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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.

Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts. The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

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.

1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured): - 1.1 Direct, light cured composite and compomer restorations - 1.2 Indirect restorations; light cured, resin cemented veneers - 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers - 1.4 Composite, ceramic and amalgam repairs - 1.5 Cavity varnish for use with fresh amalgam - 2. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure): - 2.1 Direct, dual cure or self-cure composite restorations and core build-ups - 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers - 2.3 Dual cured and self-cured resin cemented endodontic post cementation - 3. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst: - 3.1 Adhesive bonding of direct amalgam restoration - 4. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing): - 4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement - 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique

Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage. When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin. *Note: Acid-tolerant resin cements may be used following application of Prime&Bond Elect® adhesive without the use of Self-Cure Activator, additionally allowing operator's choice of pre-cementation adhesive curing options (see complete Directions for Use).

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.

- A root end filling material - For the repair of repair of root canals as an apical plug during apexification - For repair of root perforations during root canal therapy or as a consequence of internal resorption - As a pulp capping material - Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations

ProRoot MTA White and ProRoot MTA Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier that fully cures over a four-week period.

RAYPEX® 6 is a microprocessor controlled device used for locating the apex.

RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex. The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal. Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal. RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device. Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories. For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.

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.