PRIME & BOND DIRECT COMPOSITE BONDING AGENT— 510(k) K951864

Name: FDA 510(k) clearance K951864
Creator: U.S. Food and Drug Administration
Published: 1995-05-23

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K951864 for PRIME & BOND DIRECT COMPOSITE BONDING AGENT, Substantially Equivalent on 1995-05-23. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1995-04-21
Decision date: 1995-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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