(427 days)
No
The summary describes a physical dental implant made of zirconia and its mechanical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "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." This clearly indicates its purpose is to treat a condition (missing teeth/lost chewing function) and restore normal function, which aligns with the definition of a therapeutic device.
No
Explanation: The device, TAV Medical's W Zirconia Implants, is designed for surgical placement to support prosthetic devices and restore chewing function. It is a therapy device, not a diagnostic one.
No
The device description clearly states that the device is a physical implant made of Yttria stabilized tetragonal zirconia (Y-TZP) and includes physical components like the implant body, neck, and abutments. It is a hardware device intended for surgical placement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical placement in the jaw to support prosthetic devices and restore chewing function. This is a surgical and mechanical function within the body.
- Device Description: The description details the physical structure, materials, and surgical placement of the implants and abutments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted within the body for structural support.
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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. 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. 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. 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. 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.
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)
Non clinical testing was performed including:
- Biocompatibility testing according to ISO 10993-1.
- Sterilization validation and shelf life testing according to ANSI/AAMI/ISO 11137 and ANSI IAAMI/ISO 17665-1:2006. Achieved SAL of 10-6. Accelerated aging applied, validating implants packaging to one year of shelf life.
- Performance Testing: Bench testing including Implant to abutment compatibility testing, Static and dynamic fatigue testing according to ISO 14801, Surface finish analysis & Zirconia Material wear testing.
The non-clinical testing results showed that the proposed implant system meet the device requirements and are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K120793, K132881, K163043, K132585, K994119, K170131
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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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:
-
- Healing caps for W One Piece Zirconia implant
-
- 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 | |
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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.
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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".
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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.
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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 "TAVMedical" with "Medical" in a lighter shade of green. To the right is the TAVDental logo, which includes a blue heart shape and the text "TAVDental Dental Division" in a smaller font size.
In terms of the outer diameter dimensions of the W one piece zirconia implant the slight dimensional differences are covered by the reference predicate devices cleared under 510(k) K120793 and K132585.
For the W two-piece zirconia implant the slight dimensional differences are covered by the reference devices cleared under 510(k) K132881 and K163043.
In terms of the design feature and prosthetic connections type for the W two-piece zirconia implant, the primary predicate is a one piece implant and therefore the two-piece reference devices cleared under 510(k) K132881 and K163043 bridge the difference. The subject device connection type is an internal Hex screw retained connection which differs from the primary predicate devices K132881 and K163043 contain an internal connection type that covers the screw retained feature.
In terms of sterilization methods, W Zirconia Implants are sterilized using Gamma irradiation is a common sterilization method that was fully validated by TAV Medical in order to assure sterilization assurance level (SAL) of at least 10-6.
TAV Medical W Zirconia Implants are packed in sterile barrier sealed tube while the primary predicate device is packed in a sterile barrier sealed blister. This difference was bridged using TAV Medical's packaging system cleared under 510(k) K170131.
It was concluded that TAV Medical's subject device fulfills the criteria for substantial equivalence.
5.19 Substantial Equivalence - Abutments
TAV Medical abutments, as its predicate devices abutments, are intended to be placed into implants of different types, diameter, lengths and platforms to provide support for prosthetions such as crowns, bridges and overdentures.
The following table summarizes the equivalence of TAV Medical abutments to its predicate devices:
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Image /page/14/Picture/0 description: The image shows the logos for TAVMedical and TAVDental. The TAVMedical logo is on the left and features a green and gray geometric shape above the text "TAVMedical," with "TAV" in black and "Medical" in green. The TAVDental logo is on the right and features a similar green geometric shape above the text "TAVDental Dental Division," with "TAVDental" in a light blue color and "Dental Division" in a smaller, gray font.
