(141 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes
The device is intended to restore a patient's esthetics and chewing function, which can be interpreted as treating a condition (missing teeth) or improving a bodily function.
No
Explanation: The device, the TOV Dental Implant System, is composed of endosseous implants and various abutments. Its intended use is 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." This description clearly indicates a therapeutic and restorative function, not a diagnostic one. There is no mention of the device being used to detect, diagnose, treat, cure, or prevent disease.
No
The device description clearly details physical components made of Ti-6AL-4V ELI, including implants, abutments, healing caps, and various attachments. The performance studies also focus on physical testing of these components (fatigue, cytotoxicity, sterilization, etc.). There is no mention of any software component.
Based on the provided information, the TOV Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for surgical placement in the jaw to support prosthetic devices and restore patient function. This is a direct medical intervention within the body.
- Device Description: The description details the physical components of the implants and abutments, which are surgically implanted devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. The TOV Dental Implant System is a surgically implanted device used within the body.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, 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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
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)
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 . 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.
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.
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 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)
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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 . 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.