Cleared Traditional

K954790 - PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
(FDA 510(k) Clearance)

K954790 · Tulsa Dental Products, Ltd. · Dental

Jan 1996

Decision

89d

Days

Class 1

Risk

K954790 is an FDA 510(k) clearance for the PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS. This device is classified as a Drill, Dental, Intraoral (Class I — General Controls, product code DZA).

Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on January 16, 1996, 89 days after receiving the submission on October 19, 1995.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number	K954790 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1995
Decision Date	January 16, 1996
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF