Cleared Traditional

MEDICAL INTERPOROUS (K051342) - FDA 510(k) Clearance

Class I Dental device.

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.

View all Bonyf AG devices

Submission Details

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
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 127d · This submission: 375d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.