EKJ · Class I · 21 CFR 872.4565

FDA Product Code EKJ: Burnisher, Operative

Leading manufacturers include Centrix, Inc., Dentsply Intl. and Zinnanti Surgical Instruments, 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 22, 1995

Cleared Sep 21, 1994

PRESTERILIZED ENDODONTIC FILES

Cleared Sep 15, 1993

APPLICATOR NOZZLE

Cleared Jun 24, 1991

HARDCOATED PLASTIC FILLING INSTRUMENT

Premier Dental Products Co.

Cleared May 15, 1991

PULPDENT PIC N STIC

Cleared May 07, 1990

Cleared May 10, 1989

RUBBER DAM CLAMPS/FORCEPS

Zinnanti Surgical Instruments, Inc.

Cleared May 02, 1989

PRICHARD PERIOSTEAL RETRACTOR #3

Zinnanti Surgical Instruments, Inc.

Cleared Feb 10, 1989

DENTAL SYRINGE APPLICATION TIP

Cleared Jan 10, 1989

Cleared Sep 15, 1988

VITRABOND LIGHT CURE GLASS IONOMER LINER

Cleared Aug 10, 1988

CENTRIX NEEDLETUBE

Cleared May 02, 1988

DENTALVISION TV SYSTEM

Cleared Mar 02, 1988

DISPOSABLE DENTAL PROBE/EXPLORER

Baxter Healthcare Corp

About Product Code EKJ - Regulatory Context

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