ESPE CAPMIX— 510(k) K891064

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K891064 for ESPE CAPMIX, Substantially Equivalent on 1989-05-30. Applicant: Espe GmbH (Us). Device class: 1.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code EFD
Device class: Class 1
Regulation: 21 CFR 872.3100
Advisory panel: Dental
Date received: 1989-03-01
Decision date: 1989-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFD

K991913 — PENTAMIX 21999-07-26
K923974 — SILIMAT PLUS1992-10-06
K922203 — IPT CAPSULE MIXER1992-06-03
K915847 — AUTOMIX DENTAL AMALGAMATOR1992-03-02
K914340 — DUOMAT 3 AMALGAMATOR1991-11-13

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.