Who is the manufacturer of W Zirconia Implants?

Tav Medical , Ltd. filed the 510(k) submission for W Zirconia Implants (K172668).

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).

What are the predicate devices for W Zirconia Implants?

Pure Ceramic Implants (K151328).

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

K172668 · Tav Medical , Ltd. · DZE · Nov 6, 2018 · Dental

Device Facts

Record ID	K172668
Device Name	W Zirconia Implants
Applicant	Tav Medical , Ltd.
Product Code	DZE · Dental
Decision Date	Nov 6, 2018
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.

Device Story

W Zirconia Implants are endosseous dental implants designed for surgical placement in the upper or lower jaw to support prosthetic restorations (crowns, bridges, overdentures). The system includes one-piece (monotype) and two-piece implants, along with titanium abutments and PEEK healing caps. Implants are manufactured from yttria-stabilized tetragonal zirconia (Y-TZP) using ceramic injection molding (CIM). The endosteal region features a rough surface (Ra 2.3 µm) to facilitate osseointegration. Two-piece implants utilize an internal hex screw-retained connection. The device is used in a dental clinic setting by a dentist. The clinician selects the appropriate implant and abutment based on tooth position and patient anatomy. The implant is placed into the alveolar bone; the abutment serves as an adapter for the final prosthetic crown. The device benefits patients by replacing missing teeth and restoring chewing function. The system is supplied non-sterile (abutments/caps) or sterile (implants) and requires sterilization by the clinician where applicable.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, including implant-to-abutment compatibility, static and dynamic fatigue testing (ISO 14801), surface finish analysis, and zirconia material wear testing. Biocompatibility was evaluated per ISO 10993-1.

Technological Characteristics

Materials: Yttria-stabilized tetragonal zirconia (Y-TZP) per ISO 13356; Titanium alloy (Ti6AL4V ELI) for abutments/screws; PEEK for healing/temporary caps. Design: Tissue-level, one-piece or two-piece root-form implants. Surface: Roughness Ra 2.3 µm. Sterilization: Gamma irradiation (implants); Moist heat (abutments). Standards: ISO 14801 (fatigue), ISO 10993-1 (biocompatibility), ISO 11137 (radiation sterilization), ISO 17665-1 (moist heat sterilization).

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. Suitable for immediate loading when primary stability is achieved and occlusal loading is appropriate.

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

Pure Ceramic Implants (K151328)

Reference Devices

Z-Systems AG (K120793)
Z-Systems AG (K132881)
Dentalpoint AG (K163043)
COHO Technology Co. Ltd. (K132585)
Institute Straumann AG (K994119)
TAV Medical Ltd. (K170131)

