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510(k) Data Aggregation

    K Number
    K083869
    Device Name
    BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI
    Manufacturer
    Date Cleared
    2009-03-27

    (88 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTLOCK SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BT-Tite CV3: It is intended to be used in maxilla or mandible, for post-extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis. Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to replace lateral teeth, dental agenesis and inferior incisors. Slot implant: It is intended to be used as temporary intra-oral anchorage unit in the orthodontic treatment in the superior or inferior arch or extra arch in case of edentulous patients, when necessary teeth for the anchorage are absent or the next teeth are compromised from a parodontal point of view. It facilitates the orthodontic movement of teeth. It is removed after orthodontic treatment has been completed. Slot implants are intended for single use only.
    Device Description
    BTLock implant are intended for use in the upper and/or lower jaw to support prosthetic devices. such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients. The main feature of BTLock implant system is an original and patented connection (US patent n° 6659700 B2 dated December 9th 2003, attachment nº 11). This connection has no compatibility with other systems. All prosthetic components and accessories are exclusive for BTLock implant system. It included BT-Tite CV2 and BT-Tite Standard lines which have been approved by the FDA with the 510(K) number 073458. BT-Tite CV3 is an implant line which includes fixture and abutment joined together by a through screw. CV3 fixture is machined from titanium, with a deep thread, micro-grooves on the collar, 6 longitudinal long grooves along the body till the collar, DMA surface and a platform designed for the platform-switching. The surface treatment called DMA (which stands for doppia mordenzatura acida, that is double acid-etching) is obtained by the combination of sand-blasting and double acid-etching. This treatment is absolutely equivalent to BT-Tite (no material is added, no changes in the material used for the treatment: just acid-etching is performed twice instead than once). This line features a conical-cylindrical shape as the other fixtures of BTLock system. Therefore, because of this equivalence, I submitted the same tests carried for the other lines (BT-Tite One, BT-Tite CV2, BT-Tite Standard). It is available in 3 diameters (3,75 - 4,5 - 5,5 mm) and 5 lengths (8 - 10 - 11,5 - 13 -16 mm). The technical details of the product are included in its own drawing (see attachment nº 18). Mini Implant: The fixture of the mini implant line is machined from titanium and self-threading. They are available in 3 diameters (2 - 2,5 - 3 mm) and 3 lengths (11,5 - 13 - 16 mm). The implant length includes the machine-cut collar (1,5 mm) and the threaded part which features a surface treatment called BT-Tite, which is obtained by the combination of sand-blasting and acid-etching. Mini Single: It is a self-threaded and tapered implant made of titanium alloy. The fixture's body features BT-Tite as surface treatment (already approved by FDA, see K073458). This implant has a one-piece design, that is the abutment is integrated to the implant, and an anatomic design. The implant and the abutment are made of the same material. It is available in 2 diameters (2,5 - 3 mm) and 4 lengths (10 - 11,5 - 13 - 16 mm). Slot Implant: This device is made of titanium alloy, has a tapered and self-tapping shape. The head has 2 slots, one hole and one neck. The neck is polished (in order not to interfere with soft tissue). It can be loaded immediately.Its smooth threaded surface allows easy removal at the end of treatmet: as a matter of fact because complete osteointegration is neither expected nor desired with this anchorage system because its utilization is temporary. It is available in 2 diameters (1,6 - 2 mm) and 3 lengths (6 - 7,5 - 9 mm).
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    K Number
    K073458
    Device Name
    BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)
    Manufacturer
    Date Cleared
    2008-04-04

    (116 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTLOCK SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BT-Tite Standard (or VSM) It is intended to be used in maxilla or mandible, and for every kind of reconstruction, preferably not immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. BT-Tite One (or CV1) It is intended to be used in maxilla or mandible, for extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. BT-Tite CV2 (or CV2) It is intended to be used in maxilla or mandible. It is indicated in any situation for extraction sites, where the implant would be immediately loaded and where the bone crest is stable. In case of post-extraction sites, it has to be inserted some millimetres under the bone. It is intended to be used in a single stage or two stage surgical procedure.
    Device Description
    BTLock implant system is composed by a fixture and an abutinent, joined together by a through screw. Main feature of BTLock implant system is an original and patented internal connection (US patent nº 6659700 B2 dated December 9th 2003). This connection has not compatibility with other system. All prosthetic components and accessories are exclusive for BTLock implant system, BTLock implants are threaded, root-form dental implants, intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients. BTLock implants are machined from titanium and available tapered. The implants may a) have a surface that consists of a titanium oxide layer, i. e. TiUnite implants (BT-Tite Standard Line); b) be coated with hydroxyapatite powder, i. e. HA Coated implants, (HA Coated Standard Linc); or c) Acid-Etched (Acid-Etched Standard Line). BTLock implant lines may differ also for the kind of thread (One or Standard), while keeping always the same kind of connection. All prosthetic components are indecd compatible with same-sized diameter of all lines. BTLock implants may be placed in the oral cavity using cither a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.
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