Unit, X-Ray, Extraoral With Timer
Regulation 872.1800
6510(k)s in 12 months (191 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in EHD
| Company | 510(k)s | Recalls |
|---|---|---|
| Planmeca Oy | 14 | 0 |
| Digimed Co., Ltd. | 6 | 1 |
| Gendex Dental Systems | 1 | 6 |
| Villa Sistemi Medicali S.P.A. | 7 | 0 |
| Trophy Radiologie | 6 | 0 |
| VATECH Co., Ltd. | 6 | 0 |
| Aribex | 3 | 2 |
| Dentsply Intl. | 4 | 0 |
| Gendex Corp. | 3 | 1 |
| Instrumentarium Corp. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 1996 | K962631 | DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM Fair Image, Inc. | EHD |
| Oct 2, 1996 | K963185 | ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER Electronic Control Concepts | EHD |
| Sep 23, 1996 | K961826 | DIGIPAN Trophy Radiologie, FR | EHD |
| Jul 25, 1996 | K962337 | ELITYS OR ELITYS-E Trophy Radiologie, FR | EHD |
| Jul 25, 1996 | K962120 | TOMOGRAPH ACCESSORIES Steri-Oss, Inc. | EHD |
| Dec 11, 1995 | K955429 | PROSTYLE INTRA Planmeca Oy, FI | EHD |
| Oct 7, 1995 | K952763 | PANORAMIC X-RAY UNIT (MODIFICATION) Planmeca Oy, FI | EHD |
| Mar 21, 1994 | K931300 | FLASH DENT Chicago X-Ray Systems, Inc. | EHD |
| Feb 18, 1994 | K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 Gendex Corp. | EHD |
| Jan 25, 1994 | K932111 | DENTAL X-RAY UNIT Castellini S.P.A., IT | EHD |
| Dec 15, 1993 | K934063 | PANORAMIC X-RAY UNITS, MODIFICATION Planmeca Oy, FI | EHD |
| Sep 29, 1993 | K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS Gendex Corp. | EHD |
| Sep 14, 1993 | K931001 | ORALIX DC Gendex Corp. | EHD |
| Jul 14, 1993 | K931725 | ALPHA II Dynarad Corp. | EHD |
| Apr 27, 1993 | K930338 | ORTHOCEPH OC100 Instrumentarium Corp., FI | EHD |
| Mar 30, 1993 | K926575 | MAMMOTEST PRODUCT, MODIFICATION Fischer Imaging Corp. | EHD |
| Mar 30, 1993 | K923360 | PORT-XD Mobile Dental Equipment Corp. | EHD |
| Nov 27, 1992 | K924130 | COFFMAN IMPLANT TOMOGRAPH Coffman Dental | EHD |
| Nov 27, 1992 | K923067 | SENS-A-RAY Regam Medical Systems, CA | EHD |
| Nov 5, 1991 | K912893 | ORTHOPANTOMOGRAPH 100 Instrumentarium Corp., FI | EHD |
| Oct 30, 1991 | K913652 | COFFMAN TOMOGRAPH Coffman Dental | EHD |
| Apr 25, 1990 | K894935 | S-70 PORTABLE DENTAL X-RAY SYSTEM Lorad Medical Systems, Inc. | EHD |
| Nov 17, 1989 | K895467 | ORTHOPHOS AND ORTHOPHOS C Siemens Medical Solutions USA, Inc. | EHD |
| Aug 4, 1988 | K882436 | LASER - 1000 Panoramic Corp. | EHD |
| Jun 17, 1988 | K875212 | PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE Kevex Corp. | EHD |
| Mar 31, 1988 | K872825 | AXIAL TOME, 60, FLUORO AND TOMAX Axialtome Corp. | EHD |
| Dec 7, 1987 | K874238 | MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY Belmont Equipment Corp. | EHD |
| Jul 16, 1987 | K872240 | PORTABLE DENTAL X-RAY UNIT MODEL 4000 Home/Office Dental, Inc. | EHD |
| May 4, 1987 | K871051 | FIAD EXPLOR-X; MODEL 70 KVP United States Dental | EHD |
| Feb 13, 1987 | K870236 | PANORAMIC X-RAY MODEL PC-1000 Panoramic Corp. | EHD |
| Nov 26, 1986 | K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC Planmeca USA, Inc. | EHD |
| Jul 1, 1986 | K860835 | CEPHALOSTAT Dallas Dental Co. | EHD |
| Mar 6, 1986 | K854741 | X-RANGE 65 Alpine Dental Equipment Co. | EHD |
| Sep 3, 1985 | K851095 | INTRAORAL DENTAL X-RAY SYSTEM 70-X Trophy Radiologie, FR | EHD |
| Jun 9, 1981 | K811103 | GE 900 General Electric Co. | EHD |
| Mar 3, 1980 | K800133 | PANOREX II DENTAL X-RAY UNIT Pennwalt Corp. | EHD |
| Jan 16, 1980 | K792581 | GENERAL ELECTRIC PANELIPSE LD General Electric Co. | EHD |
| Sep 11, 1978 | K781288 | DENTAL X-RAY UNIT HELIODENT 70 Siemens Corp. | EHD |
| Sep 11, 1978 | K781286 | DENTAL X-RAY UNIT Siemens Corp. | EHD |
| Apr 10, 1978 | K780469 | PANORAMIC X-RAY, DENTAL Den-Tal-Ez Mfg Co., Inc. | EHD |
| Dec 2, 1977 | K772164 | PANORAMIC X-RAY SYSTEM MODEL A Sybron Corp. | EHD |
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