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Medentika Custom Abutments AS (Angulated Screw Channel) are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.

Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Custom Abutments (previously named MedentiCAD and PreFace abutments) can be used in combination with cemented prosthetics, e.g., crowns and superstructures, to reconstruct the function and esthetics of lost teeth. The Custom Abutment is a one-piece abutment, which is a customized abutment that is digitally designed by the customer with Straumann® CARES® Visual and can be only milled and ordered from the Straumann validated milling center. The abutments have an implant-specific connection interface for the respective compatible implant. The previously cleared Custom Abutments feature a straight screw channel for the abutment screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments AS (Angulated Screw Channel) to the Medentika Custom Abutment Portfolio. The subject Medentika Custom Abutments AS can be designed and manufactured with an angled screw channel (as opposed to the predicate straight screw-channel), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angulated to allow screwdriver access at an angle up to 25°.

Each of the abutment to implant connection geometries (in terms of Series and implant diameter) currently exists for the existing marketed Medentika Custom Abutments (with straight screw channel). No new compatible implant is added, in terms of series, implant diameter, and implant platform diameter within this submission.

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SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Pre-Milled Blank, Patient-specific abutment

Ti-Base abutment

Multi-unit abutment

Multi-unit Abutment is only compatible with Straumann BLX Implant System.

All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.

SIMDA Abutment is intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank, Ti-Base, Multi-unit Abutment, Multi-unit Base. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant.

Pre-milled Blank Design
This device is a patient-specific abutment composed of titanium alloy (Ti-6Al-4V ELI, ASTM F136) which is designed by a clinician or lab, and milled at a SIMDA validated milling center.

Pre-Milled Blank Design Limitation for Patient-specific abutment:

Pre-Milled Blank Design Limitation for Patient-specific abutment:
Astra OsseoSpeed EV, Astra Tech OsseoSpeed TX is minimum and maximum abutment angle 0~15 º

Ti-Base Abutment
Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured titanium component that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.

Raw material blanks

• InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.

Cement

• RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.

Design Limitation for Zirconia superstructure:

Multi-unit Abutment and Base
Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). The Multi-unit Abutment has a post height less than 4mm and are always combined with Multi-unit Base, increasing the post height to a minimum of 4.5mm.

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CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For BH 3.0 S, NC Variobase C 3.3, Camlog 3.3 S and S BL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

The system comprises three parts:

• CEREC Tessera Abutment Block
• TiBase
• CAD/CAM system

The CEREC Tessera ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:

Implant Systems:

• Dentsply Sirona: Astra Tech OsseoSpeed TX, Ankylos
• BioHorizons: Internal connection
• Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Concial Connection, Branemark, NobelSpeedy Groovy
• Straumann: Tissue Level, Bone Level
• Thommen Medical: Element, Contact
• Osstem/Hiossen: Osstem TS, (USA:Hiossen ET)
• Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent
• MIS: C1 Conical connection, V3 Conical connection, SEVEN internal hex, M4 internal hex
• Altatec - Camlog
• MIS: C1 Conical connection (NP and WP), V3 Conical connection, SEVEN internal hex, M4 internal hex

CAD/CAM Systems:

• Sirona Dental CAD/CAM System

Titanium Bases:

Implant: AstraTech Osseospeed TX

• Platform: 3.5/4.0; TiBase AT TX 3.5/4.0 GH1 L; Reference 6598093; Size L
• Platform: 4.5/5.0; TiBase AT TX 4.5/5.0 GH1 L; Reference 6598101; Size L
• Platform: 3.5/4.0; TiBase AT OS 3.5/4.0 GH1 L; Reference 6282532; Size L
• Platform: 4.5/5.0; TiBase ATOS 4.5/5.0 GH1 L; Reference 6282540; Size L

Implant: Ankylos

• Platform: C/X; TiBase ANK C/ GH 1 S; Reference 6586528; Size: S

• Platform: C/X; TiBase ANK C/ GH 2 S; Reference 6586536; Size: S

• Platform: C/X; TiBase ANK /X GH 1 S; Reference 6586544; Size: S

• Platform: C/X; TiBase ANK /X GH 2 S; Reference 6586551; Size: S

Manufacturer: M.I.S. Implants

Implant: C1 Conical Connection

• Platform: NP; CN-TB001 C1 NP GH 0.5; Reference CN-TB001; Size: L
• Platform: NP; CN-B015 C1 NP GH 1.5; Reference CN-TB015; Size: L

