3Delta UNlimited— 510(k) K243720

Substantially Equivalent

Deltamed GmbH

FDA 510(k) clearance K243720 for 3Delta UNlimited, Substantially Equivalent on 2024-12-18. Applicant: Deltamed GmbH. Device class: 2.

Clearance details

Applicant: Deltamed GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2024-12-03
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friedberg, DE

Download summary PDF View on FDA.gov ↗

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More clearances from Deltamed GmbH

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K211804 — 3Delta Crown2021-12-06
K200039 — P pro Crown & Bridge2020-07-31
K102776 — EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM2011-02-18

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