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510(k) K242537

BracePaste Fluoride Sealant by American Orthodontics Corp. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2024
Date Received
August 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K172953 — Acid Etchant (February 6, 2018)
  • K160782 — BracePaste Adhesive (October 14, 2016)
  • K143117 — Wire Sterilization Package with Indicators (October 29, 2015)
  • K122753 — EMPOWER CLEAR (December 14, 2012)
  • K080749 — RADIANCE (August 4, 2008)
  • K925012 — PLASTIC CHAIN (September 13, 1993)
  • K922984 — ORTHODONTIC BITE (March 31, 1993)

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