Who is the manufacturer of TOV Dental Implant System?

Rdj Tov Implant, Ltd. filed the 510(k) submission for TOV Dental Implant System (K240837).

What is the FDA product code for TOV Dental Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TOV Dental Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TOV Dental Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TOV Dental Implant System

Q: What are the predicate devices for TOV Dental Implant System?

OsseOne Dental Implant System (K182293).

K240837 · Rdj Tov Implant, Ltd. · DZE · Aug 15, 2024 · Dental

Device Facts

Record ID	K240837
Device Name	TOV Dental Implant System
Applicant	Rdj Tov Implant, Ltd.
Product Code	DZE · Dental
Decision Date	Aug 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

Device Story

TOV Dental Implant System consists of endosseous dental implants (Maer, Ragil, TCX designs) and various abutments; surgically placed in jaw arches by dental professionals; provides support for prosthetic devices (artificial teeth) to restore chewing function and esthetics. Implants feature internal hex or conical connections; grit-blasted and acid-etched surface. Supports immediate or delayed loading protocols. Abutments include healing caps, straight, angled, UCLA, ball, and multi-unit attachments. System components are manufactured from Ti-6AL-4V ELI. Clinical benefit includes restoration of oral function and aesthetics. Device is used in dental clinics; output is the physical implant/abutment assembly integrated into the patient's jaw.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing (ISO 14801), biocompatibility (cytotoxicity, skin sensitization, irritation per ISO 10993), sterilization validation (ISO 17665-1, ISO 11137-2), bacterial endotoxin testing (ANSI/AAMI ST72:2019, USP <161>), and shelf-life/package integrity testing (ASTM D999-08, F3039-13, D5276-98, F1929-12, F1980-07). Surface cleanliness validated via SEM/EDX and organic carbon analysis.

Technological Characteristics

Materials: Ti-6AL-4V ELI. Surface: Grit-blasted and acid-etched (SLA). Connection: Internal hex and conical. Components: Implants (Maer, Ragil, TCX), abutments (straight, angled, UCLA, ball, multi-unit), healing caps, cover screws. Sterilization: Steam (ISO 17665-1) and Gamma irradiation (ISO 11137-2).

Indications for Use

Indicated for patients requiring endosseous dental implants in upper or lower jaw arches to support prosthetic devices (artificial teeth) for restoration of esthetics and chewing function. Includes single/multiple unit restorations. Ragil 3.3 implants indicated for maxillary lateral incisors or mandibular central/lateral incisors; mandibular incisors require splinting if adjacent 3.3 implants are used.

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

OsseOne Dental Implant System (K182293)

Reference Devices

Surgikor Dental Implant System (K182615)
Cortex Dental Implants (K163385)
Straumann (K171784)

