dima Print Teeth & Temp— 510(k) K233868

Substantially Equivalent

Kulzer, LLC

FDA 510(k) clearance K233868 for dima Print Teeth & Temp, Substantially Equivalent on 2024-05-23. Applicant: Kulzer, LLC. Device class: 2.

Clearance details

Applicant: Kulzer, LLC
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2023-12-06
Decision date: 2024-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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