Cleared Traditional

DENTRAY II PLUS TRAY ADHESIVE

K952930 · Confi-Dental Products Co. · Dental
Sep 1995
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K952930 is an FDA 510(k) clearance for the DENTRAY II PLUS TRAY ADHESIVE, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on September 8, 1995, 81 days after receiving the submission on June 19, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K952930 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1995
Decision Date September 08, 1995
Days to Decision 81 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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