Atlantis Abutment for MIS Implant

K172225 · Dentsply Sirona · NHA · Nov 30, 2017 · Dental

Device Facts

• Record ID: K172225
• Device Name: Atlantis Abutment for MIS Implant
• Applicant: Dentsply Sirona
• Product Code: NHA · Dental
• Decision Date: Nov 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant. The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant. The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

Device Story

Patient-specific endosseous dental implant abutments; fabricated via CAD/CAM technology. Inputs: clinician prescription instructions; implant interface geometry. Outputs: custom-designed abutments (straight or up to 30° angulation) for screw-retained, cement-retained, or friction-fit prosthetic attachment. Used in dental clinics by clinicians to restore chewing function. Benefits: provides customized substructure for final dental restorations; ensures mechanical compatibility with specific MIS implant platforms.

Clinical Evidence

Bench testing only. Includes static and dynamic compression-bending fatigue testing per ISO 14801 and geometric compatibility analyses for MIS implant platforms. Sterilization validated per ISO 17665-1 and ISO 20857.

Technological Characteristics

Materials: Titanium alloy, Zirconia. Design: Patient-specific CAD/CAM fabricated. Connection: Internal hex. Dimensions: Platform diameters 3.30mm to 6.0mm; heights 3.3mm to 13mm. Angulation: Straight to 30°. Sterilization: Moist heat and dry heat.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla via endosseous implants. Compatible with MIS M4 and SEVEN implant systems. MIS short implants (6mm) restricted to straight abutments.

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

• ATLANTIS® Abutment for HIOSSEN ET Implant (K160626)

Reference Devices

• MIS Dental Implant System (K040807)
• MIS Short Implants (K103089)

Submission Summary (Full Text)

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November 30, 2017

Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401

Re: K172225

Trade/Device Name: ATLANTIS® Abutment for MIS Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 31, 2017 Received: September 1, 2017

### 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

# Andrew I. Steen -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172225

Device Name ATLANTIS® Abutment for MIS Implant

### Indications for Use (Describe)

The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.

The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.

The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.

ATLANTIS® products are compatible with the implants shown in the table below.

| Implant manufacturer | MIS-IMPLANT TECHNOLOGIES INC |
|----------------------|------------------------------|
|----------------------|------------------------------|

| Trade Name | Abutment Platform Diameter | Implant Diameter |
|------------------------------------------|----------------------------|------------------|
| MIS Implant M4 & SEVEN Narrow Platform | Ø3.30 mm | Ø3.30 mm |
| MIS Implant M4 & SEVEN Standard Platform | Ø3.75 and 4.2 mm | Ø3.75 and 4.2 mm |
| MIS Implant M4 & SEVEN Wide Platform | Ø5.0 and 6.0 mm | Ø5.0 and 6.0 mm |

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Dentsply Sirona 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 leaf or wave in gray. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font, also in gray. The overall design is clean and modern.

# SECTION 5. 510(k) SUMMARY K172225

# ATLANTIS® Abutment for MIS Implant

- 1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

| Contact Person: | Karl Nittinger |
|-------------------|-------------------|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
| Date Prepared: | November 30, 2017 |

#### 2. Device Name:

- Proprietary Name: .
- Classification Name: ●
- Endosseous dental implant abutment CFR Number: 21 CFR 872.3630
- Device Class: .
- II Product Code: NHA

#### 3. Predicate Device:

●

| Predicate Device Name | 510(k) | Company Name |
|-----------------------------------------------------------|---------|------------------------------|
| ATLANTIS® Abutment for<br>HIOSSEN ET<br>Implant | K160626 | DENTSPLY IMPLANTS |
| MIS Dental Implant System<br>(Reference Predicate Device) | K040807 | MIS-IMPLANT TECHNOLOGIES INC |
| MIS Short Implants<br>(Reference Predicate Device) | K103089 | MIS-IMPLANT TECHNOLOGIES INC |

ATLANTIS® Abutment for MIS Implant

#### 4. Description of Device:

The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.

