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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: EGS FDA class 1

    Handpiece, Contra- And Right-Angle Attachment, Dental

    Dental

    View full classification →

    The Contra- and Right-Angle Attachment Handpiece is a dental instrument attachment that connects to the main handpiece motor and redirects the rotational drive at an angle, allowing access to posterior teeth and difficult-to-reach areas of the oral cavity. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and does not require premarket notification. The product code is EGS, regulated under 21 CFR 872.4200 in the Dental (DE) specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable Prophy Angle
    Star E900 Handpiece Series
    General Cutting Straight
    FX Contra
    Lotus Prophy Angle
    Smooth Drive contra angle and straight handpieces
    Dental Handpiece, Model CA160, CA160L, and CA500L
    SURGmatic S15 L Pro
    General Cutting Contra Handpiece
    TRAUS Dental Handpieces
    General Cutting Contra Handpiece
    STRONG Dental Handpieces
    STRONG Dental Handpieces
    Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
    Titan 3 Low Speed Angle Attachments
    LUXATOR LX HANDPIECE
    STRONG Dental Handpieces
    Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
    U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
    SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
    TI-MAX Z45
    VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
    ENDO-EXPRESS (R) HANDPIECE
    TORQTECH
    MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
    STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
    DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
    PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
    STRONG DENTAL HANDPIECES
    MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
    EXCEL CONTRA ANGLE HANDPIECE
    ANTHOGYR CONTRA ANGLES AND HANDPIECES
    DR DISPOSABLE PROPHY ANGLE MODEL H310
    E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
    AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
    B&R DEVICE
    CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
    PROANGLE DISPOSABLE PROPHY ANGLE
    ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
    CLEAN 'N' OIL
    AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
    SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
    EXTENDED STRAIGHT ATTACHMENT
    STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
    23:1 REDUCTION ANGLE
    E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
    SERIES XE, SERIES SE, SERIES TE
    E-TYPE CONTRA ANGLE NAC-E
    SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
    J SINGLE USE HEAD AND JD REUSABLE HANDLE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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