MIS Internal Hex Dental Implant System

K180282 · Mis Implants Technologies , Ltd. · DZE · Jun 22, 2018 · Dental

Device Facts

• Record ID: K180282
• Device Name: MIS Internal Hex Dental Implant System
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 & UNO) 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

Device Story

Endosseous dental implant system comprising M4 and SEVEN implant families; used for anchoring prosthetic devices (artificial teeth) to restore masticatory function. Implants are root-shaped, screw-type, self-tapping, and feature internal hex connections. Input: surgical placement into jaw bone. Transformation: osseointegration provides stable foundation for prosthetic abutments. Output: support for various prosthetic components (cover screws, healing caps, cement-retained/gold/multi-unit/temporary abutments, ball attachments). Used in dental clinics by trained clinicians. Healthcare providers select specific implant/abutment geometry based on patient anatomy; output affects prosthetic stability and patient chewing function. Benefits: restoration of oral function in edentulous patients.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including fatigue testing per ISO 14801:2016, sterilization validation (ISO 11137, ISO 17665), and shelf-life testing (ISO 11607-1).

Technological Characteristics

Materials: Titanium 6Al-4V ELI (ASTM F136), Gold Alloy, POM, PEEK. Surface: Sand-blasted, acid-etched, and anodized. Connection: Internal hex. Sterilization: Gamma irradiation (sterile) or steam sterilization (non-sterile). Form factor: Root-form, screw-type, various diameters (3.3-6.0mm) and lengths (6-20mm).

Indications for Use

Indicated for partially or fully edentulous patients requiring tooth replacement to restore masticatory function. Narrow implants restricted to mandibular central/lateral incisors and maxillary lateral incisors; must be splinted if multiple narrow implants are used. Long implants (18-20mm) may be tilted. Short implants restricted to straight abutments. M4 short implants restricted to delayed loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MIS Dental Implant System (K040807)
• MIS Short Implants (K103089)
• Xive S plus Dental Implant System (K073075)
• MIS V3 Conical Connection Dental implant System (K163349)
• 3i OSSEOTITE Certain Dental Implants (K063341)
• Dentium Implantium & SuperLine Prosthetics (K160828)

Submission Summary (Full Text)

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June 22, 2018

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

Re: K180282

Trade/Device Name: MIS Internal Hex Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: Mav 29, 2018 Received: May 29, 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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

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### Indications for Use

510(k) Number (if known) K180282

Device Name

MIS Internal Hex Dental Implant System

### Indications for Use (Describe)

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 (03.3mm & UNO) 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

| 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)

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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 dot above it. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font size.

## K180282 510(k) Summary

### 1. Submitter

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

Telephone: [phone] Fax: [phone]

Contact: Arbel Shezaf Date Prepared: 21 June 2018

### 2. US Agent: Motti Weisman - VP Marketing

MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: [phone] Fax: [phone]

### 3. Device Identification

| Trade/Proprietary Name: | MIS Internal Hex 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: MIS Dental Implant System cleared under 510(k) K040807. Reference devices:

- MIS Short Implants K103089
- Xive S plus Dental Implant System K073075
- MIS V3 Conical Connection Dental implant System K163349
- 3i OSSEOTITE Certain Dental Implants K063341
- K160828 Dentium Implantium & SuperLine Prosthetics

### Device Description

The MIS internal hex implant system includes two implant families: M4 and SEVEN. The subject implants system are endosseous dental implants and Endosseous dental implant abutments, manufactured from

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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 a stylized, blue font. To the right of the letters is the text "Implants Technologies Ltd." in a smaller, sans-serif font. The overall design is clean and modern.

titanium TI-6Al-4V ELI. The implants 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. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments.

The implants are self-tapping, root-form with tapered threads and their surface is sand blasted and acid etched. The implants are supplied sterilized by gamma irradiation.

MIS M4 implants are cylindrical and conical shaped, self-tapping, have a V shaped thread design with three spiral channels and a flat, cutting tapered apex.

