Cleared Traditional

K880475 - SKEMA (DENTAL UNIT) (FDA 510(k) Clearance)

Class I Dental device.

K880475 · Alpine Dental Equipment Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
232d
Days
Class 1
Risk

K880475 is an FDA 510(k) clearance for the SKEMA (DENTAL UNIT). Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on September 23, 1988 after a review of 232 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 Alpine Dental Equipment Co. devices

Submission Details

510(k) Number K880475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1988
Decision Date September 23, 1988
Days to Decision 232 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 127d · This submission: 232d
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.