(389 days)
TAV Medical 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 and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."
Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:
| Test/Characteristic | Acceptance Criteria (Implicit from Standards/Statements) | Reported Device Performance |
|---|---|---|
| Premarket Equivalence | Substantial equivalence to predicate devices in: Indications for Use, technological characteristics, mode of operation, performance specifications. Minor differences justified by testing and reference devices. | TAV Medical Dental Implant System is stated to be substantially equivalent to predicate devices (MIS Dental Implant System, Hahn Tapered Implant System, Noris Medical Dental Implant System, SGS Dental Implants System, AB DENTAL Devices Ltd., Implant Direct, Ditron Dental Ltd.) in all device features, indications for use, materials, dimensions (with minor differences justified by other predicate devices or testing), prosthetic connection, device features, and sterilization method. Minor differences in implant diameter, packaging, healing cap dimensions, and abutment materials (Zirconia) and duration of use (PEEK abutments) were addressed by referencing other predicate devices or conducting specific mechanical/biological tests with "satisfactory results." |
| Material Biocompatibility | Conformance to ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-18 (chemical characterization). FDA guidance "Use of International Standard ISO 10993-1" also followed. | "TAV Medical Dental Implant System products were tested and evaluated for materials biocompatibility... in order to demonstrate the biocompatibility of the system." (Implies successful demonstration). |
| Sterilization Validation | ANSI/AAMI/ISO 11137 parts 1 and 2 standards. Sterility Assurance Level (SAL) of 10^-6. All testing requirements met. | "Test results have demonstrated that the SAL of 10^-6 was achieved and all testing requirements were met." |
| Pyrogenicity | Acceptance criteria as required by USP <85> and <161>. | "Tested using LAL method with satisfactory results that met the acceptance criteria." |
| Shelf Life | Successful accelerated aging validation, followed by real-time shelf-life validation for 5 years. | "Accelerated aging have been applied on the final packaging followed by a real time shelf life aging validation for 5 years shelf life." (Implies successful validation for 5 years). |
| Human Factors Study | Safe handling of the sterile single unit packaging, meeting study criteria. | "The study's criteria were met and passed successfully. Positive feedbacks received from the users participated in the study." |
| Performance Testing | Meets design specifications and performs as intended, similar to predicate devices. Includes: Implant to abutment compatibility, Static and Dynamic fatigue testing (ISO 14801:2007), Corrosion testing (ASTM F746-04), Surface finish analysis, Zirconia Material testing (ISO 13356:2008). | "Descriptive information, laboratory bench testing, and biocompatibility testing are provided to demonstrate Tav Medical Dental Implant System meets its design specifications, performs as intended... The non-clinical testing results showed that the proposed dental implant system meet the device requirements and is considered equivalent to its predicate device." Specific tests mentioned performed with "satisfactory results" where material differences existed (e.g., Zirconia locker). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
- Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance
Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device.
7. The Type of Ground Truth Used
The "ground truth" for the TAV Medical Dental Implant System is based on:
- Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
- Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
- Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
- Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
- Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML medical device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
February 10, 2018
TAV Medical Ltd. Revital Shabtai General Manager - Dental Division Dora Industrial Park P.O. Box 88 Shlomi 2283202 ISRAEL
Re: K170131
Trade/Device Name: TAV Medical Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 1, 2018 Received: January 4, 2018
Dear Revital Shabtai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
TAV Medical Dental Implant System
Indications for Use (Describe)
TAV Medical 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 and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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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Image /page/3/Picture/0 description: The image shows the logo and contact information for Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. The phone number is 972-4-9808615, and the fax number is 972-4-9808356. The website is www.tavmedical.com, and the email address is info@tavmedical.com.
Image /page/3/Picture/1 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the letters "TAV" in bold black font next to it. The word "Medical" is written in a light green, sans-serif font. Below the company name is the tagline "PRECISION, PASSION, PARTNERSHIP" in a smaller, lighter font.
510(K) Summary for TAV Medical Dental Implant System
510(K) Number: K170131
Applicant's Name:
TAV Medical Ltd.
Dora Industrial Park P.O.B 88, Shlomi 2283202 Israel T +972 (4) 9808615/503 F +972 (4) 9808356 E-mail: info@TAVmedical.com
| Contact Person: | Revital Shabtai |
|---|---|
| TAV Medical Ltd. | |
| Dora Industrial Park | |
| P.O.B 88, Shlomi 2283202 | |
| Israel | |
| T +972 (4) 9808615/503 | |
| F +972 (4) 9808356 | |
| E-mail: revitals@TAVmedical.com |
Date Prepared: 10 February 2018
Trade Name: TAV Medical Dental Implant System
Classification Name: Implant, Endosseous, Root-Form
Medical Specialty: Dental
Product Code: DZE (primary), NHA (secondary)
Device Class: Class II
Regulation Number: Primary 872.3640
Review Panel: Dental
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Image /page/4/Picture/0 description: The image shows the contact information for Tav Medical Ltd. Their VAT registration number is 511513673. Their address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. Their phone number is 972-4-9808615 and their fax number is 972-4-9808356. Their website is www.tavmedical.com and their email address is info@tavmedical.com.
Image /page/4/Picture/1 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the letters "TAVMedical" to the right of it. The "Medical" portion of the name is in green. Below the name is the tagline "PRECISION, PASSION, PARTNERSHIP" in a smaller font.
