Home / 510(k) Clearances / K183537

510(k) K183537

PANAVIA SA Cement Universal by Kuraray Noritake Dental, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2019
Date Received
December 19, 2018
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 Kuraray Noritake Dental, Inc.

  • K250673 — CERABIEN MiLai (May 29, 2025)
  • K233285 — KATANA Zirconia ONE For IMPLANT (May 24, 2024)
  • K231039 — CLEARFIL Universal Bond Quick 2 (December 13, 2023)
  • K220369 — Esthetic Colorant (September 23, 2022)
  • K213147 — CERABIEN MiLai (March 28, 2022)
  • K210504 — PANAVIA Veneer LC (June 11, 2021)
  • K193060 — Noritake Super Porcelain EX-3 (January 30, 2020)
  • K191980 — CLEARFIL MAJESTY ES Flow (November 18, 2019)
  • K191133 — KATANA Cleaner, KATANA Cleaner (Trial) (October 8, 2019)
  • K190436 — KATANA Zirconia Block (May 23, 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)