Cleared Traditional

K843436 - DENTAL CHAIR

K843436 is an FDA 510(k) clearance for DENTAL CHAIR, manufactured by Swedish Dental Products, Inc.. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K843436 · Swedish Dental Products, Inc. · Dental device
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Sep 1984
Decision
23d
Days
Class 1
Risk

K843436 is an FDA 510(k) clearance for the DENTAL CHAIR. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Swedish Dental Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 23 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 Swedish Dental Products, Inc. devices

FDA 510(k) Submission Details - K843436

510(k) Number K843436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date September 27, 1984
Days to Decision 23 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 faster than avg
Panel avg: 128d · This submission: 23d
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 K843436.
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
SIROPORT
K800172 · Siemens Corp. · Feb 1980