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 (Ø3.3mm) 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.

Device Description

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

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, the "MIS CONNECT Conical Connection System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness or establishing performance criteria based on an AI model or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study components related to AI/ML medical devices (such as MRMC studies, ground truth establishment for a test set, etc.) are not applicable to this submission.

The "device" in this context is a physical dental implant component (abutments and superstructures), not a software or AI/ML-driven diagnostic tool. The "acceptance criteria" here refer to demonstrating that the new device is as safe and effective as the predicate device.

Here's an analysis of the "acceptance criteria" and "study" as implied by a 510(k) submission for a physical medical device, addressing the relevant points from your request:

Device Name: MIS CONNECT Conical Connection System (dental abutments and superstructures)

Nature of Device: Physical dental implant components, not an AI/ML-driven diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a physical device like this, "acceptance criteria" typically relate to demonstrating the new device performs equivalently to the predicate devices through non-clinical testing (e.g., mechanical testing, biocompatibility, sterilization). There are no "performance metrics" in the sense of accuracy, sensitivity, or specificity as would be for a diagnostic AI.

Acceptance Criterion (Type of Testing)	Reported Device Performance (Conclusion)
Fatigue Testing	Dynamic fatigue testing of worst-case representative samples performed according to ISO 14801:2016 (Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants). Results support substantial equivalence.
Biocompatibility	The proposed devices are composed of identical materials, manufactured in the identical facility, and under identical processes as the primary predicate device (K173326). Intended conditions of use, patient contact type, and duration are identical to the predicate (per ISO 10993-1). No new biocompatibility data needed; substantial equivalence supported by reference to predicate.
Sterilization	For Sterile Devices: Validation conducted for worst-case construct according to ISO 11137-2:2013 (Radiation). Results support a sterility assurance level (SAL) of 10^-6.For Non-Sterile Devices: Validation conducted for worst-case construct according to ANSI/AAMI/ISO 17665-1:2006/(R)2013 (Moist Heat). Results support a sterility assurance level (SAL) of 10^-6 for end-user sterilization.
Packaging & Shelf Life	Packaging and packaging materials are identical to the predicate and proposed devices. Shelf life data referenced by equivalence to support substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified in terms of number of cases/patients. For physical device performance testing (fatigue, sterilization), samples would refer to the number of physical devices or batches tested, not patient data. The document mentions "worst case representative samples."
Data Provenance: Not applicable in the context of patient data (e.g., country of origin, retrospective/prospective). The data submitted for this 510(k) are from non-clinical laboratory testing (e.g., mechanical fatigue testing, sterilization validation).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable. This is not a study assessing diagnostic accuracy or clinical decision-making based on expert consensus. The "ground truth" for mechanical performance is established by engineering standards (e.g., ISO 14801 for fatigue) and laboratory measurements.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" of patient cases requiring adjudication as in a diagnostic accuracy or clinical trial setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for evaluating the performance of diagnostic tools (especially those involving human readers and AI assistance). This 510(k) is for a physical dental implant component, not a diagnostic tool, and involves no human readers or AI assistance in its function.

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 algorithm.

7. The Type of Ground Truth Used

For Fatigue Testing: Ground truth is defined by the ISO 14801:2016 standard specifications for dynamic fatigue of endosseous dental implants. The "truth" is whether the device withstands specified forces for a specified number of cycles.
For Biocompatibility: Ground truth is established by ISO 10993-1, and the "truth" is that the materials and manufacturing processes are identical to a previously cleared device.
For Sterilization: Ground truth is defined by ISO 11137-2:2013 (radiation) and ANSI/AAMI/ISO 17665-1:2006/(R)2013 (moist heat) standards, ensuring a specific sterility assurance level.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML device requiring machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable.