Related Devices

K192053 — W Zirconia Implants · Tav Medical , Ltd. · Oct 29, 2019
K151328 — PURE Ceramic Implants · Straumann USA · Jan 11, 2016
K210336 — Neodent Implant System - Zirconia Implant System · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Aug 13, 2021
K221488 — Z7 Zirconia Implant System · Z7, LLC · Jun 26, 2023
K132585 — ZIBONE CERAMIC DENTAL IMPLANT SYSTEM · Coho Technology Co., Ltd. · Jun 4, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". November 6, 2018 TAV Medical Ltd. Revital Shabtai General Manager - Dental Division Dora Industrial Park, P.O. Box 88 Shlomi, 2283202 ISRAEL Re: K172668 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: October 9, 2018 Received: October 12, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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 Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172668 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 patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logos for TAV Medical and TAV Dental. The TAV Medical logo is in black and green, and the TAV Dental logo is in blue and green. Both logos have a stylized leaf or sprout symbol. The logos are simple and modern. # 510(K) Number: K172668 # 5.1 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 ### 5.2 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: November 6, 2018 5.3 - 5.4 Trade Name: W Zirconia Implants - 5.5 Classification Name: Endosseous Dental Implant - 5.6 Common Name: Endosseous Dental Implant - 5.7 Medical Specialty: Dental - Product Code: DZE, NHA 5.8 - 5.9 Device Class: Class II - 5.10 Regulation Number: 872.3640 - Review Panel: Dental 5.11 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logos for TAVMedical and TAVDental. The TAVMedical logo is in black and green, with the text "TAVMedical" in a sans-serif font. To the left of the text is a geometric shape in green and gray. The TAVDental logo is in blue and green, with the text "TAVDental" in a sans-serif font. The text "Dental Solutions" is below the main text in a smaller font. To the left of the text is a geometric shape in green and blue. # 5.12 Predicate Devices TAV Medical's W Zirconia Implants include implants and abutments that are substantially equivalent to the following Predicate Devices: Primary Predicate device | | Device Owner/ Trade Name | 510(k) # | Product Code | |-------------------|-----------------------------|----------|------------------------------------------------------------------------------------------| | Primary Predicate | Institute Straumann AG | K151328 | DZE (Implant, Endosseous, Root-Form) & NHA (Endosseous Dental Implant Abutment) | ### Reference devices | | Device Owner/ Trade Name | 510(k) # | Product Code | |------------------|--------------------------------|-------------|---------------------------------------------------------------------------------------------| | Reference device | Z-Systems AG | K120793 | DZE (Implant, Endosseous, Root- Form | | Reference device | Z-Systems AG | K132881 | DZE (Implant, Endosseous, Root- Form) & NHA (Endosseous Dental Implant Abutment | | Reference device | Dentalpoint AG | K163043 | DZE (Implant, Endosseous, Root- Form) & NHA (Endosseous Dental Implant Abutment | | Reference device | COHO Technology Co. Ltd. | K132585 | DZE (Implant, Endosseous, Root- Form | | Reference device | Institute Straumann AG | K994119 | DZE (Implant, Endosseous, Root- Form) & NHA (Endosseous Dental Implant Abutment | | Reference device | TAV Medical Ltd. | K170131 | DZE (Implant, Endosseous, Root- Form) & NHA (Endosseous Dental Implant Abutment | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logos for TAV Medical and TAV Dental. The TAV Medical logo features a stylized green geometric shape resembling a flower or abstract design, followed by the text "TAV Medical" in a combination of gray and light green. The TAV Dental logo includes a similar green geometric shape and the text "TAV Dental Dental Division" in a smaller, less prominent font. The logos are placed side by side, suggesting a connection or affiliation between the two entities. ### 5.13 Intended use / Indication 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. ### Implant Description 5.14 W Zirconia Implants are suitable for one or two stage endosseous form of dental implants. One Piece and Two-Piece implants are available. The abutments are used in conjunction with the endosseous dental implant in order to support in the prosthetic rehabilitation. The implantation procedure can be accomplished, for the One-piece implant in a one stage and for the two piece implant in a one or two stage surgical procedures. TAV Medical's W Zirconia Implants are composed of the following implant models: W One Piece – monotype implant with integrated abutment. W Two Piece –implant for screw retained Abutment. In both implants the endosteal region is provided with a roughness with a Ra value of 2.3 µm. The implants and abutments are tissue level designed and includes a body portion (implant body diameter 4.1 mm with a 4.8 mm platform, and implant body diameter 4.8 mm with a 6.0 mm platform) 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for TAV Medical and TAV Dental. The TAV Medical logo is in black and green, while the TAV Dental logo is in blue. The logos are simple and modern, and they are likely used to represent the two companies. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). Each Two piece implant is accompanied with a standard titanium cover screw. ### Titanium Abutments for the W Two Piece Zirconia Implant 5.15 Dental implants abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by distinct geometrically features: Height/length, angle and diameter. Abutment device refers to the fixture that is connected to the implant. The crown is then built on the abutment for final restoration. TAV Medical titanium abutments and abutment screws, as in other available in the market dental abutments are dental components composed of titanium (Ti6AL4V ELI). The abutments are supplied non-sterile to be sterilized by the physician before use according to the instruction for use. TAV Medical abutments are intended to be connected to W Zirconia implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The abutments are available in different sizes and angles to fit individual patient needs. The appropriate abutment type is selected in relation to the tooth position for the proposed implant. Various abutments types are available as follows: ### 5.16 PEEK 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. TAV Medical healing caps are indicated to be placed in patients' mouth at the end of TAV Medical implant placement for a maximum of 180 days. