(399 days)
No
The summary describes a physical dental implant system and its materials and performance testing, with no mention of AI or ML capabilities.
Yes
The device is a dental implant system used to restore chewing function, which is a therapeutic purpose.
No
This device is an implant system designed for surgical placement and support of prosthetic devices, not for diagnosing conditions. The performance studies mentioned focus on material properties and fatigue, not diagnostic accuracy.
No
The device is a physical dental implant system made of zirconia and PEEK, intended for surgical placement. While it mentions image processing for surface characterization, this is a testing method for the physical device, not the primary function of the device itself.
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 therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is a dental implant, a physical object surgically placed in the body.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on material properties, fatigue strength, surface characteristics, biological compatibility, sterilization, and shelf-life – all relevant to a surgically implanted device, not a diagnostic test.
- No Mention of Diagnostic Output: There is no mention of the device producing any kind of diagnostic result or measurement.
While the device description mentions "Surfaces macro and micro morphological characterization through 3D Scanning Electron Microscope (SEM) Imaging," this is a method used during the manufacturing and testing of the implant to ensure its quality and characteristics. It is not a diagnostic function performed on a patient sample.
Therefore, the Z7 Zirconia Implant System is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Z7 Zirconia Implant System is 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 ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. 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. The implants come in corresponding diameters of 3.7 and 4.3 mm.
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
Summery of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing Summary:
- Test: Material Performance Testing
- Test Method Summary: Per ISO 13356:2015 Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
- Results: PASS Device met all predetermined acceptance criteria
- Test: Fatigue Testing
- Test Method Summary: Per ISO 14801:2016 Dentistry — Implants — Dynamic loading test for endosseous dental implants
- Results: PASS Substantially equivalent fatigue strength to reference device (K132585)
- Test: Implant Surface Roughness and Chemical Analysis Validation
- Test Method Summary: Surfaces macro and micro morphological characterization through 3D Scanning Electron Microscope (SEM) Imaging. Surface chemical analysis through Energy Dispersive Spectrometry (EDS Analysis).
- Results: PASS Device met all predetermined acceptance criteria
Biological evaluation of the subject device was performed according to ISO 10993-1 (cytotoxicity testing per ISO 10993-5). Endotoxin testing on the subject device or suitable test specimens was performed following USP and USP according to the sponsor's endotoxin sampling plan.
The implants are provided sterile to the end user via Ethylene Oxide (EO) sterilization. The applicable cycle was validated in compliance with ISO 11135:2014 "Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices" to a sterility assurance level of 10-6 for the worst-case configuration of the subject device. All cycle parameters were within the limits established by the protocol and residue testing yielded acceptable results for EO and ECH (ethylene chlorohydrin) per ISO 10993-7:2008 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals". The subject device non-sterile components are end-user steam sterilized. The applicable steam sterilization cycle was validated in compliance with ISO 17665 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" and demonstrated a sterility assurance level of 10-6.
Accelerated aging has been applied on the final sterile implant packaging and is being followed by real time aging to validate a five-year shelf life.
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.
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" followed by the words "U.S. Food & Drug Administration".
Z7 LLC % Linda Braddon Chief Executive Officer Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K221488
Trade/Device Name: Z7 Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 25, 2023 Received: May 25, 2023
Dear Linda Braddon:
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.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Z7 Zirconia Implant System
Indications for Use (Describe)
The Z7 Zirconia Implant System is 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 ø3.7 mm 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
K221488
| Date Prepared | June 26, 2023 |
|---|---|
| Sponsor | Z7, LLC |
| 28 Felmley Road | |
| Whitehouse Station, NJ | |
| 908-399-1359 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Z7 Zirconia Implant System |
| Common Name | Endosseous Dental Implant |
| Code – | |
| Classification | DZE, NHA |
| 21 CFR 872.3640: Class II | |
| Primary Predicate | K192053 TAV Medical Ltd. W Zirconia Implants |
| Reference Device | K172668 TAV Medical Ltd. W Zirconia Implants |
| K132585 Zibone Ceramic Dental Implant System | |
| Device Description | The Z7 Zirconia Implant System is an integrated system of endosseous dental |
| implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 | |
| Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) | |
| dental implants composed of a One Piece, monotype implant with an | |
| integrated abutment. The implant is manufactured via a ceramic injection | |
| molding with the macro and micro surface characteristics of the implant | |
| directly structured in the mold. 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. The implants come in | |
| corresponding diameters of 3.7 and 4.3 mm. | |
| Indications for Use | |
| Statement | The Z7 Zirconia Implant System is 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 Ø3.7mm reduced diameter implants are recommended for central and
lateral incisors only. |
4
Comparison of Indications for Use
| Subject Device
Z7 Zirconia Implant System | Primary Predicate Device
TAV Medical's W Zirconia Implants
K192053 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 $ø$ 3.7 mm reduced diameter implants are
recommended for central and lateral incisors
only. | The $ø$ 3.6 mm reduced diameter implants are
recommended for central and lateral incisors
only. |
There are no significant differences between the subject and predicate device indications for use. The minor differences in wording to align with the provided sizes of the subject device do not change the intended use for demonstration of substantial equivalence.
