Cleared Traditional

LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT

K970776 · Lifecore Biomedical, Inc. · Dental
May 1997
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K970776 is an FDA 510(k) clearance for the LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT, 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 May 27, 1997, 84 days after receiving the submission on March 4, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K970776 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1997
Decision Date May 27, 1997
Days to Decision 84 days
Submission Type Traditional
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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