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510(k) K931717

YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY by Kaycor Intl., Ltd. — Product Code EAP

K931717 is an FDA 510(k) premarket notification submitted by Kaycor Intl., Ltd. for the device "YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY". The FDA issued a decision of Substantially Equivalent on September 20, 1993. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Kaycor Intl., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1993
Date Received
April 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

Other clearances by Kaycor Intl., Ltd.

  • K965072 — PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT (January 27, 1997)
  • K832063 — ROBIN CORDLESS HANDPIECE (August 26, 1983)
  • K822740 — K30000 DENTAL CHAIR (September 28, 1982)
  • K813348 — YOSHIDA RIDO-F, MODEL LM-01 (January 7, 1982)
  • K811210 — YOSHIDA-PANOURA 10 (August 24, 1981)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)

Other clearances for product code EAP

  • K113360 — MEDICAL IMAGE PROCESSING UNIT (February 7, 2012)
  • K102573 — PROVU (TM) DENTAL X-RAY SYSTEM (June 30, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K080738 — DENTRON SENSOR (May 13, 2008)
  • K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (September 27, 2005)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (March 1, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)

FDA data resources