LUXATEMP ULTRA /STAR— 510(k) K101710

Substantially Equivalent

Dmg USA, Inc.

FDA 510(k) clearance K101710 for LUXATEMP ULTRA /STAR, Substantially Equivalent on 2010-09-28. Applicant: Dmg USA, Inc.. Device class: 2.

Clearance details

Applicant: Dmg USA, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2010-06-17
Decision date: 2010-09-28
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.