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 Description

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a dental implant system, not an AI/software device. Therefore, the information typically required for describing the acceptance criteria and study proving device meets acceptance criteria for an AI/software device, such as those related to AI performance metrics (sensitivity, specificity, AUROC), expert reader studies, ground truth establishment, training/test set details, and MRMC studies, is not present in this document.

The document primarily focuses on demonstrating substantial equivalence of the "MSDI Dental Implants System" to legally marketed predicate devices. This involves comparing:

Intended Use/Indications for Use: The devices serve the same purpose.
Technological Characteristics: Material, design (screw type, internal hex), surface treatment, dimensions, and accessories (abutments, healing caps) are compared.
Performance Testing: Non-clinical tests like dynamic fatigue testing (ISO 14801), sterilization validation (ISO 11137-1/2, ISO 17665-1/2), biocompatibility (ISO 10993-5), endotoxin testing (USP 161), and cleanliness (ISO 19227) are mentioned to show the device performs comparably and safely.

Therefore, I cannot extract the requested information regarding AI/software device acceptance criteria and study data from this document. The document explicitly states: "No clinical performance data is provided in this submission," further indicating the absence of human-in-the-loop or standalone performance studies in a clinical context that would yield the types of performance data you're asking for.

If you have a document related to an AI/software medical device, please provide that, and I will be able to answer your questions.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 972-54-932-0515

Establishment Registration Number: 3013167159

Contact Name: Iman Khorshid - QA/RA Manager Mobile: +972-54-3023043 Fax: +972-4-6860006 Email: iman@qrs-global.com
US Agent: MID-LINK INTERNATIONAL Co., Ltd 2219 Rimlang Drive, Suite 301, Bellingham-Barkley Village, WA, 98226 Tel: 360-325-7028 Email: us.agent@mid-link.net

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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Description of the device:

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.