Related Devices

K250872 — Bioline Dental Implant System · Bioline Dental Implant Systems, Ltd. · Jun 18, 2025
K242217 — Surcam Dental Implant System · Surcam Medical Devices and Developments, Ltd. · Jan 29, 2025
K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus · Jdentalcare Srl · Aug 16, 2024
K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 15, 2024 RDJ TOV Implant Ltd % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172 Re: K240837 Trade/Device Name: TOV Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 16, 2024 Received: July 17, 2024 Dear Angela Blackwell: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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 Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240837 Device Name TOV Dental Implant System #### Indications for Use (Describe) The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another. Type of Use (Select one or both, as applicable)> 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." {4}------------------------------------------------ # 510k Summary August 12, 2024 TOV Dental Implant System Name and address: RDJ TOV Implant Ltd Mutsafi Street 8/4, View Tower Jerusalem 96420 Israel Contact Person: David Elkouby Phone Number: +972 548397143 Email: contact@tov-implant.com Name of device: TOV Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA Device Description: The TOV Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user. Maer implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 6.0mm diameter). Ragil implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth. Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available. Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm. {5}------------------------------------------------ Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm. Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm. Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm. Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm. Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified. Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. Internal Hex Double Loc Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The Double Loc attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm. Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm. TCX implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. TCX comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm. Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available. Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm. Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm. {6}------------------------------------------------ Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP. Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP. Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm. ### Indications for Use: The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another. Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. Cytotoxicity testing according to ISO 10993 was done on both implants and abutments. Skin sensitization testing to ISO 10993-10:2021 was conducted on implants. Irritation testing according to ISO 10993-23:2021 was conducted on implants. Steam sterilization was conducted according to ISO 17665-1. Bacterial endotoxin testing was conducted according to ANSI/AAMI ST72:2019 and USP <161>. Gamma irradiation was conducted according to ISO 11137-2. Package testing was conducted according to ASTM D999-08, ASTM F3039-13, and ASTM D5276-98(2009) and then shelf life testing was conducted according to ASTM F1929-12, and ASTM F1980-07. Testing of the modified surface included testing for organic carbon, hydrocarbons, and SEM/EDX. All were within the limits based on relevant standards set in the cleaning validation protocol. {7}------------------------------------------------ #### MR Environment Condition Non-clinical worst-case MRI review was performed to evaluate the metallic TOV Dental Implant System devices in the MRI environment using scientific rationale and published literature (e.g., 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 including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. 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. ## Primary Predicate Device: OsseOne Dental Implant System K182293 Reference Predicates: Surgikor Dental Implant System K182615 Cortex Dental Implants K163385 healing abutment 3.8mm with 2mm platform height and angled abutment anatomic/shouldered 3.75mm with 4mm collar, Straumann K171784 NC 3.3 and 3.6mm healing abutment and straight multiunit in gingival height of 5.5mm ### Substantial Equivalence: The TOV Dental Implant System is substantially equivalent to OsseOne Dental Implants in indications for use, materials, design, and fatigue performance. Slight differences in implant and abutment design between the subject devices and the predicate devices were addressed by showing both had adequate fatigue performance. Some