(167 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on material properties, mechanical strength, sterilization, and biocompatibility.
Yes.
Explanation: The device is a dental implant system intended to restore masticatory function by providing support for artificial teeth, which is a therapeutic purpose.
No
The device described is a dental implant system, intended for surgical placement in the jaw to support prosthetic devices. Its function is to restore masticatory function, not to diagnose a condition or disease.
No
The device description clearly details physical components made of titanium alloy, such as implants, abutments, cover screws, and healing caps. It also describes physical testing and sterilization procedures for these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The QRS Dental Implants Systems are described as surgically placed devices intended to support prosthetic teeth and restore chewing function. They are physical implants made of titanium alloy.
- Intended Use: The intended use clearly states surgical placement in the jaw bone to support prosthetic devices. There is no mention of analyzing biological specimens.
The device is a surgically implanted medical device, not an IVD.
N/A
Intended Use / Indications for Use
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 (O3.3mm 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arches; mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Dynamic fatigue testing, Surface analysis, Sterilization validation, Abutment steam sterilization validation, Package integrity testing, Accelerated aging, Biocompatibility (cytotoxicity, skin sensitization, intracutaneous), Endotoxin testing, Cleanliness testing, MRI Environment review.
Key Results:
- Dynamic fatigue testing according to ISO 14801 showed equivalence to the predicate devices.
- 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.
- Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature, based on the entire system to include all variations 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, confirming MRI Conditional status.
- Fatigue testing per ISO 14801:2016 assessed the impact of minor differences in threading, apex, body design and neck design, and demonstrates at least equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K221910
Device Name QRS Dental Implants System
Indications for Use (Describe)
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 (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 – CEO
Mobile: +972-54-3023043
Fax: +972-4-6860006
Email: iman@qrs-global.com |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|
| US Agent: | Pragmatic Compliance LLC DBA I |
| US Agent: | Pragmatic Compliance LLC DBA FDAbasics
15815 SW 11th Court Rd.
Ocala, Florida 34473
WA, 98226
Tel: (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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Image /page/4/Picture/0 description: The image shows a logo with the letters "QRS" in a stylized design. The "Q" is formed by a blue circle with a blue checkmark extending from the bottom right of the circle, creating a visual connection between the "Q" and the checkmark. The letters "R" and "S" are in gray and are positioned to the right of the "Q", completing the acronym.
Description of the device:
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
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Image /page/5/Picture/0 description: The image shows a logo with the letters "QRS" in a stylized design. The "Q" is blue and has a checkmark incorporated into its design. The letters "RS" are in gray and are positioned to the right of the "Q". The overall design is simple and modern.
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
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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.
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.
Indications for Use:
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
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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."
8
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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Image /page/9/Picture/0 description: The image shows a logo with the letters "QRS" in a stylized design. The "Q" is blue and has a checkmark incorporated into its design. The letters "RS" are in gray and are positioned to the right of the "Q". The overall design is simple and modern.
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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Image /page/10/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" to the top right. The letters "RS" are in gray and are to the right of the "Q". The logo is simple and modern.
| | QRS Dental
Implants System
from QRS
MEDICAL Ltd. | MIS Dental
Implant System
from MIS
Implant
Technologies Ltd
Ltd. | Alpha-Bio Tec
Dental Implant
System | T.A.G. Dental
Implant System |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K221910 | K180282 | K063364 | K143326 |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Indications for
Use | 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 ( $Ø$ 3.3
mm 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 | MIS dental implant
systems are intended
to be surgically
placed in the bone of
the upper or lower
jaw arches to
provide support for
prosthetic devices,
such as artificial
teeth, in order to
restore masticatory
function. When a
one-stage surgical
procedure is applied,
the implant may be
immediately loaded
when good primary
stability is achieved
and the occlusal load
is appropriate.
Narrow implants
( $Ø$ 3.3mm & UNO)
are indicated for use
in surgical and
restorative
applications for
placement only in
the mandibular
central, lateral
incisor and
maxillary lateral
incisor regions of
partially edentulous
jaws, to provide
support for
prosthetic devices
such as artificial | The Alpha-Bio Tec
Dental implant
System is indicated
for use in surgical
and restorative
applications for
placement in the
bone of the upper
or lower jaw to
provide support for
prosthetic devices,
such as artificial
teeth, in order to
restore the patient's
chewing function.
Alpha-Bio Dental
Implant System is
indicated for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | The T.A.G. Dental
Implant System is
intended to replace
single or multiple
teeth in the fully or
partially edentulous
mandibular or
maxillary alveolar
process. The
implants are
appropriate for
immediate loading
when good primary
stability is achieved
and with
appropriate
occlusal loading.
The TAG
"Crestone" dental
implant ( $Ø$ 3.0-
$Ø$ 3.5) system is
intended to replace
single or multiple
teeth in the fully or
partially edentulous
mandibular or
maxillary alveolar
process .The
implants are
appropriate for
immediate loading
when good primary
stability is achieved
and with
appropriate
occlusal loading |
| | QRS Dental
Implants System
from QRS
MEDICAL Ltd.
such as artificial
teeth. Mandibular
central and lateral
incisors must be
splinted if using
two or more narrow
implants adjacent to
one another. | MIS Dental
Implant System
from MIS
Implant
Technologies Ltd
Ltd.
teeth. Mandibular
central and lateral
incisors must be
splinted if using two
or more
narrow implants
adjacent to one
another.
The long MIS (18 &
20 mm) implants
can be used in a
tilted manner.
MIS short implants
are to be used only
with straight
abutments.
M4 short implants
are indicated for
delayed loading | Alpha-Bio Tec
Dental Implant
System | T.A.G. Dental
Implant System |
| Supplied Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of
Implants | 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 |
| Connection
method | Screw | Screw | Screw | Screw |
| Implants
Surface | Sand blasted and acid
etched | Sand blasted and
acid etched | Sand blasted and
acid etched | Sand blasted and acid
etched |
| One piece
implant | Ø3.3- Ø3.5
length 10-16 mm | Ø3.0- Ø3.5
length 10-16 mm | | Ø3.0- Ø3.5
length 10-16 mm |
| Implants Length | 8, 10, 11.5, 13 and 16mm | 8, 10, 11.5, 13, And 16
mm | 8, 10, 11.5, 13 and 16
mm | 6,8,10,11.5,13 and 16
mm |
| Implants
Diameter | 3.3, 3.75, 4.2, 5 and 6.0
mm | 3.3, 3.75, 4.2, 5.0 and 6.0
mm | 3.3, 3.7, 4.2, 5.0, and 6.0
mm | 3.3, 3.75, 4.2, 5.0, and
6.0 mm |
| | QRS Dental
Implants System
from QRS
MEDICAL Ltd. | MIS Dental
Implant System
from MIS
Implant
Technologies Ltd
Ltd. | Alpha-Bio Tec
Dental Implant
System | T.A.G. Dental
Implant System |
| Abutments | Straight, 15° and 25° | Straight 10°,15°,20° and
25° | Straight, 15° and 25° and
35° | Straight, 15° and 25° |
| Material of
abutments | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI |
| Surface
treatment of
abutments | None | None | None | None |
| Types of
abutments | Multi-unit abutments in
heights of 2,3,4 and 5
mm | Multi-unit abutments
in heights of 2,3,4 and 5
mm | Multi-unit
Attachment in heights of
0.7, 1.6, 2.6, 3.6, 4.6 and
5.6 mm | Multi-unit abutments in
heights of 1,2,3,4 and
5mm |
| | Straight Ball attachments
in heights of 2,3, and
4mm | Ball attachments in
heights of 2,3,4 and 5mm | Ball attachments heights
of 0.5,2,3,4,5, and 6mm | Ball attachments in
heights of 1,2,3,4and
5mm |
| | Healing Caps 4.5 diameter
in heights of 3,4,5,6 and
7mm | Healing Cap 4.6 in
3,4,5,6, mm height | Standard Healing
Abutment heights of
2,3,4,5,6 and 7mm | Healing Caps 4
diameter in heights of
2,3,4,5 and 6mm |
| | Wide Healing Cap 6
diameter in heights
3,4,5and 6mm | Healing cap 5.5 in 3,4,5
and 6mm height. | Wide healing 5,5.5,6
abutment in heights of 3
and 5mm | Wide Healing Cap 5.8
diameter in heights
2,3,4and 5mm |
| | Straight Abutment SP
Titanium Abutment
with height of 5,7 and
9mm | 4.5mm Standard
Titanium Abutment
with heights of 10 mm | with height of 8.5mm
and 12mm | Standard Titanium
Abutment with height
of 9mm |
| | Standard shoulder
abutment in heights of
1,2,3 and 4mm | Standard shoulder
abutment in heights of
1,2,3 and 4mm | TLASP1 height 1
TLASP2 height 2
TLASP3 height 3
TLASP4 height 4 | Standard shoulder
abutment in heights of
1,2,3 and
4mm |
| | Standard Wide Shoulder
Abutment with heights of
1,2,3 and 4mm | Standard Wide shoulder
abutment in heights of
1,2,3 and 4mm | TLA02 height of 2 mm
TLA04 height of 4 mm | Standard Wide
Shoulder Abutment
with heights of 1,2,3
and 4mm |
| | Standard 15°
Abutment with
heights of 2,3 and
4mm | Standard 15° Abutment
with heights of 2 and
3mm | Standard 15° Abutment
with heights of 1 and
2mm | Standard 15° Abutment
with heights of 1,2 and
3mm |
| | Standard 25° Abutment
with heights of 2,3 and
4mm | Standard 25° Abutment
with heights of 2 and
3mm | Standard 25° Abutment
with heights of 1 and
2mm | Standard 25° Abutment
with heights of 1,2 and
3mm |
| | Smart attachment with
heights of 1,2,3 and
4mm | Lockit attachment
System with heights of
1,2,3 and 4mm | ALPHALOC attachment
with heights of
0.5,1,2,3,4 and 5mm | Equator attachment
with heights of 1,2,3,
and 4mm |
11
12
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".
13
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.