(418 days)
Not Found
No
The document describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device is designed to be surgically inserted into the bone structure of the mouth to replace missing teeth and restore chewing function, which addresses a medical condition or improves a health outcome.
No
This device is a dental implant system designed to replace missing teeth and restore oral function, not to diagnose medical conditions.
No
The device description explicitly states that the WINSIX Implant System includes physical components such as "Fixtures and Abutments" made of commercially pure titanium, which are surgically inserted into bone. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches." It is designed to be "surgically inserted in the bone structure of the mouth in order to replace missing teeth." This describes a surgical implant for structural replacement, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details the physical components of the implant system (fixtures and abutments) and their materials (commercially pure titanium). It describes their function in supporting prosthetic restorations. This aligns with a medical device for surgical implantation, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, the WINSIX Implant System is a surgical dental implant system, which falls under the category of medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended 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
The family of WINSIX Implant System is intended for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The family of WINSIX Implant Systems can also be used for immediate or early load implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single tooth and/or appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). The family of WINSIX Implant System includes the following devices:
- Fixtures
- Abutments
The fixtures are the endosseous dental implantable devices produced in commercially pure titanium (grade 4) , available in following models:
- K Model
- KT Model
- Conical Model
- TTi Model
with various diameters and lengths in order to meet diverse anatomical requirements. They are single use devices, supplied sterile and cannot be re-sterilised
Fixtures technical features and available length are summarized in the table below:
| K | KT | Conical | TTi | |
|---|---|---|---|---|
| Shape: | ||||
| Body | Cylindrical Screw | Cylindrical Screw | Conical screws | Cylindrical Tapered |
| thread | ||||
| Neck | Straight | |||
| with micro thread | ||||
| (Submersed) | Conical | |||
| Without Microthread | ||||
| (Transmucosal) | Straight | |||
| Without Microthread | ||||
| (Submersed) | Conical | |||
| Without Microthread | ||||
| (Submersed) | ||||
| Surface: | ||||
| Body | A) MRS: Sandblasted and etched | |||
| B) FCC: electrochemical roughening with Titanium oxide | ||||
| Neck | Smooth | Smooth | Smooth | Smooth |
| K | KT | Conical | TTi | |
|---|---|---|---|---|
| Dimensions: | ||||
| Endosseus | ||||
| Diameter | ||||
| (mm) | 3,3 – 3,8 – 4,5 – 5,2 | 3,3 - 3,8 - 4,5 - 5,2 - | ||
| 5,9 | 3,3 – 3,8 – 4,5 – 5,2 | 3,8 - 4,5 - 5,2 | ||
| Length of | ||||
| submerged | ||||
| part (mm) | 9 - 11 - 13 - 15 | 7 – 9 – 11 – 13 – 15 | 9 – 11 – 13 – 15 | 9 – 11 – 13 – 15 |
| Diameter / | ||||
| Length | ||||
| combination | Each Length is | |||
| available for each | ||||
| diameter | Each Length is | |||
| available for each | ||||
| diameter except: | ||||
| L:15 mm –D: 5,9 mm | Each Length is | |||
| available for each | ||||
| diameter | Each Length is | |||
| available for each | ||||
| diameter | ||||
| Connection: | ||||
| Shape | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm |
The abutments give at the physician a complete prosthetic solutions in order to use the WINSIX implant system as intended. They have been divided in followings main groups:
- COVER SCREWS are used for the restorative phase after implantation .
- HEALING SREWS are used to cover the fixtures and to model the mucosa during her healing
- ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. In detail:
- The straight abutments are used for the construction of the fixed prosthesis when the implant axis are parallel in relation to the prosthetic axis
- The angulated abutments with an anqulation of 15°,17°,20°,25° and 30° are used for the creation of fixed or screwed prostheses in the case of disparallelism between implant axis and prosthetic axis.
- The millable abutments can be personalised thanks to the precision of the industrially manufactured connection and the possibility to shape of the abutment through hand milling.
