STERILE SUREFLEX FILES AND INSTRUMENTS— 510(k) K971603

Name: FDA 510(k) clearance K971603
Creator: U.S. Food and Drug Administration
Published: 1997-06-04

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K971603 for STERILE SUREFLEX FILES AND INSTRUMENTS, Substantially Equivalent on 1997-06-04. Applicant: Dentsply Intl.. Device class: 1.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1997-05-01
Decision date: 1997-06-04
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.