Cleared Traditional

SUREFLEX FILES

K951607 · Dentsply Intl. · Dental
Jun 1995
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K951607 is an FDA 510(k) clearance for the SUREFLEX FILES, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 22, 1995, 98 days after receiving the submission on March 16, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K951607 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1995
Decision Date June 22, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKJ — Burnisher, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565