BEUDAMED
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    Filters Classification: Class Ii ×

    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·April 6, 2016

    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 16, 2015

    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

    FDA Enforcement
    Class II ·Ongoing·Implant Direct Sybron Manufacturing LLC·August 6, 2025

    Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·November 6, 2019

    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 17, 2018

    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·July 11, 2018

    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing LLC·February 19, 2020

    Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·May 31, 2017

    RePlant¿ Angled Abutment Part Number 6050-52-60

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·August 10, 2016

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 27, 2017

    GoDirect Screw-Retaining Top Part Numbers: 4500-61

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·January 18, 2017

    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing LLC·February 19, 2020

    Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·February 14, 2018

    6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the laboratory technician.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·June 29, 2016

    SwishTapered Implant

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·February 8, 2017

    Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 11, 2017