The MIS M4 Implants are available in the following diameters, platforms and lengths:

- Narrow platform: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
- Standard platform: 3. 75 mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm, 18mm and 20mm
- . Standard platform: 4.2 mm diameter: 6mm, 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
- Wide platform: 5.0 mm diameter: 6mm, 8mm, 11.5mm, 13mm and 16mm
- . Wide platform: 6.0 mm diameter: 6mm, 8mm, 10mm, 11.5mm, 13mm

MIS SEVEN implants are conical shaped with a domed apex. Their geometric design includes dual threads, three spiral channels stemming from the apex for self-tapping, micro rings on the implant neck, and a changing thread thickness along the implants are color coded for platform identification. The MIS SEVEN Implants are available in the following diameters, platforms and lengths:

- Narrow platform (yellow): 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
- Standard platform (purple): 3. 75mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
- Standard platform (purple): 4.2mm diameter: 8mm, 13mm, 16mm, 16mm, 18mm and 20mm
- Wide platform (green): 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
- . Wide platform(green): 6.0 mm diameter: 8mm, 10mm, 11.5mm, 13mm
- The implants are designed for both two-stage procedures, with one internal thread for screwed abutment.

The MIS Internal Hex Dental Implant System is a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.

### Components:

The MIS Internal Hex Dental Implant System is to be used in combination with variety of the internal hex abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-

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Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), including up to 300 angulated abutments.

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. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate the patients specific needs. They are available in 0, 10 or 20 degrees angulation in narrow platform, 0, 15 or 25 degrees angulation in standard platform and 0 or 15 degrees angulation for wide platform. They are made of TI 6AL 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 cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments indicated for 0 degree angulation for straight implantation only. 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 TI 6AL 4V ELI. Their additional components intended for impression taking and casting are made of POM. Plastic healing caps intended to cover the CPK abutment until final restoration placement are made of PEEK. 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 burned out for casting with precious metals.. 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 straight abutments intended for 0 degree angulation for straight implantation only. The abutments are supplied non 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 intended for use in a completely edentulous jaw when screw retained prosthetis is preferred, for anchoring a fixed overdenture. Multi-units are available in 0 degrees for narrow platform, and in 0, 17 or 30 degrees for standard and wide platforms. 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 multiunit by a screw. All multi units are made of TI 6AL 4V ELI. They are supplied sterile and intended for single use.

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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 blue, with the "i" having a unique design. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font size.

OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are mostly used in completely edentulous jaws to connect to an overdenture bar to allow its insertion and removal. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Ball attachments are available straight for narrow and wide platforms, and in 0, 15 or 25 degrees for standard platform. OT Equators are available straight only. Both are made from TI 6AL 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 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. They are straight abutments. 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, as directed 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.

There are two types of emergence profiles among the abutments, concave or straight emergence profile.

### 5. Indications for Use

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 & UNO) 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only. .

### 6. 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

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Image /page/7/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" being stylized as a wave. To the right of the letters is a vertical line, followed by the words "Implants Technologies Ltd." in a smaller, lighter font.

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.

- a. MIS SEVEN and M4 Internal hex Standard and Wide Platform Implants: The predicate device for the subject MIS SEVEN and M4 Internal hex standard and wide platform implants is MIS Lance Internal hex Implant cleared under K040807. Predicate and subject devices have the same intended use and similar indications, although the subject device mentions indications for narrow implants and for long implants as well, which the predicate device does not contain as it does not have a narrow platform or long implants. Subject and predicate devices all have the exact same internal hex connection and internal geometry per platform. They have the same following diameters: 3.75, 4.20 and 5.0 mm diameters, with an additional 6.0 mm diameter for the subject implants. The length range of the predicate device is 10 -16 mm while the subject devices have an additional 8 mm length. They all undergo the same surface treatment that was cleared under K040807, with additional anodizing in the internal hex connection of the SEVEN implants. Although there are minor differences in threading, apex, body design and neck design, these differences are common in endosseous implants and do not raise different safety or efficacy questions. Fatigue testing per ISO 14801:2016 assessed the impact of these differences and demonstrates at least equivalent performance.

