CEREC Cercon 4D CAD/CAM Blocks— 510(k) K242462

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K242462 for CEREC Cercon 4D CAD/CAM Blocks, Substantially Equivalent on 2024-10-24. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2024-08-19
Decision date: 2024-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Dentsply Sirona

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K260785 — DS Core CBCT Anatomy2026-04-23
K253959 — Primevision 3D2026-02-05
K252343 — Atlantis® Abutments in Titanium2025-12-09
K252248 — CEREC Tessera Abutment System2025-11-26

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