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Data / Medical devices / United States / Brasseler U.S.A. Dental, LLC

Brasseler U.S.A. Dental, LLC: FDA-registered device maker in Savannah, GA, United States, 36 510(k) clearances

Brasseler U.S.A. Dental, LLC is registered with the FDA (registration 1032227) in Savannah, GA, United States. It lists 78 device types. The FDA files 36 510(k) clearances under its listings, the newest dated August 27, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Brasseler U.S.A. Dental, LLC
FDA registration number
1032227
Address
1 Brasseler Blvd, Savannah, GA, United States, 31419
Owner or operator
PETER BRASSELER HOLDINGS, L.L.C. (1032227)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
November 9, 1983
Registered through
2026
Brand names listed
Brasseler Electric Motor, Brasseler Enlite Curing Light Set, Brasseler Forza Attachments, Brasseler Irrigation solutions, Brasseler USA Bur Block, Core Build Up, Dental KIts, EdgePro and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeler, Specification developeraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Aligner, SequentialNXC2Contract manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Repackager or relabeleraccessdata.fda.gov
Bone MillLYS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Broach, EndodonticEKW1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bur, DentalEJL1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Burnisher, OperativeEKJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Carver, Wax, DentalEIK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeler, Specification developeraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Cleanser, Root CanalKJJURepackager or relabeleraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Curette, OperativeEKE1Repackager or relabeler, Specification developeraccessdata.fda.gov
Curette, PeriodonticEMS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Curette, Surgical, DentalEMK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Dental Prophylaxis KitNYC1Manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Repackager or relabeleraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Endodontic KitNYD2Manufactureraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Explorer, OperativeEKB1Repackager or relabeler, Specification developeraccessdata.fda.gov
File, PeriodonticEMR1Repackager or relabeler, Specification developeraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeler, Specification developeraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
General Purpose Dental TrayOFX1Manufacturer, Specification developeraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeler, Specification developeraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Knife, PeriodonticEMO1Repackager or relabeler, Specification developeraccessdata.fda.gov
Laser, Dental, Soft TissueNVK2Repackager or relabeleraccessdata.fda.gov
Locator, Root ApexLQYURepackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Material, ImpressionELW2Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Needle, DentalDZM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Repackager or relabeler, Specification developeraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Point, AbrasiveEHL1Repackager or relabeler, Specification developeraccessdata.fda.gov
Point, Paper, EndodonticEKN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Repackager or relabeleraccessdata.fda.gov
Probe, PeriodonticEIX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Repackager or relabeleraccessdata.fda.gov
Remover, CrownEIS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Resin, Root Canal FillingKIF2Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Strip, Polishing AgentEHM1Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Repackager or relabeleraccessdata.fda.gov
Tester, PulpEAT2Repackager or relabeleraccessdata.fda.gov
TrephineHWK1Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Repackager or relabeleraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 27, 2024K241354Sealer SolventKJJSubstantially EquivalentInter-Med, Inc.accessdata.fda.gov
August 31, 2022K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20MUHSubstantially EquivalentRealcloud Imaging Inc. Dba Realcloud Imagingaccessdata.fda.gov
December 22, 2021K213428EdgeProNVKSubstantially EquivalentBiolase, Inc.accessdata.fda.gov
May 10, 2021K203320Endo MotorEKXSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
February 24, 2021K201703PROXEO Twist Cordless Polishing System PL-40 HEKXSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
October 27, 2020K202960General Cutting Contra HandpieceEGSSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
December 12, 2019K190537BIO-C Sealer Ion+KIFSubstantially EquivalentAngelus Industria DE Produtos Odontologicos S/Aaccessdata.fda.gov
December 11, 2019K190508EVO 450 series High Speed HandpiecesEFBSubstantially EquivalentTtbio Corp.accessdata.fda.gov
April 16, 2019K182999General Cutting Contra HandpieceEGSSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
October 11, 2018K173920LS OILEKXSubstantially EquivalentJ. Morita USA, Inc.accessdata.fda.gov
August 31, 2017K163402NLZ Motor SystemEBWSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
February 23, 2017K162926Air-Powered Handpieces and Handpiece AttachmentsEFBSubstantially EquivalentW&H Dentalwerk Burmoos GmbHaccessdata.fda.gov
July 25, 2016K160577PacEndo ChlorhexidineKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
February 1, 2016K153528PacEndo EDTAKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
November 10, 2015K151852PacEndo Sodium HyprochloriteKJJSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
August 24, 2015K150205LED Curing LightEBZSubstantially EquivalentMonitex Industrial Co., Ltd.accessdata.fda.gov
February 27, 2015K141183EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECESEFBSubstantially EquivalentTtbio Corp.accessdata.fda.gov
March 5, 2013K113717ULTRASONIC SCALERELCSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
February 28, 2013K121901TI-MAX Z45EGSSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
June 20, 2012K112024TI-MAX X450EFBSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
May 4, 2012K112665TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECEEKXSubstantially EquivalentJ. Morita USA, Inc.accessdata.fda.gov
April 17, 2012K112305VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECESEGSSubstantially EquivalentThunder Tiger Corp.accessdata.fda.gov
April 5, 2012K113674SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANTEFBSubstantially EquivalentHandpiece Headquarters, Inc. - Hpr, Inc.accessdata.fda.gov
March 5, 2012K113655TI-MAX X TURBINEEFBSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
November 23, 2009K090925MULTIPLE (APEX LOCATOR), MODEL RCM-7LQYSubstantially EquivalentJ. Morita USA, Inc.accessdata.fda.gov
January 6, 2009K082943IROOT BP, MODEL IRBP 4609KIFSubstantially EquivalentInnovative Bioceramix, Inc.accessdata.fda.gov
November 15, 2005K053014POLY SILOXANE IMPRESSION MATERIALELWSubstantially EquivalentClinician'S Choice Dental Products, Inc.accessdata.fda.gov
November 22, 2004K042614S&C-SELF ETCH PR-BONDKLESubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
September 11, 2001K011926ELEC-MATE EEBWSubstantially EquivalentNakanishi, Inc.accessdata.fda.gov
November 13, 2000K002521SPARTAN MTSELCSubstantially EquivalentSpartan Marketing Groupaccessdata.fda.gov
March 24, 1999K990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)EKXSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov
January 14, 1999K983223DENTAL STERLIZATION TRAY/CASSETTEFRGSubstantially EquivalentBrasseler USA I, L.P.accessdata.fda.gov
October 8, 1997K972569E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATIONEGSSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov
September 24, 1996K962542AIR MOTOR HANDPIECE TN-102EFBSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov
September 12, 1996K962540E-TYPE CONTRA ANGLE NAC-EEGSSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov
September 11, 1996K962543ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TUEFBSubstantially EquivalentNsk Nakanishi, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 11, 202493809Class IIOngoingBrasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.accessdata.fda.gov

Compare with other makers

Updated August 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.