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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 the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2021-12-18 under 510(k) 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. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K212932.

When did Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Nobel Biocare Services AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231219NobelZygoma PureSet™ TrayK220339Esthetic Abutments Nobel Biocare N1K220048NobelProcera Zirconia N1 BaseK211109N1 TiUltra TCC Implant System

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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