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510(k) K232994

Vittra APS Unique Flow by Dentscare Ltda — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2024
Date Received
September 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Dentscare Ltda

  • K231859 — PrimmaArt (November 26, 2024)
  • K210231 — Vittra APS Unique (October 14, 2021)
  • K201707 — Opallis, Opallis Flow (December 22, 2020)
  • K192682 — Orthocem, Ortho Bite (August 14, 2020)
  • K191389 — Allcem Veneer APS (February 25, 2020)
  • K191306 — Llis, Vittra APS (December 16, 2019)
  • K183424 — Ambar, Ambar APS, Ambar Universal APS (December 13, 2019)
  • K183465 — Allcem, Allcem Core (November 2, 2019)
  • K190758 — Opus Bulk Fill APS, Opus Bulk Fill Flow APS (September 4, 2019)

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  • K251946 — G aenial Universal Injectable II (August 29, 2025)
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  • K250317 — EsFlow PLUS (May 30, 2025)