PROTEMP H— 510(k) K002364

Substantially Equivalent

Espe Dental AG

FDA 510(k) clearance K002364 for PROTEMP H, Substantially Equivalent on 2000-08-10. Applicant: Espe Dental AG. Device class: 2.

Clearance details

Applicant: Espe Dental AG
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2000-08-03
Decision date: 2000-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

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