(141 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "TOV Dental Implant System" and compares it to predicate devices to establish substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. As such, most of the requested fields cannot be populated from the provided document.
The document primarily focuses on demonstrating the substantial equivalence of the TOV Dental Implant System to existing predicate devices based on design, materials, indications for use, and mechanical performance (fatigue testing). It confirms biocompatibility (cytotoxicity, skin sensitization, irritation), sterilization, and packaging stability, which are standard tests for such devices, rather than clinical performance studies.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document mentions "Sufficient run out load for their intended use" as the performance criteria for ISO 14801 Fatigue Testing for all devices (TOV Dental Implant System, OsseOne Dental Implant System, and Surgikor Dental Implant System). Specific numerical acceptance criteria or reported performance values (e.g., in Newtons or cycles) are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 14801 Fatigue Testing | Sufficient run out load for their intended use |
| Cytotoxicity (ISO 10993) | Passed |
| Skin Sensitization (ISO 10993-10:2021) | Passed |
| Irritation (ISO 10993-23:2021) | Passed |
| Steam Sterilization (ISO 17665-1) | Passed |
| Bacterial Endotoxin (ANSI/AAMI ST72:2019, USP <161>) | Passed |
| Gamma Irradiation (ISO 11137-2) | Passed |
| Package Testing (ASTM D999-08, ASTM F3039-13, ASTM D5276-98) | Passed |
| Shelf Life Testing (ASTM F1929-12, ASTM F1980-07) | Passed |
| Post Surface Treatment Cleanliness (Organic carbon, hydrocarbons, SEM/EDX) | Within limits based on relevant standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes mechanical and biological safety testing, which typically use laboratory samples, not human patient test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a dental implant system (hardware), not an AI/ML diagnostic or image analysis tool. Ground truth in this context typically refers to objective measurements in material science or toxicology, not expert interpretations of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a dental implant system.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable for a dental implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable for a dental implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests conducted (fatigue, cytotoxicity, etc.), the "ground truth" would be established by the physical and chemical properties of the materials, the mechanical limits defined by ISO standards, and the biological responses observed in laboratory tests (e.g., cell viability, immune response). There is no "expert consensus" in the clinical sense for this type of device's performance validation.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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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.
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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.
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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
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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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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.
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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.
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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.
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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 DentalImplant System | OsseOne DentalImplant SystemK182293Predicate Device | Surgikor's DentalImplant SystemK182615Reference Device |
|---|---|---|---|
| Indications forUse | The TOV DentalImplant Systemare endosseousimplants intendedto be surgicallyplaced in theupper or lowerjaw arches toprovide supportfor prostheticdevices, such as anartificial tooth, inorder to restorepatient's estheticsand chewing | OsseOne DentalImplants areendosseousimplants intendedto be surgicallyplaced in theupper or lowerjaw arches toprovide supportfor prostheticdevices, such as anartificial tooth, inorder to restorepatient's estheticsand chewing | Surgikor's DentalImplant System isindicated for usein surgical andrestorativeapplications forplacement in thebone of the upperor lower jaw toprovide supportfor prostheticdevices, such asartificial teeth, inorder to restorethe patient's |
