Cleared Traditional

PRE-VISION FILL

K993602 · Heraeus Kulzer, Inc. · Dental
Dec 1999
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K993602 is an FDA 510(k) clearance for the PRE-VISION FILL, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 15, 1999, 51 days after receiving the submission on October 25, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K993602 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1999
Decision Date December 15, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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