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FDA 510(k)

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

K-Number: K212932 · 2021-12-18

ApplicantNobel Biocare Services AG
Decision Date2021-12-18
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray is a medical device manufactured by Nobel Biocare Services AG. It received FDA 510(k) clearance on 2021-12-18 under approval number K212932. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray?

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray is a medical device that received FDA 510(k) clearance on 2021-12-18. It is manufactured by Nobel Biocare Services AG. The 510(k) number is K212932.

When was Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray approved by the FDA?

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray received FDA 510(k) clearance on 2021-12-18, under approval number K212932.

What company makes Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray?

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray is manufactured by Nobel Biocare Services AG.

What is the FDA product code for Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray?

The FDA product code for Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray is KCT.

Related Clinical Trials

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Other Devices by Nobel Biocare Services AG

K211109N1 TiUltra TCC Implant System K220339Esthetic Abutments Nobel Biocare N1 K220048NobelProcera Zirconia N1 Base K231219NobelZygoma PureSet™ Tray

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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