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510(k) K200775

LOOP LED Curing Light System by Garrison Dental Solutions, LLC — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2020
Date Received
March 25, 2020
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

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Other clearances for product code EBZ

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  • K223414 — Curing Light, Model: MaxCure 9 (November 15, 2023)
  • K233518 — BASE290 LED Curing Light (November 2, 2023)
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