Cleared Traditional

TETRIC FLOW

K993783 · Ivoclar North America, Inc. · Dental
Dec 1999
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K993783 is an FDA 510(k) clearance for the TETRIC FLOW, 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 December 13, 1999, 35 days after receiving the submission on November 8, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K993783 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1999
Decision Date December 13, 1999
Days to Decision 35 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