- The flat shift abutments are used to create a screw retained prosthesis, to increase the gingival height, in case of soft tissue thickness over 2 mm. In this case, the Flat shift abutment could be fixed to the fixture and then the flat shift cylindrical direct abutment can be fixed over the flat shift abutment. The flat shift retentive direct flared abutment is used for impression taking. The Flat shift abutments can be used only with internal hexagon fixtures
According to the results of fatique testing maximum recommended abutment anqulation is 30°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible and/or the maxilla, mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, Patient
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)
BIOCOMPATIBILITY
- Citotoxicity
- Intracutaneous reactivity
These tests were performed on abutments to evaluate the impact of the process of coloration.
The results of the reports listed above show that the WINSIX abutments are: - Not Cytotoxic
- Satisfying the requirements for intracutaneous reactivity test
SURFACE VALIDATION TESTS
Surface treatment is performed on implants through a MRS -Micro Rough Surface (sandblasted and acid-etched) treatment or with FCC – Full Contact Covering (superficial chemical treatment. A specific study has been done on each surface treatment, as summarized below:
MRS - The following assays were performed:
XPS analyses providing the qualitative and quantitative composition of the Micro Rough Surface coming in contact with the bone tissue
SEM analyses providing either qualitative chemical information of the implant's Micro Rough surface or the evidence of the effectiveness of metallic material decontamination protocol.
Cytotoxicity test on human osteoblastic cells (Saos-2) in contact with WINSIX implant with MRS. -
The results demonstrate that the chemical composition of the micro-rough surface is exactly the same as the predicate device. The SEM analyses quarantee the total absence of accumulations, residuals and stains. The cytotoxicity test points out that the Micro-rough surface is not cytotoxic. Overall, such results demonstrate equivalent performance and chemical characteristics as the predicate devices.
FCC – The following assays were performed:
XPS analyses providing the qualitative and quantitative composition of the Full Contact - Covering surface.
SEM analyses providing either qualitative chemical information of the FCC surface or the evidence of the effectiveness of metallic material decontamination protocol.
Cytotoxicity test on mouse connective tissue fibroblasts (L-929) in contact with the FCC treated fixtures of the WINSIX implants.
The results demonstrate that FCC surfaces have the typical composition of the Ti and thus they may be found substantial equivalent to the predicate device. The SEM analyses quarantee the total absence of accumulations, residuals and stains. Finally the cytotoxicity test points out that the FCC surfaces are not cytotoxic. Overall, such results support technical and performance features of the FCC WINSIX Implants.
MECHANICAL TESTS
The Mechanical test were performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatique test for endosseous dental implants" and demonstrated that the worst case chosen is able to resist to 5.000.000 cycles.
STERILIZATION AND PACKAGING SHELF LIFE
WINSIX implant system are sterilized with gamma ray sterilization to assure a SAL level of 10-9 Shelf life granted is 5 years
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.
K073458, K053384, K050406, K063286, K063341, K033922, K073628, K061477
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.
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2015
BIOSAF IN S.R.L. C/O Mr. Maurizio Pantaleoni C.E.O. ISEMED S.R.L. Via A. Altobelli Bonetti. 3/A Imola, BO 40026 ITALY
Re: K133733
Trade/Device Name: WINSIX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: December 23, 2014 Received: December 29, 2014
Dear Mr. Pantaleoni:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133733
Device Name WINSIX IMPLANT SYSTEM
Indications for Use (Describe)
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| 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
510(k) Summary for the WINSIX Implant System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | BIOSAF IN SRL is located at:
Via Tiraboschi, 36/G
60131 - Ancona
Italy |
|-----------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Maurizio Pantaleoni
ISEMED srl
Via A. Altobelli Bonetti 3/A
40026 Imola (BO)
Italy |
Mob.phone: +39-348.4435155 Telephone: +39-0542-683803 Fax: +39-0542-698456 Email: mpantaleoni@isemed.eu
Summary Preparation Date:
December 22, 2014
- Names 2.
