BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CA 1:5 L

    DI: J0071600386001USA1 · Model: 1600386-001USA · BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CA 1:5 L
    Primary DI
    J0071600386001USA1
    Version / Model
    1600386-001USA
    Company Name
    BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
    Labeler DUNS
    338234588
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-05
    Public Version
    2
    Public Version Date
    2026-02-11
    Public Version Status
    Update
    Public Device Record Key
    2179532d-e2b2-41fb-87d9-8309076ea7da

    Device Description

    CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EFB Handpiece, Air-Powered, Dental

    GMDN Terms

    Code Name
    66247 Dental power tool handpiece motorless component

    Identifiers

    Type ID
    Primary J0071600386001USA1

    Customer Contacts

    Phone
    +1 949-477-6050
    Email
    [email protected]