MIS V3 Conical Connection Dental Implant System is 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 V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants. The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone. The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm; 3. 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants surface is sand blasted and acid etched. The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation. For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows: "Narrow Platform" (NP) – 3.3mm diameter: blue; "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple. The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch). Components: The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental implant system (MIS V3 Conical Connection Dental Implant System) and focuses on demonstrating substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria based on a clinical study of its performance. The document primarily details mechanical and material equivalency, as well as biocompatibility and sterilization, as opposed to performance metrics that would typically arise from an AI/ML-based medical device.

Therefore, many of the requested items (acceptance criteria table, sample size for test set, expert involvement, adjudication, MRMC study, standalone performance, ground truth types, training set details) are not applicable to this document as it pertains to a physical dental implant, not an AI/ML device requiring such performance studies.

However, I can extract and present the acceptance criteria for mechanical performance and the study that proves the device meets those from the document, as it is a physical device and not an AI/ML algorithm.

Here's the information that can be extracted relevant to the device's mechanical and material acceptance:

Acceptance Criteria and Device Performance for MIS V3 Conical Connection Dental Implant System

The "acceptance criteria" for this dental implant system are implicitly defined by proving its substantial equivalence to legally marketed predicate devices, particularly regarding mechanical performance and material properties. The primary study proving this is Fatigue Testing per ISO 14801:2007, which is a standard for dental implants.

1. Table of Acceptance Criteria (Implicit from Predicate Equivalence) and Reported Device Performance:

Acceptance Criteria (Inferred from Equivalence to Predicates)	Reported Device Performance (MIS V3 System)
Material: Biocompatible and equivalent to predicates.	Manufactured from Ti-6Al-4V ELI (ASTM F136-13), same as pre-cleared predicate (K112162). Higher tensile strength compared to some predicates using CP Titanium.
Fatigue Strength: Withstand mechanical loads for long-term use (aligned with ISO 14801:2007).	Withstood 5,000,000 cycles without failure at a substantially equivalent load to cited predicates per ISO 14801:2007. This was tested for both narrow and standard platform implants and abutments.
Sterilization: Achieve a sterility assurance level (SAL) of 10^-6.	Achieved SAL of 10^-6 per ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12. Steam sterilization validated per ISO 17665-1:2006.
Shelf Life: Maintain integrity and sterility after aging.	Successful results from real-time aged implants (at least five years) with no growth determined for sterility.
Risk Profile: Risks are acceptable and as low as reasonably possible.	Risk analysis conducted per ISO 14971; all risks determined acceptable.

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

Test Set (for Fatigue Testing): The specific number of implants/abutments used in the fatigue test is not explicitly stated as a "sample size" in the document, but it's implied that sufficient samples were tested to demonstrate compliance with ISO 14801:2007.
Data Provenance: The tests were conducted internally by MIS Implants Technologies Ltd. and by an "independent testing laboratory" for shelf-life testing. The country of origin for the data is not explicitly stated beyond Israel (MIS Implants Technologies Ltd. is based in Israel) for the company and general international standards for the testing. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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

N/A. This information is relevant for studies involving human interpretation or clinical outcomes for AI/ML devices. For a physical device demonstrating mechanical and material properties, "ground truth" is established by adherence to recognized international standards (e.g., ISO for mechanical testing, AAMI/ISO for sterilization), and expert judgment is inherent in the development and validation of these standards, not typically in individual "readers" of test results.

4. Adjudication Method for the Test Set:

N/A. Adjudication methods (like 2+1, 3+1) are primarily used in clinical studies or expert review processes for AI/ML performance evaluation. For mechanical and sterilization testing, the "adjudication" is the pass/fail result based on the quantitative measurements against the standard's criteria.

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

No. An MRMC study is specific to evaluating the clinical effectiveness of a diagnostic tool (often imagery-based) with and without AI assistance, involving multiple human readers. This document is for a physical dental implant.

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

No. This question applies to AI/ML algorithms. The performance assessment here is for the physical device itself (mechanical, material properties).

7. The Type of Ground Truth Used:

For mechanical and physical properties (fatigue, material composition, sterility, shelf-life), the "ground truth" is adherence to established international standards and engineering specifications (e.g., ISO 14801:2007, ASTM F136-13, ANSI/AAMI/ISO 11137-1:06, EN ISO 11137-2:12, ISO 17665-1:2006, ISO 14971). Pathological or outcomes data (clinical ground truth) was not required for this 510(k) as per section 9.

8. The Sample Size for the Training Set:

N/A. This term is relevant for AI/ML models. This is a physical device.

9. How the Ground Truth for the Training Set was Established:

N/A. This term is relevant for AI/ML models.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

MIS Implants Technologies Ltd. Arbel Shezaf RA Coordinator P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, 2015600 ISRAEL

Re: K163349

Trade/Device Name: MIS V3 Conical Connection Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 18, 2017 Received: May 18, 2017

Dear Arbel Shezaf:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S6

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163349

Device Name

MIS V3 Conical Connection Dental Implant System

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "I" having a vertical line extending above the other letters. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font size.

K163349 510(k) Summary

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: Arbel Shezaf +972-4-9016802 arbel@mis-implants.com

Date Prepared: May 23, 2017

2. US Agent: Motti Weisman - VP Marketing

MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: (201) 797-9144 Fax: (201) 797-9145

3. Device Identification

Trade/Proprietary Name:	MIS V3 Conical Connection Dental Implant System
Common/Usual Name:	Dental Implant
Classification Name:	Endosseous dental implant
Regulation Number:	872.3640;
Product Code:	DZE, NHA
Device Class:	Class II
Classification Panel:	Dental Devices Panel

4. Predicate Device(s)

Primary predicate device:

ASTRA TECH OsseoSpeed TX S from Astra Tech AB cleared under 510(k) K101732
Reference devices:
MIS Conical Connection Implants from MIS Implants Technologies cleared under 510(k) K112162.
. ANKYLOS C/X Dental Implant System from Dentsply International cleared under 510(k) K140347.
NobelActive Internal Connection Implants from Nobel BioCare cleared under 510(k) K071370.
. UTA and UHA cleared under 510(k) K102467.

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Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" slightly offset to the right. To the right of the letters, there is a vertical line, followed by the text "Implants Technologies Ltd." in a smaller font size.

Multi-Unit Abutments for AstraTech, Camlog and Ankylos Implant Systems from Nobel BioCare cleared under 510(k) K061477.

5. Device Description

The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone.

The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths:

3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm
1. 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
. 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

The implants surface is sand blasted and acid etched.

The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.

For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows:

"Narrow Platform" (NP) – 3.3mm diameter: blue
"Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple

The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch).

Components:

The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.

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Image /page/5/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "mis" in blue, with the "i" having a dot above it. To the right of the letters is a vertical line, followed by the words "Implants Technologies Ltd." in a smaller font.

Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of Ti-6Al-4V ELI, and supplied sterile to the user, for single use.

Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Later on, the crown is cemented to the abutment. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate specific needs according to the patient. The angulated abutments allow a maximum angulation of 25º. The straight abutments are intended for 0º angulation and straight implantation only. They are made of Ti6Al-4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.

CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments are intended for 0° angulation and straight implantation only. They are cement retained, meaning the crown is cemented to the abutment. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of T-6AI-4V ELI, while their additional components are made of POM. They are supplied non sterilized by the user according to the labeling, and intended for single use.

Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is dissolved once the casting is done. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are intended for 0º angulation and straight implantation only. The abutments are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.

Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the multiunit abutment or connection to a fixed overdenture bar. Multi-units are available both straight and angulated, with a maximum of 30º angulation. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of Ti-6Al-4V ELI. The overdenture is connected to the multi-unit by a screw. All multi units are made of Ti-6Al-4V ELI. They are supplied sterile and intended for single use.

OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are used in completely edentulous jaws for anchoring an overdenture to allow its insertion and removal. OT-Equators and Ball attachments

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Image /page/6/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with the "I" having a dot above it. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font. The logo is simple and modern, with a clean design.

allow a maximum of 15º angulation. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Both are made from Ti6Al-4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.

Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation, for a maximum of 180 days. They are available in Ti-6Al-4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from Ti-6Al-4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration. Free rotation temporary abutments allow a maximum of 15º angulation. Anti-rotation temporary abutments are intended for 0º angulation and straight implantation only. Directions and limitations for modifications are given in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.

For a quick and simple identification of the diameters and in order to ensure the use of the proper abutment with the right implant, the components are colored by anodizing as follows:

"Narrow Platform"(NP) – 3.3mm diameter, blue
. "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple

6. Indications for Use

MIS V3 Conical Connection dental implant system is 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.

7. Substantial Equivalence Discussion

The Indications for Use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are intended to be surgically placed in the bone of the upper or lower jaw arches for anchoring or supporting tooth replacement to restore chewing function, in partially or fully edentulous patients.

The main difference is in the subject device's indication for narrow platform implants, regarding the need for splinting mandibular central and lateral incisors when using two or more narrow implants

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Image /page/7/Picture/0 description: The image contains the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, blue font. To the right of the letters, there is a vertical line separating the logo from the company's name, "Implants Technologies Ltd.", which is written in a smaller, sans-serif font.

adjacent to one another. We believe this indication only improves the safety of the narrow implants as compared to the predicate device and does not alter the intended use.

The subject and predicate devices have the same intended use and similar indications for use. Their geometrical design is similar with minor differences which do not raise different safety or efficacy questions. The following tables compare the MIS V3 Conical Connection Dental Implant System to the predicate devices with respect to indications for use, principles of operation, technological characteristics and materials.

Under each table is a discussion of the differences and similarities.

Table 1 – Comparison of Endosseous Implant Characteristics – Narrow Platform

Trade Name	MIS V3 Conical Connection DentalImplant System, Narrow Platform	ASTRA TECH OsseoSpeed TX S
510(k) Number	Subject	K101732
Manufacturer	MIS Implants Technologies Ltd.	Astra Tech AB
Device Class	Class II	Class II
Product Code(s)	DZE	DZE
RegulationDescription	Endosseous dental implant	Endosseous dental implant
Regulation Number	872.3640	872.3640
Intended use:	Intended to be surgically placed in thebone of the upper or lower jaw archesfor anchoring or supporting toothreplacement to restore chewingfunction.	Intended to be surgically placed in thebone of the upper or lower jaw archesfor anchoring or supporting toothreplacement to restore chewingfunction.
Indications for use:	MIS V3 Conical Connection DentalImplant System is intended to besurgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, such asartificial teeth, in order to restoremasticatory function.When a one-stage surgical procedure isapplied, the implant may beimmediately loaded when good primarystability is achieved and the occlusalload is appropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateral	The OsseoSpeed implants are intendedto be used:• to replace missing teeth in single ormultiple unit applications within themandible or maxilla• for immediate placement in extractionsites and partially or completely healedalveolarridge situations•for both one- and two-stage surgicalprocedures• especially well in soft boneapplications where implants with otherimplant surfacetreatments may be less effective• together with immediate loading

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Image /page/8/Picture/0 description: The image shows the logo for MIS Implants. The logo is in blue and consists of the letters "mis" in a stylized font. To the right of the letters is a vertical line, followed by the word "Impla" in a smaller, sans-serif font. The overall design is clean and modern.

