SUREFLEX FILES— 510(k) K951607

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K951607 for SUREFLEX FILES, Substantially Equivalent on 1995-06-22. Applicant: Dentsply Intl.. Device class: 1.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EKJ
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1995-03-16
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKJ

K961714 — ASEPTYLUM, UNI-CARRIER1996-06-10
K953707 — MEDTROL DENTAL KIT1996-01-04
K945815 — DENTAL KIT1995-07-19
K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL1994-11-30
K943820 — STAT PAK1994-11-02

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