Cleared Traditional

HEMO-WEDGE (K790555) - FDA 510(k) Clearance

Class I Dental device.

K790555 · Parker Laboratories, Inc. · Dental device
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Jan 1980
Decision
304d
Days
Class 1
Risk

K790555 is an FDA 510(k) clearance for the HEMO-WEDGE. Classified as Instruments, Dental Hand (product code DZN), Class I - General Controls.

Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Parker Laboratories, Inc. devices

Submission Details

510(k) Number K790555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1979
Decision Date January 17, 1980
Days to Decision 304 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 127d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZN Instruments, Dental Hand
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.