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510(k) K896963

TRIMODE SP DENTAL INTRA ORAL X-RAY by Tempo Technology, Inc. — Product Code EAP

K896963 is an FDA 510(k) premarket notification submitted by Tempo Technology, Inc. for the device "TRIMODE SP DENTAL INTRA ORAL X-RAY". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Tempo Technology, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
December 15, 1989
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 Tempo Technology, Inc.

  • K963220 — TEMPRA COLD PACK, REORDER NO. TC150 (October 10, 1996)
  • K934700 — MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY (March 16, 1994)

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