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 DentalImplants Systemfrom MedicalSystems and DevicesInternational Ltd.	Spiral DentalImplants from GPImplants Ltd.	Alpha-Bio TecDental ImplantSystem	DSI DentalImplant Systemfrom DSI DentalSolutions Ltd.
510(k) number	K191443	K162299	K063364	K200188
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Indications forUse	MSDI DentalImplants System isindicated for use insurgical andrestorativeapplications forplacement in the boneof the upper or lowerjaw to providesupport or prostheticdevices, such asartificial teeth, inorder to restore thepatient's chewingfunction.It is intended forimmediate loadingwhen good primary	The Spiral DentalImplants is indicatedfor use in surgicaland restorativeapplications forplacement in thebone of the upper orlower jaw to providesupport or prostheticdevices, such asartificial teeth, inorder to restore thepatient's chewingfunction.It is intended forimmediate loadingwhen good primarystability is achieved	The Alpha-BioTec Dentalimplant System isindicated for usein surgical andrestorativeapplications forplacement in thebone of the upperor lower jaw toprovide supportfor prostheticdevices, such asartificial teeth, inorder to restore thepatient's chewingfunction.Alpha-Bio Dental	DSI Dental Implantsare endosseousimplants intended tobe surgically placedin theupper or lower jawarches to providesupport forprosthetic devices,such as an artificialtooth, in orderto restore patientsesthetics andchewing function.DSI implants areintended for singleor multiple unitrestorations on
	MSDI DentalImplants Systemfrom MedicalSystems and DevicesInternational Ltd.	Spiral DentalImplants from GPImplants Ltd.	Alpha-Bio TecDental ImplantSystem	DSI DentalImplant Systemfrom DSI DentalSolutions Ltd.
	stability is achievedand with appropriateocclusal loading.	and with appropriateocclusal loading.	Implant System isindicated forimmediate loadingwhen good primarystability is achievedand withappropriateocclusal loading.	splinted or non-splintedapplications.Premium Spiralimplants areintended forimmediate loadingwhen good primarystability is achieved,and with appropriateocclusive loading.These implants canalso be used forloading after aconventionalhealing period.
Supplied Sterile	Yes	Yes	Yes	Yes
Re-use	No	No	No	No
Material ofImplants	Ti-6Al-4V, ELI	Ti-6Al-4V, ELI	Ti-6Al-4V, ELI	ASTM F136 Ti 6Al4V ELI
Implants Shape	Screw type	Screw type	Screw type	Premium Spiral
ImplantsConnection	Internal Hexagon	Internal Hexagon	Internal Hexagon	Internal Hexagon
ImplantsSurface	Sand blasted and acidetched	Sand blasted andacid etched	Sand blasted andacid etched	Sand blasted andacid etched
Implants Length	8, 10, 11.5, 13 and16mm	8, 10, 11.5, 13 and16 mm	8, 10, 11.5, 13 and16 mm	8, 10, 11.5, 13, 16(6.0mm diameter notin 13 or 16 length)
ImplantsDiameter	3.3, 3.7, 4.2, 5.0 and6.0 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, 5.0,6.0 mm
Abutments	Straight, 15° and 25°	Straight, 15° and 25°	Straight, 15° and25°	Straight, 15° and 25°
Material ofabutments	Titanium Alloy -Ti6Al4V ELI	Titanium Alloy -Ti6Al4V ELI	Titanium Alloy -Ti6Al4V ELI	Titanium Alloy -Ti6Al4V ELI
Surfacetreatment ofabutments	None	None	None	None
	MSDI DentalImplants Systemfrom MedicalSystems and DevicesInternational Ltd.	Spiral DentalImplants from GPImplants Ltd.	Alpha-Bio TecDental ImplantSystem	DSI DentalImplant Systemfrom DSI DentalSolutions Ltd.
Types ofabutments	Multi-unitabutments in heightsof 1,2,3 and 4 mm	Multi-unitabutments in heightsof 1,2,3 and 4 mm	AlphaLocAttachment inheights of0.5,1,2,3,4,5,6 and7 mm	Multi-unitabutmentsin heights of 1,2,3and 4 mm
	Ball attachments inheights of 1,2,3,4,5,and 6mm	Ball attachments inheights of 1,2,3,4,5,and 6mm	Ball attachments inheights of0.5,2,3,4,5, and6mm	Ball attachments inheights of 2,3,4,5,and 6mm
	Healing Caps 4.5diameter in heights of3,4,5,6 and 7mm	Healing Caps 4.5diameter in 2 and7mm height	Standard HealingAbutment inheights of 2,3,4,5,6and 7mm	Healing Cap 3.8 in3,4,5,6,7mm height
	Wide Healing Cap5.5 diameter inheights 2,3,4,5,6 and7mm	Healing Cap 5.5diameter in heights2,3,4,5,6 and 7mm	Wide healingabutment in heightsof 3 and 5mm	Healing cap 4.6 and5.5 in 2,3,4,5,6,and 7mm height.Healing Caps 6.3 in2,3,4and 5 mm height
	Standard TitaniumAbutment withheight of 7mm	Standard TitaniumAbutment withheight of 7mm	TLA with height of8.5mm	4.5mm StandardTitanium Abutmentwith heights of 7,9,and11 mm
	Standard narrowabutment withheights of 7,9, and11mm	Standard narrowabutment withheights of 7,9, and11mm	TLASP1 Height8.9TLASP2 Height9.9TLASP3 Height10.9TLASP4 Height11.9	3.8mm Standardnarrow abutmentwithheights of 7,9 and 11mm
	Standard shoulderabutment in heightsof 1,2,3 and 4mm	Standard shoulderabutment in heightsof 1,2,3 and 4mm	ETLASP1 height 1ETLASP1 height 2ETLASP1 height 3ETLASP1 height 4	4.5mm Standardshoulder abutmentinheights of 1,2,3 and4mm
	Standard WideShoulderAbutment withheights of 1,2,3and 4mm	Standard WideShoulder Abutmentwith heights of 1,2,3and 4mm	TLA02 height of 2mmTLA04 height of 4mm	5.4mm StandardWideShoulder Abutmentwith heights of 1,2,3and 4mm
MSDI DentalImplants Systemfrom MedicalSystems and DevicesInternational Ltd.	Spiral DentalImplants from GPImplants Ltd.	Alpha-Bio TecDental ImplantSystem	DSI DentalImplant Systemfrom DSI DentalSolutions Ltd.
Standard 15°Abutmentwith heights of 8, 12,and 13mm	Standard 15°Abutmentwith heights of 8,12, and 13mm	TLA15 height of8.5mmTLAL15 height of11.5mm	Standard 15°Abutmentwith heights of 1,2,3 mm
Standard 25°Abutment withheights of 9 and12mm	Standard 25°Abutment withheights of 9 and12mm	TLA25 height of8.5mmTLAL25 height of11.5mm	Standard 25°Abutmentwith heights of 1,2,3 mm

510 (k) MSDI Dental Implants System Section E - Page 5 of 8

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510 (k) MSDI Dental Implants System
Section E - Page 6 of 8

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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

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.