abutment types and sizes needed a reference device so Surgikor Dental Implant System is used. Some individual devices needed a reference device for a specific size or dimension so these are listed in the right column. | Company & Device Name | TOV Dental Implant System | OsseOne Dental Implant System K182293 Predicate Device | Surgikor's Dental Implant System K182615 Reference Device | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing | OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing | Surgikor's 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 | | | function. Implanet implants are intended for single or multiple unit restorations on splinted or non- splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another. | function. OsseOne implants are intended for single or multiple unit restorations on splinted or non- splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another. | chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region. | | | | | | | Implant Diameters | Maer 3.5, 3.75, 4.2, 5.0, 6.0 mm Ragil 3.3, 3.75, 4.2, 5.0, 6.0 mm TCX 3.5, 4.3, 5.0 mm NP = 3.5 RP = | OsseoLock 3.3, 3.75, 4.2, 5.0, 6.0mm OsseoPlus 3.5, 3.75, 4.2, 5.0, 6.0mm | Versatile Hex 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm Immediate Hex 3.5, 3.75,4.2, 4.5, 5.0, 6.0, 7.0mm | | | | | Fixation Narrow Platform 3.0mm Fixation Regular Platform 3.5, 3.9mm Fixation Wide Platform 4.3, 5.0mm | | Implant Lengths | Maer 8, 10, 11.5, 13,16mm (no 16mm in 6.0mm diameter) Ragil 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter) TCX 8, 10, 11.5, 13,16mm | 8, 10, 11.5, 13, 16 (OsseoLock 5.0 and 6.0 not in 16mm) | Versatile Hex 8, 10, 11.5, 13, 16, 18 (4.2 only), 20 (4.2 only)mm Immediate Hex 8 (no 3.5 diameter) 10, 11.5, 13, 16mm 7.00 diameter not in 11.5, 13 or 16mm. Fixation Narrow Platform 10, 11.5, 13, 15mm Fixation Regular Platform 8.5, 10, 11.5, 13, 15, 18mm Fixation Wide Platform 8.5, 10, 11.5, 13, 15, 18mm Solution5 Narrow Platform 10,11.5, 13, 15mm Solution5 Regular Platform 3.5, 4.0mm Solution5 Wide Platform 4.5, 5.0, 5.5, 6.0mm Solution2 3.25mm | | | | | | | | | | diameter only), 8.5, 10, 11.5, 13, 15mm Solution5 Wide Platform 7.0, 8.5, 10, 11.5, 13, 15mm Solution2 10, 11.5,13 16mm | | Material of devices included in the submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI | | Type of abutment and maximum angulation | Pre-manufactured of no more than 30° | Pre-manufactured of no more than 30° | Pre-manufactured of no more than 30° | | Interface type/shape | Internal hex, conical | Internal hex | Internal hex, conical | | ISO 14801 Fatigue Testing | Sufficient run out load for their intended use | Sufficient run out load for their intended use | Sufficient run out load for their intended use | | Surface Treatment | SLA | SLA | HA blasted and double acid etched | | Post Surface Treatment Cleanliness Demonstrated | Yes | Yes | Yes | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Cover screw | Cover screw for IH NP and RP | Cover Screw for IH | Cover screws NP and RP | Reference Device for individual devices | |--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Multi-Unit Abutments in IH, NP and RP | 4.8 mm diameter multi-units in IH, NP and RP with cuff heights of 1,2,3,4,5mm | 4.5 mm multi-unit abutments in heights of 1,2,3 and 4 mm | 5.00 mm multi- unit abutments in heights of 1,2,3 and 4 mm | Straumann K171784 straight multi-unit in gingival height of 5.5mm | | 17° and 30° Angled Multi- Unit Abutments IH, NP and RP | 17° and 30° Angled Multi-Unit Abutments IH, NP and RP with platform heights of 1,2 mm | 17° and 30° overdenture abutments in heights of 1,2, and 3 mm | 18° and 30° Multi- unit abutments in platform heights of 1,2,3 and 4 mm | | | Locator Abutments with metal | Double Loc / Conical Retentor attachments IH | 3.85mm diameter Flat abutment in | 3.85mm diameter Locator abutments in | | | housing and retention cap allowing 20° divergence of the implants | (3.85mm), NP and RP (3.9mm) Cuff heights of 1, 2, 3, 4, 5, 6 mm (5 and 6 only in IH) | heights of 1,2,3,4, 5, and 6 mm | heights of 1,2,3,4,5, and 6mm | | | | Ti6AL4V ELI housing | Ti6AL4V ELI housing | Ti6AL4V ELI housing | | | | Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg | Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg | Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg | | | Ball attachments with metal housing and retention cap allowing 14° divergence of the implants | ball attachments IH (4.00mm diameter), NP (3.5mm diameter) and RP (5.0mm diameter) Cuff heights of 2, 3, 4, 5, 6, 7 mm for IH and 1.2.3.4.5.6 mm for NP and RP | 4.00 mm Ball attachments in platform heights of 2,3,4,5, and 6mm | 4.1 mm Ball attachments in heights of 1,2,3,4,5, and 6mm | | | | Stainless steel 316 housing | Stainless steel 316 housing | Polyamide or polyether retention cap with retention levels from 0.5 to 2.7 kg | | | | Polyamide or polyether retention cap with retention levels