DENTI-TRAY(TM)— 510(k) K871493

Substantially Equivalent

Advanced Medical, Inc.

FDA 510(k) clearance K871493 for DENTI-TRAY(TM), Substantially Equivalent on 1987-06-24. Applicant: Advanced Medical, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Medical, Inc.
Product code: Code EKW
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1987-04-16
Decision date: 1987-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, 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.