Cleared Traditional

ACCU. CROWN COLD CURE

K771527 · Parker Laboratories, Inc. · Dental
Aug 1977
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K771527 is an FDA 510(k) clearance for the ACCU. CROWN COLD CURE, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1977, 8 days after receiving the submission on August 8, 1977. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K771527 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1977
Decision Date August 16, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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