Cleared Traditional

K202344 - TiUltra Implants and Xeal Abutments

K202344 is the FDA 510(k) clearance for TiUltra Implants and Xeal Abutments by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K202344 · Nobel Biocare AB · Dental device
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Nov 2020
Decision
90d
Days
Class 2
Risk

K202344 is an FDA 510(k) clearance for the TiUltra Implants and Xeal Abutments. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Vastra Hamngatan 1, SE). The FDA issued a Cleared decision on November 16, 2020 after a review of 90 days - within the typical 510(k) review window.

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 AB devices

Submission Details

510(k) Number K202344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2020
Decision Date November 16, 2020
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K202344.
Neodent Implant System - Zirconia Implant System
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S.I.N. Dental Implant System
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JTK Dental Implant System
K183044 · Jiangyin Jintech Biotech Co., Ltd. · Nov 2020
MS Lide Implant Systems
K181477 · Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. · Oct 2020
MINICONE Implant
K200906 · Medentika GmbH · Oct 2020