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510(k) K930925

INTREX INTERORAL DENTAL X-RAY UNIT by Keystone X-Ray, Inc. — Product Code EAP

K930925 is an FDA 510(k) premarket notification submitted by Keystone X-Ray, Inc. for the device "INTREX INTERORAL DENTAL X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on July 13, 1993. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Keystone X-Ray, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1993
Date Received
February 23, 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 Keystone X-Ray, Inc.

  • K931486 — INTREX VSK INTERORAL DENTAL X-RAY UNIT (November 23, 1993)
  • K883354 — VARIABLE KV INTREX VSK 60 - 90 KVP (December 21, 1988)
  • K812217 — FLUORO AUTOMATIC BRIGHTNESS SYS (September 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