Cleared Traditional

K883761 - IONODENT II (6 VOLTS)

K883761 is an FDA 510(k) clearance for IONODENT II (6 VOLTS), manufactured by U.S. Apatite Corp.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883761 · U.S. Apatite Corp. · Dental device
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Dec 1988
Decision
90d
Days
Class 1
Risk

K883761 is an FDA 510(k) clearance for the IONODENT II (6 VOLTS). Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by U.S. Apatite Corp. (Canoga Park, US). The FDA issued a Cleared decision on December 5, 1988 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 872.6855 - 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 U.S. Apatite Corp. devices

FDA 510(k) Submission Details - K883761

510(k) Number K883761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date December 05, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EFW Device Classification - Class 1, General Controls

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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 - EFW Toothbrush, Manual

All 15
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K883761.
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · Procter & Gamble Co. · Mar 1998
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · Personal Products Co. · Jul 1997
ORALCHEK SUPER-SOFT BRUSH
K892264 · Pfizer, Inc. · Jun 1989
REACH* TOOTHBRUSH
K834580 · Johnson & Johnson Professionals, Inc. · Feb 1984
TOOTHBRUSH, REACH
K770749 · Johnson & Johnson Professionals, Inc. · Jun 1977
DENTAL STAIN REMOVER
K761352 · Concept, Inc. · Jan 1977