Cleared Traditional

Flexible Block

K213994 · Shandong Huge Dental Material Corporation · Dental
Mar 2022
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K213994 is an FDA 510(k) clearance for the Flexible Block, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on March 4, 2022, 73 days after receiving the submission on December 21, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K213994 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2021
Decision Date March 04, 2022
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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