PENTAMIX 2— 510(k) K991913

Substantially Equivalent

Espe Dental AG

FDA 510(k) clearance K991913 for PENTAMIX 2, Substantially Equivalent on 1999-07-26. Applicant: Espe Dental AG. Device class: 1.

Clearance details

Applicant: Espe Dental AG
Product code: Code EFD
Device class: Class 1
Regulation: 21 CFR 872.3100
Advisory panel: Dental
Date received: 1999-06-07
Decision date: 1999-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFD

K923974 — SILIMAT PLUS1992-10-06
K922203 — IPT CAPSULE MIXER1992-06-03
K915847 — AUTOMIX DENTAL AMALGAMATOR1992-03-02
K914340 — DUOMAT 3 AMALGAMATOR1991-11-13
K914341 — MIXOMAT AMALGAMATOR1991-11-13

More clearances from Espe Dental AG

K011394 — LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM2001-06-29
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K002793 — KETAC CEM U2000-09-26
K002364 — PROTEMP H2000-08-10
K001494 — MODIFICATION TO PROMPT L-POP2000-07-07

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