Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
Summary
Nobel Biocare Services AG received 510(k) clearance for Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray, a KCT device. Cleared on 2021-12-18.
Details
Source
510(k) Clearance
External ID
K212932
Action Date
2021-12-18
Status
Traditional
Category
device
Product Code
KCT
Product Description
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray. Product code: KCT.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Nobel Biocare Services AG has received 5 total clearances in our database.
Nobel Biocare Services AG has 5 FDA actions in our database, including 5 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Nobel Biocare Services AG have FDA actions?
Nobel Biocare Services AG has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212932" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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