Cleared Traditional

NobelZygoma TiUltra Implant system

K243834 · Nobel Biocare AB · Dental
Aug 2025
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K243834 is an FDA 510(k) clearance for the NobelZygoma TiUltra Implant system, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on August 25, 2025, 255 days after receiving the submission on December 13, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K243834 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date August 25, 2025
Days to Decision 255 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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