Cleared Traditional

K903488 - MERIDIEN DENTAL SYSTEMS

K903488 is an FDA 510(k) clearance for MERIDIEN DENTAL SYSTEMS, manufactured by Anco Merchandise Co., Ltd.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K903488 · Anco Merchandise Co., Ltd. · Dental device
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Jul 1991
Decision
342d
Days
Class 1
Risk

K903488 is an FDA 510(k) clearance for the MERIDIEN DENTAL SYSTEMS. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Anco Merchandise Co., Ltd. (Taipei, Taiwan, R.O.C., CN). The FDA issued a Cleared decision on July 9, 1991 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Anco Merchandise Co., Ltd. devices

FDA 510(k) Submission Details - K903488

510(k) Number K903488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date July 09, 1991
Days to Decision 342 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 127d · This submission: 342d
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 10
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K903488.
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · Bausch & Lomb, Inc. · Jan 1994
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K926246 · Omron Healthcare, Inc. · Apr 1993
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K926247 · Omron Healthcare, Inc. · Apr 1993
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K910610 · Bausch & Lomb, Inc. · Jul 1991