Dental Device Guide
Add your company

Surgical devices · 21 CFR 872 Subpart E

Operative Burnisher

FDA device type “Burnisher, Operative”.

FDA codeEKJClass121 CFR872.4565Pathway510(k) exemptCategoryDental hand instruments
Companies listing it
9576 makers
Brands and models
95
510(k) clearances
720 in five years
FDA name
Burnisher, Operative
1982: 11987: 11988: 121989: 181990: 141991: 61992: 21993: 31994: 111995: 21996: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EKJ

95 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Premier Dental Products CompanyUnited StatesMakerPREMIER OPERATIVE BURNISHER282026
Young Innovations IncUnited StatesMakerAEI Burnishers232025
Shenzhen Rogin Medical Co., Ltd.ChinaMakerE-LITE Polisher12025
Pulpdent CorporationUnited StatesMakerPIC-N-STIC1072021
Hu-Friedy Mfg Co., LLCUnited StatesMakerHu-Friedy82012
Integra LifeSciences CorporationUnited StatesMakerIntegra · Jarit · Miltex22014
Storz AM Mark GmbHGermanyMakerBurnisher22008
Osung Mnd Co LtdSouth KoreaMakerBB26-27S · BB27-29 · BB31-32 · BBL3——
Schobell Industrial LtdaBrazilMakerBrunisher n.29 · Brunisher n.33——
Shanghai Kangqiao Dental Instruments FactoryChinaMakerBurnishers E1/E2/E3/E4/E5/E6/E2-4/E3-8/E5-6/R26/27S——
B. Ali ImpexPakistanMakerBALI · DOCTOR NICE——
Prodont-HolligerFranceMakerBRUNISHER 125 reference 108.14SI - brunisher dble N 4 bliss——
Shenzhen Denco Medical Co LtdChinaMakerEMATE Polisher——
Aspen Surgical ProductsUnited StatesMakerSymmetry Surgical——
Technimen SkillersPakistanMakerAcorn Burnisher, Egg Burnisher, T-Ball Burnisher, Ball Burnisher——
Cislak Manufacturing, Inc.United StatesMakerCislak · Zoll Dental——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerBurnisher——
Pomee CorporationPakistanMakerBurnisher——
Endo Tech InstrumentsPakistanMakerBurnisher D/E · OSTIUM BURNISHER ELEVATOR BALL #42 DOUBLE END 1.2/1.9mm 6 1/2——
Medcave Private LimitedPakistanMakerBURNISHER——
Nordent MFG., Inc.United StatesMakerNORDENT AMALGAM BURNISHERS——
Panorama InternationalPakistanMakerBURNISHER, OPERATIVE——
Accompany SurgicalPakistanMakerACORN——
Lacigrus InternationalPakistanMakerBURNISHER, OPERATIVE——
Comfort Surgical InstrumentsPakistanMakerBurnisher——
Aesculap AGGermanyMakerAesculap——
PDT Inc.United StatesMakerPDT, Inc.——
Adolf Schweick Hardt GmbH & CoGermanyMaker———
Confident InstrumentsPakistanMakerArtman Instruments——
Denta Craft InstrumentsPakistanMakerACORN——
Medisporex Private LimitedPakistanMakerMEDIS——
Dentag SRLItalyMakerDEN TAG S.R.L.——
Garish ApparelsPakistanMakerTamzon Instruments Inc.——
Goldman Products, Inc.United StatesMakerGoldman · MicroDent——
Harf IndustriesPakistanMakerBall Burnisher, 27/29 Ball Burnisher——
Silver Plus Corp.PakistanMakerBURNISHER, OPERATIVE——
Shanghai Medical Instruments (Group) Ltd. Corp.ChinaMakerBURNISHER——
SurgiscapePakistanMakerBURNISHER, OPERATIVE——
Towne Brothers (Pvt) LtdPakistanMakerEKJ - BURNISHER, OPERATIVE——
Choose Surgical InstrumentsPakistanMakerBURNISHER, OPERATIVE——
Lohar Medical CompanyPakistanMakerEKJ / BURNISHER, OPERATIVE——
Mident LtdUnited KingdomMakerBurnishers——
Acme Commercial Ways Ltd.PakistanMakerBURNISHER——
