Cleared Traditional

DENTAL ENDODONTIC CEMENT (MODIFICATION)

K894092 · The Hygenic Corp. · Dental
Jan 1990
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K894092 is an FDA 510(k) clearance for the DENTAL ENDODONTIC CEMENT (MODIFICATION), a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on January 10, 1990, 216 days after receiving the submission on June 8, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K894092 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1989
Decision Date January 10, 1990
Days to Decision 216 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820