Cleared Traditional

K820944 - DENTAL ARCH BAR

K820944 is an FDA 510(k) clearance for DENTAL ARCH BAR, manufactured by Unisplint Corp.. The device is a Class 2 Dental device with product code DYX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K820944 · Unisplint Corp. · Dental device
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May 1982
Decision
29d
Days
Class 2
Risk

K820944 is an FDA 510(k) clearance for the DENTAL ARCH BAR. Classified as Lock, Wire, And Ligature, Intraoral (product code DYX), Class II - Special Controls.

Submitted by Unisplint Corp. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4600 - 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 Unisplint Corp. devices

FDA 510(k) Submission Details - K820944

510(k) Number K820944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1982
Decision Date May 05, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYX Device Classification - Class 2, Special Controls

Product Code DYX Lock, Wire, And Ligature, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.