Cleared Abbreviated

ABSOLUTE AMERICA (K050571) - FDA 510(k) Clearance

Class I Dental device.

K050571 · Eurodent S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
243d
Days
Class 1
Risk

K050571 is an FDA 510(k) clearance for the ABSOLUTE AMERICA. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Eurodent S.P.A. (Hoboken, US). The FDA issued a Cleared decision on November 2, 2005 after a review of 243 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Eurodent S.P.A. devices

Submission Details

510(k) Number K050571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2005
Decision Date November 02, 2005
Days to Decision 243 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 127d · This submission: 243d
Pathway characteristics
Standards-based clearance path.

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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