| Trade Name | MIS SEVEN Internal Hex<br>Implants standard & wide<br>platforms | MIS M4 Internal Hex Implants<br>standard & wide platforms | MIS Dental Implant System -<br>Lance Internal Hex Implants |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | Subject | K040807 |
| Manufacturer | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. |
| Device Class | Class II | Class II | Class II |
| Product Code(s) | DZE | DZE | DZE |
| Regulation<br>Description | Endosseous dental implant | Endosseous dental implant | Endosseous dental implant |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 |
| Intended use: | Intended to be surgically placed<br>in the bone of the upper or<br>lower jaw arches for anchoring<br>or supporting tooth<br>replacement to restore<br>chewing function. | Intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches for anchoring or<br>supporting tooth replacement to<br>restore chewing function. | Intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches for anchoring or<br>supporting tooth replacement to<br>restore chewing function. |

### Table 1 - Comparison of Implant Characteristics - M4 and SEVEN Standard and Wide Platform implants and predicate

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Image /page/8/Picture/0 description: The image shows the logo for MIS, which is written in blue. The letters are stylized and connected. The 'i' has a small accent mark above it.

| Indications for<br>use: | MIS dental implant systems are<br>intended to be surgically placed<br>in the bone of the upper or<br>lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.3mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central,<br>lateral incisor and maxillary<br>lateral incisor regions of<br>partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth.<br>Mandibular central and lateral<br>incisors must be splinted if<br>using two or more narrow<br>implants adjacent to one<br>another.<br>The long MIS (18 & 20 mm)<br>implants can be used in a tilted<br>manner.<br>MIS short implants are to be<br>used only with straight<br>abutments.<br>M4 short implants are<br>indicated for delayed loading<br>only.. | MIS dental implant systems are<br>intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function. When a<br>one-stage surgical procedure is<br>applied, the implant may be<br>immediately loaded when good<br>primary stability is achieved and<br>the occlusal load is appropriate.<br>Narrow implants (Ø3.3mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices<br>such as artificial teeth.<br>Mandibular central and lateral<br>incisors must be splinted if using<br>two or more narrow implants<br>adjacent to one another.<br>The long MIS (18 & 20 mm)<br>implants can be used in a tilted<br>manner.<br>MIS short implants are to be used<br>only with straight abutments.<br>M4 short implants are indicated<br>for delayed loading only. | The MIS dental implant system is<br>indicated for use in surgical and<br>restorative applications for<br>placement in the bone of the<br>upper or lower jaw to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order to<br>restore the patient's chewing<br>function. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant<br>Material(s) | Titanium 6Al-4V ELI per ASTM<br>F136 | Titanium 6Al-4V ELI per ASTM<br>F136 | Titanium grade 4 |
| Surface<br>Treatment | Anodized, sand blasted and<br>acid etched | Sand blasted and acid etched | Sand blasted and acid etched |
| Connection Type | Internal hexagon | Internal hexagon | Internal hexagon |
| Body design | Tapered, conical shape,<br>threaded | Cylindrical upper half and conical<br>lower half design, threaded | Tapered, conical shape,<br>threaded |
| Neck Design | Cylindrical, with micro-rings | Cylindrical | Cylindrical |
| Apex | Domed | Flat | Domed |
| Thread | Dual | Dual | Triple |
| Type of implant | Bone level implant | Bone level implant | Bone level implant |
| Implant<br>Diameters (mm) | 3.75, 4.20, 5.0, 6.0 | 3.75, 4.20, 5.0, 6.0 | 3.75, 4.20, 5.0 |
| Implant Lengths<br>(mm) | 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Sterilization<br>Method | Radiation | Radiation | Radiation |

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Image /page/9/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, gray font.

