Cleared Traditional

K073539 - PROVISA CEM (FDA 510(k) Clearance)

Class I Dental device.

K073539 · Cavex Holland BV · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
45d
Days
Class 1
Risk

K073539 is an FDA 510(k) clearance for the PROVISA CEM. Classified as Zinc Oxide Eugenol (product code EMB), Class I - General Controls.

Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on January 31, 2008 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K073539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2007
Decision Date January 31, 2008
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 127d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMB Zinc Oxide Eugenol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3275
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.