(90 days)
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and 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 for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
TAV Medical's W Zirconia Implants are dental implants, composed of the following implant models: W One Piece - monotype implant with integrated abutment. W Two Piece – implant for screw retained Abutment. The implants are tissue level designed and includes a body portion and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). This material conforms with ISO 13356:2015 standard for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The Titanium abutments are going through anodizing process using an electrolytic process that adjusts the oxide level of the metal surface. This adjustment changes the spectrum of light, resulting in perceived color. By controlling the surface oxide level, an entire range of colors can be achieved. The Subject Device includes the following dimensions: W One-Piece implants: Diameter of 3.6mm for lengths of 8mm, 10mm, 12mm and 14mm and; Diameters of 4.1mm and 4.8mm for length of 14mm. W Two-Piece implants: Diameters of 4.1mm and 4.8mm for lengths of 8mm, 10mm, 12mm and 14mm. Cover Screw are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol. Cover screws are made of Titanium alloy Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Titanium Healing Caps are intended to protect the 2-piece implants during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. The healing caps are available in different geometrical features such as height and diameter. The Titanium Healing Caps manufactured from Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Each diameter is provided with height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Healing Caps are designed to protect the two-piece implant during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. Peek healing caps are available in different geometrical features such as height and diameter and available in 2 different designs, one design for the one-piece implant and second design for the two-piece implant. Both designs are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK healing caps are available in diameters of 4.1mm and 4.8mm and height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Temporary Caps serves as a basis for temporary restoration. TAV Medical temporary restoration caps available in two configurations, temporary Cap for Crown and Temporary Cap for Bridge. The caps are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK temporary caps are available in diameter of 3.6mm. Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown. The abutments are characterized by distinct geometrical features such as length and angulation. The titanium abutments are manufactured from ASTM F136-13 compatible Titanium Ti 6Al 4V ELI & Anodize. TAV Medical abutments are intended to be connected to 2-piece W Zirconia implants with titanium screw, to provide support for prosthetic reconstructions. The abutments are available in the following dimensions: Length of 5.0mm and 6.0mm and Angles of 0°, 5°, 10° and 15°. The 0º serves also for bridges.
The provided document is a 510(k) Premarket Notification for the TAV Medical Ltd. W Zirconia Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set and ground truth in the way one might evaluate a diagnostic AI system.
However, I can extract the information related to performance testing that supports the claim of substantial equivalence.
Here's an analysis of the "acceptance criteria" (which are more akin to performance benchmarks against predicate devices and regulatory standards in this context) and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are implicitly meeting the performance of predicate devices and adherence to relevant ISO standards and FDA guidance documents. The document doesn't explicitly list numerical acceptance criteria with pass/fail thresholds in the same way a diagnostic AI study would. Instead, it states that the subject device's performance was "substantially equivalent" to the predicate devices and conformed to standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Conformance | Material (Yttria stabilized tetragonal zirconia, Y-TZP) conforms with ISO 13356:2015. |
| Biocompatibility | Established through identical manufacturing methods, facility, raw materials as the primary predicate device (K172668), |
| and compliance with ISO 10993-1, 10993-5 and FDA Guidance for Use of ISO 10993-1. No additional tests were conducted, as it was concluded biocompatibility was already established. | |
| Sterilization (Implants) | Validation leveraged from primary predicate K172668, conducted in accordance with ANSI/AAMI/ISO 11137-2:2013. Achieved SAL of 10^-6. |
| Sterilization (Abutments) | Steam heat sterilization validation performed in compliance with FDA Guidance (Jan 21, 2016) and ANSI/AAMI/ISO 17665-1:2006. Achieved SAL of 10^-6. |
| Shelf Life | Accelerated aging applied to final packaging, followed by real-time aging validating implants packaging. (No specific duration or results reported in this summary, but implies positive validation). |
| Mechanical Performance (Fatigue Testing) | Performed according to FDA guidance (May 2004) and ISO 14801:2016. Results indicated substantial equivalence to the primary predicate device. |
| Mechanical Performance (Implant-to-Abutment Connection Wear) | Bench tests conducted after fatigue testing to assess wear of implant body, abutment, and fixation screw, and screw loosening. Data concluded 'comparable behavior' to reference devices. |
| Overall Equivalence | Same intended use, indications for use, mode of operation, materials, manufacturing technology, and body contact as predicate devices, demonstrating substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (dental implants), not an AI algorithm. Therefore, the concept of a "test set" for an AI model (like images with ground truth labels) does not directly apply.
