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 MIS CONNECT Conical Connection abutment is an endosseous dental implant abutment device which is intended for use by a dental clinician with a root-form endosseous dental implant to aid in prosthetic rehabilitation, by incorporation in the upper or lower jaw for supporting tooth replacements to restore chewing function. The MIS CONNECT Conical Connection abutment is intended to be used with MIS Conical Connection Implants, such as MIS V3 Conical Connection Dental Implant System and Connection Implants cleared under K112162 and K163349, respectively, and is intended to be placed above the bone level and within the gingival tissue. The MIS CONNECT Conical Connection abutment can be fitted with a variety of complementary accessories, including Healing caps, Cementing caps and Temporary abutments (which are proposed for clearance in the present submission), and also including Prosthetic screws, Impression copings, Analogs, and Scan posts (which are class I products and are therefore exempt from clearance requirements). The MIS CONNECT Conical Connection abutment is not intended to be removed.

AI/ML Overview

The provided text describes the 510(k) summary for the MIS CONNECT Conical Connection Abutment. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) is generally not present in such a document.

However, based on the provided text, I can extract and infer some information regarding acceptance criteria and performance studies, specifically non-clinical ones.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance (MIS CONNECT Conical Connection Abutment)
Fatigue Testing (per ISO 14801:2007)	Withstood 5,000,000 cycles without failure at a substantially equivalent load to the cited reference device.
Screw Loosening Testing (per Tsuge et al, 2009)	Demonstrated a higher release torque post loading than its initial tightening torque before loading, indicating no screw-loosening hazard during lateral dynamic loading.
Biocompatibility (comparison to predicate K163349)	Not required; device manufactured using identical methods, facility, raw material, sterilization, packaging, and has the same intended use, patient contact duration, and type as the predicate.
Sterilization Validation (Gamma Irradiation for abutments, healing caps) (per ANSI/AAMI/ISO 11137-1 & -2)	Achieved a Sterility Assurance Level (SAL) of 10-6. All testing requirements were met.
Sterilization Validation (Steam for cementing caps, temporary abutments) (per ANSI/AAMI/ISO 17665-1:2006 & -2:2009)	Validated for two methods: gravity displacement steam sterilization and pre-vacuum steam sterilization.
Disinfection Validation (for user-steam-sterilized abutments) (per ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011, AAMI TIR 12:2010)	Demonstrated a reduction of at least 10^3 of the microbiological challenge. This appears to be a typo in the original document, often 10^6 reduction is required but 10^3 is stated. Assuming the intent was a significant reduction. (Clarification: The PDF excerpt says "10º", which is likely a rendering error for "10^3" or similar, representing a log reduction.)
Shelf Life Testing (for sterile products) (per ISO 11607-1)	Test results were successful and supported a 5-year shelf life for sterilized products.

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

Test Set Sample Size: The document does not specify the exact number of units used for each non-clinical test (e.g., how many abutments were subjected to fatigue testing). It refers to "test articles."
Data Provenance: The studies are non-clinical, laboratory-based mechanical and sterilization tests, performed by MIS Implants Technologies Ltd. (Israel) and an "independent testing laboratory" for shelf life. No geographical or temporal patient data (retrospective/prospective) is involved, as these are not clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The studies described are non-clinical (mechanical, sterilization, biocompatibility rationale), not requiring expert consensus on clinical findings or "ground truth" as might be established for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for radiology or pathology assessments, to establish a definitive diagnosis based on multiple reader opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These types of studies are relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. The submission describes non-clinical testing for a dental implant abutment and its superstructures.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This concept applies to AI/software as a medical device (SaMD). The device in question is a physical dental implant component, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the context of this 510(k) submission for a physical medical device. "Ground truth" (e.g., pathology, outcomes data) is typically established in clinical studies or for diagnostic devices. For this device, "ground truth" in the context of the studies means adherence to established engineering standards (e.g., ISO 14801:2007 for fatigue, specific ISO and AAMI standards for sterilization).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The device is a manufactured medical component.

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

This information is not applicable as there is no training set or AI component.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2018

MIS Implants Technologies LTD. % Randy Prebula Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004

Re: K173326

Trade/Device Name: MIS CONNECT Conical Connection Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 12, 2018 Received: February 12, 2018

Dear Randy Prebula:

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.

{1}------------------------------------------------

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.