Predicate Devices
TAV Medical Dental Implant System including Implants and Abutments are substantially equivalent to the following Predicate Devices, divided to primary and reference devices:
| Device Owner /Trade name | Primary Predicate Device510(k) number | Product code |
|---|---|---|
| MIS DentalImplant System | K040807 | DZE (primary) and NHA(secondary) |
The following devices are used as reference devices:
| Device Owner /Trade name | Reference device 510(k)number | Product code |
|---|---|---|
| MIS DentalImplant System | K112162 | DZE (primary) and NHA(secondary) |
| Hahn TaperedImplant System | K143353 | DZE |
| Noris MedicalDental ImplantSystem | K140440 | NHA |
| SGS DentalImplants System | K133362 | NHA |
| AB DENTALDevices Ltd. | K132125 | NHA |
| Implant Direct | K143011 | NHA |
| Ditron Dental Ltd. | K140728 | DZE |
Indications for Use
TAV Medical 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 and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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Image /page/5/Picture/0 description: The image shows the logo and contact information for Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 228320. The phone number is 972-4-9808615 and the fax number is 972-4-9808356. The website is www.tavmedical.com and the email address is info@tavmedica.
Image /page/5/Picture/1 description: The image contains the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the letters "TAV" in bold black font to the right of the shape. The word "Medical" is written in a light green font to the right of "TAV". Below the company name is the slogan "PRECISION. PASSION. PARTNERSHIP" in a smaller font.
Implant Description
TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments.
The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses.
TAV Medical implants include the following brands:
Silhouette
A Cylindrical-apically tapered screw type implant. The implant has a self-tapping design and a progressive thread. The Silhouette internal profile varies depending on the implant length. The internal core of the implant has a tapered shape. Silhouette implants are designed with:
- Platform switching design over the implant top geometry. ●
- Implant outer surface achieved by sand blasting and acid etching processes ●
- Cylindrical Implant Body in its apical region ●
- Self-Tapping design ●
- The implant is recommended for bone types: D1, D2 and D3. ●
- The implants are suitable for both one and two stage implant procedures. . Silhouette implant is designed in two platforms: Narrow Platform (NP)
- . Internal Hex Connection 2.41mm
- Available in the following dimensions: ● Diameter: 3.3mm Lengths: 10mm, 11.5mm, 13mm and 16mm
Standard Platform (SP):
- Internal Hexagon for anti-rotation 2.44mm ●
- available in the following dimensions: . Diameters: 3.75mm, 4.2mm, 5mm, and 6mm Lengths: 8mm, 10mm, 11.5mm, 13mm and 16mm
Sirius
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Image /page/6/Picture/0 description: The image contains two identical logos, each featuring a stylized eye symbol enclosed within a triangle. The eye symbol is detailed with concentric circles, suggesting a focus or lens. The logos are stacked vertically, creating a repetitive pattern. The overall design is simple and modern, likely representing vision, focus, or observation.
VAT registration number 511513673
Dora Industrial Park, P.O.B 88, Shlomi 2283202
Tel: 972-4-9808615 Fax: 972-4-9808356
Image /page/6/Picture/3 description: The image is a logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the text "TAVMedical" to the right of it. The word "Medical" is in a lighter green color than the rest of the text. Below the text is the tagline "PRECISION. PASSION. PARTNERSHIP" in a smaller font.
TAV Medical Sirius implants has a tapered apex with three cutting notches which makes the implant's rough surface extends from bottom to the top of the implant. The internal core of the implant has a tapered shape. Sirius implants are designed with:
- Platform switching design on the implant top geometry .
- Additional two starts on the coronal region ●
- Deep micro thread at the coronal region ●
- Implant outer surface achieved by sand blasting and acid etching ●
- . Self-Tapping design
- The implant is recommended for bone types: D2, D3 and D4. ●
- Apically tapered implant body ●
- The implants are suitable for both one and two stage implant procedures. . Sirius implant is designed in two platforms:
Narrow Platform (NP):
- Internal Hex Connection 2.41mm
- · available in the following dimensions: Diameter: 3.3mm
Lengths: 10mm, 11.5mm, 13mm and 16mm Standard Platform (SP):
- Internal Hexagon for anti-rotation 2.44mm ●
- . available in the following dimensions: Diameters: 3.75mm, 4.2mm, 5mm, and 6mm Lengths: 8mm, 10mm, 11.5mm, 13mm and 16mm
iCone
Conical Connection implants which merges cylindrical body with a conical connection. iCone implants are available in a versatile range of diameters and lengths and in two platforms, Standard and Wide platforms that are color coded for easy identification. The implants are suitable for both one and two stage implant procedures. iCone implants are designed with:
- 11° cone at the interior of the implant .
- Internal Hexagon features 6 indexing positions .
- . Platform switching design
- Micro threads in top coronal section ●
- Double Thread Design ●
- The implant is recommended for bone types: D1, D2 and D3. ●
- Implant outer surface achieved by sand blasting and acid etching . iCone implant is designed in two platforms:
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Image /page/7/Picture/0 description: The image shows a logo with a stylized house shape and the text "Tav" above the text "VAT". The house shape is a simple outline with a triangular roof and a rectangular base. The text is in a simple, sans-serif font.
VAT registration number: 511513673
Image /page/7/Picture/3 description: The image shows the address "Dora Industrial Park, P.O.B 88, Shlomi 2283202". The address is written in a simple, sans-serif font. The text is clear and legible, making it easy to read the address information.
