Cleared Traditional

Nobel Biocare S Series Implants

K252197 · Nobel Biocare AB · Dental
Feb 2026
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K252197 is an FDA 510(k) clearance for the Nobel Biocare S Series Implants, 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 February 18, 2026, 219 days after receiving the submission on July 14, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K252197 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2025
Decision Date February 18, 2026
Days to Decision 219 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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