MODIFIED PERMAGUM ADHESIVE— 510(k) K881838

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K881838 for MODIFIED PERMAGUM ADHESIVE, Substantially Equivalent on 1988-07-27. Applicant: Espe GmbH (Us). Device class: 1.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code EBH
Device class: Class 1
Regulation: 21 CFR 872.3670
Advisory panel: Dental
Date received: 1988-05-02
Decision date: 1988-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBH

K933745 — PERMAGEN UNIVERSAL BONDING RESIN1994-01-26
K930487 — PALATRAY LC MINT1993-06-18
K923979 — LC TRAY MATERIAL1992-11-17
K923549 — PALADISC LC1992-09-29
K912820 — POLYESTER RESIN HAND MOLDED TRAY1991-08-21

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.