Home / 510(k) Clearances / K123220

510(k) K123220

VERTEX THERMOSENS RIGID by Vertex-Dental B.V. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
October 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Vertex-Dental B.V.

  • K241071 — NextDent Jet Denture Base; NextDent Jet Denture Teeth (September 4, 2024)
  • K231388 — NextDent Base (October 20, 2023)
  • K221022 — NextDent Ortho Flex (October 21, 2022)
  • K191497 — NextDent Denture 3D+ (November 1, 2019)
  • K162572 — NextDent Denture, E-Denture (June 30, 2017)
  • K102640 — VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS (March 25, 2011)
  • K102654 — VERTEX RAPID SIMPLIFIED (December 3, 2010)

Other clearances for product code EBI

  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)
  • K242897 — Partial Flex (June 3, 2025)
  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)