Dental

EKJ · Burnisher, Operative

Dental · 21 CFR 872.4565 · Class 1

Overview

Product CodeEKJ
Device NameBurnisher, Operative
Regulation21 CFR 872.4565
Device ClassClass 1
Review PanelDental

Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Classification Rationale

Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Cleared Devices (72)

RecordDevice NameApplicantDecision DateDecision
K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.Jun 10, 1996SESE
K953707MEDTROL DENTAL KITMedtrol, Inc.Jan 4, 1996SESE
K945815DENTAL KITConstancy Ent., Inc.Jul 19, 1995SESE
K951607SUREFLEX FILESDentsply Intl.Jun 22, 1995SESE
K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.Nov 30, 1994SESE
K943820STAT PAKMagnum Instruments, Inc.Nov 2, 1994SESE
K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTSMagnum Instruments, Inc.Oct 7, 1994SESE
K943584PRESTERILIZED ENDODONTIC FILESDentsply Intl.Sep 21, 1994SESE
K935127SOUTHLAND STERILE DENTAL SYSTEMSouthland, Ltd.Jul 28, 1994SESE
K941954NON-FOGGING DENTAL MIRRORBuffalo Dental Mfg. Co., Inc.Jul 8, 1994SESE
K925115AMD DENTIST AND HYGIENIST KITSAdvance Medical Designs, Inc.Jul 5, 1994SESE
K925890MIRROR, MOUTHProtector, Inc.Feb 15, 1994SESE
K925889FORCEPS, DRESSING, DENTALProtector, Inc.Feb 15, 1994SESE
K925888EXPLORER, OPERATIVEProtector, Inc.Feb 15, 1994SESE
K935217LC DENTAL HAND INSTRUMENTL.C. DentalJan 5, 1994SESE
K932511SILICONE MIRRORMoyco Industries, Inc.Nov 5, 1993SESE
K926368APPLICATOR NOZZLECentrix, Inc.Sep 15, 1993SESE
K923902STERILE DENTAL KITSProfessional Sterile Systems, Inc.Jun 29, 1993SESE
K922988ECO/DENTAL GENERAL DENTAL PACKDyna-Pace Systems, Inc.Nov 4, 1992SESE
K921354BLUNT TIP IRRIGATION NEEDLESInnovators, Inc.Sep 25, 1992SESE
K914368PART 872 DEGUFILL H & DEGUFILL M DADegussa AGNov 13, 1991SESE
K911655IMPLARETTEImplant Innovations International, Inc.Oct 21, 1991SESE
K912473ACCU-PLACER TM KITHu-Friedy Mfg. Co., Inc.Jul 24, 1991SESE
K911214NUTIP (TM) SYRINGE SHIELDWestern M/D, Inc.Jul 17, 1991SESE
K912149HARDCOATED PLASTIC FILLING INSTRUMENTPremier Dental Products Co.Jun 24, 1991SESE
K911281PULPDENT PIC N STICPulpdent Corp.May 15, 1991SESE
K901053MIRROR SHIELDPulpdent Corp.May 7, 1990SESE
K901178AMALGAM CONDENSERAmerican Medical Ceramics, Inc.Apr 27, 1990SESE
K901177DISCOID/CLEOID DOUBLE END AMALGAM CARVERAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K901176#23 EXPLORERAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K901175HAND MIRRORAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K901174ELEVATOR #11American Medical Ceramics, Inc.Apr 16, 1990SESE
K901173DISCOID SPOON EXCAVATORAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K901172GRACEY CURETTE #13-14American Medical Ceramics, Inc.Apr 16, 1990SESE
K901171U-15 SINGLE END SCALERAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K901170PERIODONTAL KNIFEAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K9011695 STRAIGHT SCISSORSAmerican Medical Ceramics, Inc.Apr 16, 1990SESE
K896843EXPLORER 24 DENTAL HAND INSTRUMENTAmerican Medical Ceramics, Inc.Mar 6, 1990SESE
K896565DMV(R) VENEER SUCTION GRIPPERDmv Corp.Feb 2, 1990SESE
K895985SANI-PIKS DENTAL HAND INSTRUMENTBison-Lee Co.Jan 10, 1990SESE
K895958BREVET FLOSS PICK (AUTOCLAVE STERILIZER)Brevet, Inc.Dec 4, 1989SESE
K895959BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)Brevet, Inc.Nov 29, 1989SESE
K894897ANSWER DENTAL IMPLEMENT, FORCEPSTern Chien Ent. Co., Ltd.Oct 30, 1989SESE
K894896ANSWER DENTAL IMPLEMENT, EXPLORERTern Chien Ent. Co., Ltd.Oct 30, 1989SESE
K894895ANSWER DENTAL IMPLEMENTS, MIRRORTern Chien Ent. Co., Ltd.Oct 30, 1989SESE
K892239DENTAL HAND INSTRUMENTSImplant Support Systems, Inc.May 18, 1989SESE
K892261RUBBER DAM CLAMPS/FORCEPSZinnanti Surgical Instruments, Inc.May 10, 1989SESE
K892260PRICHARD PERIOSTEAL RETRACTOR #3Zinnanti Surgical Instruments, Inc.May 2, 1989SESE
K884308MANDIBLE MANIPULATORLeonard Medical, Inc.Mar 31, 1989SESE
K890357DENTAL IMPRESSION SYINGEInnotek Dental Corp.Feb 13, 1989SESE
K890064DENTAL SYRINGE APPLICATION TIPCentrix, Inc.Feb 10, 1989SESE
K885219DENTAL DRESSING PLIERSWen Hao, Inc.Jan 19, 1989SESE
K885218DISCARD DENTAL MIRRORWen Hao, Inc.Jan 19, 1989SESE
K885217DISCARD DENTAL EXPLORERWen Hao, Inc.Jan 19, 1989SESE
K884653RACESTYPTINESpecialites SeptodontJan 19, 1989SESE
K885162BENDA BRUSHCentrix, Inc.Jan 10, 1989SESE
K885040DENTAL MIRROR RETRACTORNu-Lite Retractor, Inc.Jan 10, 1989SESE
K884515BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDEDGatewood and Associates, Ltd.Jan 10, 1989SESE
K883126BREVET DENTAL INSTRUMENTSBrevet, Inc.Oct 5, 1988SESE
K882821VITRABOND LIGHT CURE GLASS IONOMER LINER3M CompanySep 15, 1988SESE
K883322DENTAL HAND INSTRUMENTSCollagen Corp.Aug 26, 1988SESE
K882651CENTRIX NEEDLETUBECentrix, Inc.Aug 10, 1988SESE
K882834TISSUE PUNCHTri-Stage, Inc.Aug 2, 1988SESE
K881992SYRETTEOratec Corp.Jul 26, 1988SESE
K882309THE DIRECTION DIALLawhorn InnovationsJun 23, 1988SESE
K882399ASEPTIPKoppa Innovative Dental Products, Inc.Jun 21, 1988SESE
K880849EXAMIX DISPENSERG-C Intl. Corp.May 11, 1988SESE
K880542DENTALVISION TV SYSTEMDentsply Intl.May 2, 1988SESE
K880590DISPOSABLE DENTAL PROBE/EXPLORERBaxter Healthcare CorpMar 2, 1988SESE
K874964DENTAL HAND INSTRUMENTSSolway, Inc.Jan 27, 1988SESE
K874335EXPLORER-DENTAL PROBERMilitary Engineering, Inc.Dec 29, 1987SESE
K821779BEACH AMALGAM CARRIER, GUN TYPEPacific Dental Corp.Jul 6, 1982SESE

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