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The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.

The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, Approver and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners. The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time. Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment.

The Steri-Cassettes and Steri-Cages are intended to contain dental instruments for cleaning, sterilization, organization, storage and handling. The Steri-Cassettes and Steri-Cages are suitable for pre-vacuum and gravity displacement steam sterilization methods. The cassettes and cages are not intended to maintain sterility; they are intended to be used in conjunction with validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The validated steam sterilization cycle parameters are as follows: | Steam Sterilization<br>Cycle | Minimum Exposure<br>Temperature | Minimum<br>Exposure Time | Minimum Dry Time | |-------------------------------------------------------------|---------------------------------|--------------------------|------------------| | Gravity<br>Displacement<br>(wrapped) | 250°F (121°C) | 30 Minutes | 15 Minutes | | Gravity<br>Displacement<br>(wrapped) | 270°F (132°C) | 15 Minutes | 15 Minutes | | Gravity<br>Displacement<br>(wrapped) | 275°F (135°C) | 10 Minutes | 30 Minutes | | Gravity<br>Displacement<br>(unwrapped for<br>immediate use) | 132°C (270°F) | 3 Minutes | None | | Pre-Vacuum<br>(wrapped) | 270°F (132°C) | 4 Minutes | 30 Minutes | | Pre-Vacuum<br>(wrapped) | 275°F (135°C) | 3 Minutes | 16 Minutes | | Pre-Vacuum<br>(unwrapped for<br>immediate use) | 273°F (134°C) | 3 Minutes | None |

Steri-Cassettes and Steri-Cages are used to hold instruments in a secure way for cleaning, sterilization and presentation at point of use. They keep instrumentation organized in an efficient way. They are available in a variety of sizes to accommodate instruments of various sizes and are offered in an assortment of colors to aid in office organization. Steri-Cassettes and Steri-Cages have perforations consisting of open-slots on the lid and the base which allows exposure of the device to the sterilant during sterilization. All the five variations of the stackable Steri-Cassettes and Steri-Cages have the same design of open-slot perforations on their lid and base (1) Steri-Cassette AA - Shallow - High Heat, (2) Steri-Cassette AA - Shallow - Standard Heat, (3) Steri-Cassette AB - Medium -High Heat, (4) Steri-Cassette BB - Deep - High Heat and (5) Steri-Cage - Standard Heat. Steri-Cassettes include instrument holder inserts, which are removable and individually hold instruments. Cassettes and cages are manufactured by Injection Molding process from either high-heat resin or polypropylene with color - materials widely used in the medical field. The colors are already pre-mixed and vary by color in the supplier's proprietary resin mixtures: Steri-Cassettes High-Heat: RoHs-compliant, high-heat resin - Ultem Resin 1000 and Steri-Cassettes Standard Heat and Steri-Cages: polypropylene with color. The cassettes and cage have a latching lid to contain the products. The proposed devices are designed to fit any standard autoclave and ultrasonic machine, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles. Since the proposed cassettes and cages have open slots, a legally-marketed and FDA-cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents. The proposed Steri-Cassettes and Steri-Cages are packaged in non-sterile, plastic shrinkwrap, which is then appropriately labeled and includes a validated Cleaning and Sterilization/ Dry Time Instructions for use.

Image Alginate Dental Impression materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or chectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. This colloidal material forms a gel when the powder is mixed with water. It solidifies into an elastic mass capable of producing a negative reproduction of the oral cavity (an impression). Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. They are also used to fabricate bleaching trays and mouth guards. Alginate is the most universally utilized impression material in dentistry. Image Alginate is a green-colored, mint flavored alginate and comes in two options Regular Set, Fast Set. The packaging configurations include a 1 lb. (454 g) bag and a singles pack of 18 g.

The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

The Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. Then the mixture is carried to the root canal with endodontic obturation points, or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes. The proposed is available packaged in tubes (Tubli-Seal and Tubli-Seal EWT) and dualbarrel syringes (Tubli-Seal Xpress and Tubli-Seal EWT Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Tubli-Seal Xpress has the same formulation and indications for use as Tubli-Seal, and Tubli-Seal EWT Xpress has the same formulation and indications for use as Tubli-Seal EWT. The proposed syringe-delivery products are branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.

Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.

Sealapex/Sealapex Xpress is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Sealapex/Sealapex Xpress is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is indicated for use as a root canal sealing and filling material, and is used during an endodontic procedure to seal off the prepared root canal apical foramen and tubules from blood, exudates, and infection. The proposed is a two-part, base/catalyst - paste/paste system that is mixed in equal portions. Then, the mixture is carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The proposed is available packaged in tubes (Sealapex) and dual-barrel syringes (Sealapex Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Sealapex Xpress has the same formulation and indications for use as Sealapex, but is branded as "Sealapex Xpress" since it offers the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Sealapex Xpress directly into the prepped root canal.

Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations.

Zone, Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements. They are self-cure materials that set by a reaction between Zinc Oxide present in the catalyst paste and Dimer Acid present in the base paste. The proposed temporary cements are to be placed in the mouth for up to 30 days. Zone comes in three options - the standard Zone cement, Zone A1 shade cement, and ZoneFree a translucent variant. The design of ZoneFree is based on Zone, but uses only small particle size Zinc Oxide to achieve both translucency and color-blending properties. Zone and Zone A1 are designed to set one minute slower than ZoneFree. The delivery systems include an automix syringe, 15 ml syringe, and a unit dose. Zone and Zone A1 are also available in a tube delivery.

Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants. * Adhesive application on the preparation is required for veneer cementation using Nexus Universal Chroma.

Nexus Universal / Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants. * Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma. Nexus Universal and Nexus Universal Chroma are offered in paste/paste formulations for use as self-etch, self-adhesive resin cements or as bonded resin cements. These cements are considered permanent and not temporary. The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration and/or tooth preparation. Nexus Universal and Nexus Universal Chroma are offered in multiple shades. The difference between Nexus Universal and Nexus Universal Chroma is that Nexus Universal Chroma offers a gel-state color indicator, which visually displays the optimal time to remove the excess cement.

Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set.

SonicFill 2 is indicated for direct placement in all cavity classes in anterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of povisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.

SonicFill 2 is a light-cured, low-shrink, resin-based, dental restorative designed for direct placement. SonicFill 2 is used in combination with the SonicFill 2010 Handpiece (K091091), which activates the restorative sonically for delivery. Upon delivery the restorative drops in viscosity, allowing the composite to closely adapt to the cavity walls. When the cavity is filled and the SonicFill 2010 Handpiece (K091091) is deactivated, the restorative resin returns to its original viscosity. The composite in the cavity is then shaped and sculpted to the contours of the tooth. SonicFill 2 is designed to have a high depth of cure and low shrinkage stress allowing a cavity up to 5mm in depth to be filled and cured in a single bulk increment.