Cleared Traditional

K920016 - IMPROVED DENTAL CHAIR
(FDA 510(k) Clearance)

Mar 1992
Decision
60d
Days
Class 1
Risk

K920016 is an FDA 510(k) clearance for the IMPROVED DENTAL CHAIR. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).

Submitted by Den-Tal-Ez Mfg Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on March 2, 1992, 60 days after receiving the submission on January 2, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K920016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date March 02, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6250

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