Tetric PowerFill— 510(k) K183380

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K183380 for Tetric PowerFill, Substantially Equivalent on 2019-03-14. Applicant: Ivoclar Vivadent, AG. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2018-12-06
Decision date: 2019-03-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Schaan, LI

Download summary PDF View on FDA.gov ↗

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