EKX · Class I · 21 CFR 872.4200

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

Leading manufacturers include J. Morita USA, Inc., Osstell AB and Aseptico, Inc..

90

Total

90

Cleared

182d

Avg days

1976

Since

90 devices

73–90 of 90

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 May 28, 1991

Cleared Jun 23, 1987

Siemens Medical Solutions USA, Inc.

Cleared May 01, 1987

PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE

Safco Dental Supply

Cleared Aug 26, 1983

ROBIN CORDLESS HANDPIECE

Kaycor Intl., Ltd.

Cleared Jun 25, 1982

J. MORITA FLEX M-3 TORX HARDPIECE

Pacific Dental Corp.

Cleared Jan 07, 1982

YOSHIDA RIDO-F, MODEL LM-01

Kaycor Intl., Ltd.

Cleared Aug 04, 1980

TORX MICRO-MOTOR LOW SPEED HANDPIECE

Pacific Dental Corp.

Cleared Apr 28, 1978

AIR-PWOERED COLDRILL

Medishield, Inc.

Cleared Nov 23, 1976

PERITONEAL DIALYSIS SYSTEM

Physio-Control Corp.