MSDI Dental Implants System

K191443 · Medical Systems and Devices International , Ltd. · DZE · Jun 26, 2020 · Dental

Device Facts

• Record ID: K191443
• Device Name: MSDI Dental Implants System
• Applicant: Medical Systems and Devices International , Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MSDI Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Self-tapping, root-form, two-piece screw-type dental implants; surgically placed in upper or lower jaw bone; provides support for prosthetic devices (artificial teeth) to restore chewing function. Used in clinical dental settings by dental professionals. System includes implants (diameters 3.3-6.0mm; lengths 8-16mm), cover screws, healing caps, and various abutments (straight, angled, multi-unit, ball attachments). Implants feature internal hex connection and grit-blasted, acid-etched surface. Device facilitates prosthetic rehabilitation in edentulous patients. Benefits include restoration of chewing function and esthetics.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing: dynamic fatigue testing (ISO 14801), surface analysis (SEM/EDS), sterilization validation (ISO 11137, ISO 17665), package integrity (ASTM F1929), accelerated aging (ASTM F1980), biocompatibility (ISO 10993-5), endotoxin testing (USP 161), and cleanliness testing (ISO 19227).

Technological Characteristics

Material: Ti6Al4V ELI (ASTM F136). Design: Self-tapping, root-form, two-piece screw-type with internal hex connection. Surface: Grit-blasted and acid-etched. Dimensions: 3.3-6.0mm diameter; 8-16mm length. Sterilization: Provided sterile (ISO 11137).

Indications for Use

Indicated for surgical and restorative applications in partially or completely edentulous patients requiring dental implants in the upper or lower jaw to support prosthetic devices and restore chewing function; intended for immediate loading when primary stability and occlusal conditions are met.

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

• Spiral Dental Implants (K162299)

Reference Devices

• Alpha-Bio Tec Dental Implant System (K063364)
• DSI Dental Implant System (K200188)

Submission Summary (Full Text)

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June 26, 2020

Medical Systems and Devices International Ltd. % Iman Khorshid CEO, Founder ORS Industrial Park Tefen Tefen 2495900 ISRAEL

Re: K191443

Trade/Device Name: MSDI Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 21, 2020 Received: June 25, 2020

Dear Iman Khorshid:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191443

Device Name MSDI Dental Implants System

Indications for Use (Describe)

MSDI Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Type of Use (Select one or both, as applicable)

| <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 510(k) Summary K191443

## MSDI Dental Implants System

- Applicant Name: Medical Systems and Devices International Ltd. St. Ba'alei Malacha 26, P.O. Box 25414 Haifa. 3223020 ISRAEL Tel: [phone]
#### Establishment Registration Number: 3013167159

- Contact Name: Iman Khorshid - QA/RA Manager Mobile: [phone] Fax: [phone] Email: [e-mail]
- US Agent: MID-LINK INTERNATIONAL Co., Ltd 2219 Rimlang Drive, Suite 301, Bellingham-Barkley Village, WA, 98226 Tel: [phone] Email: [e-mail]

Date prepared: June 26, 2020

Trade Name: MSDI Dental Implants System Classification name: Endosseous Dental Implant Common/usual name: Dental Implant Product Code: DZE, NHA Regulation No.: 872.3640 Class: II Panel identification: Dental Devices Panel

510 (k) MSDI Dental Implants System Section E - Page 1 of 8

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Image /page/4/Picture/0 description: The image shows the logo for Medical Systems & Devices International (MSDI). The logo features the letters "MSDI" in a stylized font, with the "MS" in blue, the "D" in green, and the "I" in blue. Above the "DI" are dashed lines. Below the letters is the full name of the company, "Medical Systems & Devices International", in a smaller font.

## Description of the device:

MSDI Dental Implants System implants are self-tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.

The MSDI's dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The MSDI's implant is a two piece device to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.

MSDI dental implants System is an internal hex implant system which provided in 3.3, 3.75, 4.2, 5.0 and 6.0 mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. (There is no 6.0 mm diameter for the 16 mm length).

