QRS Dental Implants 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.

The implants (Ø3.3mm and one-piece) 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.

Device Description

QRS Dental Implants are self-tapping, root-form, one piece or two piece screw (Red Class, Blue Class and Gold Class) 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 QRS' 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 QRS' two piece implant is to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.

QRS dental implants (Red Class, Blue Class and Gold Class) are designed with a standard internal hexagon system and provided in 3.3, 3.75, 4.2, 5.0 and 6.0mm diameter for lengths of 8, 10, 11.5, 13 and 16mm.

QRS dental implant one-piece is provided in 3.3 and 3.5mm diameter for lengths of 10, 11.5, 13 and 16mm.

The ORS' two piece dental implants are to be used in combination with cover screws. healing caps, abutments, smart attachment and straight multi-unit abutment according to commonly used protocol in the dental implantation field.

The QRS 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.

All QRS' abutments, cover screws, healing caps, Straight ball attachment, smart attachment and strait multi- unit abutments are made of Ti6A14V ELI titanium alloy complying with ASTM F 136-13: Wrought Titanium-6 Aluminum -4Vanadium ELI alloy for surgical implant applications and ISO 5832-3: 2016: Implants for surgery --Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

Abutments (straight abutments, angulated abutments (15°, 25°), and anatomic angulated abutments (15°, 25°)) are intended to be used in conjunction with endosseous dental implants fixture to aid in prosthetic rehabilitation. The abutments are intended for long term use and are in contact with tissue.

The abutments are available straight or angulated, in different heights and diameters to accommodate the patient's specific needs. They are available in 0, 15 or 25 degrees angulation.

Straight Abutment SP Titanium Abutment is provided in height of 5, 7 and 9mm. Standard shoulder abutment in heights of 1, 2, 3 and 4mm Standard Wide Shoulder Abutment is provided in heights of 1, 2, 3 and 4mm Standard 15° Abutment is provided in heights of 2, 3 and 4mm Standard 25° Abutment is provided in heights of 2, 3 and 4mm The healing caps are intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process. Healing Caps are provided in 4.5 diameter in heights of 3, 4, 5, 6 and 7mm. Wide Healing Cap is provided in 6 diameter in heights 3, 4, 5 and 6mm.

Straight Ball attachment are designed to increase retention of (partial) overdentures, supported on implants. QRS titanium Ball Attachments provide firm retention and stabilization of the overdenture when used with tissue-supported implant-retained overdentures and are compatible with QRS internal hexagon connection implants.

Straight ball attachments are provided in heights of 2, 3, and 4mm

Smart Attachment - Locator abutments are designed for use with overdentures or partial dentures retained in whole or in part by dental implants in the mandible or maxilla. They offer multiple levels of retention and low vertical profile. The selfaligning design enables patients to easily seat their dentures. Smart attachment are provided with heights of 1, 2, 3 and 4mm.

Straight Multi-unit abutment are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-unit abutments are provided in heights of 2, 3, 4 and 5 mm.

Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit abutment are provided non-sterile to the user and have to be sterilized prior to use by moist heat

All the Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit are intended for single use only.

QRS Implants are especially designed for implantation in a wide range of bone types and bone augmentation procedures.

Each two piece implant is supplied with a cover screw, which is intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process.

Maximum compatibility and accuracy can be achieved when using compatible QRS tools, drills, accessories and prosthetic parts manufactured by QRS.

AI/ML Overview

The QRS Dental Implants System has demonstrated substantial equivalence to predicate devices through a combination of non-clinical performance data.

Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a quantitative table format with corresponding reported device performance, as might be found in a more detailed test report. Instead, it lists the types of tests performed and generally concludes that the device "showed equivalence to the predicate devices" or "demonstrates at least equivalent performance."

