Cleared Traditional

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

K060530 · Lifecore Biomedical, Inc. · Dental
May 2006
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K060530 is an FDA 510(k) clearance for the SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302., a Teeth, Porcelain (Class II — Special Controls, product code ELL), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on May 22, 2006, 83 days after receiving the submission on February 28, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number K060530 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2006
Decision Date May 22, 2006
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELL — Teeth, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3920

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