Who is the manufacturer of W Zirconia Implants?

Tav Medical , Ltd. filed the 510(k) submission for W Zirconia Implants (K192053).

What is the FDA product code for W Zirconia Implants?

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

What is the regulatory pathway for W Zirconia Implants?

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

Who can help prepare an FDA 510(k) submission like W Zirconia Implants?

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

W Zirconia Implants

K192053 · Tav Medical , Ltd. · DZE · Oct 29, 2019 · Dental

Device Facts

Record ID	K192053
Device Name	W Zirconia Implants
Applicant	Tav Medical , Ltd.
Product Code	DZE · Dental
Decision Date	Oct 29, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended 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 good primary stability is achieved and with appropriate occlusal loading. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.

Device Story

W Zirconia Implants are endosseous dental implants (one-piece or two-piece) designed for surgical placement in the jaw to support prosthetic restorations. The device consists of a Y-TZP zirconia body that osseo-integrates with alveolar bone, with various accessories including titanium/PEEK healing caps, cover screws, and titanium abutments. Used in dental clinics by clinicians; the device provides a foundation for artificial teeth. The system supports immediate loading protocols when primary stability is achieved. The device benefits patients by restoring chewing function and aesthetics. The two-piece system uses screw-retained abutments to connect the implant to the crown. The device is non-active and mechanical in nature.

Clinical Evidence

Bench testing only. No clinical data provided. Performance established via ISO 14801 dynamic fatigue testing, biocompatibility (ISO 10993-1, 10993-5), and mechanical wear testing of implant-to-abutment connections. Sterilization validated per ANSI/AAMI/ISO 11137-2 and 17665-1.

Technological Characteristics

Materials: Yttria-stabilized tetragonal zirconia (Y-TZP) per ISO 13356; Titanium Ti 6Al 4V ELI (ASTM F136-13) for abutments/screws; PEEK for healing/temporary caps. Manufacturing: Ceramic Injection Molding (CIM). Design: Tissue-level, macro/micro-rough surface topography. Sterilization: Gamma irradiation (implants), steam heat (abutments). Connectivity: Mechanical screw-retained connection.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Includes immediate loading if primary stability and occlusal conditions are met. ø3.6mm implants restricted to central and lateral incisors.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

W Zirconia Implants (K172668)

Reference Devices

Pure Ceramic Implants (K151328)
Straumann Pure Ceramic Implants (K180477)

Related Devices

K172668 — W Zirconia Implants · Tav Medical , Ltd. · Nov 6, 2018
K061971 — ZIRCONIA IMPLANT · Nobel Biocare AB · Mar 6, 2007
K221488 — Z7 Zirconia Implant System · Z7, LLC · Jun 26, 2023
K151328 — PURE Ceramic Implants · Straumann USA · Jan 11, 2016
K152385 — Zeramex P6 Dental Implant System · Dentalpoint AG · Jul 27, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K192053 # 510(k) Summary TAV Medical Ltd. — W Zirconia Implants # 1. Submitter Information | Submitter's Name: | TAV Medical Ltd. Dora Industrial Park P.O.B 88, Shlomi 2283202 Israel | |-------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Phone Number: +972 (4) 9808615/503 | | | Fax Number: +972 (4) 9808356 | | | Contact Person: Mrs. Revital Shabtai E-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 | {4}------------------------------------------------ # 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ ## 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: {7}------------------------------------------------ # Implants: | Owner: | TAV Medical Ltd. | TAV Medical Ltd. | Institute Straumann AG | Institute Straumann AG | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Subject Device | Primary Predicate Device | Reference Device | Reference Device | | Trade Name | W One Piece Zirconia implant | W One Piece Zirconia implant | Pure Ceramic Implants | -- | | | W Two Piece Zirconia Implant | W Two Piece Zirconia Implant | -- | Straumann Pure Ceramic Implant systems | | 510(k) Number | K192053 | Cleared under: K172668 | Cleared under: K151328 | Cleared under: K180477 | | Product Code | Primary: DZE Secondary: NHA | Primary: DZE Secondary: NHA | Primary: DZE Secondary: NHA | Primary: DZE Secondary: NHA | | Manufacturer | TAV Medical Ltd. | TAV Medical Ltd. | Institute Straumann AG | Institute Straumann AG | | Intended Use / 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 good primary stability is achieved and with appropriate occlusal loading. The ø3.6 mm reduced diameter implants are recommended for central and lateral incisors only. | 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 Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only. The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months. Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days. | Straumann PURE Ceramic Implant: The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding compnents. Closure and healing caps: Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months. Temporary Abutments: The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary | | | | | | | | Owner: | TAV Medical Ltd. | TAV Medical Ltd. | Institute Straumann AG | Institute Straumann AG | | Feature | Subject Device | Primary Predicate Device | Reference Device | Reference Device | | | | | | Abutment VITA CAD- Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days. CI RD Straumann PUREbase Abutments: CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw- retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. | | Material | yttria-stabilized zirconia (Y-TZP) | yttria-stabilized zirconia (Y-TZP) | yttria-stabilized zirconia (Y-TZP) | yttria-stabilized zirconia (Y-TZP) | | Manufacturing Technology | CIM: Ceramic injection molding | CIM: Ceramic injection molding | Turning | Turning | | Diameter (mm) | W two Piece Zirconia implant Ø 4.1, 4.8 | W two Piece Zirconia implant Ø 4.1, 4.8 | -- | Ø 4.1 | | | W one piece Zirconia implant Ø 3.6 | W One Piece Zirconia implant Ø 4.1, 4.8 | Ø 3.3, 4.1 | -- | | Length (mm) | W two piece Zirconia implant | W two piece Zirconia implant | -- | 8, 10, 12, 14 | | Owner: | TAV Medical Ltd. | TAV Medical Ltd. | Institute Straumann AG | Institute Straumann AG | | Feature | Subject Device | Primary Predicate Device | Reference Device | Reference Device | | | W One Piece Zirconia implant 8, 10, 12, 14 | W One Piece Zirconia implant 8, 10 ,12 | One Piece 8, 10, 12, 14 | -- | | Design | W Two Piece Zirconia Implant | W Two Piece Zirconia Implant | -- | Two-piece | |…