| Characteristic | Subject Device
Z7 Zirconia Implant
System | Primary Predicate
Device
TAV Medical's W
Zirconia Implants
K192053 | Reference Device
TAV Medical's W
Zirconia Implants
K172668 |
|-----------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Purpose of Device | Subject Device | Same Indications | Similar One-Piece
Sizes as Subject
Device |
| Device Classification | Class II | Class II | Class II |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Material | Yttria-stabilized
zirconia (Y-TZP) per
ISO 13356:2015 | Yttria-stabilized
zirconia (Y-TZP) per
ISO 13356:2015 | Yttria-stabilized
zirconia (Y-TZP) per
ISO 13356:2015 |
| Surface Topography | Macro and Micro
Roughness | Macro and Micro
Roughness | Macro and Micro
Roughness |
| Description | Endosseous dental
implant | Endosseous dental
implant | Endosseous dental
implant |
| Design | One-Piece Ceramic
Implants | One-Piece Ceramic
Implants | One-Piece Ceramic
Implants |
| | N/A | Two-Piece Ceramic
Implants | Two-Piece Ceramic
Implants |
| Diameter | Z7 One-Piece:
3.7mm, 4.3mm | TAV W One-Piece:
3.6mm | TAV W One-Piece:
4.1mm, 4.8mm |
Comparison of Technological Characteristics - Implants
5
| Characteristic | Subject Device
Z7 Zirconia Implant
System | Primary Predicate
Device
TAV Medical's W
Zirconia Implants
K192053 | Reference Device
TAV Medical's W
Zirconia Implants
K172668 |
|-----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | N/A | TAV W Two-Piece:
4.1mm, 4.8mm | TAV W Two-Piece:
4.1mm, 4.8mm |
| Length | Z7 One-Piece: 10mm,
13mm | TAV W One-Piece:
8mm, 10mm, 12mm,
14mm | TAV W One-Piece:
8mm, 10mm, 12mm,
14mm |
| | N/A | TAV W Two Piece:
8mm, 10mm, 12mm,
14mm | TAV W Two Piece:
8mm, 10mm, 12mm,
14mm |
| Manufacturing
Technology | CIM: Ceramic
injection molding | CIM: Ceramic
injection molding | CIM: Ceramic
injection molding |
| Sterilization Method | Ethylene Oxide | Gamma irradiation | Gamma irradiation |
| Intended Use
Environment | Dental clinic setting | Dental clinic setting | Dental clinic setting |
| Abutments | Straight | TAV W One-Piece:
Straight | TAV W One-Piece:
Straight |
| | N/A | TAV W Two-Piece:
Straight and Angled | TAV W Two-Piece:
Straight and Angled |
| Biocompatibility | Implant device with
permanent (>30 days)
contact with tissue /
bone / dentin | Implant device with
permanent (>30 days)
contact with tissue /
bone / dentin | Implant device with
permanent (>30 days)
contact with tissue /
bone / dentin |
| Shelf-Life | 5 years | Not stated in 510(k)
Summary | 1 year |
Comparison of Technological Characteristics – PEEK Healing Caps
| Characteristic | Subject Device
MABB
Z7 Zirconia Implant
System | Primary Predicate
Device
TAV Medical's W
Zirconia Implants
K192053 | Reference Device
TAV Medical's W
Zirconia Implants
K172668 |
|--------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Classification Product
Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Product Name | PEEK Healing Cap | PEEK Healing Cap
for W One Piece
Zirconia Implant | PEEK Healing Cap for
W One Piece
Zirconia Implant |
| 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 up to 180 days. |
6
| Characteristic | Subject Device
MABB
Z7 Zirconia Implant
System | Primary Predicate
Device
TAV Medical's W
Zirconia Implants
K192053 | Reference Device
TAV Medical's W
Zirconia Implants
K172668 |
|----------------|---------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Material | PEEK per ASTM
F2026-17 | PEEK | PEEK |
| Diameter (mm) | 3.7, 4.3 | 3.6, 4.1, 4.8 | 4.1, 4.8 |
| Height (mm) | 5 | 5 | 5 |
| Angle (°) | 0° (Straight) | 0° (Straight) | 0° (Straight) |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
Comparison of Technological Characteristics - PEEK Temporary Abutments