The MSDI Dental Implants are to be used in combination with cover screws, healing caps and abutments according to commonly used protocol in the dental implantation field.

The MSDI Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The implants are grit blasted and acid etched surface. The system includes standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi- unit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

## Indications for Use:

MSDI Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support or

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Image /page/5/Picture/0 description: The image shows the logo for Medical Systems & Devices International. The logo consists of the letters "MSDI" in a stylized font, with the "M" and "DI" in blue and the "S" in green. The words "Medical Systems & Devices International" are written in a smaller font below the letters. The logo is simple and modern, and it effectively communicates the company's name and focus.

prosthetic devices, such as artificial teeth, in order to restore the patient's chewing

function.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

510 (k) MSDI Dental Implants System Section E - Page 3 of 8

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Image /page/6/Picture/0 description: The image shows the logo for Medical Systems & Devices International. The logo is in blue and green, with the letters "MSDI" in a bold, sans-serif font. The words "Medical Systems & Devices International" are written in a smaller font below the logo. The "S" in MSDI is green, and the rest of the letters are blue. There are also some green dashed lines above the "S".

## Testing Summary:

Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Predicate device comparative testing was also provided. Surface analysis according to the FDA guidance document was done including SEM and EDS. Sterilization validation according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization validation was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing according to ASTM F1929-12 and accelerated aging according to ASTM F1980-07 was conducted. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Endotoxin testing according to USP 161 was conducted. Cleanliness of implants was tested according to ISO 19227.

## Primary Predicate Device:

Spiral Dental Implants manufactured by GP Implants Ltd. cleared under 510(k) K162299.

## Reference Device:

Alpha-Bio Tec Dental Implant System K063364 DSI Dental Implant System K200188

510 (k) MSDI Dental Implants System Section E - Page 4 of 8

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## Substantial Equivalence:

## Technological Characteristics

The MSDI Dental Implants System have the same intended use and principles of operation as GP Implants' Spiral Dental Implants cleared under 510(k) K162299 and have equivalent performance characteristics. The material used for the MSDI Dental Implants System, as well as the manufacturing methods, manufacturing site and subcontractor are the same as the predicate device.

Two differences exist between the subject device and primary predicate device:

The healing caps heights range, MSDI's healing caps 4.5 diameter in heights of 3,4,5,6 and 7mm and GP's healing caps 4.5 diameter in 2 and 7mm height. MSDI's Implants system include three types of implants (Alef, TAF, KAF) and the predicate device include only one type of implant (SPI). The additional two types of implants (TAF and KAF) don't affect the intended use and indication for use since they are meant to be used the same way as the primary predicate device.

