Cleared Traditional

K863016 - DENTATUS L SET

K863016 is the FDA 510(k) clearance for DENTATUS L SET by Sds Dental, Inc.. It is a Class 1 Dental device (product code KLC) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K863016 · Sds Dental, Inc. · Dental device
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Oct 1986
Decision
54d
Days
Class 1
Risk

K863016 is an FDA 510(k) clearance for the DENTATUS L SET. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Sds Dental, Inc. (Washington, US). The FDA issued a Cleared decision on October 1, 1986 after a review of 54 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 Sds Dental, Inc. devices

Submission Details

510(k) Number K863016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date October 01, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
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 22
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K863016.
A-DEC DECADE 1015 CHAIR
K903450 · A-Dec, Inc. · Oct 1990
A-DEC DECADE 1010 CHAIR
K903454 · A-Dec, Inc. · Oct 1990
A-DEC PRIORITY 1005 CHAIR
K893045 · A-Dec, Inc. · Jul 1989
HERPES-IHA KIT
K822095 · Hillcrest Biologicals · Apr 1983
RITTER MODEL H COMPANION STOOL
K800276 · Sybron Corp. · Mar 1980
SIROPORT
K800172 · Siemens Corp. · Feb 1980