ECLIPSE BONDING AGENT— 510(k) K051707

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K051707 for ECLIPSE BONDING AGENT, Substantially Equivalent on 2005-07-15. 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: 2005-06-27
Decision date: 2005-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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K061427 — PRE-IMPRESSION CONDITIONING SOLUTION2006-06-26

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