Cleared Traditional

NobelProcera Zirconia Implant Bridge

K202452 · Nobel Biocare AB · Dental

Dec 2020

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K202452 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 Gotlands Lan, SE). The FDA issued a Cleared decision on December 3, 2020, 98 days after receiving the submission on August 27, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K202452 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2020
Decision Date	December 03, 2020
Days to Decision	98 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.