	incisor and maxillary lateral incisorregions of partially edentulous jaws, toprovide support for prosthetic devicessuch as artificial teeth, in order torestore the patient chewing function.Mandibular central and lateral incisorsmust be splinted if using two or morenarrow implants adjacent to oneanother.	protocol in all indications, except insingle tooth situations in soft bone(type IV) where implant stability may bedifficult to obtain and immediateloading may not be appropriate• together with immediate loadingprotocol for single-tooth restorationson implants 8 mm or longer• with its 3.0 S product line for maxillarylateral incisors and mandibular lateraland central incisors.
Endosseous ImplantMaterial(s)	Titanium 6Al-4V ELI per ASTM F136	Titanium grade 4
Surface Treatment	Anodized ,sand blasted and acid etched	TiO2-blasted fluoride-modified surface.
Body design	Tapered design, threaded	Cylindrical, threaded
Connection Type	Conical, 3 indexes, cone angulation 12°	Internal, double hex conical connection,cone angulation 21°
Type of implant	Bone level implant	Bone level implant
Implant Diameters	Ø 3.3 mm	Ø 3.5 mm
Implant Lengths	10, 11.5, 13 and 16 mm	8, 9, 11, 13, 15 and 17 mm
Neck Design	Three-way cutaway longitude implantaxis at the cervical part of the implant	Cylindrical
Apex	Flat apex	Flat apex
Thread	Dual	Dual
Sterilization	Radiation	Radiation
Method

The length range of the subject 3.3 mm MIS V3 is 10 -16 mm. which is within the range of the predicate (8 – 17 mm).

Although the diameter of the subject device is 3.3 mm, it possesses at least equivalent strength as tested and compared to the predicate device of larger diameter (3.5 mm), likely due to the use of Ti alloy (ASTM F136) which has a higher tensile strength compared to the predicate which uses C.P. Ti grade 4. Despite the difference in the connections provide a locking mechanism for a tight fit. Similarly, although there are minor differences in threading, body design (tapered vs. cylindrical), neck design and surface treatment, these differences do not raise different safety or efficacy Fatigue testing per ISO 14801:2007 assessed the impact of these differences and questions. demonstrates at least equivalent performance.

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Image /page/9/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with the "I" having a dot above it. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font. The logo is in blue and the text is in gray.

