EAP — Unit, X-Ray, Intraoral Class II
FDA product code EAP covers "Unit, X-Ray, Intraoral", a Class II medical device regulated under 21 CFR 872.1810. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EAP
- Device Class
- Class II
- Regulation Number
- 872.1810
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K113360 | humanray co | MEDICAL IMAGE PROCESSING UNIT | February 7, 2012 |
| K102573 | advanced image science | PROVU (TM) DENTAL X-RAY SYSTEM | June 30, 2011 |
| K093453 | schick technologies | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | November 30, 2009 |
| K080738 | dentron systems | DENTRON SENSOR | May 13, 2008 |
| K052422 | flow x-ray | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | September 27, 2005 |
| K041385 | schick technologies | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | June 7, 2004 |
| K960819 | pelton and crane | HELIODENT DS | March 29, 1996 |
| K960028 | dentsply intl | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | March 1, 1996 |
| K953936 | trophy radiologie | ATLANTIS | December 28, 1995 |
| K954565 | chicago x-ray systems | EXPLOR-X (AZTEH) HF | October 27, 1995 |
| K951734 | emix u.s.a | LUMIX 70B | July 20, 1995 |
| K950533 | trophy radiologie | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | June 30, 1995 |
| K950532 | trophy radiologie | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | April 19, 1995 |
| K950667 | chicago x-ray systems | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | April 6, 1995 |
| K950030 | pelton and crane | HELIODENT MD | February 3, 1995 |
| K934645 | radworks | RADWORKS | August 17, 1994 |
| K936068 | pelton and crane | ORTHOPHOS 3/ ORTHOPHOS 3C | July 29, 1994 |
| K933455 | schick technologies | COMPUTED ORAL RADIOLOGY SYSTEM | January 31, 1994 |
| K931486 | keystone x-ray | INTREX VSK INTERORAL DENTAL X-RAY UNIT | November 23, 1993 |
| K931717 | kaycor intl | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY | September 20, 1993 |