Tel: 972-4-9808615 Fax: 972-4-9808356
www.tavmedical.com @ info@tavmedical.com
Image /page/7/Picture/5 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in shades of gray and green, followed by the text "TAVMedical" in black and green. Below the company name is the tagline "PRECISION, PASSION, PARTNERSHIP" in a smaller font size.
Standard Platform (SP):
- Internal Hex Connection 2.10mm
- · Available in the following dimensions: Diameters: 3.75mm and 4.2mm Lengths: 8mm, 10mm, 11.5mm, 13mm and 16mm
Wide Platform (WP):
- Internal Hexagon for anti-rotation 2.50mm ●
- Available in the following dimensions: . Diameters: 4.5mm and 5mm. Lengths: 9mm, 11.5mm, 13mm and 16mm.
Abutments Description
TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only.
TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI.
The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use.
Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment.
The prosthetic parts are divided into 3 main categories:
- Cemented retained restorations .
- Screw retained restorations .
- Overdenture retained 트
The appropriate abutment type is selected in relation to the tooth position for the proposed implant. Various abutment types are available:
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Image /page/8/Picture/0 description: The image contains two identical symbols, each featuring a triangle with a circle inside. Within the circle, there's a smaller, detailed design that resembles a stylized eye or a complex geometric pattern. The symbols are simple and monochromatic, suggesting they might be part of a logo, a warning sign, or an icon set.
v Medical Ltd.
Dora Industrial Park, P.O.B 88, Shlomi 2283202
Tel: 972-4-9808615 Fax: 972-4-9808356.
Image /page/8/Picture/3 description: The image is a logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the text "TAVMedical" to the right of it. The word "TAV" is in black, while "Medical" is in green. Below the text is the phrase "PRECISION, PASSION, PARTNERSHIP" in a smaller font.
Titanium Abutments
TAV Medical Titanium Abutments are intended to be placed into TAV Medical implants of different types, diameter, lengths and platforms to provide support for prosthetic reconstructions such as crowns and bridges.
Temporary Esthetic PEEK Abutments
TAV Medical temporary PEEK abutments are intended to be used with TAV Medical Implants to provide support for individual temporary crowns and are for use of a maximum duration of 180 days.
Ball attachment
The ball attachment system is intended to secure a removable prosthesis in a complete or partial restoration by endosseous implants in the mandible or in the maxilla. The ball attachment includes a metal housing and retention caps offering retention for every individual situation. The ball attachments are made of full Titanium.
Locker overdenture
The Locker, commonly known in the market as "Locator""", is a Zirconia (ZrO2) overdenture attachment system designed for use with dentures-retained in whole or in parts by endosseous implants in the mandible or in the maxilla. The locker includes a titanium denture cap and retentive caps with customizable levels of retention for multi-unit restorations in full overdentures. The locker is supplied made out fully from zirconia or partially zirconia attached to a titanium base.
Healing caps
Healing caps are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of transmucosal healing protocol.
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Image /page/9/Picture/0 description: The image shows the logo and contact information for Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. The telephone number is 972-4-9808615, and the fax number is 972-4-9808356. The website is www.tavmedical.com, and the email address is info@tavmedical.com.
Image /page/9/Picture/1 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, followed by the text "TAVMedical" in a sans-serif font. The "Medical" portion of the text is in a lighter green color. Below the text, there is a tagline that reads "PRECISION, PASSION, PARTNERSHIP" in a smaller font.
Substantial Equivalence discussion
The proposed TAV Medical Dental Implant System has the same indications for technological characteristics, mode of operation and performance use. specifications as its predicates devices.
Both the proposed device and the predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.
The following table summarizes the equivalence comparison between TAV Medical Dental Implants, its primary predicate device and its reference devices.
Substantial Equivalence Table - Implants
| Feature | TAV Medical[K170131]SubjectDevice | MIS(K040807)primary | MIS(K112162)reference | Hahn(K143353)reference |
|---|---|---|---|---|
| Trade Name: | Sirius | Seven (internalhex) | Hahn TaperedImplant System | |
| Silhouette | M4 (internal hex) | |||
| iCone | Conicalconnection | |||
| K# | K170131 | K040807(Internal Hex –Seven & M4) | K0112162(ConicalConnection) | K143353 |
| Product Code | DZE | DZE | DZE | DZE |
| Manufacturer | TAV Medical Ltd. | MIS ImplantTechnologies Ltd. | MIS ImplantTechnologies Ltd. | Prismatikdentalcraft, inc |
| DeviceDescription | SiriusTitanium dentalimplant withapically taperedbody (conicalshape body) | SevenTitanium dentalimplant withapically taperedbody (conicalshape body) | The HahnTapered ImplantSystem consistsof dentalimplants,abutments, | |
