PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer— 510(k) K150704

Name: FDA 510(k) clearance K150704
Creator: U.S. Food and Drug Administration
Published: 2015-08-21

Substantially Equivalent

Kuraray Noritake Dental, Inc.

FDA 510(k) clearance K150704 for PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer, Substantially Equivalent on 2015-08-21. Applicant: Kuraray Noritake Dental, Inc.. Device class: 2.

Clearance details

Applicant: Kuraray Noritake Dental, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2015-03-18
Decision date: 2015-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda Ku, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

view all

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Kuraray Noritake Dental, Inc.

view all

K250673 — CERABIEN MiLai2025-05-29
K233285 — KATANA Zirconia ONE For IMPLANT2024-05-24
K231039 — CLEARFIL Universal Bond Quick 22023-12-13
K220369 — Esthetic Colorant2022-09-23
K213147 — CERABIEN MiLai2022-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.