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

Device Description

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.

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.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the ATLANTIS® Abutment for MIS Implant. It does not describe an AI/ML powered medical device, but rather a dental implant abutment which is a physical device. Therefore, the questions related to AI/ML device acceptance criteria and study design are not applicable.

However, I can provide the acceptance criteria and the study that proves the physical device meets its acceptance criteria based on the information provided in the document.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance (Study Results)
Static and dynamic compression-bending capabilities according to ISO 14801: Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.	Successful. The non-clinical test data and analyses for static and dynamic compression-bending testing were "included to support substantial equivalence." (Exact numerical performance data is not explicitly quantified in this summary, but the conclusion states that "Test data to verify the performance... has been provided with mechanical testing" and supports substantial equivalence.)
Dimensional compatibility with specified MIS Implant Technologies, Inc. implant platforms (Narrow (Ø3.30 mm), Standard (Ø3.75 and 4.2 mm), and Wide (Ø5.0 and 6.0 mm), M4 and SEVEN implant platforms).	Successful. "Geometric analyses conducted on implant bodies, abutments, and screws to support the dimensional compatibility" were performed and the "dimensional compatibility analyses... support substantial equivalence."
Sterilization parameters validated according to ISO 17665-1 (Moist heat) and ISO 20857 (Dry heat).	Successful. "Sterilization parameters which have been validated according to ISO 17665-1... and ISO 20857... are included and are as referenced in the predicate device (K160626)."
Biocompatibility (implied criterion by material composition and manufacturing process).	Successful. "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the mechanical testing or geometric analyses. It also does not specify the country of origin or whether the data was retrospective or prospective. These details are typically found in the full test reports referenced in the 510(k) submission, not in the summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device, not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be established by engineering specifications, materials science standards, and established regulatory test methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical device, not an AI/ML device that requires expert adjudication for diagnostic outputs. The performance is assessed through standardized engineering tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical device, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical device, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device would be defined by engineering standards, material properties, and regulatory performance requirements. For example:

Mechanical Testing: Ground truth is defined by the requirements of ISO 14801, which sets pass/fail criteria for fatigue strength, and by the established strength and durability of the predicate device.
Dimensional Compatibility: Ground truth is defined by the precise geometric specifications and tolerances of the MIS implant interface, ensuring a proper fit.
Sterilization: Ground truth is defined by the validation criteria outlined in ISO 17665-1 and ISO 20857, ensuring a sterile product.
Biocompatibility: Ground truth is established by the accepted biocompatibility of the identical materials used in the predicate device.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI/ML device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 forHIOSSEN ETImplant	K160626	DENTSPLY IMPLANTS
MIS Dental Implant System(Reference Predicate Device)	K040807	MIS-IMPLANT TECHNOLOGIES INC
MIS Short Implants(Reference Predicate Device)	K103089	MIS-IMPLANT TECHNOLOGIES INC

ATLANTIS® Abutment for MIS Implant

4. Description of Device:

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Table 5-1: Compatibility table (The ATLANTIS® Abutment Titanium, Zirconia and Gold-shaded are compatible with MIS implant interface (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm)
ImplantManufacturer	Interface	ATLANTIS®Abutmentfor MISImplant	ATLANTIS®CrownAbutmentfor MISImplant	ATLANTIS®ConusAbutmentfor MISImplant(Custom)	ATLANTIS®ConusAbutment forMIS implant(Overdenture)
MIS-IMPLANTTECHNOLOGIESINC	MIS M4 &SEVEN ImplantSystem (MISimplant) (Ø3.3,3.75, 4.2, 5.0 and6.0 mm)	Titanium,Zirconia,Gold-shadedTitanium(Gold-Hue)	Titanium,Zirconia	Titanium,Gold-shadedTitanium(Gold-Hue)	Titanium

