Cleared Traditional

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

K233208 · Nobel Biocare AB · Dental

Jan 2024

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K233208 is an FDA 510(k) clearance for the NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium, 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 24, 2024, 118 days after receiving the submission on September 28, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K233208 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	January 24, 2024
Days to Decision	118 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.