MIS CONNECT Conical Connection System

K193078 · Dentsply Sirona · NHA · Mar 25, 2020 · Dental

Device Facts

• Record ID: K193078
• Device Name: MIS CONNECT Conical Connection System
• Applicant: Dentsply Sirona
• Product Code: NHA · Dental
• Decision Date: Mar 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3 mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Device Story

Line extension of dental abutment system; used by clinicians for prosthetic restoration in maxilla/mandible. Components include abutments (4.0/5.7mm diameter) and superstructures (healing caps, temporary/aesthetic/final/angulated abutments). Abutments connect to MIS conical connection implants; superstructures mount onto abutments via prosthetic screws. Once connected to implant, abutment is permanent. System provides foundation for artificial teeth; restores masticatory function. Design features 12-index anti-rotation for superstructures to improve precision. Fatigue testing performed per ISO 14801; biocompatibility established via identical materials (Ti-6Al-4V ELI) and processes as predicate. Clinicians use output to support prosthetic dental restorations.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, specifically dynamic fatigue testing per ISO 14801:2016, and reference to biocompatibility, sterilization, and packaging data from the predicate device.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Connection: Conical connection to implant; internal connection to superstructure. Rotational indexes: 12 (superstructure). Diameters: 4.0mm, 5.7mm. Sterilization: Radiation (sterile components) or moist heat (end-user sterilized).

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic support in the upper or lower jaw. Narrow implants (Ø3.3mm) restricted to mandibular central/lateral incisors and maxillary lateral incisors; requires splinting for adjacent narrow implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• MIS CONNECT Conical Connection abutment (K173326)

Reference Devices

• MIS V3 Cement Retained Abutment (K163349)
• MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (K172505)
• MIS Conical Connection Implants (K112162)

Submission Summary (Full Text)

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March 25, 2020

Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 W Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K193078

Trade/Device Name: MIS CONNECT Conical Connection System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 2, 2020 Received: March 2, 2020

Dear Karl Nittinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193078

Device Name MIS CONNECT Conical Connection System

Indications for Use (Describe)

MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function.

When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (03.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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Section 4-2

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Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved, segmented leaf or a stylized letter 'S'. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned with the right edge of the abstract shape.

### 510(k) SUMMARY K193078 MIS CONNECT Conical Connection System

1.0 Submitter Information:

Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401

| Contact Person: | Karl Nittinger |
|-------------------|-----------------------------------|
| Email: | [e-mail] |
| Telephone Number: | 717-487-4424 |
| Fax Number: | 717-849-4343 |
| Date Prepared: | 06 March 2020 |

### 2.0 Device Name:

- Proprietary Name: MIS CONNECT Conical Connection System
- Classification Name: Endosseous dental implant abutment
- CFR Number: 21 CFR 872.3630
- Device Class: ● Class II
- � Product Code: NHA

### 3.0 Predicate Device:

| Primary Predicate Device Name | 510(k) | Company Name |
|----------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------------------------|
| MIS CONNECT Conical Connection<br>abutment | K173326 | MIS Implants Technologies Ltd.<br>(Owner/Operator : Dentsply Sirona) |
| Reference Devices: | 510(k) | Company Name |
| MIS V3 Cement Retained Abutment | K163349 | MIS Implants Technologies Ltd.<br>(Owner/Operator : Dentsply Sirona) |
| MIS C1 Narrow Platform Conical<br>Connection Implant System, MIS C1<br>Wide Platform Conical Connection<br>Abutments | K172505 | MIS Implants Technologies Ltd.<br>(Owner/Operator : Dentsply Sirona) |
| MIS Conical Connection Implants<br>(Included as a referenced device solely for<br>identification as the compatible implant<br>system). | K112162 | MIS Implants Technologies Ltd.<br>(Owner/Operator : Dentsply Sirona) |

### 4.0 Device Description

The proposed devices consist of dental abutments and represent a line extension to the MIS CONNECT Conical Connection System.

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#### 4.1 MIS CONNECT Conical Connection Abutments

The proposed MIS CONNECT Conical Connection Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations in the upper or lower jaw and used in conjunction with MIS conical connection implants, MIS V3 and MIS C1 (K163349 and K112162, respectively).

The abutment is placed above the bone level and within the gingival tissue, and is designed to be fitted with a variety of complementary abutment superstructures, including caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject abutments.

Once connected to the implant, the MIS CONNECT Conical Connection Abutment is not intended to be removed.

The abutments are provided in 4.0 and 5.7 mm platform diameters, with an angulation of up to 20°, and at gingival heights of 1.5, 2.0, 3.0, and 4.0 mm.

