DYRACT SEAL COMPOMER PIT & FISSURE SEALANT— 510(k) K992516

Name: FDA 510(k) clearance K992516
Creator: U.S. Food and Drug Administration
Published: 1999-08-27

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K992516 for DYRACT SEAL COMPOMER PIT & FISSURE SEALANT, Substantially Equivalent on 1999-08-27. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1999-07-28
Decision date: 1999-08-27
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.