- Mechanical Testing: While not explicitly stated as "sample size," mechanical tests (like fatigue testing and wear assessment) would involve a certain number of physical implant samples. This information is typically detailed in the full test reports, which are not included in this 510(k) summary. The summary only states that tests were performed according to ISO standards, which define methodologies including sample numbers.
- Data Provenance: Not applicable in the context of an AI test set. The provenance of the device components (materials, manufacturing) is Israel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert-established ground truth for a test set. Evaluation relies on established engineering principles, material science, and bio-compatibility standards through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device. Decisions are based on objective measurements against engineering standards.
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. This is not an AI diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
For a physical medical device, "ground truth" refers to established scientific and engineering principles, validated test methodologies, and regulatory standards.
- Material Properties: Conformance to ISO 13356:2015.
- Biocompatibility: Demonstrated through adherence to ISO 10993-1, 10993-5, and FDA guidance.
- Sterilization: Demonstrated through adherence to ANSI/AAMI/ISO 11137-2:2013 and ANSI/AAMI/ISO 17665-1:2006, and FDA guidance.
- Mechanical Performance: Demonstrated through adherence to FDA guidance (May 2004) and ISO 14801:2016. Testing involved objective measurements of fatigue life, wear, and screw loosening.
The underlying "ground truth" is that the device must meet the performance and safety requirements outlined in these standards and guidance documents, demonstrating substantial equivalence to legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as this is a physical 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 Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 29, 2019
TAV Medical Ltd. Revital Shabtai General Manager - Dental Division Dora Industrial Park, P.O. Box 88 Shlomi, 2283202 ISRAEL
Re: K192053
Trade/Device Name: W Zirconia Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 31, 2019 Received: July 31, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Srinivas Nandkumar for Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192053
Device Name W Zirconia Implants
Indications for Use (Describe)
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the wing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
| 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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K192053
510(k) Summary TAV Medical Ltd. — W Zirconia Implants
1. Submitter Information
| Submitter's Name: | TAV Medical Ltd.Dora Industrial ParkP.O.B 88, Shlomi 2283202Israel |
|---|---|
| Phone Number: +972 (4) 9808615/503 | |
| Fax Number: +972 (4) 9808356 | |
| Contact Person: Mrs. Revital ShabtaiE-mail: revitals@tavmedical.com | |
| Date: October 29, 2019 |
2. Device
| Trade Name: | W Zirconia Implants |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Endosseous Dental Implant Abutment | |
| Classification Name: | 21 CFR 872.3640 |
| Device Class: | Class II |
| Primary Product Code: | DZE |
| Secondary Product Code: | NHA |
3. Predicate Devices
| Primary Predicate: | K172668 W Zirconia Implants |
|---|---|
| Reference Devices: | K151328 Pure Ceramic Implants |
| K180477 Straumann Pure Ceramic Implants |
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4. Device Description
TAV Medical's W Zirconia Implants are dental implants, composed of the following implant models:
W One Piece - monotype implant with integrated abutment. W Two Piece – implant for screw retained Abutment.
The implants are tissue level designed and includes a body portion and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level.
TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). This material conforms with ISO 13356:2015 standard for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
The Titanium abutments are going through anodizing process using an electrolytic process that adjusts the oxide level of the metal surface. This adjustment changes the spectrum of light, resulting in perceived color. By controlling the surface oxide level, an entire range of colors can be achieved.
The Subject Device includes the following dimensions:
W One-Piece implants: Diameter of 3.6mm for lengths of 8mm, 10mm, 12mm and 14mm and; Diameters of 4.1mm and 4.8mm for length of 14mm. W Two-Piece implants: Diameters of 4.1mm and 4.8mm for lengths of 8mm, 10mm, 12mm and 14mm.