| | MSDI Dental<br>Implants System<br>from Medical<br>Systems and Devices<br>International Ltd. | Spiral Dental<br>Implants from GP<br>Implants Ltd. | Alpha-Bio Tec<br>Dental Implant<br>System | DSI Dental<br>Implant System<br>from DSI Dental<br>Solutions Ltd. |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K191443 | K162299 | K063364 | K200188 |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Indications for<br>Use | MSDI Dental<br>Implants System is<br>indicated for use in<br>surgical and<br>restorative<br>applications for<br>placement in the bone<br>of the upper or lower<br>jaw to provide<br>support or prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's chewing<br>function.<br>It is intended for<br>immediate loading<br>when good primary | The Spiral Dental<br>Implants is indicated<br>for use in surgical<br>and restorative<br>applications for<br>placement in the<br>bone of the upper or<br>lower jaw to provide<br>support or prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's chewing<br>function.<br>It is intended for<br>immediate loading<br>when good primary<br>stability is achieved | The Alpha-Bio<br>Tec Dental<br>implant System is<br>indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement in the<br>bone of the upper<br>or lower jaw to<br>provide support<br>for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's chewing<br>function.<br>Alpha-Bio Dental | DSI Dental Implants<br>are endosseous<br>implants intended to<br>be surgically placed<br>in the<br>upper or lower jaw<br>arches to provide<br>support for<br>prosthetic devices,<br>such as an artificial<br>tooth, in order<br>to restore patients<br>esthetics and<br>chewing function.<br>DSI implants are<br>intended for single<br>or multiple unit<br>restorations on |
| | MSDI Dental<br>Implants System<br>from Medical<br>Systems and Devices<br>International Ltd. | Spiral Dental<br>Implants from GP<br>Implants Ltd. | Alpha-Bio Tec<br>Dental Implant<br>System | DSI Dental<br>Implant System<br>from DSI Dental<br>Solutions Ltd. |
| | stability is achieved<br>and with appropriate<br>occlusal loading. | and with appropriate<br>occlusal loading. | Implant System is<br>indicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with<br>appropriate<br>occlusal loading. | splinted or non-<br>splinted<br>applications.<br>Premium Spiral<br>implants are<br>intended for<br>immediate loading<br>when good primary<br>stability is achieved,<br>and with appropriate<br>occlusive loading.<br>These implants can<br>also be used for<br>loading after a<br>conventional<br>healing period. |
| Supplied Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of<br>Implants | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | ASTM F136 Ti 6Al<br>4V ELI |
| Implants Shape | Screw type | Screw type | Screw type | Premium Spiral |
| Implants<br>Connection | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| Implants<br>Surface | Sand blasted and acid<br>etched | Sand blasted and<br>acid etched | Sand blasted and<br>acid etched | Sand blasted and<br>acid etched |
| Implants Length | 8, 10, 11.5, 13 and<br>16mm | 8, 10, 11.5, 13 and<br>16 mm | 8, 10, 11.5, 13 and<br>16 mm | 8, 10, 11.5, 13, 16<br>(6.0mm diameter not<br>in 13 or 16 length) |
| Implants<br>Diameter | 3.3, 3.7, 4.2, 5.0 and<br>6.0 mm | 3.3, 3.7, 4.2, 5.0, and 6.0 mm | 3.3, 3.7, 4.2, 5.0, and 6.0 mm | 3.5, 3.75, 4.2, 5.0,<br>6.0 mm |
| Abutments | Straight, 15° and 25° | Straight, 15° and 25° | Straight, 15° and<br>25° | Straight, 15° and 25° |
| Material of<br>abutments | Titanium Alloy -<br>Ti6Al4V ELI | Titanium Alloy -<br>Ti6Al4V ELI | Titanium Alloy -<br>Ti6Al4V ELI | Titanium Alloy -<br>Ti6Al4V ELI |
| Surface<br>treatment of<br>abutments | None | None | None | None |
| | MSDI Dental<br>Implants System<br>from Medical<br>Systems and Devices<br>International Ltd. | Spiral Dental<br>Implants from GP<br>Implants Ltd. | Alpha-Bio Tec<br>Dental Implant<br>System | DSI Dental<br>Implant System<br>from DSI Dental<br>Solutions Ltd. |
| Types of<br>abutments | Multi-unit<br>abutments in heights<br>of 1,2,3 and 4 mm | Multi-unit<br>abutments in heights<br>of 1,2,3 and 4 mm | AlphaLoc<br>Attachment in<br>heights of<br>0.5,1,2,3,4,5,6 and<br>7 mm | Multi-unit<br>abutments<br>in heights of 1,2,3<br>and 4 mm |
