(224 days)
No
The summary describes a traditional dental implant system with mechanical components and does not mention any software, image processing, or AI/ML capabilities.
Yes.
The device is used to restore a patient's chewing function, which is a therapeutic purpose.
No
The device, GMI Frontier Dental Implant System, is described as being used for surgical placement to support prosthetic devices and restore chewing function. There is no indication that it diagnoses any condition or disease; rather, it is a treatment device.
No
The device description explicitly lists physical components such as dental implants, attachments, and clinical screws, indicating it is a hardware 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 that the device is for surgical placement in the jaw to support prosthetic devices and restore chewing function. This is a surgical and restorative function, not a diagnostic one.
- Device Description: The components listed (implants, abutments, screws) are all physical devices used in a surgical procedure and subsequent prosthetic attachment. They are not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. The GMI Frontier Dental Implant System does not fit this description.
N/A
Intended Use / Indications for Use
GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed loading.
Product codes
DZE, NHA
Device Description
GMI Frontier consists of dental implant, attachments (straight and angled abutments, healing abutments, ball abutments, temporary cylinders, straight and angled multi-esthetic abutments and their accessories), and clinical screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
As part of demonstrating the GMI Frontier Dental Implant System substantial equivalence to the predicate devices that are subject to this 510(k) submission, llerImplant completed a number of nonclinical performance tests. The GMI Frontier Dental Implant System meets all the requirements for overall design, sterilization, and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.
The GMI Frontier Dental Implant System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility evaluation (ISO 10993-1:2009 and ISO 7405:2008):
- Cytotoxiticy test (ISO 10993-5:2009)
- Intracutaneous Reactivity Test (ISO 10993-10:2010)
- Delayed Hypersensitivity Test (ISO 10993-10:2010)
- Acute Systemic Toxicity Test (ISO 10993-11:2006)
- Bacterial Reverse Mutation Assay Test (ISO 10993-3:2014)
- Mouse Lymphoma Test (ISO 10993-3:2014)
- Bone Implantation Test (ISO 10993-6:2007)
- Surface analysis (SEM/EDX) for the implants as required by FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments
- Evaluation of functional and mechanical properties, through a combination of physical testing and finite element analysis for implants and abutments:
- Bending Compression Static and Fatigue Testing (ISO 14801:2007)
- Torsional Testing are intended to determine the static torsion strength of hexagonal connection. The torsional testing is applicable to implants, clinic screws, cover screw, healing abutments and ball abutments and consists of applying an incremental torsional stress to the hexagonal connection until rupture and recording the rupture torque value (N.cm).
- Retention Testing is intended to determine the retention force that occurs between the ball abutments and the different retention caps. The retention testing is applicable to ball abutments and consists of applying an incremental tension force on the ball abutment assembled with the retention caps until both components are dismounted. The retention testing also consists of 4000 mounting-dismounted cycles (1Hz) to determine the final retention force.
- Cleaning and Sterilization Testing (ISO 11137-1:2006, ISO 11137-2:2006, ISO 17665-1:2006 and ISO/TS 17665-2:2009)
- LAL Pyrogen Testing (USP 38-NF33:2015, )
- Shelf Life Testing (ASTM F1980-07:2011):
- Dye Testing (European Pharmacopoeia 3.2.9)
- Sterility testing (ISO 11737-2:2009)
- Transport Testing (ASTM D4169-14)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
IlerImplant S.L. c/o Alexandre Pétiard Senior Consultant, Regulatory Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K161593
Trade/Device Name: GMI Frontier Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 22, 2016 Received: December 27, 2016
Dear Alexandre Pétiard:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. 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) K161593
Device Name GMI Frontier Dental Implant System
Indications for Use (Describe)
GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed 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
GMI Frontier Dental Implant System
K161593
1. Submission Sponsor
IlerImplant S.L.
C/ Enginyer Míes, 705 - B
25191
Lleida
Spain
Phone number: +34 973.184.350
Contact: Gabernet Xavier
Title: QA&RA Technical Manager
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327.9997
Contact: Alexandre Petiard, Senior Consultant, RA
Email: project.management@emergogroup.com
3. Date Prepared
January 17th, 2017
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4. Device Identification
| Trade/Proprietary Name: | GMI Frontier Dental Implant System |
|---|---|
| Common/Usual Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | 872.3640 |
| Product Code: | DZE |
| Subsequent Product Code: | NHA |
| Device Class: | Class II |
| Classification Panel: | Dental |
5. Legally Marketed Predicate Device(s)
Primary predicate
K040807 MIS Dental Implant System (MIS - Implant Technologies Ltd)
Reference predicates
K142211 OT Equator (Rhein '83 SRL)
K142260 NobelActive (Nobel Biocare AB)
6. Device Description
GMI Frontier consists of dental implant, attachments (straight and angled abutments, healing abutments, ball abutments, temporary cylinders, straight and angled multi-esthetic abutments and their accessories), and clinical screws.