- b. MIS SEVEN and M4 Internal Hex Narrow Platform Implants: The predicate device for the subject MIS SEVEN and M4 Internal hex narrow platform implants is Xive S plus dental implant. Predicate and subject devices have the same intended use and similar indications for use, although the predicate device is not limited to a specific region of the mouth, and may be splinted when using multiple implants, while the subject implants are limited for use in the mandibular central, lateral incisor and maxillary lateral incisor regions and must be splinted when using two or more implants. Predicate and subject devices all feature an internal hex connection. The subject implants have a 3.30 mm diameter, while the predicate has a 3.40 mm diameter. The length range of the subject devices is 10 -16 mm and are within the range of the predicate (9.5 – 18 mm). Predicate and subject devices are sand blasted and acid etched. The subject devices are made from TI 6AI-4V ELI while the predicate is made from CP Titanium grade 2. There are minor differences in diameter, threading, body design, apex and neck design, and these differences are common in endosseous implants and do not raise different safety or efficacy questions. Fatigue testing per ISO 14801:2016 assessed the impact of these differences and demonstrates at least equivalent performance.

| Trade Name | MIS SEVEN Internal hex narrow<br>platform Implants | MIS M4 Internal hex narrow<br>platform Implants | Xive S plus Dental Implant System |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | Subject | K073075 |
| Manufacturer | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. | Dentsply Implants |
| Device Class | Class II | Class II | Class II |
| Product Code(s) | DZE | DZE | DZE |
| Regulation<br>Description | Endosseous dental implant | Endosseous dental implant | Endosseous dental implant |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 |
| Intended use: | Intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches for anchoring or<br>supporting tooth replacement to<br>restore chewing function. | Intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches for anchoring or<br>supporting tooth replacement to<br>restore chewing function. | Intended to be surgically placed in<br>the bone of the upper or lower jaw<br>arches for anchoring or supporting<br>tooth replacement to restore<br>chewing function. |
| Indications for<br>use: | MIS dental implant systems are<br>intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function. When a<br>one-stage surgical procedure is<br>applied, the implant may be<br>immediately loaded when good<br>primary stability is achieved and<br>the occlusal load is appropriate. | MIS dental implant systems are<br>intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function. When a<br>one-stage surgical procedure is<br>applied, the implant may be<br>immediately loaded when good<br>primary stability is achieved and<br>the occlusal load is appropriate. | The FRIADENT Implant systems<br>(FRIALIT® plus Dental Implant<br>System, XiVE® S plus Dental<br>Implant System, XiVE® TG plus<br>Dental Implant System, ANKYLOS®<br>plus Dental<br>Implant System) are for single-<br>stage or two-stage surgical<br>procedures and cemented or screw<br>retained restorations. The<br>FRIADENT Implant Systems are<br>intended for immediate placement |

### Table 2 – Comparison of Implant Characteristics – M4 and SEVEN narrow platform implants and predicate

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| | Narrow implants (Ø3.3mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices<br>such as artificial teeth.<br>Mandibular central and lateral<br>incisors must be splinted if using<br>two or more narrow implants<br>adjacent to one another.<br>The long MIS (18 & 20 mm)<br>implants can be used in a tilted<br>manner.<br>MIS short implants are to be used<br>only with straight abutments.<br>M4 short implants are indicated<br>for delayed loading only.. | Narrow implants (Ø3.3mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central, lateral<br>incisor and maxillary lateral<br>incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices<br>such as artificial teeth.<br>Mandibular central and lateral<br>incisors must be splinted if using<br>two or more narrow implants<br>adjacent to one another.<br>The long MIS (18 & 20 mm)<br>implants can be used in a tilted<br>manner.<br>MIS short implants are to be used<br>only with straight abutments.<br>M4 short implants are indicated<br>for delayed loading only.. | and function on single tooth and/or<br>multiple tooth applications when<br>good primary stability is achieved,<br>with appropriate occlusal loading,<br>in order to restore chewing<br>function. Multiple tooth<br>applications may be splinted with a<br>bar. |
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| Implant<br>Material(s) | Titanium 6Al-4V ELI per ASTM<br>F136 | Titanium 6Al-4V ELI per ASTM<br>F136 | CP Titanium grade 2 |
| Surface<br>Treatment | Anodized, sand blasted and acid<br>etched | Sand blasted and acid etched…