However, we can infer the acceptance criteria from the tests conducted and the stated conclusions of equivalence:

Acceptance Criterion (Inferred from testing)	Reported Device Performance (as stated in the document)
Dynamic Fatigue Performance (ISO 14801)	Demonstrated equivalence to the predicate devices.
Surface Analysis (FDA Guidance, SEM, XPS)	Conducted and deemed acceptable.
Sterilization Validation (ISO 11137-1, 11137-2)	Validated according to standards.
Abutment Steam Sterilization Validation (ISO 17665-1, ISO 17665-2)	Validated according to standards.
Package Integrity Testing (ASTM F1929-12)	Conducted and deemed acceptable.
Accelerated Aging (ASTM F1980-07)	Conducted and deemed acceptable.
Material Compliance (ASTM F 136)	Materials meet ASTM F136.
Biocompatibility - Cytotoxicity (ISO 10993-5)	Demonstrated acceptable cytotoxicity.
Biocompatibility - Skin Sensitization and Intracutaneous (ISO 10993-10)	Demonstrated acceptable skin sensitization and intracutaneous properties.
Endotoxin Testing (USP 161)	Conducted and deemed acceptable.
Cleanliness of Implants (ISO 19227)	Tested and deemed acceptable.
MRI Environment Compatibility (FDA Guidance, scientific rationale, published literature)	Determined to be "MRI conditional" based on non-clinical worst-case MRI review.
Overall Equivalence to Predicate Device	Demonstrated a similar intended use, fundamental technology, and indications for use, with performance testing supporting substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the test sets for any of the non-clinical tests (e.g., dynamic fatigue, surface analysis).

The data provenance is non-clinical, indicating these are laboratory tests performed on the physical devices. There is no mention of country of origin for the data; typically, such non-clinical tests are performed by the manufacturer or a contracted testing lab. The nature of these tests means they are inherently prospective in execution, as new devices are produced and specifically subjected to these tests to gather performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the type of studies described. The studies are non-clinical, laboratory tests evaluating the physical and material properties of a dental implant system. They do not involve interpretation of medical images or patient data requiring expert consensus or ground truth establishment in the traditional sense of clinical studies for diagnostic or treatment effectiveness. The "ground truth" for these tests are the standards themselves (e.g., ISO 14801, ASTM F 136) and the measured physical properties of the device.

4. Adjudication method for the test set

This is not applicable as the studies are non-clinical laboratory tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The submission solely relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, without involving human readers or AI assistance.

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

No standalone algorithm-only performance study was done. This device is a physical dental implant system, not an AI-powered diagnostic or therapeutic algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by:

International Standards: e.g., ISO 14801 (dynamic fatigue), ISO 11137-1/2 (sterilization), ISO 17665-1/2 (abutment sterilization), ISO 10993-5/10 (biocompatibility), ISO 19227 (cleanliness). The device's performance is compared against the requirements and methodologies outlined in these standards.
ASTM Standards: e.g., ASTM F136 (material specification), ASTM F1929-12 (package integrity), ASTM F1980-07 (accelerated aging).
FDA Guidance Documents: For surface analysis and MRI environment testing.
Scientific Rationale and Published Literature: Used for MRI compatibility assessment.

Essentially, the ground truth is compliance with established engineering and biocompatibility standards and guidelines.

8. The sample size for the training set

This is not applicable. There is no mention of a training set as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

This is not applicable as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

QRS Medical Ltd. Iman Khorshid CEO St. Toval Ma'alot-Tarshiha, 2101001 ISRAEL

Re: K221910

Trade/Device Name: QRS Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 14, 2022 Received: November 18, 2022

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 (QS) 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 mediation-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.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K221910

Device Name QRS Dental Implants System

Indications for Use (Describe)

The implants (03.3mm and one-piece) are in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandbular 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/1 description: The image shows a logo with the letters "QRS" in a stylized design. The "Q" is a blue circle with a blue checkmark extending from the bottom right of the circle. The letters "RS" are in gray and are positioned to the right of the "Q". The overall design is simple and modern.