PEEK Healing Cap for W One Piece Zirconia Implant
| TAV Medical Ltd. | Institute Straumann AG | TAV Medical Ltd. | |
|---|---|---|---|
| Subject Device | Primary Predicate Device | Reference Device | |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA |
| K# | K172668 | K151328 | K170131 |
| Product Name | PEEK Healing Cap for W One Piece | ||
| Zirconia Implant | PURE Ceramic Protective Caps | PEEK Abutments | |
| Product | |||
| Description | 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. | N/A | ||
| Material | PEEK | PEEK | PEEK |
| Diameter (mm) | 4.1, 4.8 | 3.3, 4.1 | |
| Height (mm) | 5 | 4, 5.5 | |
| Angle (°) | 0 | 0 | 0 |
| sterility | Non Sterile | Non Sterile | Non Sterile |
Substantial Equivalence Discussion: The minor differences in the products diameter or height do not raise any performance differences due to the similarity of TAV Medical's PEEK healing cap to its predicate device design and range. In addition, the PEEK components which are manufactured in the same manufacturing processes as used for the current submission components, have been previously cleared under K170131.
Therefore, it may be concluded that TAV Medical's PEEK Healing Caps for W One Piece Zirconia Implants and its predicates share the same intended use and technological characteristics and therefore are substantially equivalent.
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Image /page/15/Picture/0 description: The image contains the logos for TAVMedical and TAVDental. The TAVMedical logo is on the left and features a stylized green and gray icon resembling a stylized leaf or abstract shape, followed by the text "TAVMedical" in a modern, sans-serif font. The TAVDental logo is smaller and positioned to the right of the TAVMedical logo, also incorporating a similar green icon and the text "TAVDental Dental Solutions" in a smaller font size.
PEEK Temporary Caps for W One Piece Zirconia Implant
| Feature | TAV Medical Ltd.
Subject Device | Institute Straumann AG
Primary Predicate Device | TAV Medical Ltd.
Reference Device |
|------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------|
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA |
| K# | K172668 | K151328 | K170131 |
| Product Name | Temporary Caps | PURE Ceramic Temporary
Copings | PEEK Abutments |
| Product
Description | 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 | polymethylmethacrylate
(PMMA) | PEEK |
| Diameter (mm) | 4.1, 4.8 | 3.3, 4.1 | |
| Angle (°) | 0 | 0 | 0 |
| sterility | Non Sterile | Non Sterile | Non Sterile |
Substantial Equivalence Discussion: 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. the PEEK components which are manufactured in the same manufacturing processes as used for the current submission components, have been previously cleared under K170131 for 180 days.
The minor differences in the products diameter do not raise any performance differences due to the similarity of TAV Medical's PEEK temporary cap to its predicate device design and range. Therefore, it may be concluded that TAV Medical's PEEK temporary caps for W One Piece Zirconia Implants and its predicates share intended use and technological characteristics and therefore are substantially equivalent.
16
Image /page/16/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. The TAV Medical logo is a green and gray color scheme, while the TAV Dental logo is a blue and white color scheme. Both logos have a similar design, with a stylized letter "T" and "V".
PEEK Healing Cap for W Two Piece Zirconia Implant
| Feature | TAV Medical Ltd. | Z-Systems AG | Dental Point AG | TAV Medical Ltd. |
|---|---|---|---|---|
| Subject Device | Primary Predicate | |||
| Device | Reference Device | Reference Device | ||
| Product Code | NHA | NHA | NHA | DZE, NHA |
| K# | K172668 | K132881 | K163043 | K170131 |
| Product Name | PEEK Healing Cap for | |||
| Zirconia Implant | Healing caps / Gingiva | |||
| former | Healing caps / Gingiva | |||
| former | PEEK Abutments | |||
| Product | ||||
| Description | Used to allow the gingiva | |||
| to heal | Used to allow the | |||
| gingiva to heal | Used to allow the | |||
| gingiva to heal | ||||
| Material | PEEK+ Titanium | |||
| connecting screw | PEEK | PEEK | PEEK | |
| Diameter (mm) | 4.8, 6 | 4,5 | 6 | |
| Height (mm) | 1, 2 ,3, 4mm | 0.6, 2.8, 3.3mm | 0.5, 3, 4mm | |
| Angle (°) | 0 | 0 | 0 | |
| sterility | Non Sterile | Non Sterile | Non Sterile | Non Sterile |
Substantial Equivalence Discussion: as can be seen in the above comparison table all TAV Medical's subject device diameter and height dimensions are within the range of both, primary and reference predicate devices. In addition, the PEEK components which are manufactured in the same manufacturing processes as used for the current submission components, have been previously cleared under K170131. In addition, the TAV Medical's PEEK Healing Caps are intended to be connected with a titanium connecting screw rather than PEEK cemented as the primary predicate, however the method of connecting prosthetic device to an implant using a titanium screw is well established in the dental implant market and does not affect the performances of the product.
