TopCEM Ceramic Primer Ceramic Coupling Agent— 510(k) K242749

Name: FDA 510(k) clearance K242749
Creator: U.S. Food and Drug Administration
Published: 2024-11-08

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K242749 for TopCEM Ceramic Primer Ceramic Coupling Agent, Substantially Equivalent on 2024-11-08. Applicant: Rizhao Huge Biomaterials Company, Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2024-09-12
Decision date: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao, 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 Rizhao Huge Biomaterials Company, Ltd.

view all

K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement2025-12-12
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K242530 — HF-Etchant Hydrofluoric Acid Etching Gel2024-12-20
K242572 — TopCEM-Try in Veneer Try-in Gel2024-12-20
K241204 — TopCEM-Veneer Light Cure Veneer Cement2024-06-28

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