Implant: V3 Conical Connection

• Platform: NP; VN-TB001 V3 NP GH 0.5; Reference VN-TB001; Size: L
• Platform: NP; VN-TB015 V3 NP GH 1.5; Reference VN-TB015; Size: L

Implant: V3 Conical Connection / C1 Conical Connection

• Platform: SP; CS-TB001 SP GH 0.5; Reference CS-TB001; Size: L
• Platform: SP; CS-TB015 SP GH 1.5; Reference CS-TB015; Size: L
• Platform: SP; CS-TB030 SP GH 3; Reference CS-TB030; Size: L

Implant: C1 Conical Connection

• Platform: WP; CW-TB001 C1 WP GH 0.5; Reference CW-TB001; Size: L
• Platform: WP; CW-TB015 C1 WP GH 1.5; Reference CW-TB015; Size: L
• Platform: WP; CW-TB030 C1 WP GH 3; Reference CW-TB030; Size: L

Implant: SEVEN internal hex, M4 internal hex

• Platform: NP; MN-TB001 INT HEX NP GH 0.5; Reference MN-TB001; Size: L
• Platform: NP; MN-TBC15 INT HEX NP GH 1.5; Reference MN-TBC15; Size: L
• Platform: SP; MD-TB001 INT HEX SP GH 0.5; Reference MD-TB001; Size: L
• Platform: SP; MD-TBC15 INT HEX SP GH 1.5; Reference MD-TBC15; Size: L
• Platform: SP; MD-TBC30 INT HEX SP GH 3; Reference MD-TBC30; Size: L
• Platform: WP; MW-TB001 INT HEX WP GH 0.5; Reference MW-TB001; Size: L
• Platform: WP; MW-TBC15 INT HEX WP GH 1.5; Reference: MW-TBC15; Size: L
• Platform: WP; MW-TBC30 INT HEX WP GH 3; Reference: MW-TBC30; Size: L

Manufacturer: BioHorizons

Implant: Internal Connection

• Platform: 3.0; TiBase BH 3.0 GH 1 S; Reference 6532779; Size: S
• Platform: 3.5; TiBase BH 3.5 GH 1 L; Reference 6532894; Size: L
• Platform: 4.5; TiBase BH 4.5 GH 1 L; Reference 6532951; Size: L
• Platform: 5.7; TiBase BH 5.7 GH 1 L; Reference 6536242; Size: L

Manufacturer: Nobel Biocare

Implant: Replace, Replace Select

• Platform: NP; TiBase NB RS 3.5 GH 1 L; Reference 6282474; Size: L
• Platform: RP; TiBase NB RS 4.3 GH 1 L; Reference 6282482; Size: L
• Platform: WP; TiBase NB RS 5.0 GH 1 L; Reference 6282490; Size: L
• Platform: 6.0; TiBase NB RS 6.0 GH 1 L; Reference 6282508; Size: L

Implant: Nobel Active, Nobel Replace Conical Connection

• Platform: NP; TiBase NB A 4.5 GH 1 L; Reference 6308188; Size: L
• Platform: RP; TiBase NB A 5.0 GH 1 L; Reference 6308253; Size: L

Implant: Branemark

• Platform: NP; TiBase NB B 3.4 GH 1 L; Reference 6282516; Size: L

Implant: NobelSpeedy Groovy

• Platform: RP; TiBase NB B 4.1 GH 1 L; Reference 6282524; Size: L

Manufacturer: Straumann

Implant: Tissue Level

• Platform: RN (4.8 mm); TiBase SSO 4.8 GH 1 L; Reference 6284249; Size: L
• Platform: WN (6.5 mm); TiBase SSO 6.5 GH 1 L; Reference 6284256; Size: L

Implant: Bone Level

• Platform: NC (3.3 mm); TiBase S BL 3.3 GH 1 L; Reference 6308154; Size: L
• Platform: RC (4.1 mm/ 4.8 mm); TiBase S BL C 4.1 GH 1 L; Reference 6308337; Size: L

Manufacturer: Thommen Medical

Implant: Element, Contact

• Platform: 3.5; TiBase TM 3.5 GH 1 S; Reference 6531854; Size: S
• Platform: 4; TiBase TM 4 GH 1 S; Reference 6532829; Size: S
• Platform: 4.5; TiBase TM 4.5 GH 1 S; Reference 6532837; Size: S
• Platform: 5; TiBase TM 5 GH 1 S; Reference 6544360; Size: S
• Platform: 6; TiBase TM 6 GH 1 S; Reference 6544378; Size: S

