Home / 510(k) Clearances / K150703

510(k) K150703

CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) by Kuraray Noritake Dental, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2015
Date Received
March 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
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 KLE

  • K252450 — Adhese 2 (March 5, 2026)
  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K251587 — VITA VMLC Primer (February 23, 2026)
  • K252151 — els unibond (December 5, 2025)
  • K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (November 6, 2025)
  • K251124 — G-Bond Universal (October 2, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)
  • K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, (November 1, 2024)
  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)