Cleared Traditional

K834545 - POCKETIP 4414

K834545 is an FDA 510(k) clearance for POCKETIP 4414, manufactured by Vipont Laboratories, Inc.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K834545 · Vipont Laboratories, Inc. · Dental device
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Mar 1984
Decision
94d
Days
Class 1
Risk

K834545 is an FDA 510(k) clearance for the POCKETIP 4414. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Vipont Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 94 days - within the typical 510(k) review window.

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 Vipont Laboratories, Inc. devices

FDA 510(k) Submission Details - K834545

510(k) Number K834545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1983
Decision Date March 30, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 128d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

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.