Cleared Traditional

COMPACT PLUS - EXTREME - PERFECT PLUS (K052574) - FDA 510(k) Clearance

Class I Dental device.

K052574 · J.O. Suarez & Cia, Ltda · Dental device
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Jul 2006
Decision
301d
Days
Class 1
Risk

K052574 is an FDA 510(k) clearance for the COMPACT PLUS - EXTREME - PERFECT PLUS. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by J.O. Suarez & Cia, Ltda (Aldeinha, Barueri, Sp, BR). The FDA issued a Cleared decision on July 17, 2006 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 J.O. Suarez & Cia, Ltda devices

Submission Details

510(k) Number K052574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2005
Decision Date July 17, 2006
Days to Decision 301 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
174d slower than avg
Panel avg: 127d · This submission: 301d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

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