Cleared Traditional

K790984 - KLIP-LITE (FDA 510(k) Clearance)

Class I Dental device.

K790984 · Innovators, Inc. · Dental device
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Oct 1979
Decision
150d
Days
Class 1
Risk

K790984 is an FDA 510(k) clearance for the KLIP-LITE. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Innovators, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1979 after a review of 150 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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. Standard predicate reliance. 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 Innovators, Inc. devices

Submission Details

510(k) Number K790984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1979
Decision Date October 22, 1979
Days to Decision 150 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.