KETAC-GLAZE— 510(k) K884752

Substantially Equivalent

Espe GmbH (Us)

FDA 510(k) clearance K884752 for KETAC-GLAZE, Substantially Equivalent on 1989-01-19. Applicant: Espe GmbH (Us). Device class: 2.

Clearance details

Applicant: Espe GmbH (Us)
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1988-11-14
Decision date: 1989-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

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.