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| Table 5-1: Compatibility table (The ATLANTIS® Abutment Titanium, Zirconia and Gold-<br>shaded are compatible with MIS implant interface (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------|
| Implant<br>Manufacturer | Interface | ATLANTIS®<br>Abutment<br>for MIS<br>Implant | ATLANTIS®<br>Crown<br>Abutment<br>for MIS<br>Implant | ATLANTIS®<br>Conus<br>Abutment<br>for MIS<br>Implant<br>(Custom) | ATLANTIS®<br>Conus<br>Abutment for<br>MIS implant<br>(Overdenture) |
| MIS-IMPLANT<br>TECHNOLOGIES<br>INC | MIS M4 &<br>SEVEN Implant<br>System (MIS<br>implant) (Ø3.3,<br>3.75, 4.2, 5.0 and<br>6.0 mm) | Titanium,<br>Zirconia,<br>Gold-shaded<br>Titanium<br>(Gold-Hue) | Titanium,<br>Zirconia | Titanium,<br>Gold-shaded<br>Titanium<br>(Gold-Hue) | Titanium |

The coronal portion of the ATLANTIS® Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment or ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).

The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.

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- న. Indications for Use:
The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.

The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.

The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

ATLANTIS® Abutment for MIS implant is compatible with MIS implant from MIS Implant System. MIS short implants (6mm) are to be used only with straight abutments.

ATLANTIS® products are compatible with the implants shown in the table below.

| Trade Name | Abutment Platform Diameter | Implant Diameter |
|---------------------------------------------|----------------------------|------------------|
| MIS Implant M4 & SEVEN<br>Narrow Platform | Ø3.30 mm | Ø3.30 mm |
| MIS Implant M4 & SEVEN<br>Standard Platform | Ø3.75 and 4.2 mm | Ø3.75 and 4.2 mm |
| MIS Implant M4 & SEVEN<br>Wide Platform | Ø5.0 and 6.0 mm | Ø5.0 and 6.0 mm |

Implant manufacturer – MIS-IMPLANT TECHNOLOGIES INC

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#### 6. Substantial Equivalence:

### Technological Characteristics

ATLANTIS® Abutment for MIS implant is a patient specific restorative device designed under the control of Dentsply Implants and manufactured by Dentsply Implants using CAD/CAM technology.

Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices.

| Table 5-2: Indications for use for the proposed and the predicate devices | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ATLANTIS® Abutment for<br>MIS Implant<br>(Proposed Device) | ATLANTIS® Abutment for<br>HIOSSEN ET Implant (K160626)<br>(Primary Predicate) | MIS Dental Implant System<br>(K040807)<br>(Reference Predicate) | MIS Short Implants<br>(K103089)<br>(Reference Predicate) | Summary of differences in the<br>indications for use |
| The ATLANTIS® Abutment is intended<br>for use with an endosseous implant to<br>support a prosthetic device in a<br>partially or completely edentulous<br>patient. It is intended for use to<br>support single and multiple tooth<br>prosthesis, in mandible or maxilla.<br>The prosthesis can be cemented or<br>screw retained to the abutment. The<br>abutment screw is intended to secure<br>the ATLANTIS® Abutment to the<br>endosseous implant.<br><br>The ATLANTIS® Crown Abutment<br>is intended for use with an endosseous<br>implant to function as a substructure<br>that also serves as the final<br>restoration, in a partially or<br>completely edentulous patient. The<br>abutment screw is intended to secure<br>the ATLANTIS® Crown Abutment to<br>the endosseous implant.<br><br>The ATLANTIS® Conus Abutment<br>is intended for use with an endosseous<br>implant to support a prosthetic device<br>in partially or completely edentulous<br>patients. It is intended for use to | The ATLANTIS® Abutment is intended<br>for<br>use with an endosseous implant to<br>support a prosthetic device in a partially<br>or completely edentulous patient. It is<br>intended for use to support single and<br>multiple tooth prosthesis, in mandible or<br>maxilla. The prosthesis can be cemented<br>or screw retained to the abutment. The<br>abutment screw is intended to secure the<br>ATLANTIS® Abutment to the<br>endosseous implant.<br><br>The ATLANTIS® Crown Abutment is<br>intended for use with an endosseous<br>implant to function as a substructure<br>that also serves as the final restoration,<br>in a partially or completely edentulous<br>patient. The abutment screw is intended<br>to secure the ATLANTIS® Crown<br>Abutment to the endosseous implant.<br><br>The ATLANTIS® Conus Abutment is<br>intended for use with an endosseous<br>implant to support a prosthetic device in<br>partially or completely edentulous<br>patients. It is intended for use to support<br>a removable multiple tooth prosthesis,<br>in the mandible or maxilla. The | The MIS Dental Implant<br>System is indicated for use in<br>surgical and restorative<br>applications for placement in the<br>bone of the upper or lower jaw<br>to provide support for prosthetic<br>devices, such as artificial teeth,<br>in order to restore the patient's<br>chewing function. | MIS Dental Implants are intended<br>to be surgically placed in the bone<br>of the upper or lower jaw arches to<br>provide support for prosthetic<br>devices, such as artificial teeth, in<br>order to restore a patient's chewing<br>function.<br><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. MIS short implants are<br>to be used only with straight<br>abutments. | The indications for use of the<br>proposed device are similar to<br>the indications for use of the<br>primary predicate device. The<br>difference is that the indications<br>for use of the primary predicate<br>device are for Hiossen ET<br>implant system.<br><br>The indications for use of the<br>reference predicate device cover<br>the entire dental system. The<br>indications for use are similar.<br>The difference between the<br>proposed device and the<br>reference predicate device is that<br>the prosthesis, in addition to<br>screw-retained restoration or<br>cement retained restoration, can<br>be attachment-retained (friction<br>fit) to the proposed device. |

