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510(k) K241238

LOOP™ LED Curing Light System (CLK01) by Garrison Dental Solutions, LLC — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
May 3, 2024
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 Garrison Dental Solutions, LLC

  • K200775 — LOOP LED Curing Light System (August 14, 2020)
  • K091533 — SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM3 (August 17, 2009)

Other clearances for product code EBZ

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  • K250009 — LED Curing Light (C01-X, C02-X) (April 10, 2025)
  • 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)
  • K221152 — CuringPen Dental Curing Light (November 23, 2022)