| Device Name: | WINSIX Implant System |
|---|---|
| Classification Name: | Implant, Endosseous, Root-form / Endosseous dental |
| implant abutment | |
| Product Code: | DZE / NHA |
| Regulation number: | 872.3640/872.3630 |
-
- Predicate Devices
The WINSIX Implant Systems is substantially equivalent to the following devices:
- Predicate Devices
| Applicant | Device name | 510(k) Number |
|---|---|---|
| BT Lock | BT Lock Implant System | K073458 |
| AstraTech | Microtherad Osseosped | K053384 |
| Nobel Biocare | Nobel Speedy Implants | K050406 |
| Implant Innovation | 3i Osseotite Dental Implants | K063286 |
| Implant Innovation | 3i Osseotite Certain Dental Implants | K063341 |
| Straumann USA | ITI Dental Implant System | |
| (Strauman Plus Implant) | K033922 |
4
| Applicant | Device name | 510(k) Number |
|---|---|---|
| BT Lock | BT Lock Implant System | K073458 |
| Straumann USA | Straumann RN synOcta | K073628 |
| Nobel Biocare | Multi Unit Abutment for Astratech, | |
| Camlog and Ankilos Implant System | K061477 |
For the endosseous dental implant Abutments the predicate devices considered are:
-
- Device Description
The family of WINSIX Implant System is intended for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The family of WINSIX Implant Systems can also be used for immediate or early load implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single tooth and/or appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). The family of WINSIX Implant System includes the following devices:
- Device Description
-
Fixtures .
-
Abutments .
The fixtures are the endosseous dental implantable devices produced in commercially pure titanium (grade 4) , available in following models:
- K Model
- KT Model ●
- Conical Model ●
- TTi Model ●
with various diameters and lengths in order to meet diverse anatomical requirements. They are single use devices, supplied sterile and cannot be re-sterilised
Fixtures technical features and available length are summarized in the table below:
| K | KT | Conical | TTi | |
|---|---|---|---|---|
| Shape: | ||||
| Body | Cylindrical Screw | Cylindrical Screw | Conical screws | Cylindrical Tapered |
| thread | ||||
| Neck | Straight | |||
| with micro thread | ||||
| (Submersed) | Conical | |||
| Without Microthread | ||||
| (Transmucosal) | Straight | |||
| Without Microthread | ||||
| (Submersed) | Conical | |||
| Without Microthread | ||||
| (Submersed) | ||||
| Surface: | ||||
| Body | A) MRS: Sandblasted and etched | |||
| B) FCC: electrochemical roughening with Titanium oxide | ||||
| Neck | Smooth | Smooth | Smooth | Smooth |
5
| K | KT | Conical | TTi | |
|---|---|---|---|---|
| Dimensions: | ||||
| Endosseus | ||||
| Diameter | ||||
| (mm) | 3,3 – 3,8 – 4,5 – 5,2 | 3,3 - 3,8 - 4,5 - 5,2 - | ||
| 5,9 | 3,3 – 3,8 – 4,5 – 5,2 | 3,8 - 4,5 - 5,2 | ||
| Length of | ||||
| submerged | ||||
| part (mm) | 9 - 11 - 13 - 15 | 7 – 9 – 11 – 13 – 15 | 9 – 11 – 13 – 15 | 9 – 11 – 13 – 15 |
| Diameter / | ||||
| Length | ||||
| combination | Each Length is | |||
| available for each | ||||
| diameter | Each Length is | |||
| available for each | ||||
| diameter except: | ||||
| L:15 mm –D: 5,9 mm | Each Length is | |||
| available for each | ||||
| diameter | Each Length is | |||
| available for each | ||||
| diameter | ||||
| Connection: | ||||
| Shape | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm | Internal hexagon | |||
| Free lock | ||||
| Key 2,3mm |
The abutments give at the physician a complete prosthetic solutions in order to use the WINSIX implant system as intended. They have been divided in followings main groups:
- COVER SCREWS are used for the restorative phase after implantation .
- . HEALING SREWS are used to cover the fixtures and to model the mucosa during her healing
- ABUTMENTS are used for creation of screwed temporary or fixed elements. They have . different features to allow the physician to adapt to the different anatomical situation. In detail:
- The straight abutments are used for the construction of the fixed prosthesis when O the implant axis are parallel in relation to the prosthetic axis
- o The angulated abutments with an anqulation of 15°,17°,20°,25° and 30° are used for the creation of fixed or screwed prostheses in the case of disparallelism between implant axis and prosthetic axis.
