Cleared Traditional

DYNA SYSTEM

K855167 · Parker Laboratories, Inc. · Dental
Mar 1986
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K855167 is an FDA 510(k) clearance for the DYNA SYSTEM, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Parker Laboratories, Inc. (Farmingdale, US). The FDA issued a Cleared decision on March 4, 1986, 68 days after receiving the submission on December 26, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number K855167 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1985
Decision Date March 04, 1986
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EGG — Attachment, Precision, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3165

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