Cleared Traditional

K141576 - Maxima PRO 45L

K141576 is an FDA 510(k) clearance for Maxima PRO 45L, manufactured by Kavo DO Brasil Industria E Comercio Ltda. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K141576 · Kavo DO Brasil Industria E Comercio Ltda · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
326d
Days
Class 1
Risk

K141576 is an FDA 510(k) clearance for the Maxima PRO 45L. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Kavo DO Brasil Industria E Comercio Ltda (Santa Catarina, BR). The FDA issued a Cleared decision on May 4, 2015 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 - K141576

510(k) Number K141576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2014
Decision Date May 04, 2015
Days to Decision 326 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 128d · This submission: 326d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 247
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K141576 · Maxima PRO 45L
Download PDF FDA Summary Kavo DO Brasil Indust…