Trade Name	MIS V3 Conical ConnectionDental Implant SystemStandard Platform Ø3.9and 4.3 mm	MIS Conical ConnectionImplants Ø3.75 and4.20mm	ASTRA TECH OsseoSpeedTX S
510(k) Number	Subject	K112162	K101732
Manufacturer	MIS Implants TechnologiesLtd.	MIS Implants TechnologiesLtd.	Astra Tech AB
Device Class	Class II	Class II	Class II
ProductCode(s)	DZE	DZE	DZE
RegulationDescription	Endosseous dental implant	Endosseous dental implant	Endosseous dental implant
RegulationNumber	872.3640	872.3640	872.3640
Intended use:	Intended to be surgicallyplaced in the bone of theupper or lower jaw archesfor anchoring or supportingtooth replacement torestore chewing function.	Intended to be surgicallyplaced in the bone of theupper or lower jaw archesfor anchoring or supportingtooth replacement torestore chewing function.	Intended to be surgicallyplaced in the bone of theupper or lower jaw archesfor anchoring or supportingtooth replacement torestore chewing function.
Indications foruse:	MIS V3 Conical ConnectionDental Implant System isintended to be surgicallyplaced in the bone of theupper or lower jaw archesto provide support forprosthetic devices, such asartificial teeth, in order torestore masticatoryfunction.When a one-stage surgicalprocedure is applied, theimplant may beimmediately loaded whengood primary stability isachieved and the occlusalload is appropriate.Narrow implants (Ø3.3mm)are indicated for use insurgical and restorativeapplications for placementonly in the mandibularcentral, lateral incisor and	MIS Conical ConnectionImplants are intended tobe surgically placed in thebone of the upper or lowerjaw arches to providesupport for prostheticdevices, such as artificialteeth, in order to restore apatient's chewing function.When a one stage surgicalprocedure is applied, theimplant may beimmediately loaded whengood primary stability isachieved and the occlusalload is appropriate.	The OsseoSpeed implantsare intended to be used:• to replace missing teethin single or multiple unitapplications within themandible or maxilla• for immediate placementin extraction sites andpartially or completelyhealed alveolarridge situations• for both one- and two-stage surgical procedures• especially well in softbone applications whereimplants with otherimplant surfacetreatments may be lesseffective• together with immediateloading protocol in allindications, except in singletooth situations in soft
Trade Name	MIS V3 Conical ConnectionDental Implant SystemStandard Platform Ø3.9and 4.3 mm	MIS Conical ConnectionImplants Ø3.75 and4.20mm	ASTRA TECH OsseoSpeedTX S
	maxillary lateral incisorregions of partiallyedentulous jaws, toprovide support forprosthetic devices such asartificial teeth, in order torestore the patientchewing function.Mandibular central andlateral incisors must besplinted if using two ormore narrow implantsadjacent to one another.		bone (type IV) whereimplant stability may bedifficult to obtain andimmediate loading may notbe appropriate• together with immediateloading protocol for single-tooth restorations onimplants 8 mm or longer• with its 3.0 S product linefor maxillary lateral incisorsand mandibular lateral andcentral incisors.
EndosseousImplantMaterial(s)	Titanium 6Al-4V ELI perASTM F136	Titanium 6Al-4V ELI perASTM F136	Titanium grade 4
SurfaceTreatment	Anodized, sand blasted andacid etched	Anodized, sand blasted andacid etched	TiO2-blasted fluoride-modified surface.
Body design	Tapered design, threaded	Tapered design, threaded	Cylindrical, threaded
ConnectionType	Conical - 6 indexes, coneangulation 12°	Conical – 6 indexes, coneangulation 12°	Internal, double hex conicalconnection, coneangulation 21°
Type of implant	Bone level implant	Bone level implant	Bone level implant
ImplantDiameters	Ø 3.90 and 4.30 mm	Ø 3.75 and 4.2 mm	Ø 3.5, 4.0 mm
ImplantLengths	8, 10, 11.5, 13 and 16 mm	8, 10, 11.5, 13 and 16 mm	3.5 mm: 8, 9, 11, 13, 15and 17 mm4.0 mm: 6-17 mm
Neck Design	Three-way cutawaylongitude implant axis atthe cervical part of theimplant	Cylindrical	Cylindrical
Apex	Flat apex	Domed apex	Flat apex
Thread	Dual	Dual	Dual
SterilizationMethod	Radiation	Radiation	Radiation
Trade Name	MIS V3 Conical Connection DentalImplant System, Standard PlatformØ5.0 mm	ANKYLOS C/X Implant System Ø5.5 mm
510(k) Number	Subject	K140347
Manufacturer	MIS Implants Technologies Ltd.	Dentsply International, Inc.
Device Class	Class II	Class II
Product Code(s)	DZE	DZE
RegulationDescription	Endosseous dental implant	Endosseous dental implant
RegulationNumber	872.3640	872.3640
Intended use:	Intended to be surgically placed in thebone of the upper or lower jaw archesfor anchoring or supporting toothreplacement to restore chewingfunction.	Intended to be surgically placed in thebone of the upper or lower jaw arches foranchoring or supporting tooth replacementto restore chewing function.
Indications foruse:	MIS V3 Conical Connection DentalImplant System is intended to besurgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, such asartificial teeth, in order to restoremasticatory function.When a one-stage surgical procedureis applied, the implant may beimmediately loaded when goodprimary stability is achieved and theocclusal load is appropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateral	ANKYLOS® C/X Implants of 8 mm in lengthor longer are for single-stage or two-stagesurgical procedures and cemented,removable or screw retained restorations.The ANKYLOS® C/X Implants may be usedfor immediate placement and function onsingle tooth and/or multiple toothapplications when adequate primarystability is achievable, with appropriateocclusal loading, in order to restorechewing function. Multiple toothapplications may be splinted.ANKYLOS® C/X Implants of 6.6 mm inlength are for two-stage surgicalprocedures and cemented, removable orscrew retained restorations. The ANKYLOS®

