ESPE TULUX-CEM— 510(k) K891020

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K891020 for ESPE TULUX-CEM, Substantially Equivalent on 1989-05-26. 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: 1989-02-28
Decision date: 1989-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

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.