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ATLANTIS™ ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: Implants: Biomet 3i Certain 3.25, 4/3 - Prevail 3/4/3, 4/3 Biomet 3i Certain 4.0, 5/4 – Prevail 4/5/4. 5/4 Biomet 3i Certain 5.0, XP 4/5 - Prevail 5/6/5, 6/5 Biomet 3i Certain 6.0, XP 5/6 BioHorizons Internal/Tapered 3.5, 4.5, 5.7 Camlog Screw-line Implant 3.3 Camlog Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0 DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5 DENTSPLY Implants OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0 DENTSPLY Implants Osseospeed™ Profile TX 4.5/5.0 DENTSPLY Implants Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4 DENTSPLY Implants Osseospeed™ Profile EV 4.2, 4.8 Keystone Dental PrimaConnex SD 3.3/3.5 Keystone Dental PrimaConnex RD 4.0/4.1 Keystone Dental PrimaConnex WD 5.0 Keystone Dental Genesis 3.8, 4.5, 5.5/6.5 Nobel Biocare NobelActive NP 3.5 - RP 4.3, 5.0 Nobel Biocare NobelReplace NP-3.5 - RP 4.3 - WP 5.0 – 6.0 Straumann Bone Level 3.3 NC - 4.1, 4.8 NC Straumann Standard Plus 3.5 NN Straumann Standard / Standard Plus 4.8 RN – 4.8 WN Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5 Zimmer Dental Tapered Screw Vent 5.7 Abutments: Biomet 3i Low Profile Abutment DENTSPLY Implants ATIS Uni Abutment EV DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45° DENTSPLY Implants ATIS Angled Abutment EV DENTSPLY Implants ATIS Angled Abutment 20° DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 DENTSPLY Implants XiVE TG 3.4, TG 3.8, TG 4.5 Nobel Biocare Multi-Unit Abutment RP Straumann Bone Level Multi-Base Angled Abutment Straumann Bone Level Multi-Base Abutment D3.5, D4.5 Straumann RN Abutment Level, WN Abutment Level Straumann Screw-Retained Abutment 3.5, 4.6 Zimmer Dental Tapered Abutment

The ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424. The ATLANTIS™ ISUS Implant Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424: 1. Bar Intended as a fixed supporting structure for a removable dental prosthesis. 2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis. 3. Hybrid Intended as a fixed denture framework. Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment. In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.

ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring function. ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: Implants: - 3i Internal Connection: D3.4, D4.1, D5, D6 - Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5 - Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm) - Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm - Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm) - Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm) - Zimmer Screw Vent: D3.5, D4.5, D5.7 Abutments: - 3i Low Profile Abutment - ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2 - ASTRA TECH 20° and 45° UniAbutment - Astra Tech UniAbutment EV 3.6 - Friadent XiVE MP D3.8, D4.5, D5.5 - Friadent XiVE TG D3.8,D 4.5, D5.5 - Nobel Biocare Multi-Unit Abutment RP: 4.0 mm - Straumann Bone Level Angled Abutment: 4.0 mm - Straumann Bone Level: Multi-Base Abutment D3.5, D4.5 - Straumann RN (4.8 mm), WN (6.5 mm) - Zimmer Tapered Abutment: 4.5 mm

ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of ATLANTIS™ ISUS is fabricated using computer-assisted manufacturing (CAM) to produce a custom patient specific device. ATLANTIS™ ISUS is available in four design types: Bar, Bridge, Hybrid, and 2 in 1. It also features Angulated Screw Access (ASA) allowing the screw-channel opening to be angled up to 30° off the implant/abutment axis.

The ATLANTIS™ Crown is intended for use with an ATLANTIS™ Abutment and an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient.

The ATLANTIS™ Crown is a patient-specific dental prosthetic component intended for use with an ATLANTISTM Abutment, abutment screw, and an endosseous implant to support a single-tooth prosthetic restoration. The ATLANTIS™ Crown is made of yttria stabilized zirconia powder (Y-TZP) and fabricated according to the clinician's prescription using CAD/CAM technology. The crown can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. The ATLANTIS™ Crown is finally cemented to the ATLANTIS™ Abutment.

The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS™ Crown Abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant. ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis. The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant. ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 mm. The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

Used for ultrasonic procedures: - All general supra and subgingival scaling applications . - Periodontal debridement for all types of periodontal diseases .

The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology.

Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.

The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.

MTM® Clear-Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear-Aligner sequentially positions teeth by way of continuous gentle force.

MTM® Clear-Aligner is a system of plastic aligners fabricated in an orthodontic appliance laboratory. The formed aligners contain force points and spaces necessary for tooth movement by way of continuous gentle force. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After the entire series of aligners are produced by the MTM® Service Center for the prescribed case, they are shipped to the dental practitioner. Each individual aligner moves the patient's teeth in small increments from their original state to a final state.

The ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants. ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems: Implants: - Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm - Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm) - Zimmer Screw Vent: D3.5, D4.5, D5.7 - Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm) - Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm) - 31 Internal Connection: D3.4, D4.1, D5, D6 - Friadent XiVE S: D3, D3.4, D3.8, D4.5, D5.5 Abutments: - ASTRA TECH 20° and 45° UniAbutment - ASTRA TECH UniAbutment EV: 3.6 - ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2 - Nobel Biocare Multi -Unit Abutment RP: 4.0 mm - Zimmer Tapered Abutment: 4.5mm - Straumann RN(4.8mm), WN (6.5 mm) - Straumann Bone Level: Multi-Base Abutment D3.5, D4.5 - Straumann Bone Level Angled Abutment:4.0 mm - 3I Low Profile Abutment - Friadent XiVE MP D3.8. D4.5. D5.5 - Friadent XiVE TG D3.8, D4.5, D5.5

The ISUS Implant Suprastructures are metallic dental restorative devices which are intended for attachment by screw retention to dental implants to aid in the treatment of partially and totally edentulous patients for the purpose of restoring chewing function. The ISUS system consists of the Suprastructure devices themselves as well as retention screw accessories which facilitate their attachment to the dental implants. The design of the ISUS Implant Suprastructures is derived from models of patient dentition which are produced by the dental professional using standard dental techniques. The dental models are converted to digital representations by DENTSPLY to facilitate DENTSPLY's Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) of the customized, patient-specific ISUS Implant Suprastructure. The ISUS Implant Suprastructures consist of three (3) device types: - Bars Intended to act as a supporting structure to facilitate attachment of removable dental prostheses. - Bridges - Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis. - Hybrids Intended as a metallic substructure to which finished dentures are bonded to form a fixed prosthesis. The ISUS Implant Suprastructures are manufactured in versions composed of titanium and cobalt-chromium alloy and feature customized designs derived from individual patient dental impressions.

MTM® Clear Aligner In-Office is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

MTM® Clear Aligner In-Office is a system of plastic aligners fabricated in the dental professional's office that are modified with thermoplier accessories to create force points and spaces necessary for tooth movement by way of continuous gentle force. Commercially available auxiliaries such as hooks and orthodontic elastics may also be used in order to create the desired tooth movement. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After each desired incremental tooth movement has occurred, the aligner can be modified to increase the size of the force points or a new aligner may be fabricated. Each aligner moves the patient's teeth in small increments from their original state.

5% Sodium Fluoride Varnish is indicated for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparations.

5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.