| Feature | TAV Medical[K170131]SubjectDevice | MIS(K040807)primary | MIS(K112162)reference | Hahn(K143353)reference |
| SilhouetteTitanium implantbody combines acylindricalshape in its apicalregion and aconical shape inthe coronalregion | M4Titanium implantbody combines acylindrical shapein its apicalregion and aconical shape inthe coronalregion | screws, andsurgicalinstruments. Theyare manufacturedfrom Titaniumalloy, grade 23.The implant isdesigned with aninternal hexconnection and atapered body toreplace one ormore missingteeth. | ||
| iConeConicalconnection | Conicalconnection | |||
| Indicationsfor Use | The TAV MedicalDental ImplantSystem isindicated for usein surgical andrestorativeapplications forplacement in thebone of theupper or lowerjaw to providesupport forprostheticdevices, such asartificial teeth, inorder to restorethe patientchewing function.The TAV MedicalDental ImplantSystem isindicated also forimmediateloading whengood primarystability isachieved andwith appropriateocclusal loading | The MIS DentalImplant Systemare intended tobe surgicallyplaced in thebone of theupper or lowerjaw arches toprovide supportfor prostheticdevices, such asartificial teeth, inorder to restorethe patient'schewing function. | The MIS DentalImplant Systemare intended tobe surgicallyplaced in thebone of theupper or lowerjaw arches toprovide supportfor prostheticdevices, such asartificial teeth, inorder to restorethe patient'schewing function.When a onestage surgicalprocedure isapplied, theimplant may beimmediatelyloaded whengood primarystability isachieved and thefunctional load isappropriate | Hahn Implantsare indicated foruse in maxillaryand mandibularpartially or fullyedentulous cases,to support single,multiple-unit, andoverdenturerestorations. Theimplants are tobe used forimmediateloading only inthe presence ofprimary stabilityand appropriateocclusal loading. |
| Feature | TAV Medical[K170131]SubjectDevice | MIS(K040807)primary | MIS(K112162)reference | Hahn(K143353)reference |
| Material | Titanium Alloy –Ti 6AL4V ELI | Titanium Alloy –Ti 6AL4V ELI | Titanium Alloy –Ti 6AL4V ELI | Titanium Alloy –Ti 6AL4V ELI |
| Diameter(mm) | Sirius &Silhouette3.3, 3.75, 4.2, 5,6iCone3.75, 4.2, 4.5 , 5 | Seven & M43.3, 3.75, 4.2 5 | Conicalconnection3.75, 4.2, 5 | 3.0, 3.5, 4.3, 5.0,and 7.0 |
| Length(mm) | Sirius &Silhouette8, 10, 11.5, 13,16ICone8, 9, 10, 11.5,13, 16 | Seven & M48, 10, 11.5, 13,16mm | Conicalconnectionimplans8, 10, 11.5, 13,16mm | 8, 10, 11.5, 13,and 16 |
| ProstheticConnection | Sirius &SilhouetteInternal HexiConeConical | Seven & M4Internal Hex | Conicalconnection | Internal Hex |
| Devicefeatures | Screw type | Screw type | Screw type | Screw type |
| Surfacetreatment | Sirius &SilhouetteSandblasting andacid etchingiConeSandblasting andacid etching &anodized | Seven & M4Sandblasting andacid etching &anodized | Sandblasting andacid etching &anodized | Blasted withHydroxylApatit |
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Image /page/10/Picture/0 description: The image contains two identical symbols, each consisting of a triangle with a circle inside. The circle within each triangle has a smaller, darker circle at its center. The symbols are simple and appear to be icons or logos, possibly related to water or nature due to the teardrop shape of the triangle.
Tav Medical Ltd.
VAT registration number: 511513673
Dora Industrial Park, P.O.B 88, Shlomi 2283202.
Tel: 972-4-9808615 Fax: 972-4-9808356 网 www.tavmedical.com @ info@tavmedical.com
Image /page/10/Picture/5 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in shades of gray and green, followed by the text "TAVMedical" in black and green. Below the company name is the text "PRECISION. PASSION. PARTNERSHIP" in a smaller font.
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Image /page/11/Picture/0 description: The image shows two triangular warning signs. The top sign has a symbol inside the triangle, while the bottom sign is a plain triangle. The signs are white with a red border.
Tav Medical Ltd.
VAT registration number: 511513673
Dora Industrial Park, P.O.B 88, Shlomi 2283202.
Tel: 972-4-9808615 Fax: 972-4-9808356
网 www.tavmedical.com @ info@tavmedical.com
Image /page/11/Picture/6 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the text "TAVMedical" to the right. The word "Medical" is in a lighter green color. Below the text is the phrase "PRECISION, PASSION, PARTNERSHIP" in smaller letters.
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Image /page/12/Picture/0 description: The image shows two logos. The top logo features a triangle with a circle inside, and a smaller circle inside that. The bottom logo is a simple triangle. The text next to the logos is cut off, so it is not possible to determine what the logos represent.
VAT registration number: 51.151.3673
Dora Industrial Park, P.O.B 88, Shlomi 228320
Tel: 972-4-9808615 Fax: 972-4-9808356
.tavmedical.com @ info@tavmedical.com
Image /page/12/Picture/5 description: The image contains the logo for TAVMedical. The logo consists of a stylized geometric shape in shades of gray and green, followed by the text "TAVMedical" in a combination of black and green. Below the company name, there is a tagline that reads "PRECISION. PASSION. PARTNERSHIP" in a smaller, sans-serif font.
