Cleared Traditional

K892937 - REUSABLE BOWL AND SPATULA FOR MIXING BO...

K892937 is the FDA 510(k) clearance for REUSABLE BOWL AND SPATULA FOR MIXING BO... by Dentsply Intl.. It is a Class 1 Orthopedic device (product code JDZ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K892937 · Dentsply Intl. · Orthopedic device
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Jun 1989
Decision
62d
Days
Class 1
Risk

K892937 is an FDA 510(k) clearance for the REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS. Classified as Mixer, Cement, For Clinical Use (product code JDZ), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4210 - 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 K892937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date June 22, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JDZ Mixer, Cement, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4210
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.

Regulatory Peers - JDZ Mixer, Cement, For Clinical Use

All 11
Devices cleared under the same product code (JDZ) and FDA review panel - the closest regulatory comparables to K892937.
EXACTECH ALL POLY ACETABULAR CUP
K934253 · Exactech, Inc. · Apr 1994
PRISM BONE CEMENT MIXING SYSTEM
K925025 · Depuy, Inc. · Jan 1994
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190 · Stryker Corp. · Aug 1991
ZIMMER VACUUM MIXING SYSTEM
K861086 · Zimmer, Inc. · Apr 1986
MIX EVAC II
K854077 · Stryker Corp. · Jan 1986
SIMPLEX ENHANCEMENT MIXER
K853310 · Howmedica Corp. · Sep 1985