THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM— 510(k) K992727

Name: FDA 510(k) clearance K992727
Creator: U.S. Food and Drug Administration
Published: 2000-01-18

Substantially Equivalent

Mds

FDA 510(k) clearance K992727 for THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM, Substantially Equivalent on 2000-01-18. Applicant: Mds. Device class: 2.

Clearance details

Applicant: Mds
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 1999-08-13
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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K253167 — Any-Paste2026-01-12

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