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510(k) K193388

GlassLok Kits, GlassLok Powder, GlassLok Liquid by Reliance Orthodontic Products, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2020
Date Received
December 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

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  • K123348 — CLEAR ALIGNER ADHESIVE (February 28, 2013)
  • K111814 — PADLOCK (September 14, 2011)
  • K101951 — LIGHT CURE RETAINER (October 26, 2010)
  • K083051 — FLOWTAIN & FLOWTAIN LV (February 20, 2009)
  • K073243 — LED PRO SEAL (February 8, 2008)
  • K071688 — RELIANCE S.E.P. (September 7, 2007)

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