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The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices. Sterilization parameters: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time. Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface. Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270° F) during 4 minutes with 30 minutes drying time. Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the associated instrument. The worst-case recommended load is: 886 g. The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm. The cassettes are not intended to be stacked during sterilization process.

Anthoqyr cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g. The device dimensions are listed below for Anthogyr Surgical Cassettes: - INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm - INMODIGM, INMODIGMV: 76x155x47 mm The cassettes are not intended to be stacked during sterilization process.

Anthogyr Surgical Cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

The Nobel Biocare PureSet™ Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment. Nobel Biocare PureSet™ Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap. Sterilization validations for the worst-case PureSet™ Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles. The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ PureSet™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray). Method: Steam Sterilization (Moist Heat Sterilization) for Wrapped Instruments Cycle: Dynamic-Air-Removal (fractionated vacuum), Gravity-Displacement Temperature: 132°C (270°F), 132°C (270°F) Exposure time for a single-use pouched device: 4 minutes (full-cycle), 15 minutes (full-cycle) Minimum drying times: 20 minutes, 30 minutes

PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surgical and reprocessing procedures. PureSet Trays are not intended to maintain sterility on their own; they are intended to be used in conjunction with an FDA cleared sterilization wrap, pouch, or container. All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents. PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.

The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations. The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment. - SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. - SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors. - SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder. The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies. The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools. The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base: (1) end user creation of a press-ceramic material by conventional wax-up technique, (2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and (3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission): - Ceramic material: ZirCAD Prime (K142233) . - . Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469) - . Composite: Kerr Harmonized (K151332) - Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner - Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352) - . Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.

Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.

· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base: The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation. · Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.

NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines: - NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and - - -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following: a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing. NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3. The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).

The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The PrimeLOC Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) to serve in a similar function to LOCATOR® abutments for resilient attachment of prostheses to endosseous dental implants. All PrimeLOC abutments are made of titanium alloy and have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. The PrimeLOC Attachment System is designed to accommodate a path of insertion divergence of up to 20° per implant and no more than 40° of divergence between implants. PrimeLOC abutments are provided with a titanium nitride (TiN) coating and are available in cuff heights up to 6 mm, with an implant interface diameter of 3.5 mm. Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate. A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process. This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.

N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.

N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.

The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time. The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.

Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission. In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission.