Cleared Traditional

K990315 - MONOPAQUE

K990315 is the FDA 510(k) clearance for MONOPAQUE by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K990315 · Ivoclar North America, Inc. · Dental device
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Mar 1999
Decision
31d
Days
Class 2
Risk

K990315 is an FDA 510(k) clearance for the MONOPAQUE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K990315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date March 04, 1999
Days to Decision 31 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
96d faster than avg
Panel avg: 127d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K990315.
FLC COMPOSITE
K991491 · Harry J. Bosworth Co. · Jun 1999
FLOW LINE
K990756 · Heraeus Kulzer, Inc. · May 1999
PRODIGY 4
K990898 · Sybron Dental Specialties, Inc. · Apr 1999
R-30 AESTHETIC RESTORATIVE
K984387 · Dentsply Intl. · Jan 1999
ADVENT
K984112 · Bisco, Inc. · Dec 1998
PRODIGY- 3
K983370 · Sybron Dental Specialties, Inc. · Nov 1998