Cleared Abbreviated

PRIMACONNEX CAD/CAM ABUTMENT SYSTEM

K072241 · Lifecore Biomedical, Inc. · Dental

Nov 2007

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K072241 is an FDA 510(k) clearance for the PRIMACONNEX CAD/CAM ABUTMENT SYSTEM, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on November 9, 2007, 88 days after receiving the submission on August 13, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K072241 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2007
Decision Date	November 09, 2007
Days to Decision	88 days
Submission Type	Abbreviated
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.