KETAC-CEM MAXICAP— 510(k) K897188

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K897188 for KETAC-CEM MAXICAP, Substantially Equivalent on 1990-03-27. Applicant: Espe GmbH (Us). Device class: 2.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1989-12-28
Decision date: 1990-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

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K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

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.