BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AHP-101 - HPCE 1:1 STRT LOW SPEED DORIOT

    Reg #: 3017604 · FEI: 3017604 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASEPTICO, INC.
    Registration Number
    3017604
    FEI Number
    3017604
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8333 216th St SE
    City
    WOODINVILLE
    State
    WA
    ZIP
    98072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051077

    Owner / Operator

    Firm Name
    ASEPTICO, INC.
    Operator Number
    3017604
    Address
    8333 216TH ST., S.E., --
    City
    Woodinville
    State
    WA
    Postal Code
    98072
    Country
    US

    Products

    Device Name Product Code
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    AHP-101 - HPCE 1:1 STRT LOW SPEED DORIOT AHP-65TI - HPCE 1:3 INCREASER W/ WATER AHP-85MB-STP - DEPTH STOP ONLY FOR AHP-85MB-C AHP-85MB-CX - HPCE 20:1 PB CONTRA ANGLE MONT BLANC CONTROL AHP-63NAK - HPCE 1:1 CONTRA LATCH ANGLE AHP-85MBFO-CX - HPCE 20:1 PUSH BTN CONTRA ANG W/FIB OPT MONT BLANC CONTROL AHP-72C-FO - HPCE 1:5 CONTRA INCREASER SPEED W/FIBER OPT & AIR AHP-53 - HPCE 1:1 DORIOT CONTRA AHP-77DS - HPCE ORAL SURGERY 1:2 NSK STRAIGHT AHP-62MN - HPCE 16:1 MICRO-NITI CONTRA ANGLE LATCH HEAD AHP-50 - MOTOR AIR 20K RPM 4H AHP-88MNP - HPCE 8:1 MICRO-NITI PUSH BUTTON AHP-88MN - HPCE 8:1 MICRO-NITI CONTRA ANGLE LATCH HEAD AHP-85P-I - HPCE 20:1 PUSH BUTTON CONTRA REINFORCED IMPULSION AHP-85-SS - HPCE 20:1 NON-OPTIC AHP-56FUE - HPCE 4:1 CONTRA FUE DRIVE AHP-09 - ASEPTISPRAY HPCE LUBRICANT WITH E TYPE NOZZLE ADAPTER AHP-55T - TURBINE FOR AHP-55 AHP-63MBFO-XL - HPCE 1:1 CONTR W/FIB OPT & WATER MONT BLANC EVOLUTION AHP-77D-NOZ - WATER NOZZLE AHP-77D (H265A001) AHP-62MNP - HPCE 16:1 MICRO HEAD PUSH BUTTON AHP-82T - HPCE TORQUE HEAD K-STYLE VECTOR FIBER OPTIC HIGH SPEED AHP-85MB-CLP - CLIP MONT BLANC EXTERNAL AHP-51 - HPCE 1:1 STRAIGHT E TYPE L AHP-11 - ONESTEP LUBRICANT WITH E TYPE NOZZLE ADAPTER AHP-97 - HPCE HIGH SPEED 5-H W/FIBER OP (135985) AHP-85MB-CAN - CANNULA MONT BLANC INTERNAL AHP-65TI-FO - HPCE 1:3 INCREASER W/ WATER W/ FIB OPT AHP-85MB-X - HPCE 20:1 PUSH BTN CONTRA ANGLE MONT BLANC EVOLUTION AHP-71TI-X - HPCE 1:5 INCREASER W/WATER AHP-64 - HANDPIECE STRAIGHT 1:1 40K AHP-85MB-CS - DEPTH STOP FOR AHP-85MB-C HANDPIECE AHP-85-I - HPCE 20:1 CONTRA ANGLE LATCH IMPULSION AHP-55 - HPCE HI-SPEED ECONOMY 4H AHP-96 - HPCE CHAMP-AIR 4-HOLE PUSH BUTTON HIGHSPEED REF#AC5000-4P AHP-64MKI - HANDPIECE STRAIGHT 1:1 40k w/ INTERNAL IRRIGATION AHP-96MK - HANDPIECE 4-HOLE PB STD HEAD HIGHSPEED AHP-50MK - MOTOR AIR 4-HOLE E-TYPE 20K RPM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198