Cleared Traditional

K885189 - MASSAGING PICK FOR ORAL HYGIENE

K885189 is an FDA 510(k) clearance for MASSAGING PICK FOR ORAL HYGIENE, manufactured by Dentek Corp.. The device is a Class 1 Dental device with product code JET cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K885189 · Dentek Corp. · Dental device
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Mar 1989
Decision
91d
Days
Class 1
Risk

K885189 is an FDA 510(k) clearance for the MASSAGING PICK FOR ORAL HYGIENE. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Dentek Corp. (Novato, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 91 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 Dentek Corp. devices

FDA 510(k) Submission Details - K885189

510(k) Number K885189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1988
Decision Date March 17, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 128d · This submission: 91d
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.