| Feature | TAV Medical[K170131]SubjectDevice | MIS(K040807)primary | MIS(K112162)reference | Hahn(K143353)reference |
|---|---|---|---|---|
| Components | TAV MedicalDental ImplantsSystem consistsof one and twostage endosseousform dentalimplants, internalhexagonal andconicalconnection; coverscrews andhealing caps;abutmentsystems &superstructures;surgicalinstruments. | The MIS DentalImplant Systemconsists of oneand two stageimplants, internaland externalhexagonal,conical; coverscrew andhealing caps;abutmentsystems andsuprastructures;surgicalinstruments. | The MIS DentalImplant Systemconsists of oneand two stageimplants, internaland externalhexagonal,conical; coverscrew andhealing caps;abutmentsystems andsuprastructures;surgicalinstruments. | The implant isdesigned with aninternal hexconnection and atapered body toreplace one ormore missingteeth.The Implants aredesign with two(2) platformconnectiongeometries |
| SterilePackage | Sterile barriertube with innersealed sleeve | Double containersealing system | Double containersealing system | Single blister,unsealed innerholder |
| Sterilization | Gamma | Gamma | Gamma | Gamma |
| method | irradiation | irradiation | irradiation | irradiation |
| Intended Use | Dental Clinic | Dental Clinic | Dental Clinic | Dental Clinic |
| Environment | Setting | Setting | Setting | Setting |
| Abutments | Straight and | Straight and | Straight and | Straight and |
| angulated | angulated | anqulated | anqulated |
Substantial equivalence discussion: As shown in the table above, TAV Medical Dental implant System is Substantial equivalent in all devices' features. The only difference is in the maximal outer diameter of the proposed device versus the maximal outer diameter of the primary predicate device. This slight difference was bridged using K143353 which was cleared with up to 7.0 mm outer diameter.
TAV Medical's single sterile package slightly differs from the primary predicate device. While the MIS dental implant system contains two tubes and sleeve, TAV Dental's packaging contains one tube and an inner sealed sleeve. This difference was bridged using K140728 which utilizes the same packaging as TAV Medical and same sealing design.
There are no additional differences, thus it was concluded that the subject dental implant system is substantially equivalent with the predicate devices.
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Image /page/13/Picture/0 description: The image shows the logo and contact information for Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, POB 88, Shlomi 2283202. The phone number is 972-4-9808615, and the fax number is 972-4-9808356. The website is www.tavmedical.com, and the email address is info@tavmedical.com.
Image /page/13/Picture/1 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the text "TAVMedical" to the right of it. The word "Medical" is in a lighter green color. Below the company name is the tagline "PRECISION, PASSION, PARTNERSHIP" in a smaller font.
Substantial Equivalence - Abutments
TAV Medical abutments, similarly to its predicate devices, are intended to be placed in implants of different types, diameter, lengths and platforms to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
The differences between the proposed TAV Medical Abutments and the predicate devices are minor and are reflected only in the abutments' dimensions and in the addition of the Zirconia material to some of the abutment types. These differences were tested and evaluated and no issues affecting device performances were detected. Thus it was concluded that the subject dental implant system abutments is substantially equivalent with the predicate devices
| Feature | TAV Medical | MISprimary | Noris Medicalreference |
|---|---|---|---|
| Product Code | NHA | NHA | NHA |
| K# | K170131 | K112162, K040807 | K140440 |
| Product Name | Titanium Healing Cap | Titanium Healing Cap | Titanium Healing Cap |
| ProductDescription | Used to allow thegingiva to heal aroundthe Gingiva | Used to allow thegingiva to heal aroundthe Gingiva | Used to allow thegingiva to heal aroundthe implant |
| Material | Titanium Alloy+Anodize | Titanium Alloy+Anodize | Titanium Alloy |
| Diameter(mm) | 3.8, 4, 4.5, 4.7, 5, 5.5,6.5 | 4, 4.3, 4.8, 5, 5.5, 6.5 | 3.8, 4.6 ,5.5 ,6.3 |
| Height (mm) | 2, 3, 4, 5, 6 | 2, 3, 4, 5, 6, 8 | 2, 3, 4, 5, 6, 7 |
| Angle (°) | 0 | 0 | 0 |
| sterility | Non Sterile | Sterile | Non Sterile |
Titanium Healing Cap
Substantial equivalence discussion: As shown in the table above, TAV Medical titanium healing caps are Substantial equivalent in all features. A minor difference exists in the diameter dimensions however this difference is not significant since all subject device diameters are within the predicate devices dimensions range. One more difference exists in terms of sterility condition. This difference is covered by the reference device which is provided non-sterile similarly to TAV Medical titanium healing cap. Like in the predicate devices the
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Image /page/14/Picture/0 description: The image shows the logo and contact information for Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. The telephone number is 972-4-9808615 and the fax number is 972-4-9808356. The website is www.tavmedical.com and the email address is info@tavmedical.com.
Image /page/14/Picture/1 description: The image shows the logo for TAVMedical. The logo consists of a stylized geometric shape in shades of gray and green, followed by the text "TAVMedical" in a combination of black and green. Below the company name is the tagline "PRECISION. PASSION. PARTNERSHIP" in a smaller, sans-serif font.
healing cap is screwed into the implant directly in trans-mucosal healing protocol. Cover screw is used in submucosal healing protocol.
| Feature | TAV Medical | MIS | Noris Medical |
|---|---|---|---|
| Product Code | NHA | NHA | NHA |
| K# | K170131 | K112162, K040807 | K140440 |
| Product Name | Zirconia Healing Cap | Titanium Healing Cap | Titanium Healing Cap |
| ProductDescription | Used to allow thegingiva to heal aroundthe gingiva | Used to allow thegingiva to heal aroundthe gingiva | Used to allowthegingiva to heal aroundthe implant |
| Material | Zirconia | Titanium Alloy +Anodize | Titanium Alloy |
| Diameter (mm) | 4, 4.7, 5.5 | 4, 4.3, 4.8, 5, 5.5, 6.5 | 3.8, 4.6 ,5.5 ,6.3 |
| Height (mm) | 2, 3, 4, 5, 6 | 2, 3, 4, 5, 6, 8 | 2, 3, 4, 5, 6, 7 |
| Angle (°) | 0 | 0 | 0 |
| Sterility | Non Sterile | Sterile | Non Sterile |
Zirconia Healing Cap
Substantial equivalence discussion: As shown in the table above, TAV Medical zirconia healing caps are Substantial equivalent since it is the same in most features. The only features that differ from the subject device are material and sterility conditions. In terms of materials TAV Medical healing cap is made of zirconia while titanium is utilized for the predicate devices healing caps. In order to assure that this difference does not compromise the subject device performance, thorough mechanical and biological tests were performed with satisfactory results.
