Cleared Traditional

K003377 - FERMIT N PLUS

K003377 is the FDA 510(k) clearance for FERMIT N PLUS by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

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

K003377 is an FDA 510(k) clearance for the FERMIT N PLUS. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K003377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 98
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K003377.
LC TEMPORARY FILLING
K012360 · Parkell, Inc. · Sep 2001
PATTERN RESIN
K003817 · GC America, Inc. · Jan 2001
FERMIT PLUS
K003374 · Ivoclar North America, Inc. · Dec 2000
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114 · 3M Company · Jun 2000
JELTEMP
K991564 · J.F. Jelenko & Co., Inc. · Jun 1999
SMARTEMP
K991270 · Parkell, Inc. · May 1999