Cleared Traditional

STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150

K092912 · Danville Materials, Inc. · Dental

Dec 2009

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K092912 is an FDA 510(k) clearance for the STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150, 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 December 16, 2009, 85 days after receiving the submission on September 22, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K092912 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2009
Decision Date	December 16, 2009
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement