EKJ · Class I · 21 CFR 872.4565

FDA Product Code EKJ: Burnisher, Operative

Leading manufacturers include American Medical Ceramics, Inc., Centrix, Inc. and Wen Hao, Inc..

72

Total

72

Cleared

100d

Avg days

1982

Since

FDA 510(k) Cleared Burnisher, Operative Devices (Product Code EKJ)

72 devices

1–24 of 72

Cleared Jun 10, 1996

ASEPTYLUM, UNI-CARRIER

Distriflor S.A.

Cleared Jan 04, 1996

MEDTROL DENTAL KIT

Cleared Jul 19, 1995

Constancy Ent., Inc.

Cleared Jun 22, 1995

Cleared Nov 30, 1994

INSTRUMENT,FILLING,PLASTIC,DENTAL

Worldwide Dental, Inc.

Cleared Nov 02, 1994

Magnum Instruments, Inc.

Cleared Oct 07, 1994

MAUNAL DISPOSABLE DENTAL INSTRUMENTS

Magnum Instruments, Inc.

Cleared Sep 21, 1994

PRESTERILIZED ENDODONTIC FILES

Cleared Jul 28, 1994

SOUTHLAND STERILE DENTAL SYSTEM

Southland, Ltd.

Cleared Jul 08, 1994

NON-FOGGING DENTAL MIRROR

Buffalo Dental Mfg. Co., Inc.

Cleared Jul 05, 1994

AMD DENTIST AND HYGIENIST KITS

Advance Medical Designs, Inc.

Cleared Feb 15, 1994

EXPLORER, OPERATIVE

Protector, Inc.

Cleared Feb 15, 1994

FORCEPS, DRESSING, DENTAL

Protector, Inc.

Cleared Feb 15, 1994

Protector, Inc.

Cleared Jan 05, 1994

LC DENTAL HAND INSTRUMENT

Cleared Nov 05, 1993

SILICONE MIRROR

Moyco Industries, Inc.

Cleared Sep 15, 1993

APPLICATOR NOZZLE

Cleared Jun 29, 1993

STERILE DENTAL KITS

Professional Sterile Systems, Inc.

Cleared Nov 04, 1992

ECO/DENTAL GENERAL DENTAL PACK

Dyna-Pace Systems, Inc.

Cleared Sep 25, 1992

BLUNT TIP IRRIGATION NEEDLES

Innovators, Inc.

Cleared Nov 13, 1991

PART 872 DEGUFILL H & DEGUFILL M DA

Cleared Oct 21, 1991

Implant Innovations International, Inc.

Cleared Jul 24, 1991

ACCU-PLACER TM KIT

Hu-Friedy Mfg. Co., Inc.

Cleared Jul 17, 1991

NUTIP (TM) SYRINGE SHIELD

Western M/D, Inc.

About Product Code EKJ - Regulatory Context

Related FDA 510(k) Regulatory Insights