SINFONY— 510(k) K992645

Substantially Equivalent

Espe Dental AG

FDA 510(k) clearance K992645 for SINFONY, Substantially Equivalent on 1999-09-22. Applicant: Espe Dental AG. Device class: 2.

Clearance details

Applicant: Espe Dental AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1999-08-06
Decision date: 1999-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

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K001494 — MODIFICATION TO PROMPT L-POP2000-07-07

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