Cleared Traditional

K212932 - Nobel Biocare NobelSpeedy Groovy / Bran...

K212932 is an FDA 510(k) clearance for Nobel Biocare NobelSpeedy Groovy / Bran..., manufactured by Nobel Biocare Services AG. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K212932 · Nobel Biocare Services AG · General Hospital
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Dec 2021
Decision
94d
Days
Class 2
Risk

K212932 is an FDA 510(k) clearance for the Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace .... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Nobel Biocare Services AG (Goteborg, SE). The FDA issued a Cleared decision on December 18, 2021 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K212932

510(k) Number K212932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2021
Decision Date December 18, 2021
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

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All 171
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