FLEXICAST— 510(k) K003509

Substantially Equivalent

American Dent-All, Inc.

FDA 510(k) clearance K003509 for FLEXICAST, Substantially Equivalent on 2001-01-02. Applicant: American Dent-All, Inc.. Device class: 2.

Clearance details

Applicant: American Dent-All, Inc.
Product code: Code EJH
Device class: Class 2
Regulation: 21 CFR 872.3710
Advisory panel: Dental
Date received: 2000-11-14
Decision date: 2001-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

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