MIS V3 Conical Connection Dental Implant System­

K163349 · Mis Implants Technologies , Ltd. · DZE · May 26, 2017 · Dental

Device Facts

• Record ID: K163349
• Device Name: MIS V3 Conical Connection Dental Implant System­
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: DZE · Dental
• Decision Date: May 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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. 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 Story

MIS V3 Conical Connection Dental Implant System consists of titanium (Ti-6Al-4V ELI) root-form, self-tapping, screw-type implants with tapered threads and a flat apex. Designed for one- or two-stage surgical procedures in the upper or lower jaw to support prosthetic devices (artificial teeth). Implants feature a tri-surface crestal contact, platform switching, and an internal conical connection with anti-rotation indexing. Used by dental surgeons in clinical settings. Implants are placed into the jawbone; various abutments (cover screws, healing caps, cement-retained, gold, multi-unit, OT-equators, ball attachments, temporary Ti/PEEK abutments) are attached to the implant to facilitate prosthetic restoration. Output is a stable foundation for dental prosthetics, restoring masticatory function. Clinical benefit includes improved patient chewing function and esthetics. Performance is verified via fatigue testing (ISO 14801) and biocompatibility.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including fatigue testing (ISO 14801:2007) demonstrating survival at 5,000,000 cycles, sterilization validation (ISO 11137, ISO 17665), and shelf-life testing.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Design: Tapered, threaded, root-form, bone-level implant. Connection: Internal conical with 6-index (Standard) or 3-index (Narrow) anti-rotation. Surface: Sand-blasted, acid-etched, and anodized. Sterilization: Radiation. Dimensions: 3.3mm to 5.0mm diameters; 8mm to 16mm lengths.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implants for prosthetic support in the upper or lower jaw. Narrow implants (Ø3.3mm) are restricted to mandibular central/lateral incisors and maxillary lateral incisors; must be splinted if adjacent. Contraindicated for single tooth situations in soft bone (Type IV) where stability is insufficient for immediate 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

• ASTRA TECH OsseoSpeed TX S (K101732)

Reference Devices

• MIS Conical Connection Implants (K112162)
• ANKYLOS C/X Dental Implant System (K140347)
• NobelActive Internal Connection Implants (K071370)
• UTA and UHA (K102467)
• Multi-Unit Abutments for AstraTech, Camlog and Ankylos Implant Systems (K061477)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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 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: [phone] Fax: [phone]

Contact: Arbel Shezaf [phone] [e-mail]

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: [phone] Fax: [phone]

## 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 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.

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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.

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.

