Cleared Traditional

K910610 - INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT

K910610 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 147-day FDA review.

K910610 · Bausch & Lomb, Inc. · Dental device
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Jul 1991
Decision
147d
Days
Class 1
Risk

K910610 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 July 9, 1991 after a review of 147 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K910610

510(k) Number K910610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date July 09, 1991
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 128d · This submission: 147d
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 K910610.
F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND
K920644 · Fairform Mfg., Co., Ltd. · May 1992
POWER FLOSS AND BRUSH EW 129 & EW 120
K914198 · Matsushita Electric Co. · Dec 1991
MERIDIEN DENTAL SYSTEMS
K903488 · Anco Merchandise Co., Ltd. · Jul 1991
BATTERY-POWERED TOOTHBRUSH
K904401 · The B & F System, Inc. · Dec 1990
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
K903510 · Helm Toy Corp. · Sep 1990
OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
K901963 · Omron Marshall Products, Inc. · Jun 1990
K910610 · INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
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