(90 days)
No
The 510(k) summary describes a physical dental implant and associated components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
Explanation: The device is a dental implant system designed to restore chewing function and support prosthetic devices, thus providing a therapeutic benefit by addressing a physical impairment.
No
This device, TAV Medical's W Zirconia Implants, is described as a dental implant intended for surgical placement to support prosthetic devices and restore chewing function. Its purpose is structural and functional, not to diagnose a condition or disease.
No
The device description clearly states that the device is a dental implant made of physical materials (Zirconia, Titanium, PEEK) and includes various physical components like implants, abutments, cover screws, and healing caps. It is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices... and in order to restore the patient chewing function." This describes a surgical implant for structural support and functional restoration within the body.
- Device Description: The description details the physical components of dental implants (implants, abutments, screws, caps) made of materials like zirconia and titanium, designed for surgical implantation and integration with bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
The device is a dental implant, which is a type of medical device used in surgery.
N/A
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 ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
Product codes
DZE, NHA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper and lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Clinic Setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 reference devices in terms of wear on the implant-to-abutment connection and screw loosening.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) |
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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 |
| | W One Piece
Zirconia implant | W One Piece
Zirconia implant | One Piece | -- |
| Prosthetic
Connection | W Two Piece
Zirconia
Implant:
screw retained | W Two Piece
Zirconia Implant:
Internal hex screw
retained | -- | screw retained |
| Surface
Topography | macro- and
micro-roughness | macro- and micro-
roughness | macro- and micro-
roughness | macro- and micro-
roughness |
| Accessories | Surgical
Instruments | Surgical
Instruments | Surgical Instruments | Surgical Instruments |
| Sterilization
Method | Gamma
Irradiation | Gamma Irradiation | H2O2 plasma | Ethylene Oxide |
| Intended Use
Environment | Dental Clinic
Setting | Dental Clinic
Setting | Dental Clinic Setting | Dental Clinic Setting |
| Abutments | Straight and
Angulated | Straight and
Angulated | Straight | Straight and
Angulated |
8
9
10
11
Prosthetics
PEEK Healing Cap for W One Piece Zirconia Implant
| Feature | TAV Medical
Subject Device | TAV Medical
Primary Predicate
Device | Institute Straumann
AG
Reference Predicate
Device |
|------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Product
Code | NHA | NHA | NHA |
| K# | K192053 | K172668 | K151328 |
| Product
Name | PEEK Healing Cap
for W One-piece
Zirconia Implant | PEEK Healing Cap
for W One-piece
Zirconia Implant | PURE Ceramic
Protective Caps |
| Product
Description | Protect the implant
during the healing
phase up to 180
days. | Protect the implant
during the healing
phase up to 180
days. | Protect the implant
during the healing
phase after implant
Placement for up to 6
months. |
| 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 Medical
Subject Device | TAV Medical
Primary Predicate
Device | Institute Straumann
AG
Reference Predicate
Device |
|------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Product
Code | NHA | NHA | NHA |
| K# | K192053 | K172668 | K151328 |
| Product
Name | Temporary Caps | Temporary Caps | PURE Ceramic
Temporary Copings |
| Feature | TAV Medical
Subject Device | TAV Medical
Primary Predicate
Device | Institute Straumann
AG
Reference Predicate
Device |
| Product
Description | Serves as a basis for
temporary
restoration for crown
or bridge. Up to 180
days | Serves as a basis for
temporary
restoration for crown
or bridge. Up to 180
days | Serves as a base for
temporary crown or
bridge restoration. Up
to 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 Medical
Subject Device | TAV Medical
Primary Predicate Device | Feature | TAV Medical
Subject
Device | TAV Medical
Primary
Predicate
Device | Institute
Straumann AG
Reference
Predicate
Device |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NHA | NHA | Product
Code | NHA | NHA | NHA |
| K# | K192053 | K172668 | K# | K192053 | K172668 | K180477 |
| Product Name | PEEK Healing Cap for W Two
Piece Zirconia Implant | PEEK Healing Cap for W Two
Piece Zirconia Implant | Product
Name | Titanium
Healing Cap
for W Two
Piece Zirconia
Implant | PEEK Healing
Cap for W Two
Piece Zirconia
Implant | Straumann PURE
ceramic Implant
System Closure
and Healing Caps |
| Product
Description | Protect the implant during the
healing phase up to 180 days
and maintain, stabilize and
form the soft tissue during the
healing process | Protect the implant during the
healing phase up to 180 days
and maintain, stabilize and
form the soft tissue during the
healing process | Product
Description | protect the
implant during
the healing
phase and
maintain,
stabilize and
form the soft
tissue during
the healing
process | Protect the
implant during
the healing
phase up to
180 days. | Protect the inner
configuration of
the implant and
maintain, stabilize
and form the soft
tissue during the
healing process. |
| Material | PEEK + Titanium connecting
screw | PEEK + Titanium connecting
screw | Material | Titanium | PEEK+
Titanium
connecting
screw | 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 Medical
Subject Device | TAV Medical
Primary Predicate Device |
|------------------------|--------------------------------------|-----------------------------------------|
| Product Code | NHA | NHA |
| K# | K192053 | K172668 |
| Product Name | Titanium Abutments | Titanium Abutments |
| Product
Description | Screw Retained
Titanium Abutments | Screw Retained
Titanium 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
16
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
17
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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