Cleared Traditional

L'LL SQUIRT GUM ORAL RINSE DEVICE (K897053) - FDA 510(k) Clearance

Class I Dental device.

K897053 · James R. Powell · Dental device
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Aug 1990
Decision
231d
Days
Class 1
Risk

K897053 is an FDA 510(k) clearance for the L'LL SQUIRT GUM ORAL RINSE DEVICE. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by James R. Powell (Elmira, US). The FDA issued a Cleared decision on August 6, 1990 after a review of 231 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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 James R. Powell devices

Submission Details

510(k) Number K897053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date August 06, 1990
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 127d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.