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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: EFS FDA class 1

    Unit, Oral Irrigation

    Dental

    View full classification →

    The Oral Irrigation Unit is a dental device that delivers a pulsating or steady stream of water or antimicrobial solution to the gingival sulcus and interproximal areas of the teeth for the removal of debris and for adjunctive plaque control in patients with periodontal disease or at elevated caries risk. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFS and the applicable regulation is 21 CFR 872.6510, under the Dental medical specialty.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
    DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
    AGATHA-A-H2010
    DERMADAM
    BARRIER ALL FILM
    ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
    PERIOFLEX TIP
    HYDRO FLOSS
    WATER PIK PLUS PLAQUE CONTROL SYSTEM
    SHOWERFLOSS
    SHOWERFLOSS ORAL IRRIGATION UNIT
    INTERJET(TM) GINGIVAL CARE INSTRUMENT
    MAX-I-PROBE IRRIGATION SYSTEM
    OXYFRESH OXYCARE 3000
    PERIOGARD(R) PERIOPEN
    PERIO PIK
    DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
    L'LL SQUIRT GUM ORAL RINSE DEVICE
    OSSEOTITE IRRIGATION UNIT
    WATER PIK(R) W/ADD'L CLAIMS
    ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
    SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
    DYNASURG DENTAL IRRIGATION SYSTEM
    PIK POCKET(R), MODEL PP-3
    WATER PIK(R)
    HYDRODENT ANTIPLAQUE SYSTEM
    AIR WATER SYRINGE TIP SHIELD
    PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
    PERIODONTAL SCALING SOLUTION-C
    PERIODONTAL SCALING SOLUTION-A
    PERIDONTAL SCALING SOLUTION-B
    PLAK VAK - PV-10
    PIK POCKET (IRRIGATING TIP)
    SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
    BRAUN DENTAL CENTER OC-3
    ORAL IRRIGATION TIP
    PERIO PIK
    POCKETIP 4414
    PERIODONTAL IRRIGATOR #7620
    PRO PULSE PERIODONTAL IRRIGATOR 7618
    GUM MACHINE
    DENTO SPRAY ORAL IRRIGATOR
    MULTI-UNIT, MULTI-PURPOSE DEVICE
    RECOH ROOT CANAL IRRIGATOR
    WATER PIK ORAL HYGIENE CENTER
    ERGO IRRIGATION SYSTEM
    WATER PIK TRAVELER, MODEL 79

    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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