3Shape Splint Design— 510(k) K191911

Substantially Equivalent

3Shape A/S

FDA 510(k) clearance K191911 for 3Shape Splint Design, Substantially Equivalent on 2019-11-27. Applicant: 3Shape A/S. Device class: 2.

Clearance details

Applicant: 3Shape A/S
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2019-07-17
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

Download summary PDF View on FDA.gov ↗

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