BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZAPALIGN LLC

    Reg #: 3043226252 · FEI: 3043226252 · Expires 2026
    View on FDA
    Products
    156
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    156

    Registration Details

    Registration Name
    ZAPALIGN LLC
    Registration Number
    3043226252
    FEI Number
    3043226252
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2281 Griffin Rd
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33312
    Country
    US

    Regulatory Submissions

    510(k) Number
    K962065

    Owner / Operator

    Firm Name
    Zapalign LLC
    Operator Number
    10095225
    Address
    2281 Griffin Road,
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33312
    Country
    US
    Correspondent
    Marty Trabish

    Products

    Device Name Product Code
    Cement, Dental EMA
    Set, I.V. Fluid Transfer LHI
    Agent, Tooth Bonding, Resin KLE
    Disk, Abrasive EHJ
    Transducer, Pressure, Catheter Tip DXO
    Forceps, General & Plastic Surgery GEN
    System, Irrigation, Urological LJH
    Arthroscope HRX
    Material, Tooth Shade, Resin EBF
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
    Set, Administration, Intravascular FPA
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Post, Root Canal ELR
    Wrap, Sterilization FRG
    Scaler, Ultrasonic ELC
    Tape And Bandage, Adhesive KGX
    Stethoscope, Electronic DQD
    System, X-Ray, Extraoral Source, Digital MUH
    Hysteroscope (And Accessories) HIH
    Drape, Surgical, Antimicrobial KKX
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Needle, Hypodermic, Single Lumen FMI
    Apparatus, Exhaust, Surgical FYD
    Zinc Oxide Eugenol EMB
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Blade, Scalpel GES
    Continuous Measurement Thermometer FLL
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Endoscopic Bite Block MNK
    Bandage, Elastic FQM
    Gauze / Sponge,Nonresorbable For External Use NAB
    Retractor, All Types EIG
    Tube Tracheostomy And Tube Cuff JOH
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Curette, Periodontic EMS
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Scaler, Periodontic EMN
    Cannula, Manipulator/Injector, Uterine LKF
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Silk GAP
    Dressing, Wound, Drug FRO
    Varnish, Cavity LBH
    Sealant, Pit And Fissure, And Conditioner EBC
    Liner, Cavity, Calcium Hydroxide EJK
    Indicator, Biological Sterilization Process FRC
    System, Transport, Aerobic JTW
    Filter, Infusion Line FPB
    Syringe, Piston FMF
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Dna-Reagents, Neisseria LSL
    Speculum, Vaginal, Nonmetal HIB
    Automated External Defibrillators (Non-Wearable) MKJ
    Dressing, Wound, Occlusive NAD
    Laparoscope, General & Plastic Surgery GCJ
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Electrode, Electrosurgical JOS
    Anesthesia Conduction Kit CAZ
    Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) LJC
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Material, Impression ELW
    Gown, Surgical FYA
    Tube, Collection, Capillary Blood GIO
    Accessory, Surgical Apparel LYU
    Container, Sharps MMK
    Blood Pressure Cuff DXQ
    Tube, Tracheal (W/Wo Connector) BTR
    Tube, Tympanostomy ETD
    Needle, Aspiration And Injection, Disposable GAA
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Electrocardiograph DPS
    Spirometer, Diagnostic BZG
    Razor, Surgical LWK
    Syringe, Antistick MEG
    Crown And Bridge, Temporary, Resin EBG
    Container, Liquid Medication, Graduated KYW
    Mask, Surgical FXX
    Crown, Preformed ELZ
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Accessories, Arthroscopic NBH
    Scalpel, One-Piece GDX
    Forceps, Rubber Dam Clamp EJG
    Curette, Surgical, General Use FZS
    Protector, Ostomy EXE
    Bandage, Liquid KMF
    Holder, Needle, Gastroenterologic FHQ
    Helicobacter Pylori LYR
    Instruments, Dental Hand DZN
    Electrode, Electrocardiograph DRX
    Lead, Atomic Absorption DOF
    Mirror, Mouth EAX
    Caries Detector, Laser Light, Transmission NTK
    Activator, Ultraviolet, For Polymerization EBZ
    Antigens, Cf (Including Cf Control), Influenza Virus A, B, C GNX
    Dna Probe, Yeast MLA
    Elastomer, Silicone, For Scar Management MDA
    Tray, Surgical, Instrument FSM
    Container, Specimen, Sterile FMH
    Device, Intravascular Catheter Securement KMK
    Holder, Film, X-Ray EGZ
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Sleeve, Limb, Compressible JOW
    Accessories, Cleaning Brushes, For Endoscope MNL
    Wheel, Polishing Agent EJQ
    Automated Urinalysis System KQO
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Punch, Surgical LRY
    Nipper, Malleus JYR
    Spirometer, Therapeutic (Incentive) BWF
    Ligator, Hemorrhoidal FHN
    Tubes, Gastrointestinal (And Accessories) KNT
    System, Thermal Regulating DWJ
    Non-Surgical Gown OEA
    Indicator, Physical/Chemical Sterilization Process JOJ
    Gag, Mouth KBN
    Protector, Skin Pressure FMP
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Dressing, Wound, Hydrophilic NAC
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Scissors, General, Surgical LRW
    Orthosis, Cervical IQK
    Cannula, Surgical, General & Plastic Surgery GEA
    System, Hemoglobin, Automated GKR
    Surgeon'S Gloves KGO
    Elevator, Surgical, Dental EMJ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Point, Abrasive EHL
    Dispenser, Liquid Medication KYX
    Airway, Oropharyngeal, Anesthesiology CAE
    Sling, Arm ILI
    Forceps, Tooth Extractor, Surgical EMG
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Accessories, Blood Circuit, Hemodialysis KOC
    Support, Patient Position CCX
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Curette, Suction, Endometrial (And Accessories) HHK
    System, Abortion, Vacuum HHI
    Accessories, Implant, Dental, Endosseous NDP
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Electrode, Cutaneous GXY
    Bronchoscope (Flexible Or Rigid) EOQ
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Gastroscope And Accessories, Flexible/Rigid FDS
    Cord, Retraction MVL
    Otoscope ERA
    Dam, Rubber EIE
    Esthesiometer GXB
    Bur, Surgical, General & Plastic Surgery GFF
    Orthosis, Thoracic IPT
    Garment, Protective, For Incontinence EYQ
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP

    Proprietary Names

    Stocking, medical support (to prevent pooling of blood in legs) ZINC OXIDE EUGENOL Dressing, Wound, Drug SPIROMETER, DIAGNOSTIC DPS - Electrocardiograph Protector, ostomy Bandage, liquid Elastomer, silicone, for scar management Tissue adhesive for the topical approximation of skin Tube tracheostomy and tube cuff BUR, SURGICAL, GENERAL & PLASTIC SURGERY

    Establishment Types

    Repack or Relabel Medical Device Manufacture Device in the United States for Export Only