Cleared Traditional

PULPDENT ENDOPREP II

K961089 · Pulpdent Corp. · Dental

Apr 1996

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K961089 is an FDA 510(k) clearance for the PULPDENT ENDOPREP II, a Point, Silver, Endodontic (Class I — General Controls, product code EKL), submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on April 23, 1996, 35 days after receiving the submission on March 19, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3840.

Submission Details

510(k) Number	K961089 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 1996
Decision Date	April 23, 1996
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF