Orthocem, Ortho Bite— 510(k) K192682

Substantially Equivalent

Dentscare Ltda

FDA 510(k) clearance K192682 for Orthocem, Ortho Bite, Substantially Equivalent on 2020-08-14. Applicant: Dentscare Ltda. Device class: 2.

Clearance details

Applicant: Dentscare Ltda
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2019-09-26
Decision date: 2020-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Joinville, BR

Download summary PDF View on FDA.gov ↗

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