Product Code: EKJ FDA class 1 21 CFR 872.4565

Burnisher, Operative

Dental

The Operative Burnisher is a dental hand instrument with a smooth, rounded or pear-shaped tip used to smooth and adapt the surface and margins of restorations, particularly amalgam, after placement to improve marginal seal and surface finish. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKJ, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EKJ
Device Class: FDA class 1
Regulation Number: 872.4565
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 72 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K961714	ASEPTYLUM, UNI-CARRIER	Jun 10, 1996	Substantially Equivalent	Distriflor S.A.
K953707	MEDTROL DENTAL KIT	Jan 04, 1996	Substantially Equivalent	Medtrol, Inc.
K945815	DENTAL KIT	Jul 19, 1995	Substantially Equivalent	Constancy Ent., Inc.
K951607	SUREFLEX FILES	Jun 22, 1995	Substantially Equivalent	Dentsply Intl.
K945077	INSTRUMENT,FILLING,PLASTIC,DENTAL	Nov 30, 1994	Substantially Equivalent	Worldwide Dental, Inc.
K943820	STAT PAK	Nov 02, 1994	Substantially Equivalent	Magnum Instruments, Inc.
K943351	MAUNAL DISPOSABLE DENTAL INSTRUMENTS	Oct 07, 1994	Substantially Equivalent	Magnum Instruments, Inc.
K943584	PRESTERILIZED ENDODONTIC FILES	Sep 21, 1994	Substantially Equivalent	Dentsply Intl.
K935127	SOUTHLAND STERILE DENTAL SYSTEM	Jul 28, 1994	Substantially Equivalent	Southland, Ltd.
K941954	NON-FOGGING DENTAL MIRROR	Jul 08, 1994	Substantially Equivalent	Buffalo Dental Mfg. Co., Inc.
K925115	AMD DENTIST AND HYGIENIST KITS	Jul 05, 1994	Substantially Equivalent	Advance Medical Designs, Inc.
K925890	MIRROR, MOUTH	Feb 15, 1994	Substantially Equivalent	Protector, Inc.
K925889	FORCEPS, DRESSING, DENTAL	Feb 15, 1994	Substantially Equivalent	Protector, Inc.
K925888	EXPLORER, OPERATIVE	Feb 15, 1994	Substantially Equivalent	Protector, Inc.
K935217	LC DENTAL HAND INSTRUMENT	Jan 05, 1994	Substantially Equivalent	L.C. Dental
K932511	SILICONE MIRROR	Nov 05, 1993	Substantially Equivalent	Moyco Industries, Inc.
K926368	APPLICATOR NOZZLE	Sep 15, 1993	Substantially Equivalent	Centrix, Inc.
K923902	STERILE DENTAL KITS	Jun 29, 1993	Substantially Equivalent	Professional Sterile Systems, Inc.
K922988	ECO/DENTAL GENERAL DENTAL PACK	Nov 04, 1992	Substantially Equivalent	Dyna-Pace Systems, Inc.
K921354	BLUNT TIP IRRIGATION NEEDLES	Sep 25, 1992	Substantially Equivalent	Innovators, Inc.
K914368	PART 872 DEGUFILL H & DEGUFILL M DA	Nov 13, 1991	Substantially Equivalent	Degussa AG
K911655	IMPLARETTE	Oct 21, 1991	Substantially Equivalent	Implant Innovations International, Inc.
K912473	ACCU-PLACER TM KIT	Jul 24, 1991	Substantially Equivalent	Hu-Friedy Mfg. Co., Inc.
K911214	NUTIP (TM) SYRINGE SHIELD	Jul 17, 1991	Substantially Equivalent	Western M/D, Inc.
K912149	HARDCOATED PLASTIC FILLING INSTRUMENT	Jun 24, 1991	Substantially Equivalent	Premier Dental Products Co.
K911281	PULPDENT PIC N STIC	May 15, 1991	Substantially Equivalent	Pulpdent Corp.
K901053	MIRROR SHIELD	May 07, 1990	Substantially Equivalent	Pulpdent Corp.
K901178	AMALGAM CONDENSER	Apr 27, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901177	DISCOID/CLEOID DOUBLE END AMALGAM CARVER	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901176	#23 EXPLORER	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901175	HAND MIRROR	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901174	ELEVATOR #11	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901173	DISCOID SPOON EXCAVATOR	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901172	GRACEY CURETTE #13-14	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901171	U-15 SINGLE END SCALER	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901170	PERIODONTAL KNIFE	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K901169	5 STRAIGHT SCISSORS	Apr 16, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K896843	EXPLORER 24 DENTAL HAND INSTRUMENT	Mar 06, 1990	Substantially Equivalent	American Medical Ceramics, Inc.
