Cleared Traditional

K052574 - COMPACT PLUS - EXTREME - PERFECT PLUS

K052574 is an FDA 510(k) clearance for COMPACT PLUS - EXTREME - PERFECT PLUS, manufactured by J.O. Suarez & Cia, Ltda. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K052574 · J.O. Suarez & Cia, Ltda · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K052574

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.

EIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EIA Unit, Operative Dental

All 153
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K052574.
STERN'S S250 NORDAM
K092917 · Cefla S.C. · Jun 2010
KODAK 1500 INTRAORAL CAMERA
K091186 · Carestream Health, Inc. · Aug 2009
A-DEC 334/335 DELIVERY SYSTEM
K082985 · A-Dec, Inc. · Dec 2008
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · A-Dec, Inc. · Aug 2005
AEU-14CF EXPENDITION
K050201 · Aseptico, Inc. · Mar 2005
SPACELINE EMCIA, MODEL CU580
K043496 · J. Morita USA, Inc. · Feb 2005