Cleared Traditional

K790984 - KLIP-LITE

K790984 is an FDA 510(k) clearance for KLIP-LITE, manufactured by Innovators, Inc.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 150-day FDA review.

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

FDA 510(k) Submission Details - K790984

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.

EAZ Device Classification - Class 1, General Controls

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.