## 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 Dental<br>Implant 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 |
| Regulation<br>Description | Endosseous dental implant | Endosseous dental implant |
| Regulation Number | 872.3640 | 872.3640 |
| Intended use: | Intended to be surgically placed in the<br>bone of the upper or lower jaw arches<br>for anchoring or supporting tooth<br>replacement to restore chewing<br>function. | Intended to be surgically placed in the<br>bone of the upper or lower jaw arches<br>for anchoring or supporting tooth<br>replacement to restore chewing<br>function. |
| Indications for use: | MIS V3 Conical Connection Dental<br>Implant System is intended to be<br>surgically placed in the bone of the<br>upper or lower jaw arches to provide<br>support for prosthetic devices, such as<br>artificial teeth, in order to restore<br>masticatory function.<br>When a one-stage surgical procedure is<br>applied, the implant may be<br>immediately loaded when good primary<br>stability is achieved and the occlusal<br>load is appropriate.<br>Narrow implants (Ø3.3mm) are<br>indicated for use in surgical and<br>restorative applications for placement<br>only in the mandibular central, lateral | The OsseoSpeed implants are intended<br>to be used:<br>• to replace missing teeth in single or<br>multiple unit applications within the<br>mandible or maxilla<br>• for immediate placement in extraction<br>sites and partially or completely healed<br>alveolar<br>ridge situations<br>•for both one- and two-stage surgical<br>procedures<br>• especially well in soft bone<br>applications where implants with other<br>implant surface<br>treatments may be less effective<br>• 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 incisor<br>regions of partially edentulous jaws, to<br>provide support for prosthetic devices<br>such as artificial teeth, in order to<br>restore the patient chewing function.<br>Mandibular central and lateral incisors<br>must be splinted if using two or more<br>narrow implants adjacent to one<br>another. | protocol in all indications, except in<br>single tooth situations in soft bone<br>(type IV) where implant stability may be<br>difficult to obtain and immediate<br>loading may not be appropriate<br>• together with immediate loading<br>protocol for single-tooth restorations<br>on implants 8 mm or longer<br>• with its 3.0 S product line for maxillary<br>lateral incisors and mandibular lateral<br>and central incisors. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endosseous Implant<br>Material(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,<br>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 implant<br>axis 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 Connection<br>Dental Implant System<br>Standard Platform Ø3.9<br>and 4.3 mm | MIS Conical Connection<br>Implants Ø3.75 and<br>4.20mm | ASTRA TECH OsseoSpeed<br>TX S |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | K112162 | K101732 |
| Manufacturer | MIS Implants Technologies<br>Ltd. | MIS Implants Technologies<br>Ltd. | Astra Tech AB |
| Device Class | Class II | Class II | Class II |
| Product<br>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<br>placed in the bone of the<br>upper or lower jaw arches<br>for anchoring or supporting<br>tooth replacement to<br>restore chewing function. | Intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches<br>for anchoring or supporting<br>tooth replacement to<br>restore chewing function. | Intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches<br>for anchoring or supporting<br>tooth replacement to<br>restore chewing function. |
| Indications for<br>use: | MIS V3 Conical Connection<br>Dental Implant System is<br>intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches<br>to provide support for<br>prosthetic devices, such as<br>artificial teeth, in order to<br>restore masticatory<br>function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be<br>immediately loaded when<br>good primary stability is<br>achieved and the occlusal<br>load is appropriate.<br>Narrow implants (Ø3.3mm)<br>are indicated for use in<br>surgical and restorative<br>applications for placement<br>only in the mandibular<br>central, lateral incisor and | MIS Conical Connection<br>Implants are intended to<br>be surgically placed in the<br>bone of the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as artificial<br>teeth, in order to restore a<br>patient's chewing function.<br>When a one stage surgical<br>procedure is applied, the<br>implant may be<br>immediately loaded when<br>good primary stability is<br>achieved and the occlusal<br>load is appropriate. | The OsseoSpeed implants<br>are intended to be used:<br>• to replace missing teeth<br>in single or multiple unit<br>applications within the<br>mandible or maxilla<br>• for immediate placement<br>in extraction sites and<br>partially or completely<br>healed alveolar<br>ridge situations<br>• for both one- and two-<br>stage surgical procedures<br>• especially well in soft<br>bone applications where<br>implants with other<br>implant surface<br>treatments may be less<br>effective<br>• together with immediate<br>loading protocol in all<br>indications, except in single<br>tooth situations in soft |
| Trade Name | MIS V3 Conical Connection<br>Dental Implant System<br>Standard Platform Ø3.9<br>and 4.3 mm | MIS Conical Connection<br>Implants Ø3.75 and<br>4.20mm | ASTRA TECH OsseoSpeed<br>TX S |
| | maxillary lateral incisor<br>regions of partially<br>edentulous jaws, to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, in order to<br>restore the patient<br>chewing function.<br>Mandibular central and<br>lateral incisors must be<br>splinted if using two or<br>more narrow implants<br>adjacent to one another. | | bone (type IV) where<br>implant stability may be<br>difficult to obtain and<br>immediate loading may not<br>be appropriate<br>• together with immediate<br>loading protocol for single-<br>tooth restorations on<br>implants 8 mm or longer<br>• with its 3.0 S product line<br>for maxillary lateral incisors<br>and mandibular lateral and<br>central incisors. |
| Endosseous<br>Implant<br>Material(s) | Titanium 6Al-4V ELI per<br>ASTM F136 | Titanium 6Al-4V ELI per<br>ASTM F136 | Titanium grade 4 |
| Surface<br>Treatment | Anodized, sand blasted and<br>acid etched | Anodized, sand blasted and<br>acid etched | TiO2-blasted fluoride-<br>modified surface. |
| Body design | Tapered design, threaded | Tapered design, threaded | Cylindrical, threaded |
| Connection<br>Type | Conical - 6 indexes, cone<br>angulation 12° | Conical – 6 indexes, cone<br>angulation 12° | Internal, double hex conical<br>connection, cone<br>angulation 21° |
| Type of implant | Bone level implant | Bone level implant | Bone level implant |
| Implant<br>Diameters | Ø 3.90 and 4.30 mm | Ø 3.75 and 4.2 mm | Ø 3.5, 4.0 mm |
| Implant<br>Lengths | 8, 10, 11.5, 13 and 16 mm | 8, 10, 11.5, 13 and 16 mm | 3.5 mm: 8, 9, 11, 13, 15…