Cleared Traditional

CERAMIC PEDATRIC PREFORMED CROWN (K091362) - FDA 510(k) Clearance

Class I Dental device.

K091362 · Ez-Pedo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
52d
Days
Class 1
Risk

K091362 is an FDA 510(k) clearance for the CERAMIC PEDATRIC PREFORMED CROWN. Classified as Crown, Preformed (product code ELZ), Class I - General Controls.

Submitted by Ez-Pedo, Inc. (Roseville, US). The FDA issued a Cleared decision on June 29, 2009 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3330 - 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.

View all Ez-Pedo, Inc. devices

Submission Details

510(k) Number K091362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date June 29, 2009
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELZ Crown, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3330
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.