Cleared Traditional

INTERPORE THREADED IMPLANT

K960371 · Interpore Intl. · Dental
Mar 1996
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K960371 is an FDA 510(k) clearance for the INTERPORE THREADED IMPLANT, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on March 8, 1996, 42 days after receiving the submission on January 26, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K960371 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1996
Decision Date March 08, 1996
Days to Decision 42 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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