Cleared Traditional

K913535 - A-DEC DECADE 1020 CHAIR

K913535 is the FDA 510(k) clearance for A-DEC DECADE 1020 CHAIR by A-Dec, Inc.. It is a Class 1 Dental device (product code KLC) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K913535 · A-Dec, Inc. · Dental device
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Oct 1991
Decision
61d
Days
Class 1
Risk

K913535 is an FDA 510(k) clearance for the A-DEC DECADE 1020 CHAIR. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A-Dec, Inc. devices

Submission Details

510(k) Number K913535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1991
Decision Date October 09, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KLC Chair, Dental, With Operative Unit

All 20
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K913535.
A-DEC 2183 DUO UNIT, CUSP
K925323 · A-Dec, Inc. · Dec 1993
A-DEC 2184 DUO UNIT
K925324 · A-Dec, Inc. · Dec 1993
A-DEC 2185 DOCTOR'S UNIT
K925325 · A-Dec, Inc. · Dec 1993
A-DEC KNEEBREAK 1030 CHAIR
K913059 · A-Dec, Inc. · Oct 1991
A-DEC DECADE 1015 CHAIR
K903450 · A-Dec, Inc. · Oct 1990
A-DEC DECADE 1010 CHAIR
K903454 · A-Dec, Inc. · Oct 1990