Andrew I. Steen -S

for 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173326

Device Name

MIS CONNECT Conical Connection Abutment

Indications for Use (Describe)

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)
-------------------------------------------------	--

× | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY K173326

1. Submitter

MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park 2015600 ISRAEL Telephone: +972-4-9016800 Fax: +972-4-9918623

Contact: Dr. Noa Ofer +972-4-9016829 noa@mis-implants.com

Date Prepared: March 15, 2018

2. Device Identification

	Trade/Proprietary Name:	MIS CONNECT Conical Connection abutment
Common/Usual Name:	Dental Implant Abutment
Classification Name:	Endosseous dental implant abutment
Regulation Number:	21 CFR 872.3630;
Product Code:	NHA
Device Class:	Class II
Classification Panel:	Dental Devices Panel

3. Predicate Device(s)

Primary predicate device: MIS V3 Conical Connection Dental Implant System- (K163349). Reference devices: Conical Connection Implants (K112162)

4. Device Description

Components:

The MIS CONNECT Conical Connection abutment is to be used in combination with a variety of compatible superstructures (healing caps, cementing caps, and temporary abutments). The superstructures, described below, are manufactured with an external connection, ensuring compatibility to the internal connection of the MIS CONNECT Conical Connection abutment.

{4}------------------------------------------------

Healing caps are premanufactured prosthetic components directly connected to the MIS CONNECT Conical Connection abutments and are indicated as temporary components to allow healing of the soft tissue. They are made from Ti-6Al-4V ELI, and supplied sterile to the user, for single use.
-Cementing Caps are premanufactured dental implant abutments directly connected to the MIS CONNECT Conical Connection abutments by a prosthetic screw. Cementing caps are available in anti-rotation and free-rotation and are made from Ti6Al-4V ELI, supplied non sterile, and intended for single use.
-Temporary abutments are premanufactured dental implant abutments directly connected to the MIS CONNECT Conical Connection abutments, intended for use as an aid in temporary prosthetic rehabilitation, for a maximum of 180 days. They are made from Ti-6Al-4V ELI, and are available in anti-rotation and free-rotation configurations. The abutments are supplied nonsterile and intended for single use.

5. 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 (Ø3.3mm) 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.

6. Substantial Equivalence Discussion

Abutments:

The predicate device for the proposed MIS CONNECT Conical Connection abutment is MIS Conical Connection Multi-unit abutment (cleared under K163349). Both devices have similar intended use and the same indications. (Note that Indications for Use of the primary predicate and reference devices are referring to implant bodies and abutments, while the submission only includes abutments. However, as the subject abutments are to be used with implant bodies, it is important to include the implant body indications in the subject device Indications for Use.) They are made of the same material, Ti 6Al-4V ELI, go through a similar manufacturing process, get the same color anodizing surface treatment, and are provided sterilized by gamma irradiation. Both the proposed and the predicate devices are connected directly to the implant using a conical connection without indexes, and by means of an integral external thread. In addition, both the proposed and the predicate devices are intended to be connected with a superstructure for mechanically supporting a restoration.

Differences between the connection of the proposed and predicate device to the superstructure do not raise different types of safety or effectiveness questions and are addressed by fatigue testing per ISO 14801:2007. As the proposed device's intended use is for single unit restorations, as opposed to multiple restorations for the predicate device. Testing was conducted on the reference device MIS Conical Connection CPK abutment (cleared under Conical Connection Implants K116162), which is also intended for single unit restorations and subjected to similar loads. The results of the testing demonstrated equivalence.

