Cleared Traditional

D.SIGN 30

K010381 · Ivoclar North America, Inc. · Dental
Mar 2001
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K010381 is an FDA 510(k) clearance for the D.SIGN 30, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 6, 2001, 26 days after receiving the submission on February 8, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K010381 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2001
Decision Date March 06, 2001
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710