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510(k) K210231

Vittra APS Unique by Dentscare Ltda — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2021
Date Received
January 28, 2021
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

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  • K232994 — Vittra APS Unique Flow (October 18, 2024)
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  • 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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