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| Table 5-2: Indications for use for the proposed and the predicate devices | | | | | | MIS Dental<br>Implant System<br>(K040807)<br>(Reference<br>Predicate) | MIS Short Implants<br>(K103089)<br>(Reference Predicate) | Summary of<br>differences in<br>the<br>indications<br>for use | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------|--|
| ATLANTIS® Abutment for<br>MIS implant<br>(Proposed Device) | ATLANTIS® Abutment for HIOSSEN ET<br>Implant (K160626)<br>(Primary Predicate) | | prosthesis, in the mandible or maxilla.<br>The prosthesis is attachment-retained by<br>friction fit to the abutment. The abutment<br>screw is intended to secure the<br>ALTLANTIS® Conus Abutment to the<br>endosseous implant. | | friction fit to the abutment. The abutment screw is<br>intended to secure the ATLANTIS® Conus<br>Abutment to the endosseous implant. | | | | |
| ATLANTIS® Abutment for MIS Implant<br>is compatible with MIS implant from<br>MIS Implant System. MIS short implants<br>(6mm) are to be used only with straight<br>abutments.<br>ATLANTIS® products are compatible<br>with the implants shown in the table<br>below.<br>Implant manufacturer:<br>MIS IMPLANT TECHNOLOGIES, INC | ATLANTIS® products are compatible with the<br>implants shown in the table below.<br>Implant Manufacturer:<br>HIOSSEN INC | | | | | | | | |
| Trade Name | Abutment<br>Platform<br>Diameter | Implant<br>Diameter | Trade Name | Abutment<br>Platform<br>Diameter | Implant<br>Diameter | | | | |
| MIS Implant M4<br>& SEVEN<br>Narrow Platform | Ø3.30 mm | Ø3.30 mm | HIOSSEN ET III SA<br>Fixture Mini | Ø3.5mm | Ø3.5mm | | | | |
| MIS Implant<br>M4 & SEVEN<br>Standard<br>Platform | Ø3.75 and<br>4.2 mm | Ø3.75 and<br>4.2 mm | HIOSSEN ET III SA<br>Fixture Regular | Ø4.0, 4.5,<br>5.0, 6.0,7.0 mm | Ø4.0, 4.5, 5.0,<br>6.0, 7.0 mm | | | | |
| MIS Implant<br>M4 & SEVEN<br>Wide Platform | Ø5.0 and<br>6.0 mm | Ø5.0 and<br>6.0 mm | | | | | | | |

