Product code EAP— Dental
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
- Classification name
- Unit, X-Ray, Intraoral
- Device class
- Class 2
- Regulation
- 21 CFR 872.1810
- Advisory panel
- Dental
- Total cleared
- 42
- First cleared
- Most recent
Market context for product code EAP
FDA has cleared devices under product code EAP between 1976 and 2012, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2012
- 2011
- 2009
- 2008
- 2005
- 2004
- 1996
- 1995
- 1994
- 1993
- 1990
- 1988
- 1986
- 1985
- 1983
Top applicants under product code EAP
Recent clearances under product code EAP
- K113360 — MEDICAL IMAGE PROCESSING UNIT
- K102573 — PROVU (TM) DENTAL X-RAY SYSTEM
- K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
- K080738 — DENTRON SENSOR
- K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
- K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
- K960819 — HELIODENT DS
- K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
- K953936 — ATLANTIS
- K954565 — EXPLOR-X (AZTEH) HF
- K951734 — LUMIX 70B
- K950533 — TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
- K950532 — TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
- K950667 — AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
- K950030 — HELIODENT MD
- K934645 — RADWORKS
- K936068 — ORTHOPHOS 3/ ORTHOPHOS 3C
- K933455 — COMPUTED ORAL RADIOLOGY SYSTEM
- K931486 — INTREX VSK INTERORAL DENTAL X-RAY UNIT
- K931717 — YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY
- K930925 — INTREX INTERORAL DENTAL X-RAY UNIT
- K930761 — IMAGE-X 70 INTRAORAL X-RAY SYSTEM
- K923307 — HEALTHPAK X-RAY SOX BARRIERS
- K900681 — PANORAMIC MODEL X-CALIBER X-RAY
- K896024 — MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
- K896963 — TRIMODE SP DENTAL INTRA ORAL X-RAY
- K883354 — VARIABLE KV INTREX VSK 60 - 90 KVP
- K882379 — MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
- K861328 — NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
- K852019 — BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD
- K834279 — ACURAY 071A DENTAL INTRAORAL X-RAY
- K833241 — INTREX
- K832065 — ACURACY 071, DENTAL, INTRAORAL-X-RAY
- K800063 — XR-710
- K792535 — PORTARAY
- K792307 — DENTIX DENTAL X-RAY UNIT
- K792437 — RAFLEX 70
- K791014 — DENTAL XERORADIOGRAPHY
- K781630 — GE-700 INTRA ORAL X-RAY SYSTEM
- K772184 — X-RAY SYSTEM FOR DENTAL APPLICATION
- K770345 — X-RAY TUBE - PANOBEAM
- K760323 — X-RAY UNIT, DENTAL DIAGNOSTIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.