#### MIS CONNECT Conical Connection Superstructures 4.2

The proposed MIS CONNECT Conical Connection Superstructures are mounted over the proposed and predicate MIS CONNECT Conical Connection Abutment (Ø4 mm or Ø5.7 mm) and intended for use as an aid in prosthetic dental restoration. The proposed superstructures consist of healing caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject superstructures.

### 5.0 Indications for Use

MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function.

When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3 mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

6.0 Substantial Equivalence Discussion

# 6.1 MIS CONNECT CONICAL CONNECTION ABUTMENTS

A summary of the similarities and differences between the proposed and predicate abutment devices is given in Table 6.1 below. A discussion of the similarities and differences follows Table 6.1.

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| Table 6.1: Similarities and Differences between the proposed and predicate Abutment devices | | | |
|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | MIS CONNECT Conical<br>Connection abutments<br>Proposed device | MIS CONNECT Conical<br>Connection abutments<br>K173326<br>Primary Predicate Device | MIS V3 Cement Retained<br>Abutments<br>K163349<br>Reference Device |
| Pictorial<br>Representation | Image: MIS CONNECT Conical Connection abutments | Image: MIS CONNECT Conical Connection abutments K173326 | Image: MIS V3 Cement Retained Abutments K163349 |
| Intended use: | Dental implant abutments are<br>intended to be used in the upper<br>or lower jaw for supporting<br>tooth replacements to restore<br>chewing function.<br>The MIS CONNECT abutments<br>in combination with endosseous<br>implants are indicated for single<br>or multiple unit reconstructions<br>when screw retained prosthetics<br>are preferred. | Dental implant abutments are<br>intended to be used in the upper<br>or lower jaw for supporting tooth<br>replacements to restore chewing<br>function.<br>The MIS CONNECT abutments<br>in combination with endosseous<br>implants are indicated for single<br>or multiple unit reconstructions<br>when screw retained prosthetics<br>are preferred. | Dental implant abutments are<br>intended to be used in the upper<br>or lower jaw used for supporting<br>tooth replacements to restore<br>chewing function.<br>The abutments in combination<br>with two-stage endosseous<br>implants are intended to be used<br>as a foundation for anchoring<br>tooth replacements in either jaw.<br>Restorations range from replacing<br>one single tooth to fixed partial<br>dentures using cement-retained<br>supra-constructions. |
| Indications for<br>use: | MIS Dental Implant Systems<br>are intended to be surgically<br>placed in the bone of the upper<br>or lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.3mm) are<br>indicated for use in surgical and<br>restorative applications for<br>placement only in the<br>mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices<br>such as artificial teeth, in order<br>to restore the patient chewing<br>function. Mandibular central<br>and lateral incisors must be<br>splinted if using two or more<br>narrow implants adjacent to one<br>another. | MIS Dental Implant Systems are<br>intended to be surgically placed in<br>the bone of the upper or lower<br>jaw arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function.<br>When a one-stage surgical<br>procedure is applied, the implant<br>may be immediately loaded when<br>good primary stability is achieved<br>and the occlusal load is<br>appropriate.<br>Narrow implants (Ø3.3mm) are<br>indicated for use in surgical and<br>restorative applications for<br>placement only in the mandibular<br>central, lateral incisor and<br>maxillary lateral incisor regions<br>of partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth, in<br>order to restore the patient<br>chewing function. Mandibular<br>central and lateral incisors must<br>be splinted if using two or more<br>narrow implants adjacent to one<br>another. | MIS Dental Implant System are<br>intended to be surgically placed in<br>the bone of the upper or lower jaw<br>arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function.<br>When a one-stage surgical<br>procedure is applied, the implant<br>may be immediately loaded when<br>good primary stability is achieved<br>and the occlusal load is<br>appropriate.<br>Narrow implants (Ø3.3mm) are<br>indicated for use in surgical and<br>restorative applications for<br>placement only in the mandibular<br>central, lateral incisor and<br>maxillary lateral incisor regions<br>of partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth, in<br>order to restore the patient<br>chewing function. Mandibular central<br>and lateral incisors must<br>be splinted if using two or more<br>narrow implants adjacent to one<br>another |
| Material(s) | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 |
| Table 6.1 (continued): Similarities and Differences between the proposed and predicate<br>Abutment devices | | | |
| Element | MIS CONNECT Conical<br>Connection abutments | MIS CONNECT Conical<br>Connection abutments<br>K173326 | MIS V3 Cement Retained<br>Abutments<br>K163349 |
| | Proposed device | Primary Predicate Device | Reference Device |
| Surface<br>Treatment | Anodized after machining | Anodized after machining | Polished and anodized after<br>machining |
| Type of<br>Connection to<br>the Implant | Conical connection<br>without indexes | Conical connection<br>without indexes | Conical connection<br>NP: 3 indexes<br>SP: 6 indexes |
| Type of<br>Connection to<br>the<br>Superstructure | Internal connection<br>Anti-rotation: 12 indexes<br>Free-rotation: no indexes | Internal connection<br>Anti-rotation: 3 indexes<br>Free-rotation: no indexes | NA - the crown is cemented<br>directly onto the abutment post. |
| Compatible<br>implant<br>platforms | MIS CONNECT Ø4 abutment:<br>NP, SP, WP<br>MIS CONNECT Ø5.7<br>abutment: SP, WP | NP, SP, WP | NP, SP, WP |
| Gingival<br>Height | NP: 2, 3 mm<br>SP: 1.5, 2, 3, 4 mm<br>WP: 1.5, 2, 3, 4 mm | NP: 2, 3 mm<br>SP: 1.5, 2, 3, 4 mm<br>WP: 1.5, 2, 3, 4 mm | 0.5, 1, 1.5, 2, 3 mm |
| Post height | NA – the MIS CONNECT does<br>not have a post for prosthetic<br>reconstruction, but is configured<br>to be mounted with a<br>superstructure having a post. | NA – the MIS CONNECT does<br>not have a post for prosthetic<br>reconstruction, but is configured<br>to be mounted with a<br>superstructure having a post. | 8 mm |
| Diameter | NP: 4 mm<br>SP/WP: 4 mm, 5.7 mm | NP/SP/WP: 4 mm | NP: 4.0, 4.25, 4.8 mm<br>SP: 4.25, 4.8, 5.8 mm |
| Sterilization<br>Method | Radiation | Radiation | Product provided non sterile and<br>end-user sterilized. |

