Cleared Special

K073032 - PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (FDA 510(k) Clearance)

K073032 · Lifecore Biomedical, Inc. · Dental
Nov 2007
Decision
21d
Days
Class 2
Risk

K073032 is an FDA 510(k) clearance for the PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS, 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 16, 2007, 21 days after receiving the submission on October 26, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number K073032 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2007
Decision Date November 16, 2007
Days to Decision 21 days
Submission Type Special
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.

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