{5}------------------------------------------------

Trade Name	MIS CONNECT Conical Connectionabutment	MIS V3 Conical Connection DentalImplant System (K163349)	Conical ConnectionImplants(K112162)
	Proposed device	Predicate device	Reference device
510(k) Number	Subject	K163349	K112162
Manufacturer	MIS Implants Technologies Ltd.	MIS Implants Technologies Ltd.	MIS Implants Technologies Ltd.
Device Class	Class II	Class II	Class II
Product Code(s)	NHA	NHA, DZE	NHA, DZE
Regulation Description	Endosseous dental implant	Endosseous dental implant	Endosseous dental implant
Regulation Number	abutment872.3630	abutment872.3630	abutment872.3630
Intended use:	Dental implant abutments areintended to be used in the upper orlower jaw for supporting toothreplacements to restore chewingfunction.The MIS CONNECT abutments in	Dental implant abutments areintended to be used in the upper orlower jaw for supporting toothreplacements to restore chewingfunction.The Multi-Unit abutments in	Dental implant abutments areintended to be used in the upper orlower jaw used for supporting toothreplacements to restore chewingfunction.The abutments in combination with
	combination with endosseousimplants are indicated for single ormultiple unit reconstructions whenscrew retained prosthetics arepreferred.	combination with endosseousimplants are indicated for multipleunit reconstructions when screwretained prosthetics are preferred.	two-stage endosseous implants areintended to be used as afoundation for anchoring toothreplacements in either jaw.Restorations range from replacingone single tooth to fixed partialdentures using cement-retainedsupra-constructions.
Indications for use:	MIS Dental Implant Systems areintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, 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 ( $[03.3]$ mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibularcentral, lateral incisor and maxillarylateral incisor regions of partiallyedentulous jaws, to providesupport for prosthetic devices suchas artificial teeth, in order torestore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another.	MIS Dental Implant Systems areintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, 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 ( $[03.3]$ mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibularcentral, lateral incisor and maxillarylateral incisor regions of partiallyedentulous jaws, to providesupport for prosthetic devices suchas artificial teeth, in order torestore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another.	MIS Dental Implant Systems areintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, 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 ( $[03.3]$ mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibularcentral, lateral incisor and maxillarylateral incisor regions of partiallyedentulous jaws, to providesupport for prosthetic devices suchas artificial teeth, in order torestore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another.
Material(s)	Titanium 6Al-4V ELI per ASTM F136	Titanium 6Al-4V ELI per ASTM F136	Titanium 6Al-4V ELI per ASTM F136
Surface Treatment	Anodized after machined	Polished and anodized aftermachined	Polished and anodized aftermachined
Type of Connection tothe Implant	Conical connectionwithout indexes	Conical connectionwithout indexes	Conical Connectionwith indexes
Type of Connection to	Internal connection	External free-rotation	N/A – the reference device is an
the Superstructure	Anti-rotation: 3 indexesFree-rotation: no indexes		abutment being directly connectedto the implant.
Gingival Height	NP: 2, 3 mmSP: 1.5, 2, 3, 4 mmWP: 1.5, 2, 3, 4 mm	1,2,3,4,5 mm	1,2,3,4 mm
Diameter	NP/SP/WP: 4 mm	NP/SP: 4.8 mm	NP: 4mmSP:4.8 and 5.5 mm
Trade Name	MIS CONNECT Conical ConnectionabutmentProposed device	MIS V3 Conical Connection DentalImplant System (K163349)Predicate device	Conical ConnectionImplants(K112162)Reference device
Sterilization Method	Gamma radiation	Gamma radiation	Non-sterile

{6}------------------------------------------------

Superstructures:

Healing caps, Cementing Caps, and Temporary abutments were compared to equivalent MIS V3 Conical Connection Dental Implant System superstructures cleared under K163349 which share the same indications, are made of the same materials, are manufactured in the same manufacturing conditions and undergo equivalent surface treatments. (Note that Indications for Use of the primary predicate and reference devices are referring to implant bodies and abutments, while the subject submission only includes abutments. However, as the subject abutments are to be used with implant bodies, it is important to include the implant body indications in the subject device Indications for Use.)

No new angulations were introduced. Both the Cementing Caps and the Temporary abutments are provided straight and may not be further manufactured to have an angle; however, any of them may be used with a CONNECT abutment on two implants which diverge up to 40°, but no more than 20° per implant. Single unit loading may include angulation up to 20º. Although the predicate cement retained and temporary abutments are indicated for a divergence of 30%, the difference in divergence is accounted for in the fatigue testing.

The differences between subject and predicate devices did not alter the intended use and new issues of safety and effectiveness were not raised.

