ORTHOPEADIC CEMENT DELIVERY SYSTEM— 510(k) K851881

Name: FDA 510(k) clearance K851881
Creator: U.S. Food and Drug Administration
Published: 1985-06-13

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K851881 for ORTHOPEADIC CEMENT DELIVERY SYSTEM, Substantially Equivalent on 1985-06-13. Applicant: Dentsply Intl.. Device class: 1.

Clearance details

Applicant: Dentsply Intl.
Product code: Code KIH
Device class: Class 1
Regulation: 21 CFR 888.4200
Advisory panel: Orthopedic
Date received: 1985-04-29
Decision date: 1985-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIH

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K042591 — SMARTMIX PRE-FILLED MIXING SYSTEM2004-10-22
K943906 — P.F.C. CEMENT PRESSURIZING SYSTEM1994-12-21
K897134 — CMW CEMENT PRESSURISATION SYSTEM1990-03-02
K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENT1984-02-09
K833675 — BRIGHAM TIBIAL CEMENT PRESSURIZER1983-12-12

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Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

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.