- The millable abutments can be personalised thanks to the precision of the о industrially manufactured connection and the possibility to shape of the abutment through hand milling.
- The flat shift abutments are used to create a screw retained prosthesis, to increase о the gingival height, in case of soft tissue thickness over 2 mm. In this case, the Flat shift abutment could be fixed to the fixture and then the flat shift cylindrical direct abutment can be fixed over the flat shift abutment. The flat shift retentive direct flared abutment is used for impression taking. The Flat shift abutments can be used only with internal hexagon fixtures
According to the results of fatique testing maximum recommended abutment anqulation is 30°
-
- Indications for Use
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches.
- Indications for Use
The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when qood primary stability is achieved and with appropriate occlusal loading
6
6. Performance Data
Dimensions, materials and surface treatments are substantially equivalent to those of predicate devices. The following tests were performed on WINSIX implant system:
BIOCOMPATIBILITY
- Citotoxicity ●
- Intracutaneous reactivity
These tests were performed on abutments to evaluate the impact of the process of coloration.
The results of the reports listed above show that the WINSIX abutments are:
- Not Cytotoxic ●
- Satisfying the requirements for intracutaneous reactivity test ●
SURFACE VALIDATION TESTS
Surface treatment is performed on implants through a MRS -Micro Rough Surface (sandblasted and acid-etched) treatment or with FCC – Full Contact Covering (superficial chemical treatment. A specific study has been done on each surface treatment, as summarized below:
MRS - The following assays were performed:
XPS analyses providing the qualitative and quantitative composition of the Micro Rough Surface coming in contact with the bone tissue
SEM analyses providing either qualitative chemical information of the implant's Micro Rough surface or the evidence of the effectiveness of metallic material decontamination protocol.
Cytotoxicity test on human osteoblastic cells (Saos-2) in contact with WINSIX implant with MRS. -
The results demonstrate that the chemical composition of the micro-rough surface is exactly the same as the predicate device. The SEM analyses quarantee the total absence of accumulations, residuals and stains. The cytotoxicity test points out that the Micro-rough surface is not cytotoxic. Overall, such results demonstrate equivalent performance and chemical characteristics as the predicate devices.
FCC – The following assays were performed:
XPS analyses providing the qualitative and quantitative composition of the Full Contact - Covering surface.
SEM analyses providing either qualitative chemical information of the FCC surface or the evidence of the effectiveness of metallic material decontamination protocol.
Cytotoxicity test on mouse connective tissue fibroblasts (L-929) in contact with the FCC treated fixtures of the WINSIX implants.
The results demonstrate that FCC surfaces have the typical composition of the Ti and thus they may be found substantial equivalent to the predicate device. The SEM analyses quarantee the total absence of accumulations, residuals and stains. Finally the cytotoxicity test points out that the FCC surfaces are not cytotoxic. Overall, such results support technical and performance features of the FCC WINSIX Implants.
7
BIOSAF IN S.R.L. 510(K) NOTIFICATION
MECHANICAL TESTS
The Mechanical test were performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatique test for endosseous dental implants" and demonstrated that the worst case chosen is able to resist to 5.000.000 cycles.
STERILIZATION AND PACKAGING SHELF LIFE
WINSIX implant system are sterilized with gamma ray sterilization to assure a SAL level of 10-9 Shelf life granted is 5 years
7. Applicable Standards:
The Family of WINSIX Implant Systems have been developed and tested according to the following international standards:
ASTM F67 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications ASTMF136 - Standard Specification for Wrought Titanium-4Vanadium ELI Alloy for Surgical Implant Applications
ISO 14801: 2007 - Dynamic fatique test for endosseous dental implants
ISO 11137-1 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical device ASTM 1980 "Standard Guide For Accelerated Aging of Sterile Medical Devices Packages".
ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytoxicity.
ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
8. Conclusions
Based on technological characteristics (intended use, material used, dimensions and features) and performance data (mechanical tests, biocompatibility tests, sterilization and shelf life) WINSIX implant system are substantially equivalent and perform as well than the identified predicate devices