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510(k) K925629

ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT by Den-Tal-Ez Mfg Co., Inc. — Product Code EAZ

K925629 is an FDA 510(k) premarket notification submitted by Den-Tal-Ez Mfg Co., Inc. for the device "ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT". The FDA issued a decision of Substantially Equivalent on November 23, 1993. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Den-Tal-Ez Mfg Co., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1993
Date Received
November 6, 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 Den-Tal-Ez Mfg Co., Inc.

  • K932824 — EVACUATOR, ORAL CAVITY (September 28, 1993)
  • K931204 — AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) (July 8, 1993)
  • K920017 — IMPROVED DENTAL OPERATING LIGHT (March 2, 1992)
  • K920016 — IMPROVED DENTAL CHAIR (March 2, 1992)
  • K874294 — AUTOCHUCK ATTACHMENT (December 29, 1987)
  • K780469 — PANORAMIC X-RAY, DENTAL (April 10, 1978)

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)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K935390 — SIROLUX FANTASTIC (December 10, 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