ESPE(R) -SIL— 510(k) K913965

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K913965 for ESPE(R) -SIL, Substantially Equivalent on 1991-12-04. Applicant: Espe GmbH (Us). Device class: 2.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1991-09-05
Decision date: 1991-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Germany, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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More clearances from Espe GmbH (Us)

K925027 — PHOTAC-FIL APLICAP1993-06-18
K913966 — SONO(R) -CEM1992-01-14
K915005 — PHOTAC-BOND APLICAP, MODIFICATION1992-01-14
K913857 — ROCATEC(R) -PLUS1991-12-16
K905604 — VISIO-GEM ART-SYSTEM1991-03-29

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