Cleared Traditional

CRYSTALLESSENCE

K954988 · Confi-Dental Products Co. · Dental
Mar 1996
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K954988 is an FDA 510(k) clearance for the CRYSTALLESSENCE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on March 8, 1996, 129 days after receiving the submission on October 31, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K954988 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1995
Decision Date March 08, 1996
Days to Decision 129 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