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510(k) K192392

DiaPlus by DiaDent Group International — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2020
Date Received
September 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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  • K200174 — DIA-ROOT BIO MTA (September 18, 2020)
  • K200809 — D-LUX+ (August 7, 2020)
  • K200175 — DIA-ROOT BIO Sealer (June 25, 2020)
  • K190091 — Diapaste (March 27, 2020)
  • K192284 — DiaFil Flow (March 25, 2020)

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