Cleared Traditional

SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)

K003407 · Ivoclar North America, Inc. · Dental
Jan 2001
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K003407 is an FDA 510(k) clearance for the SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER), a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on January 26, 2001, 86 days after receiving the submission on November 1, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K003407 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2000
Decision Date January 26, 2001
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275