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510(k) K926081

DENTAL LIGHT by Mdt Corp., Inc. — Product Code EAZ

K926081 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "DENTAL LIGHT". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
December 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Operating, Dental
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Mdt Corp., Inc.

  • K960777 — MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (May 23, 1996)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)
  • K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (August 10, 1994)
  • K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (February 16, 1994)
  • K924955 — MDT/HARVEY MC-8 AND MC-10 (October 15, 1993)
  • K932094 — BOVIE ULTRASONIC SURGICAL ASPIRATOR (July 21, 1993)
  • K931169 — MDT DENTAL CHAIR (May 20, 1993)
  • K920930 — MDT/CASTLE 10/90 DUAL LOAD STATION (March 31, 1993)
  • K922212 — MDT CASTLE BIOSIGN TEST PACK (August 10, 1992)
  • K914758 — MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (December 19, 1991)

Other clearances for product code EAZ

  • K072309 — MICROLUX/BLU (November 19, 2007)
  • K041614 — MICROLUX DL (April 4, 2005)
  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K935390 — SIROLUX FANTASTIC (December 10, 1993)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K902685 — DEFIANCE MODEL FUS 336 (September 17, 1990)

FDA data resources