QRS Dental Implants System

K221910 · Qrs Medical , Ltd. · DZE · Dec 14, 2022 · Dental

Device Facts

Record IDK221910
Device NameQRS Dental Implants System
ApplicantQrs Medical , Ltd.
Product CodeDZE · Dental
Decision DateDec 14, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended 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 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.

Device Story

Self-tapping, root-form dental implants (one-piece or two-piece screw type) surgically placed in upper or lower jaw bone; provides support for prosthetic devices (artificial teeth) to restore masticatory function. Used in clinical settings by dental professionals. System includes implants, abutments, cover screws, healing caps, and attachments (ball, smart/locator, multi-unit). Implants feature internal hexagon connection. Two-stage or one-stage surgical protocols; immediate loading possible if primary stability achieved. Abutments aid prosthetic rehabilitation. Benefits include restoration of chewing function and stabilization of overdentures. MRI conditional status established via non-clinical assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing: dynamic fatigue (ISO 14801), surface analysis (SEM/XPS), sterilization validation (ISO 11137, ISO 17665), package integrity (ASTM F1929), accelerated aging (ASTM F1980), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Materials: Ti6Al4V ELI (ASTM F136-13, ISO 5832-3). Surface: Grit blasted and acid etched. Design: Screw-type, root-form, internal hexagon connection. Dimensions: Diameters 3.3-6.0mm, lengths 8-16mm. Sterilization: Non-sterile, requires moist heat sterilization by user. MRI conditional.

Indications for Use

Indicated for partially or completely edentulous patients requiring dental implants in upper or lower jaw arches to support prosthetic devices and restore masticatory function. Specific narrow implants (Ø3.3mm and one-piece) restricted to mandibular central/lateral incisor and maxillary lateral incisor regions; requires splinting for adjacent narrow implants.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

