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Blue Sky Plan Software orthodontic module is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts which may be used for sequential aligners, based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied during the treatment to inspect and analyze the progress of treatment, and at the end of treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. Blue Sky Bio Aligner Z and Blue Sky Bio Aligner Z FLX are series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force. The use of the Blue Sky Plan Software module requires the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

A dental clinician, using a standard personal computer prescribes the orthodontic appliance based on an assessment of the patient's teeth and determines the course of treatment using the Blue Sky Plan Software. The clinician takes molds of the patient's teeth and completes a prescription form and sends the molds to the dental lab, which in turn scans the molds and uploads the .STL files of the molds in Blue Sky Plan software. This digital file is a series of CAD files (.STL) for building models that can be used to fabricate the aligners. Alternatively, the dental clinician may generate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then send the files to the dental lab. The Blue Sky Bio Aligners (Z and Z FLX) consist of a series of clear plastic aligner trays which are fabricated with the selected thermoplastic material (either a thin polyurethane sheet or a composite of copolyester and polyurethane). Both materials are commercially used for thermoforming customized removable aligners for the intended use. The prescribing physician reviews and approves the model scheme before the aligners are produced. Once approved by the clinician, the dental lab produces the Blue Sky Bio Aligner Z or Z FLX. The finished aligners are sent to the dental clinician who then provides them to the patient, confirming fit and form. Over a period of time, additional aligner trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental clinician monitors treatment from delivery of the first aligner to the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.

Blue Sky Plan software module for Blue Sky Bio Aligner G is intended for use as a medical frontend device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. Blue Sky Bio Aligner G is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force. The use of the Blue Sky Bio Plan software module for Blue Sky Bio Aligner G requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The Blue Sky Bio Aligner G consists of a series of clear plastic aligner trays that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions. Blue Sky Bio Aligner G starts with the dental clinician prescribing aligners to treat a patient's malocclusion, and the decision to use a methacrylate-based resin for sequential aligners. A dental clinician (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligner G based on an assessment of the patient's teeth and determines the course of treatment, using Blue Sky Bio's Blue Sky Plan software (K180107). The clinician takes molds of the patient's teeth and completes a prescription form and sends the molds to the dental lab, which in turn scans the molds and uploads the .STL files of the molds in Blue Sky Plan software. This digital file is a series of CAD files (.STL) for building models that can be used to fabricate aligners. Alternatively, the dental clinician may generate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then sends the files to the dental lab. The dental lab or the clinician designs a series of digital models and plastic trays intended to gradually realign the patient's teeth, using Blue Sky Plan software. The prescribing physician reviews and approves the model scheme before the aligners are produced. Once approved by the clinician, the dental lab produces the Blue Sky Bio Aligner G sequential aligners, which are 3D printed with a clear biocompatible resin. The Blue Sky Bio Aligner G are sent to the dental clinician who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region. Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only. Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491. Blue Sky Bio PEEK abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP). The subject device implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.

Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments. For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half. Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe). Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. For the second method, the Cobalt Base Abutments (Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques. Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment. Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034. All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.

The proposed Blue Sky Bio TAD is intended to provide a fixed anchorage point for attachment of orthodonic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

The Blue Sky Bio TAD is fabricated from titanium Alloy without surface treatment, which meets the material requirements specified in the standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the Blue Sky Bio TAD in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head. The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed Blue Sky Bio TAD is threaded for quick insertion and provides stability and biomechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing.

Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to expand the Blue Sky Bio Zygomatic Implant System cleared in K153064. This submission includes abutments with two interface connection designs for attachment to the previously cleared zygomatic implants: an internal hexagon connection (with a 45° bevel) and a tapered internal hexagon connection (with a 12° taper). The internal hexagon connection abutments are provided in platforms of 3.5 mm and 4.5 mm. The tapered internal hexagon connection abutments are provided in platforms of 3.5 mm (NP) and 4.3 mm (RP). All subject abutments have an angulation of 45° and are for support of screw-retained overdenture prosthetic restorations. Except for the angulation, the subject device abutments have the same designs as corresponding abutments cleared in K153064. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device abutments are made of titanium alloy conforming to ASTM F136. The previously cleared abutment screws also are made of material conforming to ASTM F136.

Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.

- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular incisors and maxillary lateral incisors - Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws - Implants can be placed in immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. - Multi-unit abutments for fixed restorations are to be used only for multiple splinted restorations. - In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. - Blue Sky Bio 3mm Double Hex Dental Implant System is compatible with Astra Osseospeed Narrow Dental Implant System. - Blue Sky Bio 3mm Double Hex Dental Implants are compatible with Astra Osseospeed Narrow abutments. - Blue Sky Bio 3mm Double Hex Abutments are compatible with Astra Osseospeed Narrow Implants.

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants and components are supplied sterile or not sterile and are labeled accordingly.

Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. - Filling of periodontal/infrabony defects . - Ridge augmentation . - Filling of extraction sites (implant preparation/placement) . - Sinus lifts . - Filling of cystic cavities The device gradually resorbs and is replaced with bone during the healing process.

Blue Sky Bio TCP Bone Graft Substitute is porous, resorbable, and biocompatible calcium phosphate ceramic consisting of ß-tricalcium phosphate. ß-tricalcium phosphate is an osteoconductive implant that is biodegradeable. Blue Sky Bio TCP Bone Graft Substitute is provided sterile in granular form, pyrogen-free and available in granule sizes up to 2000 μm.

Intended Use for Two-Piece Implant Systems - For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis - For single tooth or multiple unit prosthesis . - For single stage or two stage surgical procedure . - For immediate placement and immediate function when multiple units are splinted and for . single units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used. - Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. . - . Taper Hex Implant System is compatible with NobelActive implants and prosthetics - Double Hex Implant System is compatible with Astra double hex implants and prosthetics . - Square Taper Implant System is compatible with Straumann Bone-Level implants and . prosthetics Intended Use for One-Piece Implant System - For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis - For single tooth or multiple unit prosthesis ● - For single stage surgical procedure . - For immediate placement and immediate function when multiple units are splinted and for . single units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. In edentulous cases four or more implants must be used - Overdenture Implants are intended for support of removable prosthesis. .

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained , screw retained and overdenture-type restorative options. The implants and abutments are made out of Ti6Al4V titanium alloy and have an internal anti-rotational geometry or have a one-piece design with the abutment portion being an integral part of the implant. The device also includes exempt accessories such as laboratory analogs and drivers for insertion of the implants. and The activFluor surface treatment of the implants is the same as on Blue Sky Bio's predicate devices and is performed by blasting the surface and chemically etching to enhance the surface roughness for apposition of bone to the implant surface. The implants and components are supplied sterile or not sterile and are labeled accordingly.