Cleared Traditional

SDI POLYCARBONATE CROWN, SCHEIN'S (K892893) - FDA 510(k) Clearance

Class I Dental device.

K892893 · Svenska Dental Instruments AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
47d
Days
Class 1
Risk

K892893 is an FDA 510(k) clearance for the SDI POLYCARBONATE CROWN, SCHEIN'S. Classified as Crown, Preformed (product code ELZ), Class I - General Controls.

Submitted by Svenska Dental Instruments AB (Sweden, SE). The FDA issued a Cleared decision on June 6, 1989 after a review of 47 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 Svenska Dental Instruments AB devices

Submission Details

510(k) Number K892893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date June 06, 1989
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
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.