Cover Screw are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol. Cover screws are made of Titanium alloy Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm.
Titanium Healing Caps are intended to protect the 2-piece implants during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. The healing caps are available in different geometrical features such as height and diameter. The Titanium Healing Caps manufactured from Ti 6Al 4V ELI & Anodize and are available in diameters
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of 4.1mm and 4.8mm. Each diameter is provided with height dimensions of 1mm, 2mm, 3mm and 4mm.
PEEK Healing Caps are designed to protect the two-piece implant during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. Peek healing caps are available in different geometrical features such as height and diameter and available in 2 different designs, one design for the one-piece implant and second design for the two-piece implant. Both designs are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK healing caps are available in diameters of 4.1mm and 4.8mm and height dimensions of 1mm, 2mm, 3mm and 4mm.
PEEK Temporary Caps serves as a basis for temporary restoration. TAV Medical temporary restoration caps available in two configurations, temporary Cap for Crown and Temporary Cap for Bridge. The caps are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK temporary caps are available in diameter of 3.6mm.
Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown. The abutments are characterized by distinct geometrical features such as length and angulation. The titanium abutments are manufactured from ASTM F136-13 compatible Titanium Ti 6Al 4V ELI & Anodize. TAV Medical abutments are intended to be connected to 2-piece W Zirconia implants with titanium screw, to provide support for prosthetic reconstructions. The abutments are available in the following dimensions: Length of 5.0mm and 6.0mm and Angles of 0°, 5°, 10° and 15°. The 0º serves also for bridges.
5. Indications for Use
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and 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 for immediate loading when qood primary stability is achieved and with appropriate occlusal loading.
The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
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6. Technological Characteristics
The proposed W Zirconia Implants have similar indications for use, technological characteristics, mode of operation and performance specifications as its predicate devices listed.
The following abutments interacts with the two-piece implants as follows:
Cover Screw protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol.
Titanium Healing Caps Protect the implant during the healing phase, and maintain, stabilize and form the soft tissue during the healing process.
PEEK Healing Caps Protect the implant during the healing phase up to 180 days, and maintain, stabilize and form the soft tissue during the healing process.
PEEK Temporary Caps Serves as a basis for temporary restoration for crown or bridge. Up to 180 days.
Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown.
The following tables summarize the equivalence comparison between TAV Medical's W Zirconia Implants systems and its primary predicate and reference devices:
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Implants:
| Owner: | TAV Medical Ltd. | TAV Medical Ltd. | InstituteStraumann AG | Institute StraumannAG |
|---|---|---|---|---|
| Feature | Subject Device | Primary PredicateDevice | Reference Device | Reference Device |
| Trade Name | W One PieceZirconia implant | W One PieceZirconia implant | Pure Ceramic Implants | -- |
| W Two PieceZirconia Implant | W Two PieceZirconia Implant | -- | Straumann PureCeramic Implantsystems | |
| 510(k) Number | K192053 | Cleared under:K172668 | Cleared under:K151328 | Cleared under:K180477 |
| Product Code | Primary: DZESecondary: NHA | Primary: DZESecondary: NHA | Primary: DZESecondary: NHA | Primary: DZESecondary: NHA |
| Manufacturer | TAV Medical Ltd. | TAV Medical Ltd. | Institute Straumann AG | Institute StraumannAG |
