TEMPOCEM— 510(k) K110759

Substantially Equivalent

Dmg USA, Inc.

FDA 510(k) clearance K110759 for TEMPOCEM, Substantially Equivalent on 2011-06-10. Applicant: Dmg USA, Inc.. Device class: 1.

Clearance details

Applicant: Dmg USA, Inc.
Product code: Code EMB
Device class: Class 1
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2011-03-18
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ayer, MA, 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.