BEUDAMED
    Product Code: EIS FDA class 1 21 CFR 872.4565

    Remover, Crown

    Dental

    The Crown Remover is a dental instrument used to dislodge and remove cemented or temporarily attached dental crowns from prepared tooth abutments without damaging the crown or the underlying tooth structure. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIS, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    19
    FEI Numbers
    124
    Registration Numbers
    124
    Unique Applicants
    7
    Years Active
    16

    Research product code EIS in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    EIS
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K992649 ATD AUTOMATIC BRIDGE REMOVER
    K951299 EASY PNEUMATIC CROWN AND BRIDGE REMOVER
    K863500 STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
    K854795 HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
    K842026 H-TYPE BRIDGE REMOVER
    K833290 C & B 40 PENTRO C & B40
    K833287 SATIN CAST ECONOCAST
    K833736 GOLD-PALLADIUM-SILVER BASED CAST/ALLOY
    K833289 C & B 61 PENTRON C & B61
    K833278 C & B 45
    K833280 SUPRA AP CHOICE 83
    K833285 RX IV PENTRON IV
    K833288 C & B57 PENTRON C & B57
    K833286 RX SEG ECONOPLUS
    K833284 RX 41 PENTRON 41
    K833283 RX ORY PENTRON C & B
    K833282 RX NYSP PENTRON 60
    K833281 RX D PENTRON
    K833279 NATURELLE-LITE

    FEI Numbers

    This FDA classification entry is associated with 124 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 124 registration numbers. Click on an entry to view related FDA registrations.