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the abuthents in the predicate are only available in 4 min diameter, the propose ble in both 4 mm and 5.7 mm diameters. The reterence device (K 163349) is includes mants in the ariginally classed meadinate daring herse 2 indoxer anti natation annual and abuturanta horio 12 indover outi-natalis a Connection Call Concession Comments of Children

Performance testing (Fatigue testing) is included in this premarket notification to support the substantial
equivalence of the proposed devices to the predicate device.

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# 6.2 Line extension to predicate MIS CONNECT Conical Connection Superstructures:

An overview of the similarities and differences between the proposed and predicate Superstructure devices is given in Tables 6.2a - 6.2e below. A discussion of the similarities and differences follows Table 6.2a - 6.2e.

| Table 6.2a: Comparison of the proposed device to the predicate device (Healing Caps) | | | |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Element | MIS CONNECT Healing Caps<br>Proposed device | MIS CONNECT Healing<br>Caps<br>K173326<br>Primary Predicate Device | MIS V3 Healing Caps<br>K163349<br>Reference Device |
| Pictorial<br>Representation | Image: Proposed device | Image: Primary Predicate Device | Image: Reference Device |
| Material(s) | TI 6Al-4V ELI per ASTM F136. | TI 6Al-4V ELI per ASTM F136. | TI 6Al-4V ELI per ASTM F136. |
| Surface<br>Treatment | Anodized after machining | Anodized after machining | Polished and anodized after<br>machining |
| Connection<br>interface | Compatible with MIS<br>CONNECT abutment | Compatible with MIS<br>CONNECT abutment | Compatible with MIS Conical<br>Connection implants |
| Type of<br>Connection to<br>the MIS<br>CONNECT<br>abutment | Internal connection<br>Without indexes | Internal connection<br>Without indexes | NA - connects directly to the<br>implant in an internal connection<br>without indexes |
| Gingival<br>Height | Ø4: 0.5, 1.5, 3 mm<br>Ø5.7: 0.5, 1.5, 3 mm | Ø4: 0.5, 1.5 mm | 2, 3, 4, 5, 6, 8 mm |
| Post Height | NA - the device is not intended<br>to serve as a basis for prosthetic<br>reconstruction | NA - the device is not intended<br>to serve as a basis for prosthetic<br>reconstruction | NA - the device is not intended to<br>serve as a basis for prosthetic<br>reconstruction |
| Diameter | 4mm, 5.7 mm | 4 mm | 3.3-5.8 mm |
| Sterilization<br>Method | Radiation | Radiation | Radiation |

