EKS · Class I · 21 CFR 872.4565

FDA Product Code EKS: File, Pulp Canal, Endodontic

Leading manufacturers include Miltex, Inc., Tycom Dental and Dental Power, Inc..

31

Total

31

Cleared

83d

Avg days

1980

Since

FDA 510(k) Cleared File, Pulp Canal, Endodontic Devices (Product Code EKS)

31 devices

1–24 of 31

Cleared Dec 13, 2006

TF ROTARY NICKEL TITANIUM FILE

Cleared Mar 28, 2001

Dental Power, Inc.

Cleared May 22, 1997

NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES

Cleared May 16, 1997

Cleared Jun 04, 1996

QUANTEC SERIES 2000 ENDODONTIC FILES

Cleared Sep 28, 1995

SHAPING HEDSTROM N.T.

Sybron Dental Specialties, Inc.

Cleared Apr 03, 1991

DENTAURUM CERAMIC DEBONDING UNIT

Dentauraum, Inc.

Cleared Aug 14, 1990

J. Morita USA, Inc.

Cleared Nov 24, 1982

DENTAL INSTRUMENTS - FILES

Cleared Nov 24, 1982

DENTAL INSTRUMENTS - EXCAVATORS

Cleared Feb 19, 1980

FILE, PULP CANAL

About Product Code EKS - Regulatory Context

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