Nadir & Co.PakistanMakerBall Burnisher——
Y. Z. CorporationPakistanMakerYZ Dental Burnishers——
Nopa Instruments Medizintechnik GmbHGermanyMakerBURNISHER——
SurjexPakistanMakerBURNISHER, OPERATIVE——
Pilotis Tech LLCUnited StatesMakerIntrace USA——
B. Braun Medical Industries Sdn. BhdMalaysiaMakerAesculap——
SGS Export Intl.PakistanMakerBurnisher, Operative——
Spartech Instruments & Co.PakistanMakerBURNISHER, OPERATIVE——
Melpex Beauty InstrumentsPakistanMakerBURNISHER, OPERATIVE——
Armatech InternationalPakistanMakerBURNISHER, OPERATIVE——
Sabokay IndustriesPakistanMakerBurnisher, Operative——
Darleys Surgical Co.PakistanMakerBURNISHER, OPERATIVE——
Hazel EnterprisesPakistanMakerBURNISHER, OPERATIVE——
SurgikarePakistanMakerBURNISHER, OPERATIVE——
T.A. Walthem & CompanyPakistanMakerBURNISHER, OPERATIVE——
Washington Surgical InternationalPakistanMakerBURNISHER, OPERATIVE——
Infirmary Medical SuppliesPakistanMakerBURNISHER, OPERATIVE——
Madina Surgical WorksPakistanMakerBURNISHER, OPERATIVE——
Emerald InstrumentsPakistanMakerBURNISHER, OPERATIVE——
Hans KoreaSouth KoreaMakerHans Korea——
Laparomed Private LimitedIndiaMakerFILLING INSTRUMNENTS (BURNISHERS, SPATULA, GAUZE PACKER, AMALGAM CARVERS, AMALGAM CARRIERS, AMALGAM GUN, WELL)——
Sabri IndustriesPakistanMakerBURNISHER, OPERATIVE——
Concise EnterprisesPakistanMakerBURNISHER, OPERATIVE——
Robinson Healthcare LimitedUnited KingdomMakerInstrapac——
Tim J. PrusaitisUnited StatesMakerPRU-DENT——
Power Dental USAUnited StatesMaker———
Peter Brasseler Holdings, LLCUnited StatesMaker———
J&J InstrumentsUnited StatesMaker———
Allied Medical LLCUnited StatesMakerBURN SHEET AND TOWELS——
Phoenix Instruments, Inc.United StatesMaker———
Xinhua Surgical Instrument Co.,Ltd.ChinaMakerDENTAL INSTRUMENT——
Helmut Zepf Medizintechnik GmbHGermanyMaker———
HGR Instrumente GmbHGermanyMaker———
Ultradent Products, Inc.United StatesContract manufacturerSYRINGE COVERS952026
Jedmed Instrument Co.United StatesRepacker / relabelerBALL BURNISHER41981
Aesculap, Inc.United StatesListerDENTAL INSTRUMENT22006
George Taub Products & Fusion Co., Inc.United StatesManufacturerBALL BURNISHER21986
One DashcorpUnited StatesRepacker / relabelerValdent USA #11/12 Double-End Stainless Steel Burnisher, Regular Handle · Valdent USA #26/27S Double-End Stainless Steel Burnisher · Valdent USA #27/29 Ball/Football DE Stainless Steel Burnisher, Regular Handle——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerAngelus——
Patterson Companies, Inc.United StatesForeign exporterPatterson Burnishers——
Soher Med LimitedHong Kong SAR ChinaForeign exporterBurnisher——
STERIS CorporationUnited StatesContract sterilizer———
Premium Plus DentalUnited StatesListerAEI Burnishers——
TBS DentalUnited StatesRepacker / relabelerTBS INOX USA——
Wise Linkers LLCUnited StatesRepacker / relabelerArtman Instruments——
Sklar CorporationUnited StatesRepacker / relabelerBurnisher——
YCH Distripark Sdn BhdMalaysiaForeign exporterAesculap——
Sontec Instruments IncUnited StatesRepacker / relabelerMultiple——
Novo Surgical Inc.United StatesRepacker / relabeler———
Kash Sales Inc.CanadaForeign exporter———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