Therefore, it may be concluded that TAV Medical's PEEK Healing Caps and its predicates share intended use and technological characteristics and therefore are substantially equivalent.
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Image /page/17/Picture/0 description: The image shows the logos for TAVMedical and TAVDental. The TAVMedical logo is in the left of the image and consists of a green geometric shape and the text "TAVMedical" in a sans-serif font. The TAVDental logo is to the right of the TAVMedical logo and consists of a blue geometric shape and the text "TAVDental Dental Solution" in a sans-serif font. The logos are both simple and modern in design.
Titanium Abutments, Straight & Angulated
| Feature | TAV Medical Ltd. | Institute Straumann AG |
|---|---|---|
| Subject Device | Primary Predicate Device | |
| Product Code | NHA | DZE |
| (cleared by the FDA as abutment on | ||
| March 17 2000) | ||
| K# | K172668 | K994119 |
| Product Name | Titanium Abutments | RN synOcta® Abutment |
| Product Description | Screw Retained | |
| Titanium Abutments | Screw Retained | |
| Titanium Abutments | ||
| Material | TI-6AL4V ELI Anodized | Titanium |
| Diameter (mm) | 4.8 | 4.8 |
| Length (mm) | 5.0, 6.0 | 5.5, 5.7, 6.7 |
| Angle (°) | 0, 5, 10, 15 | 0, 15, 20 |
| Sterility | Non Sterile | Non Sterile |
Substantial Equivalence Discussion: TAV Medical Titanium Abutments and its predicates share intended use and technological characteristics and therefore are substantially equivalent.
Summary
In summary, the differences between the subject device and the predicate devices were evaluated and tested and do not raise new concerns.
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Image /page/18/Picture/0 description: The image shows the logos for TAVMedical and TAVDental. The TAVMedical logo is larger and features a green and black color scheme. To the right of it is the TAVDental logo, which is smaller and has a blue and white color scheme. Both logos include a stylized leaf or sprout graphic.
Non clinical testing 5.20
5.19.1 Biocompatibility
Testing and evaluation for materials biocompatibility according to ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Requirements and the corresponding FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016" were performed in order to demonstrate the biocompatibility of the system.
Sterilization validation and shelf life 5.19.2
Implants sterilization validation was conducted in compliance with ANSI/AAMI/ISO 11137 in order to ensure the sterility of TAV Medical's W Zirconia Implants.
Abutments steam heat sterilization was performed in compliance to the FDA requirements' and conformance to ANSI IAAMI/ISO 17665-1:2006 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 10-6 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 to one year of shelf life.
Performance Testing 5.19.3
TAV Medical's W Zirconia Implants performance bench testing was specified through the application of a risk analysis driven process. As part of this process the forces and operating conditions the device is exposed to during the procedure were evaluated and analyzed, and as a result the required bench tests were derived.
In addition, applicable FDA quidance (and other standards) was reviewed for determining required bench testing. Bench testing was performed to demonstrate that the W Zirconia Implants meet existing acceptance criteria similar to other predicate devices.
