Cleared Traditional

K884830 - DENTAL CHAIR F1

K884830 is an FDA 510(k) clearance for DENTAL CHAIR F1, manufactured by Fimet OY. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K884830 · Fimet OY · Dental device
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Feb 1989
Decision
84d
Days
Class 1
Risk

K884830 is an FDA 510(k) clearance for the DENTAL CHAIR F1. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Fimet OY (Washington, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 84 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 Fimet OY devices

FDA 510(k) Submission Details - K884830

510(k) Number K884830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date February 10, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · This submission: 84d
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 K884830.
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
DENTATUS L SET
K863016 · Sds Dental, Inc. · Oct 1986
ANATOM SYSTEM
K843233 · Lic-Orthion · Oct 1984
HERPES-IHA KIT
K822095 · Hillcrest Biologicals · Apr 1983