6.1 Implant
Dental implants (DZE - 872.3640 – Class II) are used on patients who have lost a single tooth or who are partially or completely edentulous and their main function is to restore mastication. Dental implants are made of titanium (ISO 5832-2 and ASTM F-67 compliant) with a length from 8 to 17mm, a diameter from 3.30 to 5.75mm, a RP or WP platform and a hexagonal connection. Dental implants are tapered, selfthreading, root-form endosteal implants that have been designed to be placed fully submerged in two surgical stages: a first osteointegration stage and a loading stage.
6.2 Abutments
Dental abutments (NHA - 872.3630 – Class II) or also referred to as attachments are used on patients who have lost a single tooth or who are partially or completely edentulous and their main function is to restore mastication. Dental Attachments are all made of titanium (ISO 5832-3 and ASTM F-136
5
compliant) with the exception of temporary cylinder that are made of Polyetheretherketone or PEEK (ASTM F2026-12 compliant).
The Dental Implant are connected to the following abutments through a hexagonal connection:
- Angled (15 -20°) abutment with a length of 11mm using a RP or WP platform. The abutments are intended to create final cement-retained single or multi-unit restorations when an implant angle correction is needed, to allow the parallelization of the prosthesis in relation with the adjacent natural or prosthetic teeth.
- Straight abutment with a length from 10.25 to 12.25mm using a RP or WP platform and ● gingival height from 1.5 to 3.5mm. The abutments are intended to create final cementretained single or multi-unit restorations when an implant angle correction is not needed.
- Straight implant carrier abutments with a length of 8.7 mm using a RP or WP platform and gingival height of 1.5mm. The abutments have three possible intended uses: they are intended to be used as implant carrier, to insert the implant in the bone bed, to create temporal or final cement-retained single or multi-unit restorations when an implant angle correction is not needed, and as basis for the closed tray impression procedure when it is used in conjunction with the plastic CT impression coping.
- Straight temporary cylinders with a length of 12mm using a RP or WP platform. The abutments are intended to create temporary cement or screw-retained restorations when an implant angle correction is not needed. The non-rotary version is used for single restorations and the rotary version is for multiple restorations.
- Straight ball abutments (Ball abutment plus retention kit) with a length from 9.9 to 12.9mm using a RP or WP platform and gingival height from 1.0 to 4.0mm. The abutments are intended to create tissue-supported overdentures.
- Straight anatomic or non-anatomic healing abutments with a length from 7.6 to 11.6mm using a RP or WP platform, gingival height from 2.0 to 6.0mm and a diameter from 4.0 to 6.0mm. The abutments are intended to create the mucosal route between the implant connection and the prosthesis throughout the soft tissues. The anatomic healing abutments have an emergence profile that allow them match with the abutment shape.
- Straight multi-esthetic abutments and their accessories with a length from 8 to 11.1mm using a RP or WP platform and a gingival height from 1.0 to 4.0mm. The abutments used in conjunction with ME temporary cylinders are intended to create temporary screw-retained full-arch restorations with an existing or new acrylic overdenture, when an implant angle correction is not needed
- Angled (17 30°) multi-esthetic abutments and their accessories with a length from 6.2 to 7.2mm using a RP platform and a gingival height from 2.5 to 4.0mm. The abutments used in conjunction with ME temporary cylinders are intended to create temporary screw-retained full-arch restorations with an existing or new acrylic overdenture, when an implant angle correction is needed.
6
The abutments are connected to the top of the implant either through a "clinic screw" or directly attached when it is composed of a threaded part.
Multi-esthetic abutments are used with their accessories composed of:
- Multi-Esthetic Healing Cap made of Titanium (ISO 5832-3 and ASTM F-136 compliant) responsible for generating a mucosal route to connect the Multi-Esthetic abutment to the secondary structure or prosthesis, once osseointegration is completed,
- . Multi-Esthetic Temporary Cylinder made of Titanium (ISO 5832-3 and ASTM F-136 compliant) are intended to create temporary screw-retained full-arch restorations with an existing or new acrylic overdenture, when an implant angle correction is not needed and is fixed to the top of the Multi-Esthetic abutment using a multi-esthetic clinic screw.
