Zircos-Com— 510(k) K190139

Substantially Equivalent

Bioden Co., Ltd.

FDA 510(k) clearance K190139 for Zircos-Com, Substantially Equivalent on 2020-04-24. Applicant: Bioden Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bioden Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2019-01-29
Decision date: 2020-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Bioden Co., Ltd.

K201492 — Non-Sterile Zirconia Block2021-03-10

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