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510(k) K790984

KLIP-LITE by Innovators, Inc. — Product Code EAZ

K790984 is an FDA 510(k) premarket notification submitted by Innovators, Inc. for the device "KLIP-LITE". The FDA issued a decision of Substantially Equivalent on October 22, 1979. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Innovators, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1979
Date Received
May 25, 1979
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 Innovators, Inc.

  • K921355 — WINGMASTER (September 25, 1992)
  • K921354 — BLUNT TIP IRRIGATION NEEDLES (September 25, 1992)
  • K921406 — SILICONT BUR BLOCK (April 28, 1992)
  • K844351 — OPTI-LITE (December 21, 1984)
  • K830042 — E-Z JECTOR (January 26, 1983)

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)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)

FDA data resources