- Multi-Esthetic Clinical Screw made of Titanium (ISO 5832-3 and ASTM F-136 compliant) is used in combination with Multi-Esthetic Temporary Cylinder as detailed above.
6.3 Clinic screws
A clinic screw (NHA - 872.3630 – Class II) is used for the final anchoring of abutments to the implant. The clinic screws are made of Titanium (ISO 5832-3 and ASTM F-136 compliant). They are straight with a hexagonal connection.
7. Indication for Use Statement
GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed loading.
8. Substantial Equivalence Discussion
The following table compares the GMI Frontier Dental Implant System to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues based on the similarities to the predicate device.
| Manufacturer | IlerImplant | MIS – Implant
Technologies, LTD. | Significant Differences |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | GMI Frontier Dental
Implant System | MIS Dental Implant
System | |
| 510(k) Number | K161593 | K040807 | NA |
| Product Code | DZE, NHA | DZE, NHA | Same |
| Regulation
Number | 872.3640 | 872.3640 | Same |
| Regulation Name | Endosseous dental | Endosseous dental | Same |
| Manufacturer | IlerImplant | MIS - Implant
Technologies, LTD. | Significant Differences |
| Trade Name | GMI Frontier Dental
Implant System | MIS Dental Implant
System | |
| | implant | implant | |
| Indications for Use | GMI Frontier Dental
Implant System model
is intended to be used
for surgical placement
in upper or lower jaw
to provide a support
for prosthetic devices
such as artificial teeth,
in order to restore the
patient's chewing
function. The GMI
Frontier Dental
Implants System is
intended for delayed
loading. | The MIS Dental Implant
System is indicated for
use in surgical and
restorative applications
for placement in the
bone of the upper or
lower jaw to provide
support for prosthetic
devices, such as
artificial teeth, in order
to restore the patient's
chewing function. | Substantially Equivalent,
the indications for use are both
for surgical placement in upper
or lower jaw to provide a
support for prosthetic devices
to restore the patient's chewing
function. |
| Implant
Loading | Delayed | Immediate and delayed | Substantially Equivalent,
both are used for delayed
loading. |
| Thread | Threaded | Threaded | Same |
| Implant Type | Root form endosseous
implant | Root form endosseous
implant | Same |
| Connection | Internal Hex | Internal Hex | Same |
| Body Ø (mm) | 3.30, 3.75, 4.25, 4.75,
5.75 | 3.30, 3.75, 4.20, 5.0,
6.0 | Substantially equivalent,
the range of body diameter of
GMI Frontier Dental Implant
System is within the range of
body diameter of MIS Dental
Implant System. |
| Platform Ø (mm) | RP: 3.30 / WP: 4.30 | NP: 3.30 / RP: 3.75 /
WP: 4.50 | Substantially equivalent,
fatigue and static mechanical
strength of GMI Frontier Dental
Implant System is higher than
the anatomical loads that can
be applied and is comparable
to the predicate device |
| Manufacturer | IlerImplant | MIS – Implant
Technologies, LTD. | Significant Differences |
| Trade Name | GMI Frontier Dental
Implant System | MIS Dental Implant
System | |
| Length (mm) | 8, 10, 11.5, 13, 15, 17
Note: all implant lengths are available in all implant diameters with the following exceptions:
- 15mm implant length is only for 3.30, 3.75, and 4.25mm implant diameter.
- 17mm implant length is only for 3.75 and 4.25mm implant diameters | 8, 10, 11.5, 13, 16
Note: all implant lengths are available in all implant diameters with the following exception:
- 8mm implant length is only for 3.75, 4.20, 5.00 and 6.00mm implant diameters
- 16mm implant length is only for 3.30, 3.75, 4.20, 5.00mm implant diameters | Substantially equivalent, at the critical fracture point, all implants length including 17 mm have the same design and dimensions and can support the same strength. The critical fracture point is not affected by the additional length of implants (i.e. 17 mm) compared to the predicate device. Moreover, the reference device NobelActive (K142260) includes a 17.5mm implant length with the 3.50 and 4.30mm implant diameters. |
| Shape | Screw type | