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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

a. MIS LOCKiT Abutments System MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal. MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only. MIS LOCKiT abutments are provided in the following gingival heights: - . Narrow platform: 1, 2, 3, 4, 5 mm - . Standard platform: 1, 2, 3, 4, 5 mm - Wide platform: . 1, 3, 5 mm MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems). MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems). b. OT-Equators and Ball Attachments Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear. Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights: - . Narrow platform: 1, 2, 3, 4, 5 mm - . Standard platform: 1, 2, 3, 4, 5 mm - Wide platform: 1, 3, 5 mm . MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

The MIS internal hex implant system includes two implant families: M4 and SEVEN. The subject implants system are endosseous dental implants and Endosseous dental implant abutments, manufactured from titanium TI-6Al-4V ELI. The implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments. The implants are self-tapping, root-form with tapered threads and their surface is sand blasted and acid etched. The implants are supplied sterilized by gamma irradiation. MIS M4 implants are cylindrical and conical shaped, self-tapping, have a V shaped thread design with three spiral channels and a flat, cutting tapered apex. The MIS M4 Implants are available in the following diameters, platforms and lengths: - Narrow platform: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm - Standard platform: 3. 75 mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm, 18mm and 20mm - . Standard platform: 4.2 mm diameter: 6mm, 8mm, 10mm, 16mm, 16mm, 18mm and 20mm - Wide platform: 5.0 mm diameter: 6mm, 8mm, 11.5mm, 13mm and 16mm - . Wide platform: 6.0 mm diameter: 6mm, 8mm, 10mm, 11.5mm, 13mm MIS SEVEN implants are conical shaped with a domed apex. Their geometric design includes dual threads, three spiral channels stemming from the apex for self-tapping, micro rings on the implant neck, and a changing thread thickness along the implants are color coded for platform identification. The MIS SEVEN Implants are available in the following diameters, platforms and lengths: - Narrow platform (yellow): 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm - Standard platform (purple): 3. 75mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm and 20mm - Standard platform (purple): 4.2mm diameter: 8mm, 13mm, 16mm, 16mm, 18mm and 20mm - Wide platform (green): 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm - . Wide platform(green): 6.0 mm diameter: 8mm, 10mm, 11.5mm, 13mm - The implants are designed for both two-stage procedures, with one internal thread for screwed abutment. The MIS Internal Hex Dental Implant System is a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation. Components: The MIS Internal Hex Dental Implant System is to be used in combination with variety of the internal hex abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), including up to 300 angulated abutments. Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of TI 6AL 4V ELI, and supplied sterile to the user, for single use. Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate the patients specific needs. They are available in 0, 10 or 20 degrees angulation in narrow platform, 0, 15 or 25 degrees angulation in standard platform and 0 or 15 degrees angulation for wide platform. They are made of TI 6AL 4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use. CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments indicated for 0 degree angulation for straight implantation only. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of TI 6AL 4V ELI. Their additional components intended for impression taking and casting are made of POM. Plastic healing caps intended to cover the CPK abutment until final restoration placement are made of PEEK. They are supplied non sterilized by the user according to the labeling, and intended for single use. Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is burned out for casting with precious metals.. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are straight abutments intended for 0 degree angulation for straight implantation only. The abutments are supplied non sterilized by the user according to the labeling, and intended for single use. Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are intended for use in a completely edentulous jaw when screw retained prosthetis is preferred, for anchoring a fixed overdenture. Multi-units are available in 0 degrees for narrow platform, and in 0, 17 or 30 degrees for standard and wide platforms. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of TI 6AL 4V ELI. The overdenture is connected to the multiunit by a screw. All multi units are made of TI 6AL 4V ELI. They are supplied sterile and intended for single use. OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are mostly used in completely edentulous jaws to connect to an overdenture bar to allow its insertion and removal. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Ball attachments are available straight for narrow and wide platforms, and in 0, 15 or 25 degrees for standard platform. OT Equators are available straight only. Both are made from TI 6AL 4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterilized by the user according to the labeling and intended for single use. Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation. They are straight abutments. They are available in TI 6AL 4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from TI 6AL 4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration, as directed in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use. There are two types of emergence profiles among the abutments, concave or straight emergence profile.

MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS CONNECT Conical Connection abutment is an endosseous dental implant abutment device which is intended for use by a dental clinician with a root-form endosseous dental implant to aid in prosthetic rehabilitation, by incorporation in the upper or lower jaw for supporting tooth replacements to restore chewing function. The MIS CONNECT Conical Connection abutment is intended to be used with MIS Conical Connection Implants, such as MIS V3 Conical Connection Dental Implant System and Connection Implants cleared under K112162 and K163349, respectively, and is intended to be placed above the bone level and within the gingival tissue. The MIS CONNECT Conical Connection abutment can be fitted with a variety of complementary accessories, including Healing caps, Cementing caps and Temporary abutments (which are proposed for clearance in the present submission), and also including Prosthetic screws, Impression copings, Analogs, and Scan posts (which are class I products and are therefore exempt from clearance requirements). The MIS CONNECT Conical Connection abutment is not intended to be removed.

MIS dental implant system is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS C1 NP Conical Connection dental implants are manufactured from Ti-6AI-4V ELI. The conical root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The implants are self-tapping, root-form with tapered threads. They have a 3.3 mm diameter and the following lengths: 10mm, 11.5mm, 13mm and 16mm. The internal part of the implant and the lower part of the abutment are anodized for coloring purposes for a quick identification of the diameter and to ensure the adequate abutments. The Implants are supplied sterile. This submission also includes wide platform (WP) conical connection abutments which are compatible to the previously cleared (K112162) MIS conical connection wide platform implants. Components: The MIS C1 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants. The abutments in this submission include NP abutments, compatible with the C1 NP implants also submitted here; and WP abutments compatible with previously cleared (K112162) MIS conical connection WP implants.

MIS V3 Conical Connection Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants. The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone. The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm; 3. 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants surface is sand blasted and acid etched. The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation. For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows: "Narrow Platform" (NP) – 3.3mm diameter: blue; "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple. The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch). Components: The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.

MIS Conical Connection Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

The conical connection dental implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths: 0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm 0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm The implants surface is sand blasted and acid etched. The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures. The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.

PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

PerioPatch is a hydrogel wound dressing for use in the oral cavity. It is a hydrogel with an occlusive ethyl cellulose backing to support and help the hydrogel conform to the wound, thereby providing protection and coverage to the wound. The dressing is made entirely of GRAS natural ingredients, commonly used in ingested products, which absorb moisture and become a hydrogel. These materials adhere to the wound for up to 5-6 hours. The patch is self-adhesive after contact with moist tissue and provides an absorptive and flexible barrier over the affected area and as such protects the inflamed areas and lesions in the mouth from contact with the rest of the oral environment, thereby preventing irritation and painful aggravation of the affected area.