In terms of sterility condition, this difference was covered by the reference device which is provided non-sterile similarly to TAV Medical zirconia healing cap.
| Feature | TAV Medical | MIS |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K170131 | K112162, K040807 |
| Product Name | TAV Healing Cap | Plastic healing cap |
| Product | Used to allow the gingiva to heal | Used to allow the gingiva to heal |
| Description | around the gingiva | around the gingiva |
| Material | PEEK | PEEK |
| Height (mm) | 4, 6, 8 | 4, 6, 8 |
| Sterility | Non sterile | Non sterile |
PEEK Healing cap
Substantial equivalence discussion: As shown in the table above, TAV Medical PEEK healing caps are substantial equivalent in all features.
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Image /page/15/Picture/0 description: The image contains the text "Tav Medical Ltd.". The text appears to be a company name. The text is in a simple, sans-serif font and is left-aligned.
Image /page/15/Picture/1 description: The image shows the VAT registration number and address. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 228320.
Image /page/15/Picture/3 description: The image shows the logo for TAVMedical. The logo consists of a stylized geometric shape in shades of gray and green, followed by the text "TAVMedical" in a bold, sans-serif font. The "Medical" portion of the name is in a lighter green color. Below the name is the tagline "PRECISION. PASSION. PARTNERSHIP" in a smaller, lighter font.
Titanium Abutments, Straight
| Feature | TAV Medical | MIS |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K170131 | K112162, K040807 |
| Product Name | Titanium Abutments | Titanium Abutments |
| Product | An accessory to endosseous dental | An accessory to endosseous dental |
| Description | implants to support a prosthetic | implants to support a prosthetic |
| device | device | |
| Material | Titanium Alloy + Anodized | Titanium Alloy + Anodized |
| Diameter (mm) | 3.8, 4.8, 5.2, 5.5 | 4.8, 5.5, 5.6, 5.8, 6.3 |
| Height (mm) | 0.5, 1, 2, 3 | 1, 2, 3 |
| Length (mm) | 7, 7.5, 9, 10, 11 | 7, 7.5, 8 |
| Angle (°) | 0 | 0 |
| Sterility | Non Sterile | Non Sterile |
Titanium Abutments, Angulated
| Feature | TAV Medical | MIS |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K170131 | K112162, K040807 |
| Product Name | Titanium Abutments | Titanium Abutments |
| Product Description | An accessory to endosseous dental implants to support a prosthetic device | An accessory to endosseous dental implants to support a prosthetic device |
| Material | Titanium Alloy + Anodize | Titanium Alloy + Anodize |
| Diameter (mm) | 3.8, 4.8, 5.0, 5.5 | 4, 4.8, 4.9, 5.2, 5.5, 5.6, 5.8, 5.9 6 |
| Height (mm) | 0.5, 1, 2, 3 | 1, 2, 3 |
| Length (mm) | 6, 7, 8, 9 | 7, 7.3, 7.5, 8 |
| Angle (°) | 12, 15, 20, 25 | 10, 15, 20, 25 |
| Sterility | Non Sterile | Non Sterile |
Substantial equivalence discussion: As shown in the table above, TAV Medical Titanium abutments are substantial equivalent in all features. Minor difference in the angulated abutment lengths is not significant and covered by the mechanical tests performed by TAV Medical with satisfactory results.
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Image /page/16/Picture/0 description: The image contains the text "Tav Medical Ltd.". The text is in a sans-serif font and is black. The background is white.
VAT registration number 511513673
Image /page/16/Picture/2 description: The image shows the address "Dora Industrial Park, P.O.B 88, Shlomi 2283202". The text is in a simple, sans-serif font and is left-aligned. The background is plain and light, providing good contrast for the text.
Tel: 972-4-9808615 Fax: 972-4-9808356
Image /page/16/Picture/5 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, followed by the text "TAVMedical" in a sans-serif font. The "Medical" portion of the text is in a lighter green color. Below the text, there is a tagline that reads "PRECISION. PASSION. PARTNERSHIP." in a smaller font.
