Home / 510(k) Clearances / K844351

510(k) K844351

OPTI-LITE by Innovators, Inc. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1984
Date Received
November 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

Other clearances by Innovators, Inc.

  • K921354 — BLUNT TIP IRRIGATION NEEDLES (September 25, 1992)
  • K921355 — WINGMASTER (September 25, 1992)
  • K921406 — SILICONT BUR BLOCK (April 28, 1992)
  • K830042 — E-Z JECTOR (January 26, 1983)
  • K790984 — KLIP-LITE (October 22, 1979)

Other clearances for product code EBZ

  • K253461 — Demi Pro (October 14, 2025)
  • K242386 — Bluemoon (May 5, 2025)
  • K243921 — LED Curing Lights (DB686 HALO) (April 11, 2025)
  • K250009 — LED Curing Light (C01-X, C02-X) (April 10, 2025)
  • K241238 — LOOP™ LED Curing Light System (CLK01) (August 1, 2024)
  • K223414 — Curing Light, Model: MaxCure 9 (November 15, 2023)
  • K233518 — BASE290 LED Curing Light (November 2, 2023)
  • K223507 — CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (August 4, 2023)
  • K223142 — Coltolux Comfort LED Curing Light (December 22, 2022)
  • K220826 — LED Curing Light (December 8, 2022)