Product code EAP
- Device name
- Unit, X-Ray, Intraoral
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1810
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113360 | MEDICAL IMAGE PROCESSING UNIT | Humanray Co,Ltd | 2012-02-07 |
| K102573 | PROVU (TM) DENTAL X-RAY SYSTEM | Advanced Image Science, Inc. | 2011-06-30 |
| K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2009-11-30 |
| K080738 | DENTRON SENSOR | Dentron Systems, LLC | 2008-05-13 |
| K052422 | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | Flow X-Ray Corp. | 2005-09-27 |
| K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2004-06-07 |
| K960819 | HELIODENT DS | Pelton & Crane Co. | 1996-03-29 |
| K960028 | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | Dentsply Intl. | 1996-03-01 |
| K953936 | ATLANTIS | Trophy Radiologie | 1995-12-28 |
| K954565 | EXPLOR-X (AZTEH) HF | Chicago X-Ray Systems, Inc. | 1995-10-27 |
| K951734 | LUMIX 70B | Emix U.S.A., Inc. | 1995-07-20 |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Trophy Radiologie | 1995-06-30 |
| K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | 1995-04-19 |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Chicago X-Ray Systems, Inc. | 1995-04-06 |
| K950030 | HELIODENT MD | Pelton & Crane Co. | 1995-02-03 |
| K934645 | RADWORKS | Radworks Corp. | 1994-08-17 |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Pelton & Crane Co. | 1994-07-29 |
| K933455 | COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 1994-01-31 |
| K931486 | INTREX VSK INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | 1993-11-23 |
| K931717 | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY | Kaycor Intl., Ltd. | 1993-09-20 |
| K930925 | INTREX INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | 1993-07-13 |
| K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM | Afp Imaging Corp. | 1993-05-25 |
| K923307 | HEALTHPAK X-RAY SOX BARRIERS | Healthpak, Inc. | 1993-01-21 |
| K900681 | PANORAMIC MODEL X-CALIBER X-RAY | Belmont Equipment Corp. | 1990-05-23 |
| K896024 | MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE | Mdt Diagnostic Co. | 1990-01-22 |
| K896963 | TRIMODE SP DENTAL INTRA ORAL X-RAY | Tempo Technology, Inc. | 1990-01-22 |
| K883354 | VARIABLE KV INTREX VSK 60 - 90 KVP | Keystone X-Ray, Inc. | 1988-12-21 |
| K882379 | MINIM-X 2001-CIAS & MINIM-X 2002-CIAS | Dentomar, Inc. | 1988-09-09 |
| K861328 | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY | Belmont Equipment Corp. | 1986-04-24 |
| K852019 | BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD | Belmont Equipment Corp. | 1985-06-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D0031000086510 | Schick | Dentsply International Inc. | 2024-11-06 |
| D00367782811 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D00367782731 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D00367782401 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D00367782321 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D00367248061 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D00367247801 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D00367247721 | Xios XG Supreme | Dentsply International Inc. | 2024-11-06 |
| D0031000087210 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086650 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086630 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086620 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086600 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086580 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086560 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000072190 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086400 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086370 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086340 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086330 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086320 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086310 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086290 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086280 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086270 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086250 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000086240 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000082860 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000072210 | Schick | Dentsply International Inc. | 2024-11-06 |
| D0031000072200 | Schick | Dentsply International Inc. | 2024-11-06 |