PEEK Temporary Abutments, Straight
| Feature | TAV Medical | SGS | A.B DentalDevices Ltd. |
|---|---|---|---|
| Product Code | NHA | NHA | NHA |
| K# | K170131 | K 133362 | K132125 |
| Product Name | PEEK TemporaryAbutments | Anatomic straight peekabutments | TemporaryAnatomic AntiRotation Abutment |
| ProductDescription | Temporary restorationup to 180 days | Temporary restorationup to 30 days | Temporaryrestoration |
| Material | PEEK CLASSIX | PEEK CLASSIX | PEEK CLASSIX |
| Diameter (mm) | 5.5 | 5.5 | 4.7 |
| Height (mm) | 1, 2, 3 | 1,2,3mm | 1,2,3mm |
| Length (mm) | 8, 11 | 9 mm | 7.5mm |
| Angle (°) | 0 | 0 | 0 |
| Sterility | Non Sterile | Non Sterile | Non Sterile |
PEEK Temporary Abutments, Angulated
| Feature | TAV Medical | A.B Dental Devices LTD |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K170131 | K132125 |
| Product Name | PEEK Temporary Abutments | Temporary Anatomic AntiRotation Abutment |
| Product Description | Temporary restoration up to 180 days | Temporary restoration |
| Material | PEEK CLASSIX | PEEK CLASSIX |
| Diameter (mm) | 5.5 | 4.7 |
| Height (mm) | 1, 2, 3 | 1, 2, 3mm |
| Length (mm) | 7, 6, 10 | 9 mm |
| Angle (°) | 15, 25 | 15,25 |
| Sterility | Non Sterile | Non Sterile |
Substantial equivalence discussion: As shown in the table above, TAV Medical PEEK abutments are Substantial equivalent in most features. The difference in duration of use is that TAV Medical uses the INVIBIO PEEK-CLASSIX™ Polymer for dental applications of up to 180 days conforming to INVIBIO recommendations. TAV Medical has performed mechanical testing to evaluate the performance of its PEEK abutment to duration of 180 days with satisfactory results. Minor differences in the length are not significant and were covered by mechanical tests performed with satisfactory results.
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Image /page/17/Picture/1 description: The image contains information about Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. The telephone number is 972-4-9808615 and the fax number is 972-4-9808356. The website is www.tavmedical.com and the email address is info@tavmedical.com.
Image /page/17/Picture/2 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape on the left, followed by the text "TAVMedical" in a sans-serif font. The "Medical" part of the name is in a lighter green color. Below the name, there is the text "PRECISION, PASSION, PARTNERSHIP" in a smaller font.
| Feature | TAV Medical | MIS |
|---|---|---|
| Product Code | NHA | NHA |
| K# | To be assigned | K112162, K040807 |
| Product Name | Ball Attachment | Ball Attachment |
| Product | Removable (overdenture) | Removable (overdenture) |
| Description | restorations | restorations |
| Material | Titanium Alloy + Anodize | Titanium Alloy + Anodize |
| Diameter (mm) | 2.5 | 2.25 |
| Height (mm) | 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5 |
| Angle (°) | 0 | 0 |
| Sterility | Non Sterile | Non Sterile |
Ball Attachment Abutment
The Ball attachment is also supplied as a kit containing a complementary metal housing, plastic caps and impression coping parts.
Substantial equivalence discussion: As shown in the table above, TAV Medical ball attachment abutments are substantial equivalent in all features.
Locker abutment
TAV Medical Zirconia locker abutment is supplied in two different configurations:
| Locker type | Material |
|---|---|
| TAV Zirconia Locker full Zirconia body(Including a screw) | Zirconia (Screw is made of Titanium) |
| or, | |
| Zirconia body Locker with a titanium base.(Including a screw) | Zirconia & Titanium(Screw is made of Titanium) |
TAV Zirconia locker full Zirconia body
| Feature | TAV Medical | MIS |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K170131 | K112162, K040807 |
| Product Name | Zirconia Locker | Locator |
| Product Description | Removable attachment system | Removable attachment system |
| Material | Zirconia | Titanium Nitride Coated Titanium |
| Height (mm) | 0, 1, 2, 3, 4, 5, 6 | 0, 1, 2, 3, 4, 5, 6 |
| Angle (°) | 0 | 0 |
| Sterility | Non Sterile | Non Sterile |
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Image /page/18/Picture/0 description: The image shows two icons. The top icon features a droplet shape with a circular design inside, possibly representing water or liquid. Below it, there's a triangular icon, which could symbolize direction, stability, or a warning sign, depending on the context.
VAT registration number: 511513673
Image /page/18/Picture/3 description: The image shows the address of Dora Industrial Park, which is located at P.O.B 88, Shlomi, 2283202. The text is in a simple, sans-serif font and is easy to read. The address is likely for a business or organization located in the Dora Industrial Park.
Tel: 972-4-9808615 Fax: 972-4-9808356
Image /page/18/Picture/5 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in the upper left corner, with the text "TAVMedical" to the right of it. The text "PRECISION, PASSION, PARTNERSHIP" is located below the company name.
| Feature | TAV Medical | MIS |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K170131 | K112162, K040807 |
| Product Name | Zirconia Locker | Locator |
| Product Description | Removable attachment system | Removable attachment system |
| Material | Zirconia , Titanium | Titanium Nitride Coated Ti |
| Height (mm) | 2, 3, 4, 5, 6 | 0, 1, 2, 3, 4, 5, 6 |
| Angle (°) | 0 | 0 |
| Sterility | Non Sterile | Non Sterile |
TAV Zirconia Locker with Titanium base
The locker is also supplied as a kit containing a complementary metal housing, plastic caps and impression coping parts.
Substantial equivalence discussion: As shown in the table above. TAV Medical Locker abutments are substantial equivalent most features. The only feature that differs from the subject device is the material. In terms of materials TAV Medical Locker is made of zirconia while titanium is utilized for the predicate device. In order to assure that this difference does not compromise the subject device performance, thorough mechanical and biological tests were performed with satisfactory results.
