Cleared Traditional

K211109 - N1 TiUltra TCC Implant System

K211109 is an FDA 510(k) clearance for N1 TiUltra TCC Implant System, manufactured by Nobel Biocare Services AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K211109 · Nobel Biocare Services AG · Dental device
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Dec 2021
Decision
251d
Days
Class 2
Risk

K211109 is an FDA 510(k) clearance for the N1 TiUltra TCC Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Services AG (Kloten, CH). The FDA issued a Cleared decision on December 21, 2021 after a review of 251 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare Services AG devices

FDA 510(k) Submission Details - K211109

510(k) Number K211109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2021
Decision Date December 21, 2021
Days to Decision 251 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 127d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K211109.
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