Summary of Study Proving Substantial Equivalence:

The study proving the device meets the acceptance criteria is a collection of non-clinical performance tests and comparisons to predicate devices, rather than a clinical trial or a study assessing diagnostic accuracy. The key components of the "study" are:

Fatigue Testing: Performed on "worst case representative samples" of the proposed abutments and superstructures according to ISO 14801:2016. The results demonstrated comparable performance to ensure the new dimensions/designs maintain mechanical integrity.
Biocompatibility Assessment: No new testing was conducted. Substantial equivalence was demonstrated by asserting that the proposed device uses "identical materials" and is "manufactured in the identical manufacturing facility and under the identical manufacturing processes" as the primary predicate device (K173326), and that the intended use and patient contact are identical. This relies on the prior biocompatibility clearance of the predicate.
Sterilization Validation: For both sterile and non-sterile configurations (for end-user sterilization), validation was conducted on "worst-case construct" samples following ISO 11137-2:2013 (radiation) and ANSI/AAMI/ISO 17665-1:2006/(R)2013 (moist heat), respectively, to achieve a SAL of 10^-6.
Packaging and Shelf Life: Assessed by demonstrating identity to the predicate device's packaging and material, therefore relying on the predicate's established shelf-life data.

Key Conclusion from the Submission:

"The comparison of the indications for use, technological characteristics, with the inclusion of the results of non-clinical testing, support a conclusion of substantial equivalence of the proposed MIS CONNECT Conical Connection Abutments and Superstructures to the predicate devices." (Page 13)

Summary

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

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:	karl.nittinger@dentsplysirona.com
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 Connectionabutment	K173326	MIS Implants Technologies Ltd.(Owner/Operator : Dentsply Sirona)
Reference Devices:	510(k)	Company Name
MIS V3 Cement Retained Abutment	K163349	MIS Implants Technologies Ltd.(Owner/Operator : Dentsply Sirona)
MIS C1 Narrow Platform ConicalConnection Implant System, MIS C1Wide Platform Conical ConnectionAbutments	K172505	MIS Implants Technologies Ltd.(Owner/Operator : Dentsply Sirona)
MIS Conical Connection Implants(Included as a referenced device solely foridentification as the compatible implantsystem).	K112162	MIS Implants Technologies Ltd.(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

