Cleared Traditional

K851881 - ORTHOPEADIC CEMENT DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Orthopedic device.

K851881 · Dentsply Intl. · Orthopedic device
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Jun 1985
Decision
45d
Days
Class 1
Risk

K851881 is an FDA 510(k) clearance for the ORTHOPEADIC CEMENT DELIVERY SYSTEM. Classified as Dispenser, Cement (product code KIH), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4200 - the FDA orthopedic 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 Dentsply Intl. devices

Submission Details

510(k) Number K851881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date June 13, 1985
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIH Dispenser, Cement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4200
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.