Cleared Traditional

K942870 - ULTIMA 2 DENTAL CHAIR

K942870 is an FDA 510(k) clearance for ULTIMA 2 DENTAL CHAIR, manufactured by Dentech Corp.. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K942870 · Dentech Corp. · Dental device
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Feb 1995
Decision
255d
Days
Class 1
Risk

K942870 is an FDA 510(k) clearance for the ULTIMA 2 DENTAL CHAIR. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Dentech Corp. (Sumas, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 255 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentech Corp. devices

FDA 510(k) Submission Details - K942870

510(k) Number K942870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1994
Decision Date February 27, 1995
Days to Decision 255 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 127d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

KLC Device Classification - Class 1, General Controls

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 30
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