Table 2 – Comparison of Endosseous Implant Characteristics – Standard Platform Ø3.9 and 4.3 mm

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The subject and predicate devices have similar indications. The length range of the subject 3.9 and 4.3 mm MIS V3 is 8 -16 mm which is the same range of the predicate C1, and within the range of the predicate ASTRA TECH OsseoSpeed (6 – 17 mm). Both subject device and predicate C1 have a tapered

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Image /page/11/Picture/0 description: The image contains the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, blue font. To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name.

body design, a similar conical connection with the same number of indexes, and undergo the same surface treatment. The ASTRA TECH predicate has a cylindrical body design, and an internal, double hex conical connection. The subject device and C1 predicate are both made from Ti-6Al-4V ELI while the ASTRA TECH OsseoSpeed TX S is made from CP Titanium grade 4. Although there are minor differences in diameter, threading, apex and neck design, these differences are common endosseous implants and do not raise different safety or efficacy questions. Fatigue testing per ISO 14801:2007 assessed the impact of these differences and demonstrates at least equivalent performance, as demonstrated in the performance testing for the subject V3 Conical Connection Implants and for the predicates C1 and ASTRA TECH OsseoSpeed TX S.

Table 3 – Comparison of Endosseous Implant Characteristics – Standard Platform Ø5.0 mm

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Trade Name	MIS V3 Conical Connection DentalImplant System, Standard PlatformØ5.0 mm	ANKYLOS C/X Implant System Ø5.5 mm
	incisor and maxillary lateral incisorregions of partially edentulous jaws,to provide support for prostheticdevices such as artificial teeth, inorder to restore the patient chewingfunction. Mandibular central andlateral incisors must be splinted ifusing two or more narrow implantsadjacent to one another.	C/X Implants may be used for immediateplacement on single tooth and/or multipletooth applications when adequate primarystability is achievable, with appropriateocclusal loading, in order to restorechewing function. Multiple toothapplications may be splinted.
EndosseousImplantMaterial(s)	Titanium 6Al-4V ELI per ASTM F136	CP Titanium grade 2
Surface Treatment	Anodized , sand blasted and acidetched	Sand blasted and acid etched
Body design	Tapered design, threaded	Tapered design, threaded
Connection Type	Conical — 6 indexesCone angulation 12°	Conical: 6 indexesCone angulation 11°
Type of implant	Bone level implant	Bone level implant
Implant Diameters	Ø 5.0 mm	Ø5.5 mm
Implant Lengths	8, 10, 11.5, 13 and 16 mm	6.6, 8, 9.5, 11, 14 and 17 mm
Neck Design	Three-way cutaway longitude implantaxis at the cervical part of the implant	Cylindrical
Apex	Flat apex	Domed apex
Thread	Dual	Dual
SterilizationMethod	Radiation	Radiation

nologies Ltd.

Both subject and predicate devices have similar indications, and while there are differences in wording, both are indicated for one or two stage surgical procedures, for either cement or screw retained restorations, with the purpose of restoring chewing function. The length range of the subject 5.0 mm MIS V3 is 8 -16 mm. which is within the range of the predicate ANKYLOS (6.6 - 17 mm). They share a tapered body design, similar conical connection with the same number of indexes, and undergo similar surface treatment with the exception of anodization treatment to internal part of the subject device's implant. Although the subject device's diameter of 5.0 mm is smaller than the predicate (5.5 mm), and there are minor differences in threading, apex and neck design, fatigue testing per ISO 14801:2007 assessed the impact of these differences and demonstrates at least equivalent performance. The difference in the materials between the subject and predicate devices, does not affect the safety and effectiveness of the subject device since Titanium-6Al-4V ELI alloy, has a higher tensile strength compared to the predicate's material, CP-Titanium grade 2.