10 Jun 1996K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.
4 Jan 1996K953707MEDTROL DENTAL KITMedtrol, Inc.
19 Jul 1995K945815DENTAL KITConstancy Ent., Inc.
22 Jun 1995K951607SUREFLEX FILESDentsply Intl., Inc.
30 Nov 1994K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.
2 Nov 1994K943820STAT PAKMagnum Instruments, Inc.
7 Oct 1994K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTSMagnum Instruments, Inc.
21 Sep 1994K943584PRESTERILIZED ENDODONTIC FILESDentsply Intl., Inc.
28 Jul 1994K935127SOUTHLAND STERILE DENTAL SYSTEMSouthland, Ltd.
8 Jul 1994K941954NON-FOGGING DENTAL MIRRORBuffalo Dental Mfg. Co., Inc.
5 Jul 1994K925115AMD DENTIST AND HYGIENIST KITSAdvance Medical Designs, Inc.
15 Feb 1994K925890MIRROR, MOUTHProtector, Inc.
15 Feb 1994K925889FORCEPS, DRESSING, DENTALProtector, Inc.
15 Feb 1994K925888EXPLORER, OPERATIVEProtector, Inc.
5 Jan 1994K935217LC DENTAL HAND INSTRUMENTL.C. Dental
5 Nov 1993K932511SILICONE MIRRORMoyco Industries, Inc.
15 Sep 1993K926368APPLICATOR NOZZLECentrix, Inc.
29 Jun 1993K923902STERILE DENTAL KITSProfessional Sterile Systems, Inc.
4 Nov 1992K922988ECO/DENTAL GENERAL DENTAL PACKDyna-Pace Systems, Inc.
25 Sep 1992K921354BLUNT TIP IRRIGATION NEEDLESInnovators, Inc.
13 Nov 1991K914368PART 872 DEGUFILL H & DEGUFILL M DADegussa AG
21 Oct 1991K911655IMPLARETTEImplant Innovations International, Inc.
24 Jul 1991K912473ACCU-PLACER TM KITHu-Friedy Mfg Co., LLC
17 Jul 1991K911214NUTIP (TM) SYRINGE SHIELDWestern M/D, Inc.
24 Jun 1991K912149HARDCOATED PLASTIC FILLING INSTRUMENTPremier Dental Products Company
15 May 1991K911281PULPDENT PIC N STICPulpdent Corporation
7 May 1990K901053MIRROR SHIELDPulpdent Corporation
27 Apr 1990K901178AMALGAM CONDENSERAmerican Medical Ceramics, Inc.
16 Apr 1990K901177DISCOID/CLEOID DOUBLE END AMALGAM CARVERAmerican Medical Ceramics, Inc.
16 Apr 1990K901176#23 EXPLORERAmerican Medical Ceramics, Inc.
16 Apr 1990K901175HAND MIRRORAmerican Medical Ceramics, Inc.
16 Apr 1990K901174ELEVATOR #11American Medical Ceramics, Inc.
16 Apr 1990K901173DISCOID SPOON EXCAVATORAmerican Medical Ceramics, Inc.
16 Apr 1990K901172GRACEY CURETTE #13-14American Medical Ceramics, Inc.
16 Apr 1990K901171U-15 SINGLE END SCALERAmerican Medical Ceramics, Inc.
16 Apr 1990K901170PERIODONTAL KNIFEAmerican Medical Ceramics, Inc.
16 Apr 1990K9011695 STRAIGHT SCISSORSAmerican Medical Ceramics, Inc.
