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510(k) K041385

MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM by Schick Technologies, Inc. — Product Code EAP

K041385 is an FDA 510(k) premarket notification submitted by Schick Technologies, Inc. for the device "MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 7, 2004. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Schick Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2004
Date Received
May 25, 2004
Clearance Type
Special
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 Schick Technologies, Inc.

  • K110768 — COMPUTED DENTAL RADIOGRAPHY (April 20, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K072134 — SCHICK COMPUTED ORAL RADIOLOGY SYSTEM (November 2, 2007)
  • K053558 — CEPH, MODEL 4900 (February 17, 2006)
  • K031291 — CDR PANX, MODEL 4792 (May 5, 2003)
  • K022953 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (October 2, 2002)
  • K001429 — MODIFICATION TO ACCUDEXA BONE DENSITOMETER (May 26, 2000)
  • K982661 — CDR - PAN MODEL 4700 (December 11, 1998)
  • K981124 — ACCUDEXA BONE DENSITOMETER (June 4, 1998)
  • K971735 — ACCUDEXA BONE DENSITOMETER (December 2, 1997)

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)
  • 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)
  • K951734 — LUMIX 70B (July 20, 1995)

FDA data resources