Cleared Traditional

NobelProcera Zirconia Implant Bridge

K240346 · Nobel Biocare AB · Dental

Jan 2025

Decision

333d

Days

Class 2

Risk

About This 510(k) Submission

K240346 is an FDA 510(k) clearance for the NobelProcera Zirconia Implant Bridge, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on January 3, 2025, 333 days after receiving the submission on February 5, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K240346 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2024
Decision Date	January 03, 2025
Days to Decision	333 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.