IPS e.max One— 510(k) K211916

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K211916 for IPS e.max One, Substantially Equivalent on 2021-08-20. Applicant: Ivoclar Vivadent, AG. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-06-21
Decision date: 2021-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaan, LI

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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More clearances from Ivoclar Vivadent, AG

K210804 — Adhese Universal DC, Cention Primer2022-06-07
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K191448 — Barrier Sleeves2019-10-08
K191382 — IPS e.max CAD Abutment Solutions- extra systems2019-08-26

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