| Characteristic | Subject Device
MABB
Z7 Zirconia Implant
System | Primary Predicate
Device
TAV Medical's W
Zirconia Implants
K192053 | Reference Device
TAV Medical's W
Zirconia Implants
K172668 |
|--------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Classification Product
Code | DZE, NHA | DZE, NHA | DZE, NHA |
| Product Name | PEEK Healing Cap | PEEK Healing Cap
for W One Piece
Zirconia Implant | PEEK Healing Cap
for W One Piece
Zirconia Implant |
| Product Description | Serves as a basis for
temporary restoration
for crown. Up to 180
days. | 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. |
| Material | PEEK per ASTM
F2026-17 | PEEK | PEEK |
| Diameter (mm) | 3.7, 4.3 | 3.6, 4.1, 4.8 | 4.1, 4.8 |
| Angle (°) | 0° (Straight) | 0° (Straight) | 0° (Straight) |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
Technological Characteristics
There are no significant technological differences between the subject and predicate devices. Minor differences include the method of sterilization, and the exact size offerings. The subject device uses the same material as the additional predicates and all devices are manufactured using ceramic injection molding techniques. Any technological differences between the subject and predicate devices do not raise new concerns for safety or effectiveness.
7
Non-Clinical Performance Testing Summary
| Test | Test Method Summary | Results |
|---|---|---|
| Material | ||
| Performance | ||
| Testing | Per ISO 13356:2015 Implants for surgery — | |
| Ceramic materials based on yttria-stabilized | ||
| tetragonal zirconia (Y-TZP) | PASS | |
| Device met all | ||
| predetermined | ||
| acceptance criteria | ||
| Fatigue Testing | Per ISO 14801:2016 Dentistry — Implants — | |
| Dynamic loading test for endosseous dental | ||
| implants | PASS | |
| Substantially equivalent | ||
| fatigue strength to | ||
| reference device | ||
| (K132585) | ||
| Implant Surface | ||
| Roughness and | ||
| Chemical | ||
| Analysis | ||
| Validation | Surfaces macro and micro morphological | |
| characterization through 3D Scanning Electron | ||
| Microscope (SEM) Imaging. Surface chemical | ||
| analysis through Energy Dispersive | ||
| Spectrometry (EDS Analysis). | PASS | |
| Device met all | ||
| predetermined | ||
| acceptance criteria |
Performance testing for the subject device is summarized in the table below:
Biological evaluation of the subject device was performed according to ISO 10993-1 (cytotoxicity testing per ISO 10993-5). Endotoxin testing on the subject device or suitable test specimens was performed following USP and USP according to the sponsor's endotoxin sampling plan.
The implants are provided sterile to the end user via Ethylene Oxide (EO) sterilization. The applicable cycle was validated in compliance with ISO 11135:2014 "Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices" to a sterility assurance level of 10° for the worst-case configuration of the subject device. All cycle parameters were within the limits established by the protocol and residue testing yielded acceptable results for EO and ECH (ethylene chlorohydrin) per ISO 10993-7:2008 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals". The subject device non-sterile components are end-user steam sterilized. The applicable steam sterilization cycle was validated in compliance with ISO 17665 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" and demonstrated a sterility assurance level of 10-6
Accelerated aging has been applied on the final sterile implant packaging and is being followed by real time aging to validate a five-year shelf life.
8
Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.