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logos for TAVMedical and TAVDental. The TAVMedical logo is on the left and features a stylized green geometric shape above the text "TAVMedical", with "TAV" in a darker shade of gray and "Medical" in a lighter shade of gray. To the right of the TAVMedical logo is the TAVDental logo, which also features a green geometric shape above the text "TAVDental", with the words "Dental Supply Division" in a smaller font below. Healing caps are used during healing phase only and do not support a restoration. The components are supplied non-sterile to be sterilized by the physician before use according to the instruction for use. TAV Medical Supply Healing caps in different categories: - 1. Healing caps for W One Piece Zirconia implant - 2. Healing caps for W Two Piece Zirconia implant designed to protect the inner configuration of the implant during the healing phase in cases of transmucosal healing protocol. ### Substantial Equivalence discussion - Implants 5.17 - The proposed W Zirconia Implants have similar indications for use, technological characteristics, mode of operation and performance specifications as its predicate devices listed . Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw. The following tables summarize the equivalence comparison between TAV Medical's W Zirconia Implants systems and its predicates. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logos for TAV Medical and TAV Dental. The TAV Medical logo is on the left and features a green geometric shape above the text "TAV Medical", with "Medical" in a lighter shade of green. To the right is the TAV Dental logo, which also features a green geometric shape above the text "TAV Dental Dental Division", with the text in a smaller font size. ### Substantial Equivalence Table - Implants 5.18 | Owner: | TAV Medical Ltd. | Institute Straumann AG | Z-Systems AG | Z-Systems AG | Dental Point AG | COHO Technology Co. Ltd. | TAV Medical Ltd. | Owner: | TAV Medical Ltd. | Institute Straumann AG | Z-Systems AG | Z-Systems AG | Dental Point AG | COHO Technology Co. Ltd. | TAV Medical Ltd. | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------|--------------------------------------------------------------------|------------------------------------------|------------------------------------------|-------------------------------------------|----------------------------------------------------------------|------------------------------------------|---------------------| | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | | Trade Name | W One Piece Zirconia implant | Pure Ceramic Implants | Previous name Z- Look3 Evo SLM curent name Z5M | Reference Device | Reference Device | Zi-Bone Ceramic Dental Implant System | Reference Device | Material | yttria-stabilized zirconia (Y-TZP) | yttria-stabilized zirconia (Y-TZP) | yttria-stabilized zirconia (Y-TZP) | yttria-stabilized zirconia (Y-TZP) | Aluminum Toughened Zirconia ATZ | yttria-stabilized zirconia (Y-TZP) | | | | W Two Piece Zirconia Implant | Pure Ceramic Implants | Z5c | Z5c | Zeramex P6 | Zi-Bone Ceramic Dental Implant System | Dental Implant System | Manufacturing Technology | CIM: Ceramic injection molding | Turning | Turning | Turning | Turning | CIM: Ceramic injection molding | | | K# | K172668 | Cleared under: K151328 | Cleared under: K120793 | Cleared under: K132881 | Cleared under: K163043 | Cleared under: K132585 | Cleared under: K170131 | Body Diameter (mm) | W One Piece Zirconia implant 4.1, 4.8 | 3.3, 4.1 | 3.6, 4.0, 5.0 | | | 3.6, 4.0, 5.0 | | | Product Code | DZE & NHA | DZE & NHA | DZE | DZE & NHA | DZE | DZE | DZE & NHA | | W two Piece Zirconia implant 4.1, 4.8 | 3.3, 4.1 | | 4.0, 5.0 | 3.3, 4.1, 4.8 | | | | Manufacturer | TAV Medical Ltd. | Institute Straumann AG | Z-Systems AG | Z-Systems AG | Dental Point AG | COHO Technology Co. Ltd. | TAV Medical Ltd. | Threaded Length (mm) | W one piece Zirconia implant 8, 10, 12 | 8, 10, 12, 14 | 8, 10, 11.5, 13 | | | 8, 10, 11.5, 13 & 14.5 | | | Owner: | TAV Medical Ltd. | Institute Straumann AG | Z-Systems AG | Z-Systems AG | Dental Point AG | COHO Technology Co. Ltd. | TAV Medical Ltd. | | W two piece Zirconia implant 8, 10 ,12 | 8, 10, 12, 14 | | 8, 10, 12 | 8, 10, 12 | | | | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | Design | W One Piece Zirconia implant | One Piece | One Piece | | | One Piece | | | Device Description | TAV Medical's W Zirconia implants are made from Yttria stabilized tetragonal zirconia (Y-TZP). Cover screws are manufactured from Titanium Alloy TI 6AL 4V ELI. TAV Medical's W Zirconia implants are tissue level one piece and two piece implant. The endosteal region has rough surface. | Zirconia implant features a monotype design where the ceramic abutment for final restoration is already built in | zirconia (Y-TZP). The Z-Look3 Eva SLM surface is grit blasted with medical grade A1203 and laser modified. Implants are available in three diameters (3.6, 4.0 and 5.0 mm) and four lengths (8, 10, 11.5 and 13 mm). Z-Look3 Eva SLM implants are designed for single or multiple tooth restorations. Z- Look3 Evo SLM implants are a modification to Z-Look3 implants. The laser modified surface has been added to increase surface roughness and, therefore, the surface area available for contact with bone. | Z5c is a two piece, root-form, threaded implant and abutment system made from yttria- stabilized-zirconia (Y-TZP). The Z5c implant endosseous surface is grit blasted and laser modified. The Z5c implant and corresponding abutment are bonded together using a self- adhesive resin cement. The Z5c implant system is designed for single or multiple tooth