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

5.0 Indications for Use

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 ConicalConnection abutmentsProposed device	MIS CONNECT ConicalConnection abutmentsK173326Primary Predicate Device	MIS V3 Cement RetainedAbutmentsK163349Reference Device
PictorialRepresentation	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 areintended to be used in the upperor lower jaw for supportingtooth replacements to restorechewing function.The MIS CONNECT abutmentsin combination with endosseousimplants are indicated for singleor multiple unit reconstructionswhen screw retained prostheticsare preferred.	Dental implant abutments areintended to be used in the upperor lower jaw for supporting toothreplacements to restore chewingfunction.The MIS CONNECT abutmentsin combination with endosseousimplants are indicated for singleor multiple unit reconstructionswhen screw retained prostheticsare preferred.	Dental implant abutments areintended to be used in the upperor lower jaw used for supportingtooth replacements to restorechewing function.The abutments in combinationwith two-stage endosseousimplants are intended to be usedas a foundation for anchoringtooth replacements in either jaw.Restorations range from replacingone single tooth to fixed partialdentures using cement-retainedsupra-constructions.
Indications foruse:	MIS Dental Implant Systemsare intended to be surgicallyplaced in the bone of the upperor lower jaw arches to providesupport for prosthetic devices,such as artificial teeth, in orderto restore masticatory function.When a one-stage surgicalprocedure is applied, theimplant may be immediatelyloaded when good primarystability is achieved and theocclusal load is appropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications forplacement only in themandibular central, lateralincisor and maxillary lateralincisor regions of partiallyedentulous jaws, to providesupport for prosthetic devicessuch as artificial teeth, in orderto restore the patient chewingfunction. Mandibular centraland lateral incisors must besplinted if using two or morenarrow implants adjacent to oneanother.	MIS Dental Implant Systems areintended to be surgically placed inthe bone of the upper or lowerjaw arches to provide support forprosthetic devices, such asartificial teeth, in order to restoremasticatory function.When a one-stage surgicalprocedure is applied, the implantmay be immediately loaded whengood primary stability is achievedand the occlusal load isappropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibularcentral, lateral incisor andmaxillary lateral incisor regionsof partially edentulous jaws, toprovide support for prostheticdevices such as artificial teeth, inorder to restore the patientchewing function. Mandibularcentral and lateral incisors mustbe splinted if using two or morenarrow implants adjacent to oneanother.	MIS Dental Implant System areintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such asartificial teeth, in order to restoremasticatory function.When a one-stage surgicalprocedure is applied, the implantmay be immediately loaded whengood primary stability is achievedand the occlusal load isappropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibularcentral, lateral incisor andmaxillary lateral incisor regionsof partially edentulous jaws, toprovide support for prostheticdevices such as artificial teeth, inorder to restore the patientchewing function. Mandibular centraland lateral incisors mustbe splinted if using two or morenarrow implants adjacent to oneanother
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 predicateAbutment devices
Element	MIS CONNECT ConicalConnection abutments	MIS CONNECT ConicalConnection abutmentsK173326	MIS V3 Cement RetainedAbutmentsK163349
	Proposed device	Primary Predicate Device	Reference Device
SurfaceTreatment	Anodized after machining	Anodized after machining	Polished and anodized aftermachining
Type ofConnection tothe Implant	Conical connectionwithout indexes	Conical connectionwithout indexes	Conical connectionNP: 3 indexesSP: 6 indexes
Type ofConnection totheSuperstructure	Internal connectionAnti-rotation: 12 indexesFree-rotation: no indexes	Internal connectionAnti-rotation: 3 indexesFree-rotation: no indexes	NA - the crown is cementeddirectly onto the abutment post.
Compatibleimplantplatforms	MIS CONNECT Ø4 abutment:NP, SP, WPMIS CONNECT Ø5.7abutment: SP, WP	NP, SP, WP	NP, SP, WP
GingivalHeight	NP: 2, 3 mmSP: 1.5, 2, 3, 4 mmWP: 1.5, 2, 3, 4 mm	NP: 2, 3 mmSP: 1.5, 2, 3, 4 mmWP: 1.5, 2, 3, 4 mm	0.5, 1, 1.5, 2, 3 mm
Post height	NA – the MIS CONNECT doesnot have a post for prostheticreconstruction, but is configuredto be mounted with asuperstructure having a post.	NA – the MIS CONNECT doesnot have a post for prostheticreconstruction, but is configuredto be mounted with asuperstructure having a post.	8 mm
Diameter	NP: 4 mmSP/WP: 4 mm, 5.7 mm	NP/SP/WP: 4 mm	NP: 4.0, 4.25, 4.8 mmSP: 4.25, 4.8, 5.8 mm
SterilizationMethod	Radiation	Radiation	Product provided non sterile andend-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 CapsProposed device	MIS CONNECT HealingCapsK173326Primary Predicate Device	MIS V3 Healing CapsK163349Reference Device
PictorialRepresentation	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.
SurfaceTreatment	Anodized after machining	Anodized after machining	Polished and anodized aftermachining
Connectioninterface	Compatible with MISCONNECT abutment	Compatible with MISCONNECT abutment	Compatible with MIS ConicalConnection implants
Type ofConnection tothe MISCONNECTabutment	Internal connectionWithout indexes	Internal connectionWithout indexes	NA - connects directly to theimplant in an internal connectionwithout indexes
GingivalHeight	Ø4: 0.5, 1.5, 3 mmØ5.7: 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 intendedto serve as a basis for prostheticreconstruction	NA - the device is not intendedto serve as a basis for prostheticreconstruction	NA - the device is not intended toserve as a basis for prostheticreconstruction
Diameter	4mm, 5.7 mm	4 mm	3.3-5.8 mm
SterilizationMethod	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 TemporaryabutmentsProposed Device	MIS CONNECT TemporaryabutmentsK173326Primary Predicate Device	MIS V3 Temporary abutmentsK163349Reference Device
PictorialRepresentation	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:Ti 6Al 4V ELI per ASTM F136	Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Prosthetic screw:Ti 6Al 4V ELI per ASTM F136
Connectioninterface	Compatible with MISCONNECT abutment	Compatible with MISCONNECT abutment	Compatible with MIS ConicalConnection implants
Type ofConnection tothe MISCONNECTabutment	Anti-rotation: regular hexagonFree-rotation: no hexagon	Anti-rotation: irregular hexagonFree-rotation: no hexagon	NA - Connects directly to theimplant
GingivalHeight	N/A - connects to the MISCONNECT abutment	N/A – connects to the MISCONNECT 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 andend-user sterilized.	Product provided non-sterile andend-user sterilized.	Product provided non-sterile andend-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 EstheticAbutmentsProposed device	MIS CONNECT CementingCap AbutmentsK173326Primary Predicate Device	MIS V3 Cement RetainedAbutmentsK163349Reference Device
PictorialRepresentation	Image: MIS CONNECT Final Esthetic Abutments	Image: MIS CONNECT Cementing Cap Abutments	Image: MIS V3 Cement Retained Abutments
Material(s)	Abutment:Ti-6Al-4V ELI per ASTM F136Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Abutment:Ti-6Al-4V ELI per ASTM F136Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Abutment:Ti-6Al-4V ELI per ASTM F136Prosthetic screw:Ti 6Al 4V ELI per ASTM F136
Connectioninterface	Compatible with MISCONNECT abutment	Compatible with MISCONNECT abutment	Compatible with MIS ConicalConnection implants
Type ofConnection tothe MISCONNECTabutment	Anti-rotation: regular hexagonFree-rotation: no hexagon	Anti-rotation: irregular hexagonFree-rotation: no hexagon	NA - Connects directly to theimplant
GingivalHeight	N/A - connects to the MISCONNECT abutment	N/A – connects to the MISCONNECT 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 mmSP: 4.25, 4.8, 5.8 mm
Sterilization	Product provided non-sterile andend-user sterilized.	Product provided non-sterile andend-user sterilized.	Product provided non-sterile andend-user sterilized.

