els extra low shrinkage® composite & els extra low shrinkage® flow— 510(k) K240823

Name: FDA 510(k) clearance K240823
Creator: U.S. Food and Drug Administration
Published: 2024-06-27

Substantially Equivalent

Saremco Dental AG

FDA 510(k) clearance K240823 for els extra low shrinkage® composite & els extra low shrinkage® flow, Substantially Equivalent on 2024-06-27. Applicant: Saremco Dental AG. Device class: 2.

Clearance details

Applicant: Saremco Dental AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2024-03-26
Decision date: 2024-06-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rebstein, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

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