| Intended Use /Indications forUse | TAV Medical's WZirconiaImplants areintended forsurgicalplacement in thepatient's upperand lower jawto providesupport forprostheticdevices, such asartificial teethand in order torestore thepatient chewingfunction. Theimplants areindicated forimmediateloading whengood primarystability isachieved andwith appropriateocclusal loading.The ø3.6 mmreduceddiameterimplants arerecommendedfor central andlateral incisorsonly. | TAV Medical's WZirconia Implantsare intended forsurgical placementin the patient'supper and lowerjaw to providesupport forprosthetic devices,such as artificialteeth and in orderto restore thepatient chewingfunction. Theimplants areindicated forimmediate loadingwhen good primarystability is achievedand withappropriateocclusal loading. | The Straumann® PURECeramic Implant(Monotype) is indicatedfor restoration in singletooth gaps and in anedentulous or partiallyedentulous jaw. Theprosthetic restorationsused are single crowns,fixed partial or fulldentures, which areconnected to theimplants through thecorrespondingcomponents.The ø3.3 mm reduceddiameter implants arerecommended forcentral and lateralincisors only.The Straumann® PURECeramic ImplantProtective Cap isintended to protect theStraumann® PURECeramic Implant(Monotype) during thehealing phase afterimplant placement forup to 6 months.Temporary copings areintended to serve as abase for temporarycrown or bridgerestoration for theStraumann® PURECeramic Implant(Monotype) for up to 30days. | Straumann PURECeramic Implant:The StraumannPURE CeramicImplant is indicatedfor the restoration ofsingle-tooth gapsand in edentulous orpartially edentulousjaws. The prostheticrestorations used aresingle crowns, fixedpartial or fulldentures, which areconnected to theimplants through thecorrespondingcompnents.Closure and healingcaps:Closure and Healingcaps are intended foruse with theStraumann DentalImplant System(SDIS) to protect theinnerconfiguration of theimplant andmaintain, stabilizeand form the softtissue during thehealing process.Closure andHealing caps shouldbe used only withsuitable implantconnections. Do notuse healingcomponents forlonger than 6months.TemporaryAbutments:The provisionalcomponents areintended to serve asa base for temporarycrown or bridgerestoration out ofocclusion forthe Straumann®PURE CeramicImplant System. TheStraumann®Temporary |
| Owner: | TAV Medical Ltd. | TAV Medical Ltd. | InstituteStraumann AG | Institute StraumannAG |
| Feature | Subject Device | Primary PredicateDevice | Reference Device | Reference Device |
| Abutment VITA CAD-Temp® for theStraumann® PURECeramic Implant isindicated fortemporary usage ofup to 180 days.CI RD StraumannPUREbaseAbutments:CI RD StraumannPUREbase abutmentis a titanium baseplaced ontoStraumann ceramicdental implants toprovide support forcustomizedprostheticrestorations and isindicated for screw-retained single toothor cement-retainedsingle tooth andbridge restorations.All digitally designedcopings and/orcrowns for use withthe Straumann®Variobase Abutmentsystem are intendedto be sent toStraumann formanufacture at avalidated millingcenter. | ||||
| Material | yttria-stabilizedzirconia(Y-TZP) | yttria-stabilizedzirconia(Y-TZP) | yttria-stabilizedzirconia(Y-TZP) | yttria-stabilizedzirconia(Y-TZP) |
| ManufacturingTechnology | CIM: Ceramicinjectionmolding | CIM: Ceramicinjection molding | Turning | Turning |
| Diameter (mm) | W two PieceZirconia implantØ 4.1, 4.8 | W two PieceZirconia implantØ 4.1, 4.8 | -- | Ø 4.1 |
| W one pieceZirconia implantØ 3.6 | W One PieceZirconia implantØ 4.1, 4.8 | Ø 3.3, 4.1 | -- | |
| Length (mm) | W two pieceZirconia implant | W two pieceZirconia implant | -- | 8, 10, 12, 14 |
| Owner: | TAV Medical Ltd. | TAV Medical Ltd. | InstituteStraumann AG | Institute StraumannAG |
| Feature | Subject Device | Primary PredicateDevice | Reference Device | Reference Device |
| W One PieceZirconia implant8, 10, 12, 14 | W One PieceZirconia implant8, 10 ,12 | One Piece8, 10, 12, 14 | -- | |
| Design | W Two PieceZirconia Implant | W Two PieceZirconia Implant | -- | Two-piece |
| W One PieceZirconia implant | W One PieceZirconia implant | One Piece | -- | |
| ProstheticConnection | W Two PieceZirconiaImplant:screw retained | W Two PieceZirconia Implant:Internal hex screwretained | -- | screw retained |
| SurfaceTopography | macro- andmicro-roughness | macro- and micro-roughness | macro- and micro-roughness | macro- and micro-roughness |