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# Table 6.2b: Comparison of the proposed device to the predicate device (Temporary Abutment Superstructure)

| Element | MIS CONNECT Temporary<br>abutments<br>Proposed Device | MIS CONNECT Temporary<br>abutments<br>K173326<br>Primary Predicate Device | MIS V3 Temporary abutments<br>K163349<br>Reference Device |
|------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------|
| Pictorial<br>Representation | Image: MIS CONNECT Temporary abutments | Image: MIS CONNECT Temporary abutments K173326 | Image: MIS V3 Temporary abutments K163349 |
| Material(s) | Abutment: | Abutment: | Abutment: |
| | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 | Ti-6Al-4V ELI per ASTM F136 |
| | Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 |
| Connection<br>interface | Compatible with MIS<br>CONNECT abutment | Compatible with MIS<br>CONNECT abutment | Compatible with MIS Conical<br>Connection implants |
| Type of<br>Connection to<br>the MIS<br>CONNECT<br>abutment | Anti-rotation: regular hexagon<br>Free-rotation: no hexagon | Anti-rotation: irregular hexagon<br>Free-rotation: no hexagon | NA - Connects directly to the<br>implant |
| Gingival<br>Height | N/A - connects to the MIS<br>CONNECT abutment | N/A – connects to the MIS<br>CONNECT abutment | 1, 2, 3 mm |
| Post Height | 10 mm | 10 mm | 10, 10.5mm |
| Diameter | 4mm, 5.7 mm | 4 mm | 4.0, 4.8, 5.8 mm |
| Sterilization | Product provided non-sterile and<br>end-user sterilized. | Product provided non-sterile and<br>end-user sterilized. | Product provided non-sterile and<br>end-user sterilized. |

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| Table 6.2c: Comparison of the proposed device to the predicate device (Final Esthetic Abutment | | | |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Superstructure) | | | |
| Element | MIS CONNECT Final Esthetic<br>Abutments<br>Proposed device | MIS CONNECT Cementing<br>Cap Abutments<br>K173326<br>Primary Predicate Device | MIS V3 Cement Retained<br>Abutments<br>K163349<br>Reference Device |
| Pictorial<br>Representation | Image: MIS CONNECT Final Esthetic Abutments | Image: MIS CONNECT Cementing Cap Abutments | Image: MIS V3 Cement Retained Abutments |
| Material(s) | Abutment:<br>Ti-6Al-4V ELI per ASTM F136<br><br>Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 | Abutment:<br>Ti-6Al-4V ELI per ASTM F136<br><br>Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 | Abutment:<br>Ti-6Al-4V ELI per ASTM F136<br><br>Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 |
| Connection<br>interface | Compatible with MIS<br>CONNECT abutment | Compatible with MIS<br>CONNECT abutment | Compatible with MIS Conical<br>Connection implants |
| Type of<br>Connection to<br>the MIS<br>CONNECT<br>abutment | Anti-rotation: regular hexagon<br>Free-rotation: no hexagon | Anti-rotation: irregular hexagon<br>Free-rotation: no hexagon | NA - Connects directly to the<br>implant |
| Gingival<br>Height | N/A - connects to the MIS<br>CONNECT abutment | N/A – connects to the MIS<br>CONNECT abutment | 0.5, 1, 1.5, 2, 3 mm |
| Post Height | 6.05 mm | 6.05 mm | 5.95 mm |
| Diameter | 4mm, 5.7 mm | 4 mm | NP: 4.0, 4.25, 4.8 mm<br>SP: 4.25, 4.8, 5.8 mm |
| Sterilization | Product provided non-sterile and<br>end-user sterilized. | Product provided non-sterile and<br>end-user sterilized. | Product provided non-sterile and<br>end-user sterilized. |

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# Table 6.2d: Comparison of the proposed device to the predicate device (Final Abutment Superstructure)

| Element | MIS CONNECT Final<br>Abutments<br>Proposed Device | MIS CONNECT Cementing<br>Cap Abutments<br>K173326<br>Primary Predicate Device | MIS V3 Cement Retained<br>Abutments<br>K163349<br>Reference Device |
|--------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Pictorial<br>Representation | Image: MIS CONNECT Final Abutments | Image: MIS CONNECT Cementing Cap Abutments | Image: MIS V3 Cement Retained Abutments |
| Material(s) | Abutment:<br>Ti-6Al-4V ELI per ASTM F136 | Abutment:<br>Ti-6Al-4V ELI per ASTM F136 | Abutment:<br>Ti-6Al-4V ELI per ASTM F136 |
| | Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 | Prosthetic screw:<br>Ti 6Al 4V ELI per ASTM F136 |
| Connection<br>interface | Compatible with MIS<br>CONNECT abutment | Compatible with MIS<br>CONNECT abutment | Compatible with MIS Conical<br>Connection implants |
| Type of<br>Connection to<br>the<br>CONNECT<br>abutment | Anti-rotation: regular hexagon<br>Free-rotation: no hexagon | Anti-rotation:…