RCT GEL ROOT CANAL THERAPY GEL— 510(k) K972234

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K972234 for RCT GEL ROOT CANAL THERAPY GEL, Substantially Equivalent on 1997-06-30. Applicant: Dentsply Intl.. Device class: 1.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EIC
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1997-06-16
Decision date: 1997-06-30
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.