Flexible Block— 510(k) K213994

Name: FDA 510(k) clearance K213994
Creator: U.S. Food and Drug Administration
Published: 2022-03-04

Substantially Equivalent

Shandong Huge Dental Material Corporation

FDA 510(k) clearance K213994 for Flexible Block, Substantially Equivalent on 2022-03-04. Applicant: Shandong Huge Dental Material Corporation. Device class: 2.

Clearance details

Applicant: Shandong Huge Dental Material Corporation
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2021-12-21
Decision date: 2022-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

view all

K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

More clearances from Shandong Huge Dental Material Corporation

view all

K260376 — Denture Base2026-05-06
K260067 — Eternal Art Porcelain Powders2026-04-09
K251252 — NOBILCAM IMPAK Disc2025-08-01
K220680 — Denture Base Polymers2022-08-12
K201684 — A-Silicone for Bite Registration2020-09-24

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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