Cleared Traditional

MONOPAQUE

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

About This 510(k) Submission

K990315 is an FDA 510(k) clearance for the MONOPAQUE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 4, 1999, 31 days after receiving the submission on February 1, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K990315 FDA.gov
FDA Decision Cleared 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

Device Classification

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