Cleared Traditional

K925119 - A-DEC 1040 CHAIR (FDA 510(k) Clearance)

Jan 1994
Decision
479d
Days
Class 1
Risk

K925119 is an FDA 510(k) clearance for the A-DEC 1040 CHAIR. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on January 31, 1994, 479 days after receiving the submission on October 9, 1992.

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

Submission Details

510(k) Number K925119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1992
Decision Date January 31, 1994
Days to Decision 479 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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