Cleared Traditional

K963747 - REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.

K963747 is an FDA 510(k) clearance for REACH STIM-U-DENT PLAQUE REMOVERS WITH ..., manufactured by Whitehill Manufacturing, Inc.. The device is a Class 1 Dental device with product code JET cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963747 · Whitehill Manufacturing, Inc. · Dental device
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Dec 1996
Decision
90d
Days
Class 1
Risk

K963747 is an FDA 510(k) clearance for the REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRO.... Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Whitehill Manufacturing, Inc. (Hazlet, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - 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 Whitehill Manufacturing, Inc. devices

FDA 510(k) Submission Details - K963747

510(k) Number K963747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date December 16, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

JET Device Classification - Class 1, General Controls

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
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.