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

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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<br>Mobile: +972-54-3023043<br>Fax: +972-4-6860006<br>Email: iman@qrs-global.com | |---------------|-------------------------------------------------------------------------------------------------------------------------------| | US Agent: | Pragmatic Compliance LLC DBA I | | US Agent: | Pragmatic Compliance LLC DBA FDAbasics<br>15815 SW 11th Court Rd.<br>Ocala, Florida 34473<br>WA, 98226<br>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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ 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<br>Implants System<br>from QRS<br>MEDICAL Ltd. | MIS Dental<br>Implant System<br>from MIS<br>Implant<br>Technologies Ltd<br>Ltd. | Alpha-Bio Tec<br>Dental Implant<br>System | T.A.G. Dental<br>Implant System | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | K221910 | K180282 | K063364 | K143326 | | Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | | Indications for<br>Use | QRS Dental Implants<br>Systems are intended<br>to be surgically<br>placed in the bone of<br>the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore<br>masticatory function.<br>When a one-stage<br>surgical procedure is<br>applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and the<br>occlusal load is<br>appropriate.<br>The implants ( $Ø$ 3.3<br>mm and one-<br>piece) are indicated<br>for use in surgical<br>and restorative<br>applications for<br>placement only in<br>the mandibular<br>central, lateral<br>incisor and<br>maxillary lateral<br>incisor regions of<br>partially edentulous<br>jaws, to provide<br>support for<br>prosthetic devices | MIS dental implant<br>systems are intended<br>to be surgically<br>placed in the bone of<br>the upper or lower<br>jaw arches to<br>provide support for<br>prosthetic devices,<br>such as artificial<br>teeth, in order to<br>restore masticatory<br>function. When a<br>one-stage surgical<br>procedure is applied,<br>the implant may be<br>immediately loaded<br>when good primary<br>stability is achieved<br>and the occlusal load<br>is appropriate.<br>Narrow implants<br>( $Ø$ 3.3mm & UNO)<br>are indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement only in<br>the mandibular<br>central, lateral<br>incisor and<br>maxillary lateral<br>incisor regions of<br>partially edentulous<br>jaws, to provide<br>support for<br>prosthetic devices<br>such as artificial | The Alpha-Bio Tec<br>Dental implant<br>System is indicated<br>for use in surgical<br>and restorative<br>applications for<br>placement in the<br>bone of the upper<br>or lower jaw to<br>provide support for<br>prosthetic devices,<br>such as artificial<br>teeth, in order to<br>restore the patient's<br>chewing function.<br>Alpha-Bio Dental<br>Implant System is<br>indicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading. | The T.A.G. Dental<br>Implant System is<br>intended to replace<br>single or multiple<br>teeth in the fully or<br>partially edentulous<br>mandibular or<br>maxillary alveolar<br>process. The<br>implants are<br>appropriate for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with<br>appropriate<br>occlusal loading.<br>The TAG<br>"Crestone" dental<br>implant ( $Ø$ 3.0-<br>$Ø$ 3.5) system is<br>intended to replace<br>single or multiple<br>teeth in the fully or<br>partially edentulous<br>mandibular or<br>maxillary alveolar<br>process .The<br>implants are<br>appropriate for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with<br>appropriate<br>occlusal loading | | | QRS Dental<br>Implants System<br>from QRS<br>MEDICAL Ltd.<br>such as artificial<br>teeth. Mandibular<br>central and lateral<br>incisors must be<br>splinted if using<br>two or more narrow<br>implants adjacent to<br>one another. | MIS Dental<br>Implant System<br>from MIS<br>Implant<br>Technologies Ltd<br>Ltd.<br>teeth. Mandibular<br>central and lateral<br>incisors must be<br>splinted if using two<br>or more<br>narrow implants<br>adjacent to one<br>another.<br>The long MIS (18 &<br>20 mm) implants<br>can be used in a<br>tilted manner.<br>MIS short implants<br>are to be used only<br>with straight<br>abutments.<br>M4 short implants<br>are indicated for<br>delayed loading | Alpha-Bio Tec<br>Dental Implant<br>System | T.A.G. Dental<br>Implant System | | Supplied Sterile | Yes | Yes | Yes | Yes | | Re-use | No | No | No | No | | Material of<br>Implants | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | | Implants Shape | Screw type | Screw type | Screw type | Screw type | | Connection<br>method | Screw | Screw | Screw | Screw | | Implants<br>Surface | Sand blasted and acid<br>etched | Sand blasted and<br>acid etched | Sand blasted and<br>acid etched | Sand blasted and acid<br>etched | | One piece<br>implant | Ø3.3- Ø3.5<br>length 10-16 mm | Ø3.0- Ø3.5<br>length 10-16 mm | | Ø3.0- Ø3.5<br>length 10-16 mm | | Implants Length | 8, 10, 11.5, 13 and 16mm | 8, 10, 11.5, 13, And 16<br>mm | 8, 10, 11.5, 13 and 16<br>mm | 6,8,10,11.5,13 and 16<br>mm | | Implants<br>Diameter | 3.3, 3.75, 4.2, 5 and 6.0<br>mm | 3.3, 3.75, 4.2, 5.0 and 6.0<br>mm | 3.3, 3.7, 4.2, 5.0, and 6.0<br>mm | 3.3, 3.75, 4.2, 5.0, and<br>6.0 mm | | | QRS Dental<br>Implants System<br>from QRS<br>MEDICAL Ltd. | MIS Dental<br>Implant System<br>from MIS<br>Implant<br>Technologies Ltd<br>Ltd. | Alpha-Bio Tec<br>Dental Implant<br>System | T.A.G. Dental<br>Implant System | | Abutments | Straight, 15° and 25° | Straight 10°,15°,20° and<br>25° | Straight, 15° and 25° and<br>35° | Straight, 15° and 25° | | Material of<br>abutments | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | | Surface<br>treatment of<br>abutments | None | None | None | None | | Types of<br>abutments | Multi-unit abutments in<br>heights of 2,3,4 and 5<br>mm | Multi-unit abutments<br>in heights of 2,3,4 and 5<br>mm | Multi-unit<br>Attachment in heights of<br>0.7, 1.6, 2.6, 3.6, 4.6 and<br>5.6 mm | Multi-unit abutments in<br>heights of 1,2,3,4 and<br>5mm | | | Straight Ball attachments<br>in heights of 2,3, and<br>4mm | Ball attachments in<br>heights of 2,3,4 and 5mm | Ball attachments heights<br>of 0.5,2,3,4,5, and 6mm | Ball attachments in<br>heights of 1,2,3,4and<br>5mm | | | Healing Caps 4.5 diameter<br>in heights of 3,4,5,6 and<br>7mm…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%