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Trade Name	MIS V3 ConicalConnection Abutments	C1 Conical ConnectionAbutments	Nobel BioCare
510(k)Number	Subject	K112162	K071370
Manufacturer	MIS ImplantsTechnologies Ltd.	MIS Implants TechnologiesLtd.	NobelActive InternalConnection Implants
Device Class	Class II	Class II	Class II
ProductCode(s)	NHA	NHA	NHA
RegulationDescription	Endosseous dentalimplant abutment	Endosseous dental implantabutment	Endosseous dental implantabutment
RegulationNumber	872.3630	872.3630	872.3630
Intended use:	Dental implant abutmentsare intended to be used inthe upper or lower jawused for supporting toothreplacements to restorechewing function.The abutments incombination with two-stage endosseousimplants are intended tobe used as a foundationfor anchoring toothreplacements in eitherjaw. Restorations rangefrom replacing one singletooth to fixed partialdentures using cement-retained supra-constructions.	Dental implant abutmentsare intended to be used inthe upper or lower jaw usedfor supporting toothreplacements to restorechewing function.The abutments incombination with two-stageendosseous implants areintended to be used as afoundation for anchoringtooth replacements in eitherjaw. Restorations range fromreplacing one single tooth tofixed partial dentures usingcement-retained supra-constructions.	Dental implant abutments areintended to be used in theupper or lower jaw used forsupporting toothreplacements to restorechewing function.The abutments incombination with two-stageendosseous implants areintended to be used as afoundation for anchoringtooth replacements in eitherjaw. Restorations range fromreplacing one single tooth tofixed partial dentures usingcement-retained supra-constructions.
Indicationsfor use:	MIS V3 ConicalConnection DentalImplant System isintended to be surgicallyplaced in the bone of theupper or lower jaw archesto provide support forprosthetic devices, such asartificial teeth, in order to	MIS Conical Connectiondental implant system isintended to be surgicallyplaced in the bone of theupper or lower jaw arches toprovide support forprosthetic devices, such asartificial teeth, in order torestore masticatory function.	NobelActive InternalConnection Implants arethreaded, root-form dentalimplants intended for use inthe upper and/or lower jaw tosupport prosthetic devices,such as artificial teeth, inorder to restore patientesthetics and chewing
Trade Name	MIS V3 ConicalConnection Abutments	C1 Conical ConnectionAbutments	Nobel BioCare
	restore masticatoryfunction.When a one-stage surgicalprocedure is applied, theimplant may beimmediately loaded whengood primary stability isachieved and the occlusalload is appropriate.Narrow implants( $Ø$ 3.3mm) are indicatedfor use in surgical andrestorative applicationsfor placement only in themandibular central, lateralincisor and maxillarylateral incisor regions ofpartially edentulous jaws,to provide support forprosthetic devices such asartificial teeth, in order torestore the patientchewing function.Mandibular central andlateral incisors must besplinted if using two ormore narrow implantsadjacent to one another	When a one-stage surgicalprocedure is applied, theimplant may be immediatelyloaded when good primarystability is achieved and theocclusal load is appropriate.	function to partially or fullyedentulous patients.Nobel Biocare's NobelActiveimplants may be placedimmediately and put intoimmediate function providedthat initial stabilityrequirements detailed in themanual are satisfied.The NobelActive 3.0 implant isindicated for use in thetreatment of missing maxillarylateral incisors or themandibular central and lateralincisors to support prostheticdevices, such as artificialteeth, in order to restorechewing function in partiallyedentulous patients.The NobelActive 3.0 implantsmay be put into immediatefunction provided thatstability requirementsdetailed in the manual aresatisfied.

