Cleared Traditional

NOVUS BONDING AGENT

K900301 · The Hygenic Corp. · Dental
May 1990
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K900301 is an FDA 510(k) clearance for the NOVUS BONDING AGENT, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on May 15, 1990, 113 days after receiving the submission on January 22, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K900301 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1990
Decision Date May 15, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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