K254063

Substantially Equivalent

iCEM Universal Plus

Applicant: Kulzer, LLC
Product code: EMA
Advisory panel: Dental
Date received: 2025-12-17
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: South Bend, IN, US

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