CAULK OPAQUER— 510(k) K813357

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K813357 for CAULK OPAQUER, Substantially Equivalent on 1982-01-07. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1981-11-27
Decision date: 1982-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.