Manufacturer: Osstem / Hiossen

Implant: Osstem TS (US Hiossen ET)

• Platform: Mini; TiBase O TS 3.5 GH 1 L; Reference 6527035; Size: L
• Platform: Regular; TiBase O TS 4.0 GH 1 L; Reference 6527043; Size: L

Manufacturer: Zimmer / Biomet

Implant: External hex

• Platform: 3.4; TiBase BO 3.4 GH 1 L; Reference 6282557; Size: L
• Platform: 4.1; TiBase BO 4.1 GH 1 L; Reference 6282565; Size: L
• Platform: 5.0; TiBase BO 5.0 GH 1 L; Reference 6282573; Size: L

Implant: Certain

• Platform: 3.4; TiBase B C 3.4 GH 1 S; Reference 6308048; Size: S
• Platform: 4.1; TiBase BC 4.1 GH 1 L; Reference 6308097; Size: L
• Platform: 5.0; TiBase BC 5.0 GH 1 L; Reference 6308121; Size: L

Implant: Tapered Screw-Vent

• Platform: 3.5; TiBase Z TSV 3.5 GH 1 L; Reference 6282581; Size: L
• Platform: 4.5; TiBase Z TSV 4.5 GH 1 L; Reference 6282599; Size: L
• Platform: 5.7; TiBase Z TSV 5.7 GH 1 L; Reference 6282607; Size: L

Manufacturer: Straumann

Implant: Bone Level

• Platform: NC (3.3 mm); TiBase NC Variobase C 3.3 GH 1; Reference 220.043; Size: S
• Platform: RC (4.1 mm/ 4.8 mm); TiBase RC Variobase C 4.1 GH 1; Reference 220.044; Size: L

Manufacturer: Altatec GmbH-Camlog

Implant: Camlog

• Platform: 3.3; CAMLOG Titanium Base CAD/CAM, for Ø 3.3 mm GH 0.4; Reference K2244.3348; Size S
• Platform: 3.8; CAMLOG Titanium Base CAD/CAM, for Ø 3.8 mm GH 0.3; Reference K2244.3848; Size: S
• Platform: 4.3; CAMLOG Titanium Base CAD/CAM, for Ø 4.3 mm GH 0.3; Reference K2244.4348; Size: S
• Platform: 5.0; CAMLOG Titanium Base CAD/CAM, for Ø 5.0 mm GH 0.3; Reference K2244.5048; Size: L
• Platform: 6.0; CAMLOG Titanium Base CAD/CAM, for Ø 6.0 mm GH 0.3; Reference K2244.6048; Size: L

The proposed CEREC Tessera Abutment System is a modification of the previously cleared CEREC Tessera Abutment Block (K221402). The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The proposed CEREC Tessera Abutment System (with the additional TiBase and Implant System compatibilities and change in wall thickness) is comprised of the CEREC Tessera Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera Abutment Blocks are not provided as the finished, fully assembled dental implant medical device. The CEREC Tessera Abutment Blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device. The following patient-specific ranges for CAD/CAM fabrication of the abutments are:

• Maximum angulation of 20°
• Minimal wall thickness of 0.5 mm
• Gingival height ranges from 0.5 mm -3.0 mm
• Minimum abutment post height (i.e. length above the gingival height) of >4 mm

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Atlantis Abutment & Atlantis Abutment Milling
The Atlantis Abutment and Atlantis Abutment Milling are 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 Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.

Atlantis Crown Abutment
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 Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.

Atlantis Conus Abutment
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 an attachment-retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.

Atlantis Healing Abutment
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Implant Manufacturer: Institut Straumann
Implant System: Straumann BLX
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5
Abutment Platform Diameter (in mm): 2.69

Implant System: Neodent GM
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0
Abutment Platform Diameter (in mm): 3.0

The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment, including the Conus and Healing abutments further described below, are available in Titanium or Gold-shaded (titanium nitride layer applied using PVD (Physical Vapor Deposition)) Titanium. The Crown Abutment which is another Atlantis® Abutment in Titanium, is only available in Titanium.

The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

The Atlantis® Crown Abutment in Titanium is also a custom fabricated abutment using the same internal CAD/CAM technology. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

The Atlantis® Conus Abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

The proposed Atlantis® Abutments in Titanium for Straumann BLX Implant are compatible with the Straumann BLX Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.5 5.0, 5.5 and 6.5 mm and in lengths of 8, 10, 12, 14, 16, and 18 mm all with identical mating geometry.