Descriptive information, laboratory bench testing, and biocompatibility testing are provided to demonstrate W Zirconia Implants meets its design specifications, performs as intended.
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Image /page/19/Picture/0 description: The image contains the logos for TAVMedical and TAVDental. The TAVMedical logo is on the left and features a stylized, three-dimensional, geometric shape in shades of gray and green, followed by the text "TAVMedical" in a combination of gray and light green. To the right is the TAVDental logo, which includes a similar geometric shape and the text "TAVDental" followed by "Serving Solutions" in a smaller font.
Specifically, the system was evaluated through design verification testing including the following: Implant to abutment compatibility testing, Static and dynamic fatigue testing according to ISO 14801, Surface finish analysis & Zirconia Material wear testing
The non-clinical testing results showed that the proposed implant system meet the device requirements and are equivalent to the predicate devices. The subject devices and the predicate device have the same intended use and technological characteristics.
Animal Testing 5.20
No Animal studies were performed.
Clinical testing 5.21
No clinical studies were performed.
The System complies with the following standards: 5.22
| # | Standard # | Standard Title |
|---|---|---|
| 1. | ISO 14971:2007 | Medical devices -- Application of risk management to |
| medical devices | ||
| 2. | ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1: |
| Evaluation and testing within a risk management process | ||
| 3. | ISO 11137-1:2006 | Sterilization of health care products - Radiation - Part 1: |
| Requirements for development, validation and routine | ||
| control of a sterilization process for medical devices ( | ||
| 4. | AAMI TIR 33:2005 | Sterilization of health care products - Radiation |
- Substantiation of a selected sterilization
dose - Method |
| 5. | ISO 11607-2:2006 | Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes |
| 6. | ISO 14801:2016 | Dentistry -- Implants -- Dynamic fatigue test for
endosseous dental implants |
| 7. | ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices |
| 8. | ISO 15223-1: 2016 | Symbols to be used with medical device labels, labelling,
and information to be supplied: Part 1: General
requirements |
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Image /page/20/Picture/0 description: The image contains the logos for TAVMedical and TAVDental. The TAVMedical logo is on the left and consists of a stylized green icon above the text "TAVMedical" in a light gray sans-serif font. The TAVDental logo is on the right and is smaller, also featuring a green icon and light gray text. The text below TAVDental says "Center of Excellence".
| # | Standard # | Standard Title |
|---|---|---|
| 9. | ISO 13356: 2015 | Implants for surgery - Ceramic materials based on yttria- |
| stabilized tetragonal zirconia (Y-TZP) | ||
| 10. | ASTM D999-08 (2015) | Standard Test Methods for Vibration Testing of Shipping |
| Containers | ||
| 11. | ASTM D4169-16 | Standard Practice for Performance Testing of Shipping |
| Containers and Systems | ||
| 12. | ASTM D4332-14 | Standard Practice for Conditioning Containers, Packages, |
| or Packaging Components for Testing | ||
| 13. | ASTM D4991-07 (2015) | Standard Test Method for Leakage Testing of Empty Rigid |
| Containers by Vacuum Method | ||
| 14. | ASTM D5276-98 (2017) | Standard Test Method for Drop Test of Loaded Containers |
| by Free Fall | ||
| 15. | ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks In Porous |
| Medical Packaging By Dye Penetration | ||
| 16. | ISO 11607-1:2006 | Packaging for terminally sterilized medical devices-Part |
| 1:Requirements for materials, sterile barrier systems and | ||
| packaging systems | ||
| 17. | ISO 11737-2:2009 | Sterilization of medical devices - Microbiological methods - |
| Part 2: Tests of sterility performed in the definition, | ||
| validation and maintenance of a sterilization process |
5.23 Summary
Based on the substantial equivalence discussion, performance testing results and compliance to applicable standards, the W Zirconia Implants is substantially equivalent to its predicates.