BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    JEDENTAL VLC DENTAL CURING LIGHT

    K Number: K935718 · Decision Jan 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    57

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    JEDENTAL VLC DENTAL CURING LIGHT
    K Number
    K935718
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4620
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jedental Co., Inc.
    Date Received
    November 30, 1993
    Decision Date
    January 26, 1994
    Product Code
    EAY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EAY Light, Fiber Optic, Dental

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EAY), ordered by most recent decision date.

    MODEL A15-101

    FDA 510(k)
    FDA Class 1 ·Dental

    MODEL A15-103

    FDA 510(k)
    FDA Class 1 ·Dental

    STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM

    FDA 510(k)
    FDA Class 1 ·Dental

    POWER OPTIC

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTAL ELECTRONIC/S.B.R TRADING BU HAND

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTISCOPE

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Jedental Co., Inc.

    K Number Device Name
    K933612 JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)
    K934073 JEDENTAL GLASS IONOMER CEMENT AND LINER
    K935727 P&FS PIT AND FISSURE SEALANT
    K933656 JEDENTAL PSROFILL SELF-CURE COMPOSITE
    K933543 ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)
    K933554 JEDENTAL ZINC CEMENT IMPROVED
    K931880 PROFILL LC COMPOSITE