The proposed Atlantis® Abutments in Titanium for Neodent GM Implant are compatible with the Neodent GM Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, and 7.0 mm and in lengths of 7, 8, 9, 10, 11, 11.5, 13, 15, 16, 17 and 18 mm, all with identical mating geometry.

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant Systems: Camlog® CONELOG®, Dentium® NR Line

Compatible Implant Fixtures:
Camlog® CONELOG®: 3.3 mm/3.3 mm, 3.8 mm/3.8 mm, 4.3 mm/4.3 mm, 5.0 mm/5.0 mm
Dentium® NR Line: 3.1 mm/3.2 mm, 3.6 mm

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Camlog® CONELOG® and Dentium® NR Line Implant Systems. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments 4.5mmH and 6mmH devices are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments 4.5mmH and 6mmH devices are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the Camlog® CONELOG® and Dentium® NR Line multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The design parameters for the Titanium Abutment Blanks are:

• the minimum wall thickness is no less than 0.5 mm.
• the gingival margin diameter is no less than 0.5 mm wider than implant.
• maximum angle correction is no greater than 30°. *
• minimum margin height is no less than 0.5 mm.
• maximum gingival height is no greater than 6 mm, and
• minimum post height above the gingival collar is no less than 4.0 mm.

*Angulation up to 30° for Titanium Abutment Blanks only allowed for compatible implant bodies of Camlog® CONELOG® Ø3.3mm Implants and Dentium® NR Line Ø3.1mm Implants for anterior use in the mouth under single-unit loading.

Inclusive® Titanium Abutments Blanks compatible with Camlog® CONELOG® Ø3.8mm, Ø4.3mm, and Ø5.0mm Implants are not to be used as angled abutments in the posterior region.

The design parameters for the zirconia coping for the Titanium Abutment 4.5mmH and 6mmH are:

• the minimum wall thickness is no less than 0.5mm.
• the gingival margin diameter is no less than 0.5 mm wider than implant.
• no angulation correction, straight (0°) only.
• minimum margin height is no less than 0.5 mm.
• maximum gingival height is no greater than 6 mm, and
• minimum post height above the gingival collar is no less than 4.0 mm.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions for the DESSLoc Attachment system cleared under K170588, K191986, K212628, K222288, K240208, and K242340 and to:

• include OEM platform compatibilities to the DESSLoc Abutment design that have been previously cleared in other DESS Abutment designs,
• include new OEM platform compatibility for MIS C1 Dental Implant System,
• include attachment components (retention inserts and housing) including reprocessing information in labeling.

The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. There have been no changes to the design of the DESSLoc abutments, the design is the same that has been cleared in the above submissions. The abutments are made of titanium alloy and coated with zirconium nitride (ZrN). The nylon retention insert is manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12). The denture housing is made of titanium alloy with a machined surface or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below.

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DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add abutments to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K242340 and K240208. The subject device abutment designs include Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), and abutment screws.

Pre-Milled Blank Abutments are designed for custom abutment fabrication by a CAD-CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm and a solid cylindrical design with an engaging or non-engaging implant connection. They are available in versions with a straight screw channel and with an angled screw channel for esthetic considerations. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V).

The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:

• Minimum wall thickness – 0.45 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.0 mm
• Pre-Milled Blanks are for straight abutments only

Multi-Unit Abutments: Straight and Angled are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight (0°), angled 17°, and angled 30°. The designs of the subject Multi-Unit Abutments are similar to the designs of Multi-Unit Abutments cleared in K242340 and K240208. All Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V).

The subject device straight Multi-Unit Abutments have a non-engaging, threaded design that attaches directly to the implant. The subject device straight (0°) Multi-Unit Abutments are included in this submission are similar in design to straight Multi-Unit Abutments cleared in K242340, K230143, and K222288. Subject device straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 1 mm to 5.5 mm.

The subject device angled Multi-Unit Abutments are provided only in an engaging design that requires an abutment screw. The subject device Multi-Unit Abutments angled 17° and 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 2.5 to 4.5 mm.

Select straight and angled Multi-Unit Abutments have an added coating of zirconium nitride (ZrN). This coating is identical to the ZrN coating used on abutments with ZrN cleared in K242340.

DESS® Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of seventeen (17) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K242340 and K240208. Screws are made of titanium alloy (Ti-6Al-4V). Select subject device screws are available with DLC (Diamond-like Carbon) coating and are identical to that used on screws cleared in K240208.

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