Non clinical testing
Biocompatibility
TAV Medical Dental Implant System products were tested and evaluated for materials biocompatibility according to ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Requirements and according to the corresponding FDA guidance: "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" in order to demonstrate the biocompatibility of the system.
Sterilization validation and shelf life
Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137 parts 1 and 2. Test results have demonstrated that the SAL of 10 ° was achieved and all testing requirements were met.
Pyrogenicity of the sterile provided devices was tested using LAL method with satisfactory results that met the acceptance criteria as required by USP <85> and <161>.
Accelerated aging have been applied on the final packaging followed by a real time shelf life aging validation for 5 years shelf life.
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Image /page/19/Picture/0 description: The image shows the logo and contact information for Tav Medical Ltd. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. The phone number is 972-4-9808615 and the fax number is 972-4-9808356. The website is www.tavmedical.com and the email address is info@tavmedical.com.
Image /page/19/Picture/1 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in shades of gray and green, followed by the text "TAVMedical" in black and green. Below the company name is the tagline "PRECISION, PASSION, PARTNERSHIP" in a smaller font size.
Human Factors Study
Human factors study was performed in order to evaluate the safe handling of the sterile single unit packaging. The study's criteria were met and passed successfully. Positive feedbacks received from the users participated in the study.
Performance Testing
TAV Medical Dental Implant System performance bench testing was specified through the application of a risk analysis driven process. As part of this process the forces and operating conditions the device is exposed to during the procedure were evaluated and analyzed, and as a result the required bench tests were derived.
In addition, applicable FDA quidance and other consensus standards were reviewed for determining required bench testing. Bench testing was performed to demonstrate that the TAV Medical Dental Implant System meets existing acceptance criteria similar to other predicate devices. The device does not require EMC and Electrical Safety evaluation.
Descriptive information, laboratory bench testing, and biocompatibility testing are provided to demonstrate Tav Medical Dental Implant System meets its design specifications, performs as intended. The system was evaluated through design verification testing including the following: Implant to abutment compatibility testing, Static and Dynamic fatigue testing, Corrosion testing, Surface finish analysis & Zirconia Material testing.
The non-clinical testing results showed that the proposed dental implant system meet the device requirements and is considered equivalent to its predicate device. The subject devices and the predicate device share the same intended use and technological characteristics.
Animal Testing
No Animal studies were performed.
Clinical testing
No clinical studies were performed.
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Image /page/20/Picture/0 description: The image contains the text "Tav Medical Ltd.". The text is in a simple, sans-serif font. The text appears to be a company name.
Image /page/20/Picture/1 description: The image shows the contact information for a company. The VAT registration number is 511513673. The address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. The telephone number is 972-4-9808615, and the fax number is 972-4-9808356. The website is www.tavmedical.com, and the email address is info@tavmedical.com.
Image /page/20/Picture/2 description: The image shows the logo for TAVMedical. The logo consists of a geometric shape in shades of gray and green, followed by the text "TAVMedical" in a combination of black and green. Below the company name is the text "PRECISION, PASSION, PARTNERSHIP" in a smaller font size.
The System complies with the following standards:
| # | Standard # | Standard Title |
|---|---|---|
| 1. | ISO 14971:2007 | Medical devices -- Application of risk managementto medical devices |
| 2. | ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk managementprocess |
| 3. | ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity |
| 4. | ISO 10993-11:2006 | Biological evaluation of medical devices - Part 11:Tests for systemic toxicity |
| 5. | ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization |
| 6. | ISO 10993-18:2009 | Biological evaluation of medical devices. Chemicalcharacterization of materials |
| 7. | ISO 11137-1:2006 | Sterilization of health care products - Radiation -Part 1: Requirements for development, validationand routine control of a sterilization process formedical devices |
| 8. | ISO 11137-2:2013 | Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose |
| 9. | AAMI TIR 33:2005 | Sterilization of health care products - Radiation -Substantiation of a selected sterilization doseMethod VDmax |
| 10. | ISO 11607-2:2006 | Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealingand assembly processes |
| 11. | ISO 14801:2007 | Dentistry -- Implants -- Dynamic fatigue test forendosseous dental implants |
| 12. | ASTM F746-04 | Standard Test Method for Pitting or CreviceCorrosion of Metallic Surgical Implant Materials |
| 13. | ASTM F1980-07(2011) | Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices |
| 14. | ISO 17665-1:2006 | Sterilization of health care products - Moist heat -Part 1: Requirements for the development,validation and routine control of a sterilizationprocess for medical devices |
| 15. | ISO 15223-1: 2012 | Symbols to be used with medical device labels,labelling, and information to be supplied: Part 1:General requirements |
| 16. | ISO 13356:2008 | Implants for surgery — Ceramic materials based on |
| # | Standard # | Standard Title |
| yttria-stabilized tetragonal zirconia (Y-TZP) |
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Image /page/21/Picture/0 description: The image shows the contact information for Tav Medical Ltd. Their VAT registration number is 511513673. Their address is Dora Industrial Park, P.O.B 88, Shlomi 2283202. Their phone number is 972-4-9808615, and their fax number is 972-4-9808356. Their website is www.tavmedical.com, and their email address is info@tavmedical.com.
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Summary
Based on the substantial equivalence discussion, performance testing results, and compliance to applicable standards, TAV Medical Dental Implant System was proven to be substantially equivalent to its predicate device.
§ 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.