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| Table 5-3: Similarities and differences between the proposed and the predicate devices | | | | | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | Proposed Device<br>ATLANTIS® Abutment<br>for MIS Implant | Primary Predicate Device<br>ATLANTIS® Abutment for<br>HIOSSEN ET Implant | Reference Predicate Device<br>MIS Dental Implant<br>System | Reference Predicate Device<br>MIS Short Implants | Summary of differences |
| 510(k) | To be assigned | K160626 | K040807 | K103089 | - |
| Prosthesis<br>Attachment | Screw-retained<br>Cement-retained<br>Friction Fit | Screw-retained<br>Cement-retained<br>Friction Fit | Screw-retained<br>Cement-retained | Screw-retained<br>Cement-retained | No difference between the proposed<br>and the primary predicate device.<br>The reference device does not<br>indicate friction fit. |
| Restoration<br>Abutment<br>Platform<br>Diameter | Single or Multi-unit<br>3.3, 3.75, 4.2, 5.0, 6.0 | Single or Multi-unit<br>3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Single or Multi-unit<br>3.3, 3.75, 4.2, 5.0, 6.0 | Single or Multi-unit<br>4.2, 5.0, 6.0 | No difference<br>The proposed device is designed to<br>fit the MIS interface.<br>Therefore, no difference between the<br>proposed device and the reference<br>predicate device. |

| Table 5-3: Similarities and differences between the proposed and the predicate devices | | | | | | | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------|--|--|
| Element | Proposed Device<br>ATLANTIS® Abutment<br>for MIS Implant | Primary Predicate Device<br>ATLANTIS® Abutment for<br>HIOSSEN ET Implant | Reference Predicate Device<br>MIS Dental Implant<br>System | Reference Predicate Device<br>MIS Short Implants | Summary of differences | | |
| Abutment<br>angle | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | Straight | No difference | | |
| Connection | Internal hex connection | Internal hex connection | Internal hex connection | Internal hex connection | There is no difference between the<br>proposed device and the reference<br>predicate device. | | |
| Material<br>Implant | NA | NA | Titanium Alloy<br>Ti 6Al 4V ELI | Titanium Alloy | The proposed device is an abutment | | |
| Material:<br>Abutment | Titanium alloy, Zirconia | Titanium alloy, Zirconia | Titanium alloy | Titanium Alloy | No difference | | |
| Material:<br>Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | No difference | | |

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#### 7. Non-Clinical Performance Data

Non-clinical test data and analyses are included to support substantial equivalence:

- . Static and dynamic compression-bending testing conducted according to ISO 14801: Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.
- Geometric analyses conducted on implant bodies, abutments, and screws to support the dimensional compatibility of the ATLANTIS® Abutment for MIS Implant with the MIS Implant Technologies, Inc., Narrow (Ø3.30 mm), Standard (Ø3.75 and 4.2 mm), and Wide (Ø5.0 and 6.0 mm), M4 and SEVEN implant platforms.
- Sterilization parameters which have been validated according to ISO 17665-1: Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, and ISO 20857: Sterilization of health care products -- Dry heat --Requirements for the development, validation and routine control of a sterilization process for medical devices are included and are as referenced in the predicate device (K160626).

### Biocompatibility

The material composition and manufacturing processing methods of the subject ATLANTIS® Abutment for MIS Implant are identical to the predicate device, ATLANTIS® Abutment for Hiossen ET Implant (K160626). Therefore, no additional biocompatibility data is included to support substantial equivalence.

#### 8. Conclusion Regarding Substantial Equivalence

The ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTIS® Abutment for MIS Implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates, ATLANTIS® Abutment for HIOSSEN ET Implant (K160626), MIS Dental Implant System (K040807) and MIS Short Implants (K103089). Test data to verify the performance of the ATLANTIS® Abutment for MIS Implant has been provided with mechanical testing. The results of the test studies and dimensional compatibility analyses, combined with the design, and intended use comparison with the predicate devices, support substantial equivalence.