BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    0.535.5200 - INTRA-L-MOTOR 181 H

    Reg #: 8010493 · FEI: 1344 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    58
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAVO DENTAL GMBH
    Registration Number
    8010493
    FEI Number
    1344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BISMARCKRING 39
    City
    BIBERACH Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K073478

    Owner / Operator

    Firm Name
    KaVo Dental GmbH
    Operator Number
    10042139
    Address
    Bismarckring 39
    City
    Biberach
    State
    Baden-Wurttemberg
    Postal Code
    88400
    Country
    DE

    US Agent

    Business Name
    KaVo Dental Technologies, LLC
    Contact Name
    Crystal Bialek
    Address
    11727 Fruehauf Drive
    City
    Charlotte
    State
    NC
    ZIP
    28273
    Country
    US
    Email
    [email protected]
    Phone
    704 2886058 ext. 0

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    0.535.5200 - INTRA-L-MOTOR 181 H 0.535.5260 - INTRA 181 K 20 000 R.P.M. 0.535.5250 - INTRAmatic 181 M 0.535.5210 - INTRA L-LUX 181 L 107.1700 - GENTLEmini LUX 4500BR 101.8776 - INTRA LUX Motor KL 701 107.3600 - EXPERTtorque Mini LUX E677 L 101.7452 - GENTLEpower LUX 7 LP 103.1108 - INTRAmatic 14 E 107.5560 - EXPERTmatic E10 C 104.5380 - INTRAmatic 23 ES 101.7453 - GENTLEpower LUX 20 LP 106.9200 - EXPERTtorque E679 L 103.9882 - Trio-Pack 181P/181P/181P 101.7522 - POWERtorque 646 B 103.1107 - INTRAmatic 20 E 106780 - GENTLEsilence LUX gold 8000 BR 107.5540 - EXPERTmatic E20 L 107.5531 - EXPERTmatic E15 C 107.5550 - EXPERTmatic E25 L 108.1834 - INTRA Kopf L68 B 108.1828 - INTRA EVA Kopf L61 G 108.1825 - INTRA Mini Kopf L52 108.1830 - INTRA Kopf L62 108.1823 - INTRA Endo Kopf L3 Y 107.2400 - GENTLEsilence LUX 6500 BR 108.1832 - INTRA Kopf L67 104.6403 - INTRAmatic 19 E 101.5660 - GENTLEpower LUX 10 LP 0.535.6180 - INTRAflex LUX2 2320 LN 107.3580 - GENTLEpower LUX 25 LPR 104.6401 - INTRAmatic 80 E 103.1109 - INTRAmatic 31 ES 0.535.6210 - INTRAflex LUX2 2325 LN 101.7454 - GENTLEpower LUX 29 LP 0.535.6220 - INTRAflex LUX2 2313 LN 108.4998 - EXPERTmatic E31 C 0.535.6200 - INTRAflex LUX2 2329 LN 108.1835 - INTRA Micro Kopf L22 107.5541 - EXPERTmatic E20 C 106800 - EXPERTtorque E675 LMW 0.553820 - COMPACTtorque 636 CP 107.5530 - EXPERTmatic E15 L 108.1833 - INTRA Kopf L68 104.4503 - INTRAmatic 19 ES 107.5551 - EXPERTmatic E25 C 104.4456 - INTRA Kopf L80 108.4999 - EXPERTmatic E61 C 103.2278 - PROPHYwiz 181 P 106.6400 - EXPERTtorque E675 L 0.535.6190 - INTRAflex LUX2 2307 LN 103.6977 - INTRAmatic 10 E 108.1831 - INTRA Kopf L66 B 103.6976 - INTRAmatic 31 E 108.1824 - INTRA Prophy Kopf L31 108.1829 - INTRA EVA Kopf L61 R 108.1826 - INTRA Endo Kopf L53 108.1822 - INTRA Endo Kopf L3

    Establishment Types

    Manufacture Medical Device