510(k) Summary

QRS Dental Implants System

Applicant Name: QRS MEDICAL Ltd. St. Toval, P.O. Box 53 Ma'alot-Tarshiha, 2101001 Israel Tel: +972-04-6860006
Establishment Registration Number: 3022766614

Contact Name:	Iman Khorshid – CEOMobile: +972-54-3023043Fax: +972-4-6860006Email: iman@qrs-global.com
US Agent:	Pragmatic Compliance LLC DBA I
US Agent:	Pragmatic Compliance LLC DBA FDAbasics15815 SW 11th Court Rd.Ocala, Florida 34473WA, 98226Tel: (716) 775-0533

Date prepared: December 12, 2022

Trade Name: QRS Dental Implants System

Classification name: Endosseous Dental Implant

Common/usual name: Dental Implant

Primary Product Code: DZE, Secondary product code: NHA

Regulation No.: 872.3640

Class: II

Panel identification: Dental Devices Panel

510 (k) QRS Dental Implants System Section E - Page 1 of 11

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Description of the device:

QRS dental implant one-piece is provided in 3.3 and 3.5mm diameter for lengths of 10, 11.5, 13 and 16mm.

All QRS' abutments, cover screws, healing caps, Straight ball attachment, smart attachment and strait multi- unit abutments are made of Ti6A14V ELI titanium alloy

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complying with ASTM F 136-13: Wrought Titanium-6 Aluminum -4Vanadium ELI alloy for surgical implant applications and ISO 5832-3: 2016: Implants for surgery --Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

The abutments are available straight or angulated, in different heights and diameters to accommodate the patient's specific needs. They are available in 0, 15 or 25 degrees angulation.

Straight ball attachments are provided in heights of 2, 3, and 4mm

Smart Attachment - Locator abutments are designed for use with overdentures or partial dentures retained in whole or in part by dental implants in the mandible or

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Image /page/6/Picture/0 description: The image shows a logo with the letters "QRS". The "Q" is in blue and has a check mark incorporated into its design. The letters "R" and "S" are in gray and are positioned to the right of the "Q". The logo appears to be for a company or organization with the initials "QRS".

maxilla. They offer multiple levels of retention and low vertical profile. The selfaligning design enables patients to easily seat their dentures. Smart attachment are provided with heights of 1, 2, 3 and 4mm.

Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit abutment are provided non-sterile to the user and have to be sterilized prior to use by moist heat

All the Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit are intended for single use only.

QRS Implants are especially designed for implantation in a wide range of bone types and bone augmentation procedures.

Maximum compatibility and accuracy can be achieved when using compatible QRS tools, drills, accessories and prosthetic parts manufactured by QRS.

Indications for Use:

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Image /page/7/Picture/0 description: The image shows a logo with the letters 'QRS'. The 'Q' is a blue circle with a blue check mark extending from the bottom right of the circle. The letters 'RS' are in gray and are positioned to the right of the 'Q'. The logo has a clean and professional design.

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.

Testing Summary:

Dynamic fatigue testing according to ISO 14801 was conducted to determine the implants are strong enough for their intended use.

Surface analysis according to the FDA guidance document was done including SEM and XPS.

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 .

Biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5.

Skin Sensitization and Intracutaneous according to ISO 10993-10.

Endotoxin testing according to USP 161 was conducted.

Cleanliness of implants was tested according to ISO 19227.

MRI Environment: MRI conditional

"Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan."Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque."

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Primary Predicate Device:

Dental Implant System manufactured by MIS Implant Technologies Ltd. and cleared under K180282.

Reference Device:

T.A.G. Dental Implant System K143326 Alpha-Bio Tec Dental Implant System K063364

Substantial Equivalence:

Technological Characteristics

The QRS Dental Implants System have the same intended use and principles of operation as MIS Implants' Dental Implants cleared under 510(k) K180282 and have equivalent performance characteristics. The material used for the QRS Dental Implants System, as well as the manufacturing methods are the same as the predicate device.

QRS' Implants system include four types of implants (Red Class, Blue Class, Gold Class and one-piece) and the predicate device include three types of implants (Seven, M4, UNO).

The additional of implant (Gold Class) 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: the gold class implant 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.

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.

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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.

Predicate and subject devices have the same intended use and similar indications, Subject and predicate devices all have the same internal hex connection and internal geometry per platform.

They have the same following diameters: 3.3, 3.75, 4.2, 5 and 6.0.

The length range of the predicate device is 8 -16 mm. They all undergo the same surface treatment that was cleared under K180282, with additional anodizing in the internal hex connection of the implants.

