SavDenTM MTA Root Canal Filling Materials— 510(k) K162661

Name: FDA 510(k) clearance K162661
Creator: U.S. Food and Drug Administration
Published: 2017-04-25

Substantially Equivalent

Tyds Biotech Incorporation

FDA 510(k) clearance K162661 for SavDenTM MTA Root Canal Filling Materials, Substantially Equivalent on 2017-04-25. Applicant: Tyds Biotech Incorporation. Device class: 2.

Clearance details

Applicant: Tyds Biotech Incorporation
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2016-09-26
Decision date: 2017-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei City, Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

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K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

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