BEUDAMED
    FDA Registration Active 🇨🇳 China

    Suzhou Pac-Dent Technology Co., Ltd

    Reg #: 3004046477 · FEI: 3004046477 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    35
    Establishment Types
    3
    Classifications
    26

    Registration Details

    Registration Name
    Suzhou Pac-Dent Technology Co., Ltd
    Registration Number
    3004046477
    FEI Number
    3004046477
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 1: Floor 1, 2, 4 of Area A & Area C, Area B, Building 3, Building 5; 51 Zhousidun Road, Caohu Street
    City
    SUZHOU CITY Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160232

    Owner / Operator

    Firm Name
    Pac-Dent Inc.
    Operator Number
    10056434
    Address
    670 Endeavor Cir
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Nikki Huynh

    US Agent

    Business Name
    Pac-Dent, Inc.
    Contact Name
    Heather Hang
    Address
    670 Endeavor Cir
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    909 8390888

    Products

    Device Name Product Code
    Handle, Instrument, Dental EJB
    Holder, Film, X-Ray EGZ
    Dress, Surgical FYE
    File, Pulp Canal, Endodontic EKS
    Tray, Fluoride, Disposable KMT
    Mixer, Cement, For Clinical Use JDZ
    Retractor, All Types EIG
    Wheel, Polishing Agent EJQ
    Retainer, Matrix JEP
    Accessories, Retractor, Dental EIF
    Dental Barriers And Sleeves PEM
    Needle, Dental DZM
    Syringe, Restorative And Impression Material EID
    Scaler, Periodontic EMN
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Material, Impression Tray, Resin EBH
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Instruments, Dental Hand DZN
    Evacuator, Oral Cavity EHZ
    Heat Source For Bleaching Teeth EEG
    Cover, Barrier, Protective MMP
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Unit, Syringe, Air And/Or Water ECB
    Tray, Impression, Preformed EHY
    Cup, Prophylaxis EHK
    Unit, Operative Dental, Accessories NRD

    Proprietary Names

    131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk 131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk 131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk 131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk 131120 EzAim Individually Cut Adhesive Sensor Holder Posterior Yellow, 50/pk 131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk 131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk 131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk 131120 EzAim ComforTab Adhesive Sensor Holder Posterior Yellow, 50/pk JS Dental Pac-Dent Disposable Tray, Tooth Whitening COMPOSITE SPATULAS PLASTIC EasyProp iMatrix Clear Dental barriers and sleeves Rodin TruModel ProAngle ProMate Freestyle Pro ProMate™EZ-Q Quick Disconnect Coupler AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct ProMate™ EZ-Q Quick Disconnect Hygiene Handpiece ACCLEAN ERGO PROPHY ANGLE LF AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct AntiSplatr™ Disposable Prophy Angles ProMate™ EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler PJ-01 ProJect™ Composite Dispensing Gun Air Techniques Pac-Dent Barrier Sleeve, Cover It Barrier Film UNIVERSAL CURING LIGHT SHIELD PSP Barrier Envelopes Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device