Although there are minor differences in threading, apex, body design and neck design, these differences are common in end osseous 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.

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	QRS DentalImplants Systemfrom QRSMEDICAL Ltd.	MIS DentalImplant Systemfrom MISImplantTechnologies LtdLtd.	Alpha-Bio TecDental ImplantSystem	T.A.G. DentalImplant System
510(k) number	K221910	K180282	K063364	K143326
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Indications forUse	QRS Dental ImplantsSystems are intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches to providesupport for prostheticdevices, such asartificial teeth, inorder to restoremasticatory function.When a one-stagesurgical procedure isapplied, the implantmay be immediatelyloaded when goodprimary stability isachieved and theocclusal load isappropriate.The implants ( $Ø$ 3.3mm and one-piece) are indicatedfor use in surgicaland restorativeapplications forplacement only inthe mandibularcentral, lateralincisor andmaxillary lateralincisor regions ofpartially edentulousjaws, to providesupport forprosthetic devices	MIS dental implantsystems are intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches toprovide support forprosthetic devices,such as artificialteeth, in order torestore masticatoryfunction. When aone-stage surgicalprocedure is applied,the implant may beimmediately loadedwhen good primarystability is achievedand the occlusal loadis appropriate.Narrow implants( $Ø$ 3.3mm & UNO)are indicated for usein surgical andrestorativeapplications forplacement only inthe mandibularcentral, lateralincisor andmaxillary lateralincisor regions ofpartially edentulousjaws, to providesupport forprosthetic devicessuch as artificial	The Alpha-Bio TecDental implantSystem is indicatedfor use in surgicaland restorativeapplications forplacement in thebone of the upperor lower jaw toprovide support forprosthetic devices,such as artificialteeth, in order torestore the patient'schewing function.Alpha-Bio DentalImplant System isindicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.	The T.A.G. DentalImplant System isintended to replacesingle or multipleteeth in the fully orpartially edentulousmandibular ormaxillary alveolarprocess. Theimplants areappropriate forimmediate loadingwhen good primarystability is achievedand withappropriateocclusal loading.The TAG"Crestone" dentalimplant ( $Ø$ 3.0-$Ø$ 3.5) system isintended to replacesingle or multipleteeth in the fully orpartially edentulousmandibular ormaxillary alveolarprocess .Theimplants areappropriate forimmediate loadingwhen good primarystability is achievedand withappropriateocclusal loading
	QRS DentalImplants Systemfrom QRSMEDICAL Ltd.such as artificialteeth. Mandibularcentral and lateralincisors must besplinted if usingtwo or more narrowimplants adjacent toone another.	MIS DentalImplant Systemfrom MISImplantTechnologies LtdLtd.teeth. Mandibularcentral and lateralincisors must besplinted if using twoor morenarrow implantsadjacent to oneanother.The long MIS (18 &20 mm) implantscan be used in atilted manner.MIS short implantsare to be used onlywith straightabutments.M4 short implantsare indicated fordelayed loading	Alpha-Bio TecDental ImplantSystem	T.A.G. DentalImplant System
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	Ti-6Al-4V, ELI
Implants Shape	Screw type	Screw type	Screw type	Screw type
Connectionmethod	Screw	Screw	Screw	Screw
ImplantsSurface	Sand blasted and acidetched	Sand blasted andacid etched	Sand blasted andacid etched	Sand blasted and acidetched
One pieceimplant	Ø3.3- Ø3.5length 10-16 mm	Ø3.0- Ø3.5length 10-16 mm		Ø3.0- Ø3.5length 10-16 mm
Implants Length	8, 10, 11.5, 13 and 16mm	8, 10, 11.5, 13, And 16mm	8, 10, 11.5, 13 and 16mm	6,8,10,11.5,13 and 16mm
ImplantsDiameter	3.3, 3.75, 4.2, 5 and 6.0mm	3.3, 3.75, 4.2, 5.0 and 6.0mm	3.3, 3.7, 4.2, 5.0, and 6.0mm	3.3, 3.75, 4.2, 5.0, and6.0 mm
