Cleared Traditional

K800735 - U-STYLE ADAPTER

K800735 is an FDA 510(k) clearance for U-STYLE ADAPTER, manufactured by American Midwest. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K800735 · American Midwest · Dental device
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Apr 1980
Decision
8d
Days
Class 1
Risk

K800735 is an FDA 510(k) clearance for the U-STYLE ADAPTER. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by American Midwest (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 American Midwest devices

FDA 510(k) Submission Details - K800735

510(k) Number K800735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1980
Decision Date April 10, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 128d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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.