FDA Product Code
FDA Product Code EAP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.1810
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113360 | MEDICAL IMAGE PROCESSING UNIT | Humanray Co,Ltd | 2012-02-07 | Special | PDF ↗ |
| K102573 | PROVU (TM) DENTAL X-RAY SYSTEM | Advanced Image Science, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2009-11-30 | Special | PDF ↗ |
| K080738 | DENTRON SENSOR | Dentron Systems, LLC | 2008-05-13 | Traditional | PDF ↗ |
| K052422 | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | Flow X-Ray Corp. | 2005-09-27 | Special | PDF ↗ |
| K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2004-06-07 | Special | PDF ↗ |
| K960819 | HELIODENT DS | Pelton & Crane Co. | 1996-03-29 | Traditional | PDF ↗ |
| K960028 | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | Dentsply Intl. | 1996-03-01 | Traditional | PDF ↗ |
| K953936 | ATLANTIS | Trophy Radiologie | 1995-12-28 | Traditional | PDF ↗ |
| K954565 | EXPLOR-X (AZTEH) HF | Chicago X-Ray Systems, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K951734 | LUMIX 70B | Emix U.S.A., Inc. | 1995-07-20 | Traditional | PDF ↗ |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Trophy Radiologie | 1995-06-30 | Traditional | PDF ↗ |
| K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | 1995-04-19 | Traditional | PDF ↗ |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Chicago X-Ray Systems, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K950030 | HELIODENT MD | Pelton & Crane Co. | 1995-02-03 | Traditional | PDF ↗ |
| K934645 | RADWORKS | Radworks Corp. | 1994-08-17 | Traditional | PDF ↗ |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Pelton & Crane Co. | 1994-07-29 | Traditional | PDF ↗ |
| K933455 | COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K931486 | INTREX VSK INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | 1993-11-23 | Traditional | PDF ↗ |
| K931717 | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY | Kaycor Intl., Ltd. | 1993-09-20 | Traditional | PDF ↗ |
| K930925 | INTREX INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM | Afp Imaging Corp. | 1993-05-25 | Traditional | PDF ↗ |
| K923307 | HEALTHPAK X-RAY SOX BARRIERS | Healthpak, Inc. | 1993-01-21 | Traditional | PDF ↗ |
| K900681 | PANORAMIC MODEL X-CALIBER X-RAY | Belmont Equipment Corp. | 1990-05-23 | Traditional | PDF ↗ |
| K896963 | TRIMODE SP DENTAL INTRA ORAL X-RAY | Tempo Technology, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896024 | MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE | Mdt Diagnostic Co. | 1990-01-22 | Traditional | PDF ↗ |
| K883354 | VARIABLE KV INTREX VSK 60 - 90 KVP | Keystone X-Ray, Inc. | 1988-12-21 | Traditional | PDF ↗ |
| K882379 | MINIM-X 2001-CIAS & MINIM-X 2002-CIAS | Dentomar, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K861328 | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY | Belmont Equipment Corp. | 1986-04-24 | Traditional | PDF ↗ |
| K852019 | BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD | Belmont Equipment Corp. | 1985-06-05 | Traditional | PDF ↗ |
| K834279 | ACURAY 071A DENTAL INTRAORAL X-RAY | Belmont Equipment Corp. | 1983-12-29 | Traditional | PDF ↗ |
| K833241 | INTREX | Pennwalt Corp. | 1983-10-28 | Traditional | PDF ↗ |
| K832065 | ACURACY 071, DENTAL, INTRAORAL-X-RAY | Belmont Equipment Corp. | 1983-09-12 | Traditional | PDF ↗ |
| K800063 | XR-710 | Pennwalt Corp. | 1980-03-03 | Traditional | PDF ↗ |
| K792535 | PORTARAY | Siemens Corp. | 1980-01-28 | Traditional | PDF ↗ |
| K792307 | DENTIX DENTAL X-RAY UNIT | Precise Optics | 1980-01-09 | Traditional | PDF ↗ |
| K792437 | RAFLEX 70 | Mdt Corp., Inc. | 1980-01-09 | Traditional | PDF ↗ |
| K791014 | DENTAL XERORADIOGRAPHY | Xerox Medical Systems | 1979-09-04 | Traditional | PDF ↗ |
| K781630 | GE-700 INTRA ORAL X-RAY SYSTEM | General Electric Co. | 1978-12-04 | Traditional | PDF ↗ |
| K772184 | X-RAY SYSTEM FOR DENTAL APPLICATION | General Electric Co. | 1977-12-22 | Traditional | PDF ↗ |
| K770345 | X-RAY TUBE - PANOBEAM | Thoro-Ray, Inc. | 1977-03-08 | Traditional | PDF ↗ |
| K760323 | X-RAY UNIT, DENTAL DIAGNOSTIC | The S. S. White Co. | 1976-08-03 | Traditional | PDF ↗ |
Product code EAP · Class II · Dental. Data: openFDA.