Cleared Traditional

POLYESTER RESIN HAND MOLDED TRAY

K912820 · E&D Dental Products, Inc. · Dental
Aug 1991
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K912820 is an FDA 510(k) clearance for the POLYESTER RESIN HAND MOLDED TRAY, a Material, Impression Tray, Resin (Class I — General Controls, product code EBH), submitted by E&D Dental Products, Inc. (Westfield, US). The FDA issued a Cleared decision on August 21, 1991, 57 days after receiving the submission on June 25, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3670.

Submission Details

510(k) Number K912820 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1991
Decision Date August 21, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBH — Material, Impression Tray, Resin
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3670