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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® 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 & SEVENNarrow Platform	Ø3.30 mm	Ø3.30 mm
MIS Implant M4 & SEVENStandard Platform	Ø3.75 and 4.2 mm	Ø3.75 and 4.2 mm
MIS Implant M4 & SEVENWide 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 forMIS Implant(Proposed Device)	ATLANTIS® Abutment forHIOSSEN ET Implant (K160626)(Primary Predicate)	MIS Dental Implant System(K040807)(Reference Predicate)	MIS Short Implants(K103089)(Reference Predicate)	Summary of differences in theindications for use
The ATLANTIS® Abutment is intendedfor use with an endosseous implant tosupport a prosthetic device in apartially or completely edentulouspatient. It is intended for use tosupport single and multiple toothprosthesis, in mandible or maxilla.The prosthesis can be cemented orscrew retained to the abutment. Theabutment screw is intended to securethe ATLANTIS® Abutment to theendosseous implant.The ATLANTIS® Crown Abutmentis intended for use with an endosseousimplant to function as a substructurethat also serves as the finalrestoration, in a partially orcompletely edentulous patient. Theabutment screw is intended to securethe ATLANTIS® Crown Abutment tothe endosseous implant.The ATLANTIS® Conus Abutmentis intended for use with an endosseousimplant to support a prosthetic devicein partially or completely edentulouspatients. It is intended for use to	The ATLANTIS® Abutment is intendedforuse with an endosseous implant tosupport a prosthetic device in a partiallyor completely edentulous patient. It isintended for use to support single andmultiple tooth prosthesis, in mandible ormaxilla. The prosthesis can be cementedor screw retained to the abutment. Theabutment screw is intended to secure theATLANTIS® Abutment to theendosseous implant.The ATLANTIS® Crown Abutment isintended for use with an endosseousimplant to function as a substructurethat also serves as the final restoration,in a partially or completely edentulouspatient. The abutment screw is intendedto secure the ATLANTIS® CrownAbutment to the endosseous implant.The ATLANTIS® Conus Abutment isintended for use with an endosseousimplant to support a prosthetic device inpartially or completely edentulouspatients. It is intended for use to supporta removable multiple tooth prosthesis,in the mandible or maxilla. The	The MIS Dental ImplantSystem is indicated for use insurgical and restorativeapplications for placement in thebone of the upper or lower jawto provide support for prostheticdevices, such as artificial teeth,in order to restore the patient'schewing function.	MIS Dental Implants are intendedto be surgically placed in the boneof the upper or lower jaw arches toprovide support for prostheticdevices, such as artificial teeth, inorder to restore a patient's chewingfunction.When a one stage surgicalprocedure is applied, the implantmay be immediately loaded whengood primary stability is achievedand the occlusal load isappropriate. MIS short implants areto be used only with straightabutments.	The indications for use of theproposed device are similar tothe indications for use of theprimary predicate device. Thedifference is that the indicationsfor use of the primary predicatedevice are for Hiossen ETimplant system.The indications for use of thereference predicate device coverthe entire dental system. Theindications for use are similar.The difference between theproposed device and thereference predicate device is thatthe prosthesis, in addition toscrew-retained restoration orcement retained restoration, canbe attachment-retained (frictionfit) to the proposed device.

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Table 5-2: Indications for use for the proposed and the predicate devices
ATLANTIS® Abutment forMIS implant(Proposed Device)	ATLANTIS® Abutment for HIOSSEN ETImplant (K160626)(Primary Predicate)		prosthesis, in the mandible or maxilla.The prosthesis is attachment-retained byfriction fit to the abutment. The abutmentscrew is intended to secure theALTLANTIS® Conus Abutment to theendosseous implant.		friction fit to the abutment. The abutment screw isintended to secure the ATLANTIS® ConusAbutment to the endosseous implant.
ATLANTIS® Abutment for MIS Implantis compatible with MIS implant fromMIS Implant System. MIS short implants(6mm) are to be used only with straightabutments.ATLANTIS® products are compatiblewith the implants shown in the tablebelow.Implant manufacturer:MIS IMPLANT TECHNOLOGIES, INC	ATLANTIS® products are compatible with theimplants shown in the table below.Implant Manufacturer:HIOSSEN INC
Trade Name	AbutmentPlatformDiameter	ImplantDiameter	Trade Name	AbutmentPlatformDiameter	ImplantDiameter
MIS Implant M4& SEVENNarrow Platform	Ø3.30 mm	Ø3.30 mm	HIOSSEN ET III SAFixture Mini	Ø3.5mm	Ø3.5mm
MIS ImplantM4 & SEVENStandardPlatform	Ø3.75 and4.2 mm	Ø3.75 and4.2 mm	HIOSSEN ET III SAFixture Regular	Ø4.0, 4.5,5.0, 6.0,7.0 mm	Ø4.0, 4.5, 5.0,6.0, 7.0 mm
MIS ImplantM4 & SEVENWide Platform	Ø5.0 and6.0 mm	Ø5.0 and6.0 mm

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Table 5-3: Similarities and differences between the proposed and the predicate devices
Element	Proposed DeviceATLANTIS® Abutmentfor MIS Implant	Primary Predicate DeviceATLANTIS® Abutment forHIOSSEN ET Implant	Reference Predicate DeviceMIS Dental ImplantSystem	Reference Predicate DeviceMIS Short Implants	Summary of differences
510(k)	To be assigned	K160626	K040807	K103089	-
ProsthesisAttachment	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retained	Screw-retainedCement-retained	No difference between the proposedand the primary predicate device.The reference device does notindicate friction fit.
RestorationAbutmentPlatformDiameter	Single or Multi-unit3.3, 3.75, 4.2, 5.0, 6.0	Single or Multi-unit3.5, 4.0, 4.5, 5.0, 6.0, 7.0	Single or Multi-unit3.3, 3.75, 4.2, 5.0, 6.0	Single or Multi-unit4.2, 5.0, 6.0	No differenceThe proposed device is designed tofit the MIS interface.Therefore, no difference between theproposed device and the referencepredicate device.

Table 5-3: Similarities and differences between the proposed and the predicate devices
Element	Proposed DeviceATLANTIS® Abutmentfor MIS Implant	Primary Predicate DeviceATLANTIS® Abutment forHIOSSEN ET Implant	Reference Predicate DeviceMIS Dental ImplantSystem	Reference Predicate DeviceMIS Short Implants	Summary of differences
Abutmentangle	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 theproposed device and the referencepredicate device.
MaterialImplant	NA	NA	Titanium AlloyTi 6Al 4V ELI	Titanium Alloy	The proposed device is an abutment
Material:Abutment	Titanium alloy, Zirconia	Titanium alloy, Zirconia	Titanium alloy	Titanium Alloy	No difference
Material: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.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)