Cleared Traditional

IN TEN-S

K011492 · Ivoclar North America, Inc. · Dental
Jul 2001
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K011492 is an FDA 510(k) clearance for the IN TEN-S, 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 July 5, 2001, 51 days after receiving the submission on May 15, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K011492 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2001
Decision Date July 05, 2001
Days to Decision 51 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