	QRS DentalImplants Systemfrom QRSMEDICAL Ltd.	MIS DentalImplant Systemfrom MISImplantTechnologies LtdLtd.	Alpha-Bio TecDental ImplantSystem	T.A.G. DentalImplant System
Abutments	Straight, 15° and 25°	Straight 10°,15°,20° and25°	Straight, 15° and 25° and35°	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
Types ofabutments	Multi-unit abutments inheights of 2,3,4 and 5mm	Multi-unit abutmentsin heights of 2,3,4 and 5mm	Multi-unitAttachment in heights of0.7, 1.6, 2.6, 3.6, 4.6 and5.6 mm	Multi-unit abutments inheights of 1,2,3,4 and5mm
	Straight Ball attachmentsin heights of 2,3, and4mm	Ball attachments inheights of 2,3,4 and 5mm	Ball attachments heightsof 0.5,2,3,4,5, and 6mm	Ball attachments inheights of 1,2,3,4and5mm
	Healing Caps 4.5 diameterin heights of 3,4,5,6 and7mm	Healing Cap 4.6 in3,4,5,6, mm height	Standard HealingAbutment heights of2,3,4,5,6 and 7mm	Healing Caps 4diameter in heights of2,3,4,5 and 6mm
	Wide Healing Cap 6diameter in heights3,4,5and 6mm	Healing cap 5.5 in 3,4,5and 6mm height.	Wide healing 5,5.5,6abutment in heights of 3and 5mm	Wide Healing Cap 5.8diameter in heights2,3,4and 5mm
	Straight Abutment SPTitanium Abutmentwith height of 5,7 and9mm	4.5mm StandardTitanium Abutmentwith heights of 10 mm	with height of 8.5mmand 12mm	Standard TitaniumAbutment with heightof 9mm
	Standard shoulderabutment in heights of1,2,3 and 4mm	Standard shoulderabutment in heights of1,2,3 and 4mm	TLASP1 height 1TLASP2 height 2TLASP3 height 3TLASP4 height 4	Standard shoulderabutment in heights of1,2,3 and4mm
	Standard Wide ShoulderAbutment with heights of1,2,3 and 4mm	Standard Wide shoulderabutment in heights of1,2,3 and 4mm	TLA02 height of 2 mmTLA04 height of 4 mm	Standard WideShoulder Abutmentwith heights of 1,2,3and 4mm
	Standard 15°Abutment withheights of 2,3 and4mm	Standard 15° Abutmentwith heights of 2 and3mm	Standard 15° Abutmentwith heights of 1 and2mm	Standard 15° Abutmentwith heights of 1,2 and3mm
	Standard 25° Abutmentwith heights of 2,3 and4mm	Standard 25° Abutmentwith heights of 2 and3mm	Standard 25° Abutmentwith heights of 1 and2mm	Standard 25° Abutmentwith heights of 1,2 and3mm
	Smart attachment withheights of 1,2,3 and4mm	Lockit attachmentSystem with heights of1,2,3 and 4mm	ALPHALOC attachmentwith heights of0.5,1,2,3,4 and 5mm	Equator attachmentwith heights of 1,2,3,and 4mm

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Image /page/12/Picture/0 description: The image shows a logo with the letters "QRS". The "Q" is blue and has a checkmark extending from the bottom of the "Q" and going over the top of the "Q". The letters "RS" are gray and are to the right of the "Q".

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Image /page/13/Picture/0 description: The image shows a logo with the letters "QRS" in a stylized design. The "Q" is formed by a circle with a checkmark extending from the bottom right, both in blue. The letters "RS" are in gray and are positioned to the right of the "Q". The overall design is simple and modern.

Non-Clinical Performance Data

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

Clinical Performance Data

No clinical performance data is provided in this submission.

Summary

The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics and materials were similar, and that the differences did not raise new safety and effectiveness issues. Furthermore, performance testing showed that the predicate device is at least equivalent to the predicates by means of performance.

Conclusions

The QRS's dental system has the same intended use, incorporate the same fundamental technology, and has similar indications for use as the predicate. Test data to verify the performance of the QRS's dental system has been provided including: dynamic fatigue, sterilization validation, shelf life, and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.

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.