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
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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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 128d · 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 268
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K052574.
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
K070196 · Hr Dental Products, Inc. · Jan 2007
C-U2
K062897 · Cefla S.C.R.L. · Dec 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
K063302 · Shanghai Dental Instrument Factory · Nov 2006
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
K061175 · Sota Precision Optics, Inc. · May 2006
ABSOLUTE AMERICA
K050571 · Eurodent S.P.A. · Nov 2005
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
K052470 · Shanghai Fimet Medical Instrument Co., Ltd. · Nov 2005
K052574 · COMPACT PLUS - EXTREME - PERFECT PLUS
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