Cleared Abbreviated

PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS

K050506 · Lifecore Biomedical, Inc. · Dental
Apr 2005
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K050506 is an FDA 510(k) clearance for the PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on April 15, 2005, 46 days after receiving the submission on February 28, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K050506 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2005
Decision Date April 15, 2005
Days to Decision 46 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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