Cleared Traditional

K770600 - OROPHARYNGEAL SUCTION AIRWAY

K770600 is an FDA 510(k) clearance for OROPHARYNGEAL SUCTION AIRWAY, manufactured by W.H. Wall, D.D.S.. The device is a Class 1 Dental device with product code EBR cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K770600 · W.H. Wall, D.D.S. · Dental device
Download Printable Device Report (PDF)
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Apr 1977
Decision
10d
Days
Class 1
Risk

K770600 is an FDA 510(k) clearance for the OROPHARYNGEAL SUCTION AIRWAY. Classified as Unit, Suction Operatory (product code EBR), Class I - General Controls.

Submitted by W.H. Wall, D.D.S. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1977 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 W.H. Wall, D.D.S. devices

FDA 510(k) Submission Details - K770600

510(k) Number K770600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1977
Decision Date April 08, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

EBR Device Classification - Class 1, General Controls

Product Code EBR Unit, Suction Operatory
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.