| Accessories | SurgicalInstruments | SurgicalInstruments | Surgical Instruments | Surgical Instruments |
| SterilizationMethod | GammaIrradiation | Gamma Irradiation | H2O2 plasma | Ethylene Oxide |
| Intended UseEnvironment | Dental ClinicSetting | Dental ClinicSetting | Dental Clinic Setting | Dental Clinic Setting |
| Abutments | Straight andAngulated | Straight andAngulated | Straight | Straight andAngulated |
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Prosthetics
PEEK Healing Cap for W One Piece Zirconia Implant
| Feature | TAV MedicalSubject Device | TAV MedicalPrimary PredicateDevice | Institute StraumannAGReference PredicateDevice |
|---|---|---|---|
| ProductCode | NHA | NHA | NHA |
| K# | K192053 | K172668 | K151328 |
| ProductName | PEEK Healing Capfor W One-pieceZirconia Implant | PEEK Healing Capfor W One-pieceZirconia Implant | PURE CeramicProtective Caps |
| ProductDescription | Protect the implantduring the healingphase up to 180days. | Protect the implantduring the healingphase up to 180days. | Protect the implantduring the healingphase after implantPlacement for up to 6months. |
| Material | PEEK | PEEK | PEEK |
| Diameter(mm) | 3.6 | 4.1, 4.8 | 3.3, 4.1 |
| Height(mm) | 5 | 5 | 4, 5.5 |
| Angle (°) | 0° (Straight) | 0° (Straight) | 0° (Straight) |
| sterility | Non-Sterile | Non-Sterile | Non-Sterile |
PEEK Temporary Caps for W One-piece Zirconia Implant
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| Feature | TAV MedicalSubject Device | TAV MedicalPrimary PredicateDevice | Institute StraumannAGReference PredicateDevice |
|---|---|---|---|
| ProductCode | NHA | NHA | NHA |
| K# | K192053 | K172668 | K151328 |
| ProductName | Temporary Caps | Temporary Caps | PURE CeramicTemporary Copings |
| Feature | TAV MedicalSubject Device | TAV MedicalPrimary PredicateDevice | Institute StraumannAGReference PredicateDevice |
| ProductDescription | Serves as a basis fortemporaryrestoration for crownor bridge. Up to 180days | Serves as a basis fortemporaryrestoration for crownor bridge. Up to 180days | Serves as a base fortemporary crown orbridge restoration. Upto 30 days |
| Material | PEEK | PEEK | polymethylmethacrylate(PMMA) |
| Diameter(mm) | 3.6 | 4.1, 4.8 | 3.3, 4.1 |
| Angle (°) | 0° (Straight) | 0° (Straight) | 0° (Straight) |
| sterility | Non-Sterile | Non-Sterile | Non-Sterile |
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| Feature | TAV MedicalSubject Device | TAV MedicalPrimary Predicate Device | Feature | TAV MedicalSubjectDevice | TAV MedicalPrimaryPredicateDevice | InstituteStraumann AGReferencePredicateDevice |
|---|---|---|---|---|---|---|
| Product Code | NHA | NHA | ProductCode | NHA | NHA | NHA |
| K# | K192053 | K172668 | K# | K192053 | K172668 | K180477 |
| Product Name | PEEK Healing Cap for W TwoPiece Zirconia Implant | PEEK Healing Cap for W TwoPiece Zirconia Implant | ProductName | TitaniumHealing Capfor W TwoPiece ZirconiaImplant | PEEK HealingCap for W TwoPiece ZirconiaImplant | Straumann PUREceramic ImplantSystem Closureand Healing Caps |
| ProductDescription | Protect the implant during thehealing phase up to 180 daysand maintain, stabilize andform the soft tissue during thehealing process | Protect the implant during thehealing phase up to 180 daysand maintain, stabilize andform the soft tissue during thehealing process | ProductDescription | protect theimplant duringthe healingphase andmaintain,stabilize andform the softtissue duringthe healingprocess | Protect theimplant duringthe healingphase up to180 days. | Protect the innerconfiguration ofthe implant andmaintain, stabilizeand form the softtissue during thehealing process. |
| Material | PEEK + Titanium connectingscrew | PEEK + Titanium connectingscrew | Material | Titanium | PEEK+Titaniumconnectingscrew | Titanium |
| Diameter(mm) | 5, 6.2 | 4.8, 6 | Diameter(mm) | 5, 6.2 | 4.8, 6 | 4.8, 5.2 |
| Height (mm) | 1, 2, 3, 4 | 1, 2, 3, 4 | Height(mm) | 1, 2, 3, 4mm | 1, 2, 3, 4mm | 2, 3 mm |
| Angle (°) | 0° (Straight) | 0° (Straight) | Angle (°) | 0 | 0 | 0 |
| sterility | Non-Sterile | Non-Sterile | sterility | Non-Sterile | Non-Sterile | sterile |
PEEK Healing Cap for W Two Piece Zirconia Implant
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Titanium Healing Cap for W Two Piece Zirconia Implant
