Cleared Traditional

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT

K992582 · Pacific Implant, Inc. · Dental
Oct 1999
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K992582 is an FDA 510(k) clearance for the PACIFIC IMPLANT TITANIUM ENDODONTIC POINT, a Point, Silver, Endodontic (Class I — General Controls, product code EKL), submitted by Pacific Implant, Inc. (Washington, US). The FDA issued a Cleared decision on October 21, 1999, 80 days after receiving the submission on August 2, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3840.

Submission Details

510(k) Number K992582 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1999
Decision Date October 21, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKL — Point, Silver, Endodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3840