Cleared Traditional

K051342 - MEDICAL INTERPOROUS

K051342 is an FDA 510(k) clearance for MEDICAL INTERPOROUS, manufactured by Bonyf AG. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K051342 · Bonyf AG · Dental device
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Jun 2006
Decision
375d
Days
Class 1
Risk

K051342 is an FDA 510(k) clearance for the MEDICAL INTERPOROUS. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Bonyf AG (Silver Creek, US). The FDA issued a Cleared decision on June 2, 2006 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - 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.

FDA 510(k) Submission Details - K051342

510(k) Number K051342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2005
Decision Date June 02, 2006
Days to Decision 375 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 128d · This submission: 375d
Pathway characteristics
Predicate-based equivalence.

EFT Device Classification - Class 1, General Controls

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
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 - EFT Cleanser, Denture, Over The Counter

All 23
Devices cleared under the same product code (EFT) and FDA review panel - the closest regulatory comparables to K051342.
CLEANSE.FRESHEN.GO
K080631 · Oral Health Technologies, LLC · May 2008
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
K000996 · Dentsply Intl. · Jun 2000
OTC DENTURE CLEANSER
K942203 · Combe, Inc. · Aug 1994
PROFAST(R)-DENTURE CLEANSER
K930337 · Fittydent-Altwirth & Schmitt GmbH · Sep 1993
DENTURE PRODUCT X
K914257 · Essential Dental Systems, Inc. · Jan 1993
CFR MONOGRAPH
K925259 · Combe, Inc. · Jan 1993
K051342 · MEDICAL INTERPOROUS
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