Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray— 510(k) K212932

Substantially Equivalent

Nobel Biocare Services AG

FDA 510(k) clearance K212932 for Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray, Substantially Equivalent on 2021-12-18. Applicant: Nobel Biocare Services AG. Device class: 2.

Clearance details

Applicant
Nobel Biocare Services AG
Product code
Code KCT
Device class
Class 2
Regulation
21 CFR 880.6850
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Goteborg, SE
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