Cleared Traditional

STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387

K092319 · Danville Materials, Inc. · Dental
Sep 2009
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K092319 is an FDA 510(k) clearance for the STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on September 16, 2009, 43 days after receiving the submission on August 4, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K092319 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2009
Decision Date September 16, 2009
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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