Cleared Traditional

STARFLOW HV

K020760 · Danville Materials, Inc. · Dental
May 2002
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K020760 is an FDA 510(k) clearance for the STARFLOW HV, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on May 3, 2002, 57 days after receiving the submission on March 7, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K020760 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2002
Decision Date May 03, 2002
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690