Cleared Traditional

FERMIT N PLUS

K003377 · Ivoclar North America, Inc. · Dental
Dec 2000
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K003377 is an FDA 510(k) clearance for the FERMIT N PLUS, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on December 4, 2000, 35 days after receiving the submission on October 30, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K003377 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2000
Decision Date December 04, 2000
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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