEPOCS | J. Morita USA, Inc. | 2008-04-08 | Traditional | PDF ↗ |
| K073435 | KODAK 9000, KODAK 9000 3D | Trophy | 2008-02-11 | Traditional | PDF ↗ |
| K073350 | SCANORA 3D | Soredex Palodex Group OY | 2007-12-19 | Traditional | PDF ↗ |
| K072134 | SCHICK COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2007-11-02 | Special | PDF ↗ |
| K072244 | PLANMECA PROONE | Planmeca Oy | 2007-09-21 | Traditional | PDF ↗ |
| K072357 | NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM | Afp Imaging Corp. | 2007-09-18 | Special | PDF ↗ |
| K070811 | CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 | Dexco | 2007-07-05 | Traditional | PDF ↗ |
| K063837 | SIGMA M | Instrumentarium Dental, Palodex Group OY | 2007-07-02 | Traditional | PDF ↗ |
| K070664 | PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). | Progeny, Inc. | 2007-04-26 | Traditional | PDF ↗ |
| K070535 | RETROPAN CCD-TWAIN-USB | Video Dental Concepts, Inc. | 2007-04-24 | Traditional | PDF ↗ |
| K070505 | KRYSTAL-X WIFI | Owandy | 2007-04-05 | Traditional | PDF ↗ |
| K070304 | DIGORA PCT/DIGIPOD | Soredex Palodex Group OY | 2007-03-27 | Traditional | PDF ↗ |
| K070219 | SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM | Suni Medical Imaging, Inc. | 2007-02-07 | Traditional | PDF ↗ |
| K063459 | CRANEX NOVUS | Soredex Palodex Group OY | 2006-12-26 | Traditional | PDF ↗ |
| K062403 | IMAX CEPH DIGITAL X-RAY SENSOR | Owandy | 2006-11-14 | Traditional | PDF ↗ |
| K062529 | BELMAX CM MODEL X168 | Takara Belmont USA, Inc. | 2006-10-05 | Traditional | PDF ↗ |
| K061284 | I-CAT SCANNER | Imaging Sciences Intl., Inc. | 2006-07-03 | Traditional | PDF ↗ |
| K053172 | UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) | Owandy Sas | 2006-06-09 | Traditional | PDF ↗ |
| K061114 | WDS, SIZE 2 AND SIZE 2 | Cefla S.C.R.L. | 2006-06-06 | Abbreviated | PDF ↗ |
| K060892 | GALILEOS | Sirona Dental Systems GmbH | 2006-04-14 | Traditional | PDF ↗ |
| K060328 | PLANMECA PROMAX 3D | Planmeca Oy | 2006-03-15 | Traditional | PDF ↗ |
| K060178 | VIX WIN PRO | Gendex Dental Systems | 2006-03-10 | Traditional | PDF ↗ |
| K053558 | CEPH, MODEL 4900 | Schick Technologies, Inc. | 2006-02-17 | Traditional | PDF ↗ |
| K060179 | BIO-RAY SDX DIGITAL X-RAY SYSTEM | Sigma Biomedics, Inc. | 2006-02-08 | Traditional | PDF ↗ |
| K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM | Eastman Kodak Company | 2006-02-08 | Special | PDF ↗ |
| K060149 | SUNIPAN IMAGING SYSTEM & ACCESSORIES | Suni Medical Imaging, Inc. | 2006-02-03 | Traditional | PDF ↗ |
| K053221 | CDMX-H | Camsight Co., Inc. | 2006-01-12 | Traditional | PDF ↗ |
| K053220 | VERAVIEW IC 5, MODEL XDP1 | J. Morita USA, Inc. | 2006-01-06 | Traditional | PDF ↗ |
| K051664 | SCAN300FP / RETROPAN (VDC) | Oy Ajat, Ltd. | 2005-07-20 | Traditional | PDF ↗ |
| K050693 | ACCENT | Air Techniques, Inc. | 2005-05-26 | Traditional | PDF ↗ |
| K041834 | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM | Takara Belmont USA, Inc. | 2004-12-03 | Traditional | PDF ↗ |
| K042736 | CDX DIGITAL X-RAY IMAGING SYSTEM | Cnc Imaging, Inc. | 2004-10-13 | Traditional | PDF ↗ |
