Cleared Traditional

K881046 - SUPER PIK MASSAGING PICK FOR ORAL HYGIENE

K881046 is an FDA 510(k) clearance for SUPER PIK MASSAGING PICK FOR ORAL HYGIENE, manufactured by U.S. Dentek Corp.. The device is a Class 1 Dental device with product code JET cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K881046 · U.S. Dentek Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
63d
Days
Class 1
Risk

K881046 is an FDA 510(k) clearance for the SUPER PIK MASSAGING PICK FOR ORAL HYGIENE. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by U.S. Dentek Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K881046

510(k) Number K881046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1988
Decision Date May 13, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 128d · This submission: 63d
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.

Regulatory Peers - JET Pick, Massaging

All 12
Devices cleared under the same product code (JET) and FDA review panel - the closest regulatory comparables to K881046.
PLAKOF
K890910 · Ximex, Ltd. · Mar 1989
FLOSSIE
K883225 · Richard G. Deniro · Aug 1988
PERMA-PIC PLASTIC TOOTHPICK
K881900 · The Perma-Pic Co. · Jun 1988
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH
K860779 · William J. Forni, D.D.S. · Apr 1986
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN
K832949 · Coopercare, Inc. · Oct 1983
FIXIDENT
K821629 · Moyco Industries, Inc. · Jun 1982
K881046 · SUPER PIK MASSAGING PICK FOR ORAL HYGIENE
Download PDF U.S. Dentek Corp.