| function. Implanetimplants areintended for singleor multiple unitrestorations onsplinted or non-splintedapplications.Maer, Ragil andTCX are intendedfor immediateloading whengood primarystability isachieved, and withappropriateocclusive loading.These implantscan also be usedfor loading after aconventionalhealing period.Ragil 3.3 implantsare intended toreplace a lateralincisor in themaxilla and/or acentral or lateralincisor in themandible.Mandibularcentral and lateralincisors must besplinted if usingtwo or more 3.3implants adjacentto one another. | function. OsseOneimplants areintended for singleor multiple unitrestorations onsplinted or non-splintedapplications.OsseoPlus andOsseoLock areintended forimmediate loadingwhen goodprimary stability isachieved, and withappropriateocclusive loading.These implantscan also be usedfor loading after aconventionalhealing period.OsseoLock 3.3implants areintended toreplace a lateralincisor in themaxilla and/or acentral or lateralincisor in themandible.Mandibularcentral and lateralincisors must besplinted if usingtwo or more 3.3implants adjacentto one another. | chewing function.The DentalImplant System isindicated also forimmediate loadingwhen goodprimary stability isachieved and withappropriateocclusal loading.The 7mm implantsare intended to beused in the molarregion. | |
| ImplantDiameters | Maer 3.5, 3.75,4.2, 5.0, 6.0 mmRagil 3.3, 3.75, 4.2,5.0, 6.0 mmTCX 3.5, 4.3, 5.0mm NP = 3.5 RP = | OsseoLock 3.3,3.75, 4.2, 5.0,6.0mmOsseoPlus 3.5,3.75, 4.2, 5.0,6.0mm | Versatile Hex 3.5,3.75, 4.2, 4.5, 5.0,6.0mmImmediate Hex3.5, 3.75,4.2, 4.5,5.0, 6.0, 7.0mm |
| Fixation NarrowPlatform 3.0mmFixation RegularPlatform 3.5,3.9mmFixation WidePlatform 4.3,5.0mm | |||
| Implant Lengths | Maer 8, 10, 11.5,13,16mm (no16mm in 6.0mmdiameter)Ragil 8, 10, 11.5,13, and 16mm (no16mm in 5.0 or6.0mm diameter)TCX 8, 10, 11.5,13,16mm | 8, 10, 11.5, 13, 16(OsseoLock 5.0and 6.0 not in16mm) | Versatile Hex 8,10, 11.5, 13, 16,18 (4.2 only), 20(4.2 only)mmImmediate Hex 8(no 3.5 diameter)10, 11.5, 13,16mm 7.00diameter not in11.5, 13 or 16mm.Fixation NarrowPlatform 10, 11.5,13, 15mmFixation RegularPlatform 8.5, 10,11.5, 13, 15,18mmFixation WidePlatform 8.5, 10,11.5, 13, 15,18mmSolution5 NarrowPlatform 10,11.5,13, 15mmSolution5 RegularPlatform 3.5,4.0mmSolution5 WidePlatform 4.5, 5.0,5.5, 6.0mmSolution2 3.25mm |
| diameter only),8.5, 10, 11.5, 13,15mmSolution5 WidePlatform 7.0, 8.5,10, 11.5, 13,15mmSolution2 10,11.5,13 16mm | |||
| Material ofdevices includedin the submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Type of abutmentand maximumangulation | Pre-manufacturedof no more than30° | Pre-manufacturedof no more than30° | Pre-manufacturedof no more than30° |
| Interfacetype/shape | Internal hex,conical | Internal hex | Internal hex,conical |
| ISO 14801 FatigueTesting | Sufficient run outload for theirintended use | Sufficient run outload for theirintended use | Sufficient run outload for theirintended use |
| SurfaceTreatment | SLA | SLA | HA blasted anddouble acidetched |
| Post SurfaceTreatmentCleanlinessDemonstrated | Yes | Yes | Yes |
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| Cover screw | Cover screw for IHNP and RP | Cover Screw forIH | Cover screws NPand RP | Reference Device forindividual devices |
|---|---|---|---|---|
| Multi-UnitAbutments inIH, NP and RP | 4.8 mm diametermulti-units in IH,NP and RP withcuff heights of1,2,3,4,5mm | 4.5 mm multi-unitabutments inheights of 1,2,3and 4 mm | 5.00 mm multi-unit abutments inheights of 1,2,3and 4 mm | Straumann K171784straight multi-unit ingingival height of5.5mm |
| 17° and 30°Angled Multi-UnitAbutmentsIH, NP and RP | 17° and 30°Angled Multi-UnitAbutments IH, NPand RP withplatform heightsof 1,2 mm | 17° and 30°overdentureabutments inheights of 1,2,and 3 mm | 18° and 30° Multi-unit abutments inplatform heightsof 1,2,3 and 4 mm | |
| LocatorAbutmentswith metal | Double Loc /Conical Retentorattachments IH | 3.85mm diameterFlat abutment in | 3.85mm diameterLocatorabutments in | |
| housing andretention capallowing 20°divergence ofthe implants | (3.85mm), NP andRP (3.9mm)Cuff heights of 1,2, 3, 4, 5, 6 mm (5and 6 only in IH) | heights of 1,2,3,4,5, and 6 mm | heights of1,2,3,4,5, and6mm | |
| Ti6AL4V ELIhousing | Ti6AL4V ELIhousing | Ti6AL4V ELIhousing | ||
| Polyamide,polyether orpolyoxymethyleneretention cap withretention levelsfrom 0.6to 1.5 kg | Polyamide,polyether orpolyoxymethyleneretention cap withretention levelsfrom 0.6to 1.5 kg | Polyamide,polyether orpolyoxymethyleneretention cap withretention levelsfrom 0.6to 1.5 kg | ||