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| Feature | TAV MedicalSubject Device | TAV MedicalPrimary Predicate Device |
|---|---|---|
| Product Code | NHA | NHA |
| K# | K192053 | K172668 |
| Product Name | Titanium Abutments | Titanium Abutments |
| ProductDescription | Screw RetainedTitanium Abutments | Screw RetainedTitanium Abutments |
| Material | TI-6AL4V ELI Anodized | TI-6AL4V ELI Anodized |
| Diameter (mm) | 4.8 | 4.8 |
| Length (mm) | 5.0, 6.0 | 5.0, 6.0 |
| Angle (°) | 0, 5, 10, 15 | 0, 5, 10, 15 |
| Sterility | Non-Sterile | Non-Sterile |
Titanium Abutments, Straight & Angulated
7. Performance Testing data
The following performance tests have been provided to demonstrate that the W Zirconia Implant system is substantially equivalent to the identified primary and reference predicate devices:
Biocompatibility testing
The subject devices are manufactured using identical manufacturing methods, in the same manufacturing facility and environment, and using the exact same raw material as the primary predicate device, therefore no new issues reqarding biocompatibility according to ISO 10993-1 were raised.
For these reasons, no additional tests have been conducted, as the biocompatibility reports as well as the additional technical documentation were fully submitted within our previously cleared 510(k) K172668. It was concluded that the materials biocompatibility was already established and that no additional tests or documentation are required for the purpose of this submission.
The standards and guidance documents used to establish the biocompatibility were:
- FDA Guidance for Use of International Standard ISO 10993-1, "Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk
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management process", dated June 16, 2016.
- . ISO 10993-1:2018 for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5:2009 for Biological evaluation of medical devices Part 5: Tests . for in vitro cytotoxicity.
Sterilization and Shelf Life
Implants sterilization validation was leveraged from TAV Medical primary predicate device cleared under 510(k) number K172668. The tests were conducted in accordance with ANSI/AAMI/ISO 11137-2:2013 for Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose in order to ensure the sterility of TAV Medical's W Zirconia Implants. Abutments steam heat sterilization validation was performed in compliance to the FDA Guidance for Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (January 21, 2016) and in conformance to ANSI IAAMI/ISO 17665-1:2006 for Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
Validation results have demonstrated that the SAL of 10th was achieved and all testing requirements were met.
Accelerated aging have been applied on the final packaging and is followed by real time aging validating implants packaging.
Mechanical testing
TAV Medical performed the required performance testing for the W Zirconia Implants according to the FDA guidance document for Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments (May 2004) and ISO 14801:2016 for Dentistry-Implants- Dynamic fatigue test for endosseous dental implants. The results indicated the subject devices are substantially equivalent to the primary predicate device.
Bench tests were conducted on the subject device after fatigue testing to assess the implant-to-abutment connection comparison in order to evaluate the wear of the surfaces of the implant body, abutment and fixation screw and screw loosening. The data produced concluded of comparable behavior of the subject device to the
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reference devices in terms of wear on the implant-to-abutment connection and screw loosening.
8. Conclusion
TAV Medical's W Zirconia Implants have the same intended use, indications for use, mode of operation, materials, manufacturing technology and body contact as the predicate devices. The documentation submitted in this premarket notification demonstrates that the subject device has been determined to be substantially equivalent to the identified primary and reference predicate devices.
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§ 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.