X-Ray, Tomography, Computed, Dental
Regulation 892.1750
11510(k)s in 12 months (136 all time)
3recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in OAS
| Company | 510(k)s | Recalls |
|---|---|---|
| VATECH Co., Ltd. | 19 | 0 |
| Ray Co., Ltd. | 15 | 0 |
| Palodex Group OY | 8 | 1 |
| Prexion Corporation | 9 | 0 |
| Cefla S.C. | 7 | 0 |
| Osstem Implant Co., Ltd. | 3 | 3 |
| Trophy | 4 | 1 |
| Genoray Co., Ltd. | 4 | 0 |
| Dentium Co., Ltd (Ict Branch) | 3 | 0 |
| Dentsply Sirona | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2014 | K132983 | TON-95LH, PAX-I3D ORTHO VATECH Co., Ltd. | OAS |
| May 14, 2014 | K133620 | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM Imaging Sciences International | OAS |
| Mar 26, 2014 | K133544 | OP300 Palodex Group OY, FI | OAS |
| Mar 14, 2014 | K133406 | CS 8100 3D Trophy, FR | OAS |
| Nov 1, 2013 | K131695 | RAYSCAN A-EXPERT 3D Ray Co., Ltd. | OAS |
| Jul 18, 2013 | K123332 | NAOMI-CT Lk Consulting Group | OAS |
| Jul 3, 2013 | K130442 | NEWTOM VGI AND NEWTOM 5G Qr S.R.L. | OAS |
| Jun 14, 2013 | K130443 | I-MAX TOUCH 3D Owandy | OAS |
| May 31, 2013 | K130432 | PHT-6500, PHT-60CFO VATECH Co., Ltd. | OAS |
| May 29, 2013 | K130297 | SCANORA 3DX Palodex Group OY, FI | OAS |
| May 10, 2013 | K123381 | HYPERION X9 Cefla S.C. | OAS |
| Apr 18, 2013 | K122199 | PREXION3D ECLIPSE The Yoshida Dental Mfg. Co., Ltd., JP | OAS |
| Mar 15, 2013 | K123070 | GALILEOS FAMILY Sirona Dental Systems GmbH, DE | OAS |
| Mar 12, 2013 | K122981 | RAYSCAN A-EXPERT 3D Ray Co., Ltd. | OAS |
| Dec 21, 2012 | K120948 | PREXION 3D The Yoshida Dental Mfg. Co., Ltd., JP | OAS |
| Dec 10, 2012 | K122018 | OP300 Palodex Group OY, FI | OAS |
| Nov 20, 2012 | K122606 | PHT-6500; PHT-60CFO; PAX-I3D Mtechgroup | OAS |
| Aug 28, 2012 | K121400 | PAX-UNI3D, PHT-7500 VATECH Co., Ltd. | OAS |
| Jul 26, 2012 | K120753 | CLARISCT Icrco, Inc. | OAS |
| Jun 8, 2012 | K121412 | PAX-FLEX3D, PHT-7000 VATECH Co., Ltd. | OAS |
| May 24, 2012 | K121236 | PAX-DUO3D PLUS, PCT-5000 VATECH Co., Ltd. | OAS |
| Aug 18, 2011 | K103659 | CS 9300, CS 9300C Trophy, FR | OAS |
| Jul 19, 2011 | K101181 | BEL-CAT Takara Belmont Corp. | OAS |
| Jun 30, 2011 | K110839 | SCANORA 3D Soredex Palodex Group OY, FI | OAS |
| Apr 6, 2011 | K110260 | NEWTOM 5G / NEWTOM 5G VERSION FP Qr S.R.L., IT | OAS |
| Mar 25, 2011 | K102196 | COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. | OAS |
| Mar 22, 2011 | K103711 | ORTHOPHOS XG 3D / CEPH Sirona Dental Systems GmbH, DE | OAS |
| Jan 8, 2010 | K090467 | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D VATECH Co., Ltd. | OAS |
| Jun 2, 2009 | K083917 | X-RAY, TOMOGRAPHY, COMPUTED, DENTAL Suni Medical Imaging, Inc. | OAS |
| Apr 30, 2009 | K090171 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D E-Woo Technology | OAS |
| Oct 31, 2008 | K082410 | MASTER3DS E-Woo Technology | OAS |
| Oct 10, 2008 | K082350 | PAX-500 VATECH Co., Ltd. | OAS |
| Feb 8, 2007 | K063622 | FINECUBE DENTAL CT The Yoshida Dental Mfg. Co., Ltd. | OAS |
| Jan 31, 2007 | K063773 | VOLUMETRIC TOMOGRAPHY Instrumentarium Dental, Inc. | OAS |
| May 14, 2004 | K041137 | NEWTOM 3G QR-DVT 9000 Aperio Services, LLC | OAS |
| Mar 8, 2001 | K003787 | NEWTOM QR-DVT 9000 Aperio Services, LLC | OAS |
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