Home / 510(k) Clearances / K210473

510(k) K210473

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2021
Date Received
February 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

  • K220077 — IMICRYL Composite, Composite Flow Materials (August 9, 2022)
  • K213609 — NOVA RESIN dual cure, self adhesive resin cement (August 9, 2022)
  • K192913 — R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (January 19, 2021)
  • K192178 — R&D Series Nova Compo N (December 20, 2019)

Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)