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

Element	MIS CONNECT FinalAbutmentsProposed Device	MIS CONNECT CementingCap AbutmentsK173326Primary Predicate Device	MIS V3 Cement RetainedAbutmentsK163349Reference Device
PictorialRepresentation	Image: MIS CONNECT Final Abutments	Image: MIS CONNECT Cementing Cap Abutments	Image: MIS V3 Cement Retained Abutments
Material(s)	Abutment:Ti-6Al-4V ELI per ASTM F136	Abutment:Ti-6Al-4V ELI per ASTM F136	Abutment:Ti-6Al-4V ELI per ASTM F136
	Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Prosthetic screw:Ti 6Al 4V ELI per ASTM F136
Connectioninterface	Compatible with MISCONNECT abutment	Compatible with MISCONNECT abutment	Compatible with MIS ConicalConnection implants
Type ofConnection totheCONNECTabutment	Anti-rotation: regular hexagonFree-rotation: no hexagon	Anti-rotation: irregular hexagonFree-rotation: no hexagon	NA - Connects directly to theimplant
GingivalHeight	N/A - connects to the MISCONNECT abutment	N/A - connects to the MISCONNECT abutment	0.5, 1, 1.5 ,2 ,3 mm
Post Height	For Ø4: 8 mmFor Ø5.7: 4 mm	6 mm	5.95 mm
Diameter	4mm, 5.7mm	4 mm	NP: 4.0, 4.25, 4.8 mmSP: 4.25, 4.8, 5.8 mm
Sterilization	Product provided non-sterile andend-user sterilized.	Product provided non-sterile andend-user sterilized.	Product provided non-sterile andend-user sterilized.

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Table 6.2e: Comparison of the proposed device to the reference device (Angulated Abutment Superstructure)

Element	MIS CONNECTØ4 Angulated Abutments	MIS C1 Conical Connection Cement RetainedAbutmentK172505
	Proposed Device	Reference Device
Pictorial Representation	Image: MIS CONNECT Ø4 Angulated Abutment	Image: MIS C1 Conical Connection Cement Retained Abutment
Material(s)	Abutment:	Abutment:
	Ti-6Al-4V ELI per ASTM F136	Ti-6Al-4V ELI per ASTM F136

	Prosthetic screw:	Prosthetic screw:
	Ti 6Al 4V ELI per ASTM F136	Ti 6Al 4V ELI per ASTM F136
Surface Treatment	Polished and anodized after machining	Polished and anodized after machining
Connection interface	Connects to an MIS CONNECT abutment	Connects directly to the implant
Type of Connection tothe MIS CONNECTabutment	Anti-rotation: regular hexagonNo free-rotation is available	NA - connects directly to the implant
Platform	Connects to MIS CONNECT Ø4 abutment	Connects directly to NP conical connection implants
Gingival Height	N/A - connects to MIS CONNECT abutment	0.5, 1, 1.5, 2, 3 mm
Post Height	6 mm / 7 mm(Dependent on gingival collar thickness)	6 mm / 7 mm(Dependent on gingival collar thickness)
Diameter	4 mm	NP: 4.0, 4.2, 4.25, 4.8 mm
Abutment angulation	20°	NP: 0°, 10°, 20°
Sterilization Method	Product provided non sterile	Product provided non sterile

The proposed MIS CONNECT Conical Connection Superstructures are substantially equivalent to the predicate device with respect to indications for use, principles of operation, and materials of construction.