K896565	DMV(R) VENEER SUCTION GRIPPER	Feb 02, 1990	Substantially Equivalent	Dmv Corp.
K895985	SANI-PIKS DENTAL HAND INSTRUMENT	Jan 10, 1990	Substantially Equivalent	Bison-Lee Co.
K895958	BREVET FLOSS PICK (AUTOCLAVE STERILIZER)	Dec 04, 1989	Substantially Equivalent	Brevet, Inc.
K895959	BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)	Nov 29, 1989	Substantially Equivalent	Brevet, Inc.
K894897	ANSWER DENTAL IMPLEMENT, FORCEPS	Oct 30, 1989	Substantially Equivalent	Tern Chien Ent. Co., Ltd.
K894896	ANSWER DENTAL IMPLEMENT, EXPLORER	Oct 30, 1989	Substantially Equivalent	Tern Chien Ent. Co., Ltd.
K894895	ANSWER DENTAL IMPLEMENTS, MIRROR	Oct 30, 1989	Substantially Equivalent	Tern Chien Ent. Co., Ltd.
K892239	DENTAL HAND INSTRUMENTS	May 18, 1989	Substantially Equivalent	Implant Support Systems, Inc.
K892261	RUBBER DAM CLAMPS/FORCEPS	May 10, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K892260	PRICHARD PERIOSTEAL RETRACTOR #3	May 02, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K884308	MANDIBLE MANIPULATOR	Mar 31, 1989	Substantially Equivalent	Leonard Medical, Inc.
K890357	DENTAL IMPRESSION SYINGE	Feb 13, 1989	Substantially Equivalent	Innotek Dental Corp.
K890064	DENTAL SYRINGE APPLICATION TIP	Feb 10, 1989	Substantially Equivalent	Centrix, Inc.
K885219	DENTAL DRESSING PLIERS	Jan 19, 1989	Substantially Equivalent	Wen Hao, Inc.
K885218	DISCARD DENTAL MIRROR	Jan 19, 1989	Substantially Equivalent	Wen Hao, Inc.
K885217	DISCARD DENTAL EXPLORER	Jan 19, 1989	Substantially Equivalent	Wen Hao, Inc.
K884653	RACESTYPTINE	Jan 19, 1989	Substantially Equivalent	Specialites Septodont
K885162	BENDA BRUSH	Jan 10, 1989	Substantially Equivalent	Centrix, Inc.
K885040	DENTAL MIRROR RETRACTOR	Jan 10, 1989	Substantially Equivalent	Nu-Lite Retractor, Inc.
K884515	BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED	Jan 10, 1989	Substantially Equivalent	Gatewood and Associates, Ltd.
K883126	BREVET DENTAL INSTRUMENTS	Oct 05, 1988	Substantially Equivalent	Brevet, Inc.
K882821	VITRABOND LIGHT CURE GLASS IONOMER LINER	Sep 15, 1988	Substantially Equivalent	3M Company
K883322	DENTAL HAND INSTRUMENTS	Aug 26, 1988	Substantially Equivalent	Collagen Corp.
K882651	CENTRIX NEEDLETUBE	Aug 10, 1988	Substantially Equivalent	Centrix, Inc.
K882834	TISSUE PUNCH	Aug 02, 1988	Substantially Equivalent	Tri-Stage, Inc.
K881992	SYRETTE	Jul 26, 1988	Substantially Equivalent	Oratec Corp.
K882309	THE DIRECTION DIAL	Jun 23, 1988	Substantially Equivalent	Lawhorn Innovations
K882399	ASEPTIP	Jun 21, 1988	Substantially Equivalent	Koppa Innovative Dental Products, Inc.
K880849	EXAMIX DISPENSER	May 11, 1988	Substantially Equivalent	G-C Intl. Corp.
K880542	DENTALVISION TV SYSTEM	May 02, 1988	Substantially Equivalent	Dentsply Intl.
K880590	DISPOSABLE DENTAL PROBE/EXPLORER	Mar 02, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874964	DENTAL HAND INSTRUMENTS	Jan 27, 1988	Substantially Equivalent	Solway, Inc.
K874335	EXPLORER-DENTAL PROBER	Dec 29, 1987	Substantially Equivalent	Military Engineering, Inc.
K821779	BEACH AMALGAM CARRIER, GUN TYPE	Jul 06, 1982	Substantially Equivalent	Pacific Dental Corp.