DENU Composite Resin, DENU Flow Resin— 510(k) K213339

Name: FDA 510(k) clearance K213339
Creator: U.S. Food and Drug Administration
Published: 2022-09-23

Substantially Equivalent

Hdi, Inc.

FDA 510(k) clearance K213339 for DENU Composite Resin, DENU Flow Resin, Substantially Equivalent on 2022-09-23. Applicant: Hdi, Inc.. Device class: 2.

Clearance details

Applicant: Hdi, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2021-10-07
Decision date: 2022-09-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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K261246 — SRGC-062026-06-18

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