| K042372 | HDS INTRA-ORAL IMAGING SYSTEM | Vatech Value Added Technology Co., Ltd. | 2004-10-04 | Traditional | PDF ↗ |
| K041120 | EV APAN DIGITAL, MODEL K1VSM2000 | Afp Imaging Corp. | 2004-08-30 | Traditional | PDF ↗ |
| K041831 | PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR | Progeny, Inc. | 2004-08-09 | Traditional | PDF ↗ |
| K041580 | IMAGERAYI | Henry Schein, Inc. | 2004-06-29 | Traditional | PDF ↗ |
| K041050 | DIGORA OPTIME (OR DIGORA ONTIME) | Soredex Palodex Group OY | 2004-06-15 | Traditional | PDF ↗ |
| K024186 | X-VIEW | Sometech Corporation | 2004-04-01 | Traditional | PDF ↗ |
| K033147 | CLEARTOOTH DIGITAL X-RAY SYSTEM | Cleartooth Electronics, Inc. | 2003-12-30 | Traditional | PDF ↗ |
| K033248 | HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM | Hitachi Medical Systems America, Inc. | 2003-10-20 | Traditional | PDF ↗ |
| K031801 | PANTOS, MODELS: PANTOS 16, AND PANTOS DG | Blue X Imaging Srl | 2003-09-11 | Traditional | PDF ↗ |
| K031291 | CDR PANX, MODEL 4792 | Schick Technologies, Inc. | 2003-05-05 | Traditional | PDF ↗ |
| K023346 | TROPHYPAN | Trophy Radiologie | 2003-01-03 | Traditional | PDF ↗ |
| K023292 | APEX HRI DIGITAL RADIOGRAPHY SYSTEM | Krugman Technologies, Inc. | 2002-12-13 | Traditional | PDF ↗ |
| K022953 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2002-10-02 | Special | PDF ↗ |
| K021718 | INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY | Suni Imaging Microsystems, Inc. | 2002-08-15 | Traditional | PDF ↗ |
| K021542 | ADC DENTAL | Agfa Corp. | 2002-08-06 | Traditional | PDF ↗ |
| K020588 | X-IMAGE DIGITAL X-RAY SYSTEM | Escape Technology, Inc. | 2002-06-13 | Traditional | PDF ↗ |
| K013893 | SCANX | Air Techniques, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K012514 | DIGIPAN / DPI | Trophy Radiologie | 2001-12-21 | Traditional | PDF ↗ |
| K013271 | DXS DIGITAL X-RAY SYSTEM | Douglas C. Yoon, Dds | 2001-12-13 | Traditional | PDF ↗ |
| K013650 | ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD | Sirona Dental Systems GmbH | 2001-12-06 | Special | PDF ↗ |
| K013659 | MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM | Sirona Dental Systems GmbH | 2001-12-06 | Special | PDF ↗ |
| K012170 | DIGORA PCT | Soredex Palodex Group OY | 2001-08-10 | Traditional | PDF ↗ |
| K010915 | CDMX | Camsight Co., Inc. | 2001-05-21 | Traditional | PDF ↗ |
| K002425 | MEDIADENT HDX/MMD HDX SP XRAY SENSOR | Multi Media Dental Systems, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K001928 | SIGMA | Instrumentarium Imaging, Inc. | 2000-08-02 | Traditional | PDF ↗ |
| K001439 | ORTHOCEPH OC100 D | Instrumentarium Corp. | 2000-06-22 | Traditional | PDF ↗ |
| K992392 | RTLX | Infimed, Inc. | 2000-03-31 | Traditional | PDF ↗ |
| K000454 | DIMEX 2 | Planmeca Oy | 2000-03-31 | Traditional | PDF ↗ |
| K993958 | IDX-60 INTRAORAL X-RAY | X-Cel X-Ray Corp. | 2000-02-14 | Traditional | PDF ↗ |
| K992385 | ORTHOPANTOMOGRAPH OP100D | Instrumentarium Corp. | 1999-09-28 | Traditional | PDF ↗ |
| K992644 | SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM | Sirona Dental Systems GmbH | 1999-08-23 | Special | PDF ↗ |
Product code MUH · Class II · Dental. Data: openFDA.