restorations. Z5c implants are provided in two endosseous diameters (4.0 and 5.0mm) and each diameter is provided in three lengths (8, 10, and 12mm). Z5c abutments are provided in two designs, straight and angled 15°. | The Zeramex® P6 Dental implant System is an endosseous dental implant/ abutment system including various sizes of endosseous two piece dental implants, abutments and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools. | Zibone® Ceramic (Zirconia) Dental Implants are threaded; root- form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices. Implants for surgery- ceramic materials based on yttria- stablized tetragonal ziconia (Y-TZP). The implant has a one-piece design (both implant and abutment). | | | W Two Piece Zirconia Implant | One Piece | | 2 Piece | 2 Piece | | | | Owner: | TAV Medical Ltd. | Institute Straumann AG | Z-Systems AG | Z-Systems AG | Dental Point AG | COHO Technology Co. Ltd. | TAV Medical Ltd. | Prosthetic Connection | W One Piece Zirconia implant | One Piece | One Piece | | | One Piece | | | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | | W Two Piece Zirconia Implant: internal Hex screw retained | One Piece | | Internal Connection cement Abutment | External Hex Flat connection, screw retained abutment | | | | 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 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. | Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. | Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading. | The Zeramex P6 Dental Implant Systems is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth,in order to restore aesthetics and chewing function. The Zeramex P6 Dental Implant System can be used for single or multiple unit restorations. The Zeramex P6 implants are intended for delayed loading. The Zeramex P6 Dental Implants are specially indicated for patients with metal allergies /intolerances and chronic illnesses due to metal allergies/ intolerances. The Zeramex P6 (Ø3.3) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw. | Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved. | | Surface Topography | roughness | -roughness | roughness | -roughness | roughness | roughness | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for TAV Medical and TAV Dental. The TAV Medical logo is on the left and consists of a green triangle pointing upwards and the text "TAVMedical" in black. The TAV Dental logo is on the right and consists of the text "TAVDental Dental Solutions" in a smaller font size. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for TAVMedical. The logo features a stylized geometric shape in shades of gray and green, followed by the text "TAVMedical" in a sans-serif font. To the right of the main logo is a smaller version with the text "TAVDental Dental Division". {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for TAVMedical. The logo includes the text "TAVMedical" in a sans-serif font, with the "TAV" portion in a darker color than the "Medical" portion. There is also a small icon to the left of the text, and a smaller logo for "TAVDental" to the right of the main logo. The image also contains a table with the text "Owner:" and "TAV Medical". {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logos for TAV Medical and TAV Dental. The TAV Medical logo is in the center of the image and is larger than the TAV Dental logo. Both logos feature a green, stylized leaf-like symbol. The text in the logos is in a light gray color. | Owner: | TAV Medical Ltd. | Institute Straumann AG | Z-Systems AG | Z-Systems AG | Dental Point AG | COHO Technology Co. Ltd. | TAV Medical Ltd. | |--------------------------------|--------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|--------------------------------| | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | Reference Device | | Sterilization Method | Gamma Irradiation | Plasma | Steam | Steam | Steam | Moisture Heat | Gamma Irradiation | | Sterile Package | Sterile barrier sealed tube | Sterile barrier sealed blister | Sterile barrier sealed blister | Sterile barrier sealed blister | Sterile barrier sealed blister | Sterile barrier sealed blister | Sterile barrier sealed tube | | Intended Use Environment | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | | Abutments | Straight and Angulated | Straight and Angulated | Straight (integrated) | Straight and Angulated | Straight and Angulated | Straight (integrated) | Straight and Angulated | Substantial Equivalence Discussion: as demonstrated in the TAV Medical's subject device is equivalent to the selected predicate device. The subject device is similar to the predicate devices in terms of indications for used, technological characteristics and design key elements (including surface treatment, dimensions, connection types, etc.). Certain differences from the primary predicate device are covered by the reference devices as follows: In terms of indications for use, the Ø3.3 mm was excluded from TAV Medical indications for use such product diameter does not exist in our submission. This exclusion is not significant because it narrows the statement. The protective caps intended for use of up to 6 months in the primary predicate device are intended to be used for a similar period of time of up to 180 days in our zirconia implant system and are referred to as healing caps. The temporary caps intended for use of up to 30 days in the primary predicate device are intended to be used for up to 180 days in our zirconia implant as our temporary caps are manufactured from PEEK. We believe that this is not a significate difference as well, since the PEEK material used by TAV Medical is already cleared for 180 days in our previous 510(k) # K170131. In terms of production technology, while TAV Medical utilizes CIM, ceramic injection molding, the primary predicate is manufactured using turning technology. This difference is bridged by the reference predicate device cleared under 510(k) K132585 manufactured using the CIM technology. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the logos for TAVMedical and TAVDental. The TAVMedical logo is on the left and features a green abstract shape above the text "TAVMed…