Trade Name	MIS CONNECT Superstructures	MIS V3 Conical Connection Dental Implant System(K163349)
	Proposed device	Predicate device
510(k) Number	Subject	K163349
Manufacturer	MIS Implants Technologies Ltd.	MIS Implants Technologies Ltd.
Device Class	Class II	Class II
Product Code(s)	NHA	NHA, DZE
Regulation Description	Endosseous dental implant abutment	Endosseous dental implant abutment
Regulation Number	872.3630	872.3630
Intended use:	Dental implant abutments are intended to be usedin the upper or lower jaw used for supporting toothreplacements to restore chewing function.The abutments in combination with two-stageendosseous implants are intended to be used as afoundation for anchoring tooth replacements ineither jaw. Restorations range from replacing onesingle tooth to fixed partial dentures using cement-retained supra-constructions.	Dental implant abutments are intended to be usedin the upper or lower jaw used for supporting toothreplacements to restore chewing function.The abutments in combination with two-stageendosseous implants are intended to be used as afoundation for anchoring tooth replacements ineither jaw. Restorations range from replacing onesingle tooth to fixed partial dentures using cement-retained supra-constructions.
Indications for use:	MIS Dental Implant Systems are intended to besurgically placed in the bone of the upper or lowerjaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restoremasticatory function.When a one-stage surgical procedure is applied, theimplant may be immediately loaded when goodprimary stability is achieved and the occlusal load isappropriate.Narrow implants (Ø3.3mm) are indicated for use insurgical and restorative applications for placementonly in the mandibular central, lateral incisor andmaxillary lateral incisor regions of partiallyedentulous jaws, to provide support for prostheticdevices such as artificial teeth, in order to restorethe patient chewing function. Mandibular central	MIS Conical Connection Dental Implant System isintended to be surgically placed in the bone of theupper or lower jaw arches to provide support forprosthetic devices, such as artificial teeth, in orderto restore masticatory function. When a one-stagesurgical procedure is applied, the implant may beimmediately loaded when good primary stability isachieved and the occlusal load is appropriate.Narrow implants (Ø3.3mm) are indicated for use insurgical and restorative applications for placementonly in the mandibular central, lateral incisor andmaxillary lateral incisor regions of partiallyedentulous jaws, to provide support for prostheticdevices such as artificial teeth, in order to restorethe patient chewing function. Mandibular centraland lateral incisors must be splinted if using two or

{7}------------------------------------------------

Trade Name	MIS CONNECT Superstructures	MIS V3 Conical Connection Dental Implant System(K163349)Predicate device
	Proposed device
	and lateral incisors must be splinted if using two ormore narrow implants adjacent to one another.	more narrow implants adjacent to one another.
Material(s)	Titanium 6Al-4V ELI per ASTM F136	Titanium 6Al-4V ELI per ASTM F136
Connection Interface	Connects to MIS CONNECT abutment mounted onan MIS Conical Connection Dental Implant	Connects directly to an MIS Conical ConnectionDental Implant

7. Non-Clinical Performance Data

As part of demonstrating the substantial equivalence of the MIS CONNECT Conical Connection abutment and its compatible superstructures to the predicate and reference devices, MIS Implants Technologies completed a number of non-clinical performance tests:

. Fatigue Testing - Mechanical testing of MIS CONNECT Conical Connection abutment in accordance to ISO 14801:2007 was conducted. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited reference device.
. Screw loosening testing - Mechanical testing of MIS CONNECT Conical Connection abutment under eccentric loading in a screw loosening direction, in accordance to Tsuge et al (2009). The test articles were able to demonstrate a higher release torque post loading than its initial tightening torque before loading, indicating there is no screw-loosening hazard for the proposed device during lateral dynamic loading.
. Biocompatibility - The subject device is manufactured using identical manufacturing methods, in the same manufacturing facility, and using the same raw material as the previously cleared predicate, K163349. The subject device is sterilized and packaged using identical materials and processing as the predicate. Finally the subject device has the same intended use, patient contact duration and type as the predicate. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
Sterilization Testing -
- For products supplied sterilized by gamma irradiation (CONNECT abutments, healing o caps): Sterilization validation tests were conducted on each group of products in compliance with ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
- For products supplied non-sterile and intended to be steam sterilized by the user o (cementing caps, temporary abutments): The steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization.
Disinfection Validation: for Abutments supplied non-sterile and intended to be steam sterilized by the user, the disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-

{8}------------------------------------------------

1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 10° of the microbiological challenge.

Shelf Life Testing – for the products which are supplied sterile, shelf life studies were completed by an independent testing laboratory in order to validate the integrity of the final package. The studies were conducted in accordance with ISO 11607-1. Test results were successful and supported a 5 year shelf life of the sterilized products.

8. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device and the reference device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

9. Summary

The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics and materials were similar, and that the differences did not raise new safety and effectiveness issues. Furthermore, performance testing showed that the predicate device is substantially equivalent to the reference device.

10. Conclusions

The MIS CONNECT Conical Connection abutment and superstructures have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the primary predicate device.

The subject devices are therefore substantially equivalent to the primary predicate device and any differences were addressed through performance testing.

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.)