from 0.5 to 1.3 kg | Polyamide or polyether retention cap with retention levels from 0.5 to 2.7 kg | | | | Healing Caps 3.8mm | IH 3.8mm diameter healing cap in 3,4,5,6,7 mm cuff height 3.75 diameter NP healing cap in 2,3,4,5 mm cuff heights | 3.8mm diameter Healing Cap in 3,4,5,6,7 mm platform height | Cortex Dental Implants K163385 healing abutment 3.8mm with 2mm platform height | | | Healing Caps 4.6 diameter standard | IH 4.5mm diameter healing cap in 2,3,4,5,6,7 mm cuff height | 4.5mm diameter Healing cap in 2,3,4,5,6, and mm cuff height | 4.5mm diameter Healing cap in 2,3,4,5,6mm | | | | | | | | | Healing Caps 5.5 diameter wide | 4.5 mm diameter RP healing cap with cuff heights 2,3,4,5 mm. | 7mm platform height | | | | | IH 5.5mm diameter healing abutment in 2,3,4,5,6,7 mm cuff height | 5.5mm diameter Healing cap in 2,3,4,5,6 and 7mm platform height | | | | Healing Cap 6.3mm diameter | IH 6.3mm diameter healing abutment in 2,3,4,5 mm cuff height | | Wide emergence healing cap in 2,3,4,5,6mm height | | | Straight Abutment | IH 4.5mm diameter abutment with heights above platform of 5, 7,9,11,13,15 mm NP and RP 4.5mm diameter with heights above platform of 9 and 13 mm | | 4.9mm Non- shouldered Standard Titanium Abutment with heights of 5,7, 9, 12, and 15 mm | | | Straight Narrow Abutment | IH 3.75mm diameter abutment with total heights of 5,7,9, 11 mm | IH 3.75mm diameter abutment with total heights of 5,7,9, 11 mm | | | | Straight Wide Abutment | IH 5.5mm diameter abutment with total heights of 9,11 or 13 mm | 5.5mm diameter abutment with total heights of 9,11 or 13 mm | | | | Shoulder Abutment | 4.5 diameter IH, NP, RP shoulder abutment with shoulder heights of 1,2,3,4 mm (4 only in IH) IH total heights of 10.9, 11.9, 12.9, | 4.5mm diameter Standard Wide Shoulder Abutment with heights of 1,2,3,4 mm and total heights of 10.9, 11.9, 12.9, 13.9 | 4.3mm diameter Standard Wide Shoulder Abutment with heights of 1,2,3, and 4mm and total heights of 9.5, 10.5, 11.5, | | | | NP and RP total heights of 11.8, 12.6, and 13.6mm | 5.4mm diameter Standard Wide shoulder abutment with shoulder heights of 1.2.3 mm and total heights of 10.7, 11.7 and 12.7mm | 6.9mm diameter wide emergence abutment total heights of 5,7,9,12,15 mm | | | | 5.4mm diameter IH shoulder abutment with shoulder heights of 1.2.3.4 mm and total heights of 10.7, 11.7, 12.17 and 13.7 mm | | | | | 15° Angled Abutment | 3.75mm diameter IH 15° angled abutment with total heights of 9 or 11.4 mm | 3.5mm diameter Standard 15° Abutment with heights of 1,2,3 mm | 3.75mm diameter Standard 15° Abutment with lengths of 9,11,13mm | | | 25° Angled Abutment | 3.75mm diameter IH 25° angled abutment with total height of 8.5 mm | 3.5mm diameter Standard 25° Abutment with heights of 1,2,3 mm | 3.75mm diameter Standard 25° Abutment with lengths of 9,11,13mm | | | Shouldered 15° Angled Abutment Hex, Conical NP, and RP | IH 3.75mm diameter 15° Angled Shoulder Abutment with cuff heights of 1,2,3,4 mm and height above low side of shoulder 8,9,10,11 mm NP and RP 15° Angled Shoulder Abutment with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2 and 13.7 mm & 11, 12, 13 mm | 3.75mm diameter 15° Angled Shoulder Abutment with cuff heights of 1,2,3 mm and height above low side of shoulder 8,9,10 mm | 3.75mm diameter Anatomic Shouldered Standard 15° Abutment with collar heights of 1,2, or 3mm | Cortex Dental Implants K163385 angled abutment anatomic/shouldered 3.75mm with 4mm collar | | Shouldered 25° Angled Abutment Hex, Conical NP and RP | IH 3.75mm diameter 25° Angled Shoulder Abutment with cuff heights of 1,2,3,4 mm with | 3.75mm diameter 25° Angled Shoulder Abutment with cuff heights of 1,2,3 mm with | 3.75mm diameter Anatomic Shouldered Standard 25° Abutment with | Cortex Dental Implants K163385 angled abutment anatomic/shouldered 3.75mm with 4mm collar | | | heights above platform of 8.3,9.2,10.3,10.3 mm NP and RP 25° Angled Shoulder Abutment with cuff heights of 1,2,3 mm with total heights of 10.7, 12.2, and 13.7 mm & 11, 12, 13mm | heights above platform of 8.3,9.2,10.3 mm | collar heights of 1,2, or 3mm | | | UCLA Base Ti | 4.5mm diameter UCLA base in hexed | 4.5 mm diameter UCLA base hexed | 4.5mm hexed and non-hexed | | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ ## Conclusion: TOV Dental Implant System is substantially equivalent to OsseOne Dental Implant System. They both have the same indications for use, are of the same material, and have internal hex connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutment designs not found within the OsseOne Dental Implant System were found in the reference devices which have the same materials, similar indications for use and same internal hex and conical connections as the TOV Dental Implant System. TOV and OsseOne have the same types of performance testing with similar results. Performance testing demonstrates substantial equivalence to the identified predicate devices.