Cleared Traditional

ADA SHANK EXTENSION

K914724 · Implant Corp. of America · Dental
Jul 1993
Decision
648d
Days
Class 1
Risk

About This 510(k) Submission

K914724 is an FDA 510(k) clearance for the ADA SHANK EXTENSION, a Drill, Dental, Intraoral (Class I — General Controls, product code DZA), submitted by Implant Corp. of America (St. Petersburg, US). The FDA issued a Cleared decision on July 27, 1993, 648 days after receiving the submission on October 18, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number K914724 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 1991
Decision Date July 27, 1993
Days to Decision 648 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DZA — Drill, Dental, Intraoral
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4130

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