Endofill— 510(k) K231387

Substantially Equivalent

Lumendo AG

FDA 510(k) clearance K231387 for Endofill, Substantially Equivalent on 2023-07-10. Applicant: Lumendo AG. Device class: 2.

Clearance details

Applicant: Lumendo AG
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2023-05-12
Decision date: 2023-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Renens, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Lumendo AG

K232076 — Fibercure2023-11-02

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