EKX · Class I · 21 CFR 872.4200

FDA Product Code EKX: Handpiece, Direct Drive, Ac-powered

Leading manufacturers include J. Morita USA, Inc., Aseptico, Inc. and W&H Dentalwerk Buermoos GmbH.

89

Total

89

Cleared

183d

Avg days

1976

Since

89 devices

49–72 of 89

Cleared Dec 15, 2009

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR

W&H Dentalwerk Buermoos GmbH

Cleared Aug 17, 2007

J. Morita USA, Inc.

Cleared Mar 31, 2006

Sirona Dental Systems GmbH

Cleared Sep 06, 2005

IMPLANT HANDPIECES

Sirona Dental Systems GmbH

Cleared May 04, 2005

LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE

Lightspeed Technology, Inc.

Cleared Dec 22, 2004

TCM ENDO V, MODEL 1534

Cleared Sep 23, 2004

IMPLANTEO IMPLANTOLOGY MOTOR

Cleared Aug 21, 2003

J. Morita USA, Inc.

Cleared Mar 03, 2003

ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925

Cleared Sep 28, 1999

Phytron- Elektronik GmbH

Cleared May 26, 1999

QUANTEC-E ENDO SYSTEM

Sybron Dental Specialties, Inc.

Cleared Mar 24, 1999

PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)

Nsk Nakanishi, Inc.

Cleared Mar 19, 1999

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE

Nsk Nakanishi, Inc.

Cleared Dec 21, 1998

MODEL MS-1 HANDPIECE

Cleared Jun 04, 1997

J. Morita USA, Inc.

Cleared Jan 25, 1994

MODIFIED SITE POWER HANDPIECE II

Chiron Vision Corp.

Cleared Jul 01, 1993

FRESENIUS PD+ EXCHANGE DEVICE

Fresenius USA, Inc.

Cleared Jun 23, 1992

MODIFIED SITE POWER HANDPIECE

Chiron Vision Corp.

Cleared Jun 23, 1987

Siemens Medical Solutions USA, Inc.

Cleared Jun 25, 1982

J. MORITA FLEX M-3 TORX HARDPIECE

Pacific Dental Corp.

Cleared Aug 04, 1980

TORX MICRO-MOTOR LOW SPEED HANDPIECE

Pacific Dental Corp.

Cleared Nov 23, 1976

PERITONEAL DIALYSIS SYSTEM

Physio-Control Corp.