VISIO-GEM ART-SYSTEM— 510(k) K905604

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K905604 for VISIO-GEM ART-SYSTEM, Substantially Equivalent on 1991-03-29. Applicant: Espe GmbH (Us). Device class: 2.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1990-12-11
Decision date: 1991-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

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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
K913965 — ESPE(R) -SIL1991-12-04

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