Cleared Traditional

TETRIC CERAM HB

K010250 · Ivoclar North America, Inc. · Dental
Feb 2001
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K010250 is an FDA 510(k) clearance for the TETRIC CERAM HB, 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 February 28, 2001, 33 days after receiving the submission on January 26, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K010250 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2001
Decision Date February 28, 2001
Days to Decision 33 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