| Ballattachmentswith metalhousing andretention capallowing 14°divergence ofthe implants | ball attachmentsIH (4.00mmdiameter), NP(3.5mm diameter)and RP (5.0mmdiameter)Cuff heights of 2,3, 4, 5, 6, 7 mmfor IH and1.2.3.4.5.6 mmfor NP and RP | 4.00 mm Ballattachments inplatform heightsof 2,3,4,5, and6mm | 4.1 mm Ballattachments inheights of1,2,3,4,5, and6mm | |
| Stainless steel 316housing | Stainless steel 316housing | Polyamide orpolyetherretention cap withretention levelsfrom 0.5 to 2.7 kg | ||
| Polyamide orpolyetherretention cap withretention levelsfrom 0.5 to 1.3 kg | Polyamide orpolyetherretention cap withretention levelsfrom 0.5 to 2.7 kg | |||
| Healing Caps3.8mm | IH 3.8mmdiameter healingcap in 3,4,5,6,7mm cuff height3.75 diameter NPhealing cap in2,3,4,5 mm cuffheights | 3.8mm diameterHealing Cap in3,4,5,6,7 mmplatform height | Cortex DentalImplants K163385healing abutment3.8mm with 2mmplatform height | |
| Healing Caps4.6 diameterstandard | IH 4.5mmdiameter healingcap in 2,3,4,5,6,7mm cuff height | 4.5mm diameterHealing cap in2,3,4,5,6, andmm cuff height | 4.5mm diameterHealing cap in2,3,4,5,6mm | |
| Healing Caps5.5 diameter wide | 4.5 mm diameterRP healing capwith cuff heights2,3,4,5 mm. | 7mm platform height | ||
| IH 5.5mmdiameter healingabutment in2,3,4,5,6,7 mmcuff height | 5.5mm diameterHealing cap in2,3,4,5,6 and7mm platform height | |||
| Healing Cap6.3mm diameter | IH 6.3mmdiameter healingabutment in2,3,4,5 mm cuffheight | Wide emergencehealing cap in2,3,4,5,6mmheight | ||
| StraightAbutment | IH 4.5mmdiameterabutment withheights aboveplatform of 5,7,9,11,13,15 mmNP and RP 4.5mmdiameter withheights aboveplatform of 9 and13 mm | 4.9mm Non-shoulderedStandard TitaniumAbutment withheights of 5,7, 9,12, and 15 mm | ||
| StraightNarrowAbutment | IH 3.75mmdiameterabutment withtotal heights of5,7,9, 11 mm | IH 3.75mmdiameterabutment withtotal heights of5,7,9, 11 mm | ||
| Straight WideAbutment | IH 5.5mmdiameterabutment withtotal heights of9,11 or 13 mm | 5.5mm diameterabutment withtotal heights of9,11 or 13 mm | ||
| ShoulderAbutment | 4.5 diameter IH,NP, RP shoulderabutment withshoulder heightsof 1,2,3,4 mm (4only in IH)IH total heights of10.9, 11.9, 12.9, | 4.5mm diameterStandard WideShoulderAbutment withheights of 1,2,3,4mm and totalheights of 10.9,11.9, 12.9, 13.9 | 4.3mm diameterStandard WideShoulderAbutment withheights of 1,2,3,and 4mm andtotal heights of9.5, 10.5, 11.5, | |
| NP and RP totalheights of 11.8,12.6, and 13.6mm | 5.4mm diameterStandard Wideshoulderabutment withshoulder heightsof 1.2.3 mm andtotal heights of10.7, 11.7 and12.7mm | 6.9mm diameterwide emergenceabutment totalheights of5,7,9,12,15 mm | ||
| 5.4mm diameterIH shoulderabutment withshoulder heightsof 1.2.3.4 mm andtotal heights of10.7, 11.7, 12.17and 13.7 mm | ||||
| 15° AngledAbutment | 3.75mm diameterIH 15° angledabutment withtotal heights of 9or 11.4 mm | 3.5mm diameterStandard 15°Abutment withheights of 1,2,3mm | 3.75mm diameterStandard 15°Abutment withlengths of9,11,13mm | |
| 25° AngledAbutment | 3.75mm diameterIH 25° angledabutment withtotal height of 8.5mm | 3.5mm diameterStandard 25°Abutment withheights of 1,2,3mm | 3.75mm diameterStandard 25°Abutment withlengths of9,11,13mm | |
| Shouldered15° AngledAbutmentHex, ConicalNP, and RP | IH 3.75mmdiameter 15°Angled ShoulderAbutment withcuff heights of1,2,3,4 mm andheight above lowside of shoulder8,9,10,11 mmNP and RP 15°Angled ShoulderAbutment withcuff heights of1,2,3 mm andtotal heights of10.7, 12.2 and13.7 mm & 11, 12,13 mm | 3.75mm diameter15° AngledShoulderAbutment withcuff heights of1,2,3 mm andheight above lowside of shoulder8,9,10 mm | 3.75mm diameterAnatomicShoulderedStandard 15°Abutment withcollar heights of1,2, or 3mm | Cortex DentalImplants K163385angled abutmentanatomic/shouldered3.75mm with 4mmcollar |
| Shouldered25° AngledAbutmentHex, ConicalNP and RP | IH 3.75mmdiameter 25°Angled ShoulderAbutment withcuff heights of1,2,3,4 mm with | 3.75mm diameter25° AngledShoulderAbutment withcuff heights of1,2,3 mm with | 3.75mm diameterAnatomicShoulderedStandard 25°Abutment with | Cortex DentalImplants K163385angled abutmentanatomic/shouldered3.75mm with 4mmcollar |
| heights above platform of8.3,9.2,10.3,10.3 mmNP and RP 25°Angled ShoulderAbutment withcuff heights of1,2,3 mm withtotal heights of10.7, 12.2, and13.7 mm & 11, 12,13mm | heights above platform of8.3,9.2,10.3 mm | collar heights of1,2, or 3mm | ||
| UCLA Base Ti | 4.5mm diameterUCLA base inhexed | 4.5 mm diameterUCLA base hexed | 4.5mm hexed andnon-hexed |
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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.
§ 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.