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510(k) K221022

NextDent Ortho Flex by Vertex-Dental B.V. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2022
Date Received
April 6, 2022
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Vertex-Dental B.V.

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  • K162572 — NextDent Denture, E-Denture (June 30, 2017)
  • K123220 — VERTEX THERMOSENS RIGID (March 1, 2013)
  • K102640 — VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS (March 25, 2011)
  • K102654 — VERTEX RAPID SIMPLIFIED (December 3, 2010)

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  • K240463 — Slow Wave DS8 (SWDS802) (June 4, 2024)
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