Table 4 – Comparison of Endosseous Abutments Characteristics

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Trade Name	MIS V3 ConicalConnection Abutments	C1 Conical ConnectionAbutments	Nobel BioCare
Material(s)	Healing caps, coverscrews, Prosthetic Screws,Ball Attachment/Equators,cement retainedabutments: TI 6Al-4V ELIper ASTM F136Gold plastic abutments:Gold AlloyPlastic cylinder:Polyoxymethylene (POM)Temporary plasticabutments: PEEK	Healing caps, cover screws,Prosthetic Screws, BallAttachment/Equators,cement retained abutments:TI 6Al-4V ELI per ASTM F136Gold plastic abutments: GoldAlloyPlastic cylinder:Polyoxymethylene (POM)Temporary plasticabutments: PEEK	Abutments: TI 6Al-4V ELI perASTM F136Abutment screws: TI 6Al-4VTemporary Plastic Abutments:Polyetheretherketone (PEEK)
SurfaceTreatment	Polished and Anodizedafter machining	Polished and Anodized aftermachining	Polished and Anodized aftermachining
Angulation	NP 0°, 10°, 20°SP 0°, 15°, 17°, 25°, 30°	SP: 0°,15°,25°	RP : 0°,17°,30°

Healing caps, cover screws, cement retained abutments, gold abutments, OT-equators and ball attachments were compared to equivalent MIS conical connection abutments, which share the same indications, are made of the same materials, are manufactured in the same facility with the same manufacturing conditions and undergo the same surface treatments. The differences between the subject and predicate devices are additional platforms and diameters, with no new gingival heights or angulations. The new narrow platform abutments and differences in diameter were performance tested with their compatible implant and showed at least equivalent performance to the predicates and therefore did not raise new issues of safety and effectiveness.

Temporary abutments and multi-units were compared to Nobel Biocare's temporary abutments and multi-units. The temporary abutments share similar intended use, materials and angulations, and are both intended for up to 180 days of use. The multi units share similar intended use, materials and angulations. Both temporary abutments and multi units differ from their predicates in connection type but both of the connection types provide a locking mechanism for a tight fit. The subject multi-units were fatigue tested and met the pre-determined success criteria. The differences between subject and predicate devices did not alter the intended use and new issues of safety and effectiveness were not raised.

8. Non-Clinical Performance Data

As part of demonstrating the substantial equivalence of the V3 Conical Connection Dental Implant System to the predicate devices listed in this 510(k) submission, MIS Implants Technologies completed a

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number of non-clinical performance tests. The MIS V3 Conical Connection Dental Implant System was tested in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

. 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, K112162. The subject device is sterilized and packaged using identical materials and processing as the predicate, K112162. Finally the subject device has the same intended use, patient contact duration and type as the predicate, K112162. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
. Fatigue Testing - Mechanical testing of MIS V3 implants and abutments 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 predicates.
. Sterilization Testing - Sterilization tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 for the MIS V3 Conical Connection Dental Implant System. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Steam sterilization parameters were validated for 2 methods: gravity displacement and pre-vacuum sterilization. The studies were conducted in accordance with ISO 17665-1:2006 and demonstrated a SAL of 10 °.
Shelf Life Testing - Shelf life testing of real-time aged implants to validate the integrity of the final package was completed by an independent testing laboratory. Test results were successful and consisted of a sterility testing of product which had been aged real-time for at least five years. No growth was determined for the samples provided for this testing. Additional burst testing had been completed by contract packager.
. Risk Analysis - Risk analysis for MIS implants was conducted in accordance with ISO 14971, Medical Devices: Application of Risk Analysis, for medical devices. It was determined by MIS that all risks associated with MIS implants were acceptable and as low as reasonably possible.

9. 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. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

10. 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 at least equivalent to the predicates by means of performance.

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Image /page/17/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "I" being taller than the other letters. To the right of the letters is a vertical line, followed by the text "Implants Technologies Ltd." in a smaller font size. The logo is simple and modern, and the use of blue gives it a professional look.

11. Conclusions

Based on the comparison of the indications for use, the technological characteristics and the performance testing it was concluded that the MIS V3 Dental Implant System it substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is 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 a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.