Cleared Traditional

K854647 - POLO DENTAL UNIT

K854647 is an FDA 510(k) clearance for POLO DENTAL UNIT, manufactured by Alpine Dental Equipment Co.. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K854647 · Alpine Dental Equipment Co. · Dental device
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Jun 1986
Decision
198d
Days
Class 1
Risk

K854647 is an FDA 510(k) clearance for the POLO 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 June 5, 1986 after a review of 198 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

FDA 510(k) Submission Details - K854647

510(k) Number K854647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date June 05, 1986
Days to Decision 198 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 128d · This submission: 198d
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
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K854647.
A-DEC DECADE 1010 CHAIR
K903454 · A-Dec, Inc. · Oct 1990
A-DEC PRIORITY 1005 CHAIR
K893045 · A-Dec, Inc. · Jul 1989
DENTATUS L SET
K863016 · Sds Dental, Inc. · Oct 1986
ANATOM SYSTEM
K843233 · Lic-Orthion · Oct 1984
HERPES-IHA KIT
K822095 · Hillcrest Biologicals · Apr 1983
RITTER MODEL H COMPANION STOOL
K800276 · Sybron Corp. · Mar 1980