BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BRASSELER U.S.A. DENTAL, LLC

    Reg #: 1032227 · FEI: 1032227 · Expires 2026
    View on FDA
    Products
    76
    Proprietary Names
    12
    Establishment Types
    4
    Classifications
    76

    Registration Details

    Registration Name
    BRASSELER U.S.A. DENTAL, LLC
    Registration Number
    1032227
    FEI Number
    1032227
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1 Brasseler Blvd
    City
    SAVANNAH
    State
    GA
    ZIP
    31419
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213428

    Owner / Operator

    Firm Name
    PETER BRASSELER HOLDINGS, L.L.C.
    Operator Number
    1032227
    Address
    1 BRASSELER BLVD.
    City
    Savannah
    State
    GA
    Postal Code
    31419
    Country
    US
    Correspondent
    Carl Mazzolini

    Products

    Device Name Product Code
    Chisel, Bone, Surgical EML
    Elevator, Surgical, Dental EMJ
    Pliers, Surgical HTC
    Broach, Endodontic EKW
    Forceps, Tooth Extractor, Surgical EMG
    Powered Laser Surgical Instrument GEX
    Laser, Dental, Soft Tissue NVK
    Resin, Root Canal Filling KIF
    Material, Tooth Shade, Resin EBF
    Curette, Surgical, Dental EMK
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Knife, Periodontic EMO
    Disk, Abrasive EHJ
    Handpiece, Direct Drive, Ac-Powered EKX
    Wrap, Sterilization FRG
    Instrument, Diamond, Dental DZP
    Curette, Operative EKE
    Handpiece, Air-Powered, Dental EFB
    Wheel, Polishing Agent EJQ
    Syringe, Periodontic, Endodontic, Irrigating EIC
    File, Periodontic EMR
    Strip, Polishing Agent EHM
    Chisel, Osteotome, Surgical EMM
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Remover, Crown EIS
    Mallet, Surgical, General & Plastic Surgery GFJ
    Gutta-Percha EKM
    Aligner, Sequential NXC
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Cleanser, Root Canal KJJ
    Drill, Dental, Intraoral DZA
    Excavator, Dental, Operative EKC
    Bone Mill LYS
    Explorer, Operative EKB
    Accessories, Implant, Dental, Endosseous NDP
    Trephine HWK
    Point, Abrasive EHL
    Plugger, Root Canal, Endodontic EKR
    Material, Impression ELW
    Syringe, Restorative And Impression Material EID
    Handle, Scalpel GDZ
    Bur, Dental EJL
    Post, Root Canal ELR
    File, Pulp Canal, Endodontic EKS
    Forceps, Rongeur, Surgical EMH
    General Purpose Dental Tray OFX
    Scissors, Surgical Tissue, Dental EGN
    Controller, Foot, Handpiece And Cord EBW
    Needle, Dental DZM
    Locator, Root Apex LQY
    Scaler, Ultrasonic ELC
    Plier, Orthodontic JEX
    System, X-Ray, Extraoral Source, Digital MUH
    Carver, Wax, Dental EIK
    Retractor, All Types EIG
    Instrument, Filling, Plastic, Dental EIY
    Probe, Periodontic EIX
    Burnisher, Operative EKJ
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Instruments, Dental Hand DZN
    Curette, Periodontic EMS
    Tester, Pulp EAT
    Mirror, Mouth EAX
    Applicator, Absorbent Tipped, Sterile KXG
    Tube, Tonsil Suction KCB
    Agent, Tooth Bonding, Resin KLE
    Carver, Dental Amalgam, Operative EKH
    Punch, Surgical LRY
    Activator, Ultraviolet, For Polymerization EBZ
    Holder, Film, X-Ray EGZ
    Point, Paper, Endodontic EKN
    Cup, Prophylaxis EHK
    Handle, Instrument, Dental EJB
    Reamer, Pulp Canal, Endodontic EKP
    Gauge, Depth, Instrument, Dental EIL
    Hemostat, Surgical EMD

    Proprietary Names

    EdgePro Core Build Up Brasseler USA Bur Block VersaFlex Disc Forza + Brasseler Irrigation solutions Dental KIts Brasseler Electric Motor Brasseler Forza Attachments MPa Universal Adhesive Brasseler Enlite Curing Light Set Endodontic Hand Files/ Reamer

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)