Ceramic Etchant (HF-5 and HF-9)— 510(k) K240153

Name: FDA 510(k) clearance K240153
Creator: U.S. Food and Drug Administration
Published: 2024-10-02

Substantially Equivalent

Liaoning Upcera Co., Ltd.

FDA 510(k) clearance K240153 for Ceramic Etchant (HF-5 and HF-9), Substantially Equivalent on 2024-10-02. Applicant: Liaoning Upcera Co., Ltd.. Device class: 2.

Clearance details

Applicant: Liaoning Upcera Co., Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2024-01-19
Decision date: 2024-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benxi, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

view all

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Liaoning Upcera Co., Ltd.

view all

K253380 — FLNT Base and FLNT Temp2026-03-02
K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series2026-01-09
K231687 — Gradual Dental Zirconia Blank2023-09-07
K181167 — Upcera Glaze Paste, Glaze Powder, and Glaze Liquid2018-09-02
K162323 — Tooth Shade Resin Material2017-01-12

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