Cleared Traditional

K935561 - INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT

K935561 is an FDA 510(k) clearance for INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT, manufactured by Bausch & Lomb, Inc.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K935561 · Bausch & Lomb, Inc. · Dental device
Download Printable Device Report (PDF)
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Jan 1994
Decision
70d
Days
Class 1
Risk

K935561 is an FDA 510(k) clearance for the INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Tucker, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - 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 - K935561

510(k) Number K935561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date January 26, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

JEQ Device Classification - Class 1, General Controls

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
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 - JEQ Toothbrush, Powered

All 47
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K935561.
SONIPLAK
K935150 · American Dentronics, Inc. · May 1994
SONIFLOSS
K935148 · American Dentronics, Inc. · Jan 1994
SONIBRUSH
K935149 · American Dentronics, Inc. · Jan 1994
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
K936076 · Ohio Health Care Products, Inc. · Jan 1994
PULSE ELECTRIC TOOTHBRUSH
K933829 · Dentatech Corp. · Dec 1993
ELECTRIC TOOTH-BRUSH
K931360 · U.S. Dentek Corp. · Jul 1993
K935561 · INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
Download PDF Bausch & Lomb, Inc.