REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS— 510(k) K892937

Name: FDA 510(k) clearance K892937
Creator: U.S. Food and Drug Administration
Published: 1989-06-22

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K892937 for REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS, Substantially Equivalent on 1989-06-22. Applicant: Dentsply Intl.. Device class: 1.

Clearance details

Applicant: Dentsply Intl.
Product code: Code JDZ
Device class: Class 1
Regulation: 21 CFR 888.4210
Advisory panel: Orthopedic
Date received: 1989-04-21
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDZ

view all

K934253 — EXACTECH ALL POLY ACETABULAR CUP1994-04-29
K925025 — PRISM BONE CEMENT MIXING SYSTEM1994-01-05
K912190 — STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST1991-08-29
K861086 — ZIMMER VACUUM MIXING SYSTEM1986-04-14
K854077 — MIX EVAC II1986-01-31

More clearances from Dentsply Intl.

view all

K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC2013-02-22
K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS2008-03-27
K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE2007-03-14
K070019 — CARRARA VOLUMIA2007-01-26
K061427 — PRE-IMPRESSION CONDITIONING SOLUTION2006-06-26

Adverse events under product code JDZ

product code JDZ

Malfunction: 461
Total: 461

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.