6 Mar 1990K896843EXPLORER 24 DENTAL HAND INSTRUMENTAmerican Medical Ceramics, Inc.
2 Feb 1990K896565DMV(R) VENEER SUCTION GRIPPERDmv Corp.
10 Jan 1990K895985SANI-PIKS DENTAL HAND INSTRUMENTBison-Lee Co.
4 Dec 1989K895958BREVET FLOSS PICK (AUTOCLAVE STERILIZER)Brevet, Inc.
29 Nov 1989K895959BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)Brevet, Inc.
30 Oct 1989K894897ANSWER DENTAL IMPLEMENT, FORCEPSTern Chien Ent. Co., Ltd.
30 Oct 1989K894896ANSWER DENTAL IMPLEMENT, EXPLORERTern Chien Ent. Co., Ltd.
30 Oct 1989K894895ANSWER DENTAL IMPLEMENTS, MIRRORTern Chien Ent. Co., Ltd.
18 May 1989K892239DENTAL HAND INSTRUMENTSImplant Support Systems, Inc.
10 May 1989K892261RUBBER DAM CLAMPS/FORCEPSZinnanti Surgical Instruments, Inc.
2 May 1989K892260PRICHARD PERIOSTEAL RETRACTOR #3Zinnanti Surgical Instruments, Inc.
31 Mar 1989K884308MANDIBLE MANIPULATORLeonard Medical, Inc.
13 Feb 1989K890357DENTAL IMPRESSION SYINGEInnotek Dental Corp.
10 Feb 1989K890064DENTAL SYRINGE APPLICATION TIPCentrix, Inc.
19 Jan 1989K885219DENTAL DRESSING PLIERSWen Hao, Inc.
19 Jan 1989K885218DISCARD DENTAL MIRRORWen Hao, Inc.
19 Jan 1989K885217DISCARD DENTAL EXPLORERWen Hao, Inc.
19 Jan 1989K884653RACESTYPTINESpecialites Septodont
10 Jan 1989K885162BENDA BRUSHCentrix, Inc.
10 Jan 1989K885040DENTAL MIRROR RETRACTORNu-Lite Retractor, Inc.
10 Jan 1989K884515BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDEDGatewood and Associates, Ltd.
5 Oct 1988K883126BREVET DENTAL INSTRUMENTSBrevet, Inc.
15 Sep 1988K882821VITRABOND LIGHT CURE GLASS IONOMER LINER3M Company
26 Aug 1988K883322DENTAL HAND INSTRUMENTSCollagen Corp.
10 Aug 1988K882651CENTRIX NEEDLETUBECentrix, Inc.
2 Aug 1988K882834TISSUE PUNCHTri-Stage, Inc.
26 Jul 1988K881992SYRETTEOratec Corp.
23 Jun 1988K882309THE DIRECTION DIALLawhorn Innovations
21 Jun 1988K882399ASEPTIPKoppa Innovative Dental Products, Inc.
11 May 1988K880849EXAMIX DISPENSERG-C Intl. Corp.
2 May 1988K880542DENTALVISION TV SYSTEMDentsply Intl., Inc.
2 Mar 1988K880590DISPOSABLE DENTAL PROBE/EXPLORERBaxter Healthcare Corp
27 Jan 1988K874964DENTAL HAND INSTRUMENTSSolway, Inc.
29 Dec 1987K874335EXPLORER-DENTAL PROBERMilitary Engineering, Inc.
6 Jul 1982K821779BEACH AMALGAM CARRIER, GUN TYPEPacific Dental Corp.

Official records: FDA product classification for EKJ · 21 CFR 872.4565.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026