| | Ball attachments in<br>heights of 1,2,3,4,5,<br>and 6mm | Ball attachments in<br>heights of 1,2,3,4,5,<br>and 6mm | Ball attachments in<br>heights of<br>0.5,2,3,4,5, and<br>6mm | Ball attachments in<br>heights of 2,3,4,5,<br>and 6mm |
| | Healing Caps 4.5<br>diameter in heights of<br>3,4,5,6 and 7mm | Healing Caps 4.5<br>diameter in 2 and<br>7mm height | Standard Healing<br>Abutment in<br>heights of 2,3,4,5,6<br>and 7mm | Healing Cap 3.8 in<br>3,4,5,6,7mm height |
| | Wide Healing Cap<br>5.5 diameter in<br>heights 2,3,4,5,6 and<br>7mm | Healing Cap 5.5<br>diameter in heights<br>2,3,4,5,6 and 7mm | Wide healing<br>abutment in heights<br>of 3 and 5mm | Healing cap 4.6 and<br>5.5 in 2,3,4,5,6,<br>and 7mm height.<br>Healing Caps 6.3 in<br>2,3,4<br>and 5 mm height |
| | Standard Titanium<br>Abutment with<br>height of 7mm | Standard Titanium<br>Abutment with<br>height of 7mm | TLA with height of<br>8.5mm | 4.5mm Standard<br>Titanium Abutment<br>with heights of 7,9,<br>and<br>11 mm |
| | Standard narrow<br>abutment with<br>heights of 7,9, and<br>11mm | Standard narrow<br>abutment with<br>heights of 7,9, and<br>11mm | TLASP1 Height<br>8.9<br>TLASP2 Height<br>9.9<br>TLASP3 Height<br>10.9<br>TLASP4 Height<br>11.9 | 3.8mm Standard<br>narrow abutment<br>with<br>heights of 7,9 and 11<br>mm |
| | Standard shoulder<br>abutment in heights<br>of 1,2,3 and 4mm | Standard shoulder<br>abutment in heights<br>of 1,2,3 and 4mm | ETLASP1 height 1<br>ETLASP1 height 2<br>ETLASP1 height 3<br>ETLASP1 height 4 | 4.5mm Standard<br>shoulder abutment<br>in<br>heights of 1,2,3 and<br>4mm |
| | Standard Wide<br>Shoulder<br>Abutment with<br>heights of 1,2,3<br>and 4mm | Standard Wide<br>Shoulder Abutment<br>with heights of 1,2,3<br>and 4mm | TLA02 height of 2<br>mm<br>TLA04 height of 4<br>mm | 5.4mm Standard<br>Wide<br>Shoulder Abutment<br>with heights of 1,2,3<br>and 4mm |
| MSDI Dental<br>Implants System<br>from Medical<br>Systems and Devices<br>International Ltd. | Spiral Dental<br>Implants from GP<br>Implants Ltd. | Alpha-Bio Tec<br>Dental Implant<br>System | DSI Dental<br>Implant System<br>from DSI Dental<br>Solutions Ltd. | |
| Standard 15°<br>Abutment<br>with heights of 8, 12,<br>and 13mm | Standard 15°<br>Abutment<br>with heights of 8,<br>12, and 13mm | TLA15 height of<br>8.5mm<br>TLAL15 height of<br>11.5mm | Standard 15°<br>Abutment<br>with heights of 1,2,3 mm | |
| Standard 25°<br>Abutment with<br>heights of 9 and<br>12mm | Standard 25°<br>Abutment with<br>heights of 9 and<br>12mm | TLA25 height of<br>8.5mm<br>TLAL25 height of<br>11.5mm | Standard 25°<br>Abutment<br>with heights of 1,2,3 mm | |

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510 (k) MSDI Dental Implants System
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Image /page/9/Picture/0 description: The image shows the logo for Medical Systems & Devices International. The logo consists of the letters "MSDOI" in a bold, sans-serif font. The "M" and "I" are blue, while the "SDO" are green. Below the letters is the full name of the company, "Medical Systems & Devices International", in a smaller font.

510 (k) MSDI Dental Implants System
Section E - Page 7 of 9

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## Non-Clinical Performance Data

Fatigue test was performed according to ISO 14801 on the MSDI's dental implants and showed equivalence to the predicate devices.

The MSDI implants and abutments, as well as their predicate devices, are manufactured by the same sub-contractor "DAND" and manufactured in the same facility. Therefore, MSDI has adopted DAND's testing and validations in regard of all non- clinical DATA as it was adopted by the "GP Implants Ltd." the manufacturer of the predicate device.

Clinical Performance Data

No clinical performance data is provided in this submission.

## Conclusion:

The evaluation of the MSDI's dental System is substantially equivalent to SPI Dental Implant System. They both have the same indications for use, are of the same material, have internal hex and connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing demonstrates substantial equivalence to the identified predicate devices.

510 (k) MSDI Dental Implants System Section E - Page 8 of 8