The proposed and predicate devices have identical indications for use, are made of titanium alloy, and are intended for prosthetic restoration of maxillary and mandible.

While the Abutment Superstructures in the predicate device are only compatible with 4 mm diameter abutments (platform diameter), the proposed Abutment Superstructures are compatible with either 4 mm or 5.7 mm diameter abutments. The reference device (K163349) is included in support of substantital equivalence as it includes abutment superstructures with maximum 5.8 mm platform diameter.

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While the predicate abutment superstructures connected to the MIS CONNECT Conical Connection Abutment via 3 indexes of anti-rotation, the proposed abutment superstructures connect to the MIS CONNECT Conical Connection Abutment via 12 indexes of anti-rotation in order to enhance rotational precision. The increased number of rotational indexes does not impact substantial equivalence as the modification does not affect abutment wall thickness and therefore does not present a new worst case with respect to connection geometry.

The proposed angulated abutment supersructures are offered with a 20° angulation. Reference device K172505 is included in support of substantial equivalence as it is offered in angulations up to 20°.

7.0 Non-Clinical Performance Data

Non-clinical testing data submitted, referenced. or relied upon to demonstrate substantial equivalence includes:

. Fatigue testing: Dynamic fatigue testing of worst case representative samples of the proposed MIS CONNECT Conical Connection Abutments (line extension to the predicate) and superstructures was performed in accordance to ISO 14801:2016 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. The results of the fatgue testing support substantial equivalence.
Biocompatibility: The proposed devices are composed of the identical materials and are ● manufactured in the identical manufacturing facility and under the identical manufacturing processes as the primary predicate device (K173326). In addition, the intended conditions of use and patient contact type and duration of contact (as per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) for the proposed devices are identical to that of the primary predicate device (K173326). Therefore, no new biocompatibility data are included in support of substantial equivalence.
Sterilization: Sterilization validation of sterile devices was conducted for worst-case construct . according to ISO 11137-2:2013, Sterilization of health care products- Radiation- Part 2: Establishing the sterilization dose. The results of the sterilization support a conclusion that a sterility assurance level (SAL) of 10% is achieved under the sterilization parameters utilized.

Sterilization validation of non-sterile devices was conducted for worst-case construct according to ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products - Moist Heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The results of the sterilization support a conclusion that a sterility assurance level (SAL) of 106 is achieved under the sterilization parameters utilized by the enduser.

Packaging and packaging materials are the identical for the predicate and proposed devices. Thus, ● shelf life data are referenced by equivalence to support substantial equivalence.

8.0 Clinical Performance Data

No human clinical data were included in this premarket notification to support the substantial equivalence of the proposed line extension to predicate MIS CONNECT Connection Abutments.

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9.0 Conclusion Regarding Substantial Equivalence
The proposed line extension to predicate MIS CONNECT Conical Connection Abutments are endosseus abutments and abutment superstructures which are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible. The proposed devices incorporate the identical fundamental technology and intended use as the predicate MIS CONNECT Conical Connection Abutments and Superstructures device (K173326) and are proposed for identical indications for use. The identical materials of construction (Titanium alloy) and manufacturing processes are used to manufacture the proposed and predicate devices. Fatigue testing of the proposed device is included and the results support substantial equivalence.

The proposed angulated abutment superstructures are similar in design to the reference device MIS C1 Conical Connection Cement Retained Abutment (K172505). The proposed MIS CONNECT angulated abutment's angulation and diameter is within range of design offerings of the reference device (K172505).

The increased abutment diameter to 5.7 mm for the propsoed abutment superstructures is within range of the reference device MIS Cement Retained Abutments and Superstructures (K163349).

The comparison of the indications for use, technological characteristics, with the inclusion of the results of nonclinical testing, support a conclusion of substantial equivalence of the proposed MIS CONNECT Conical Connection Abutments and Superstructures to the predicate devices.

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.)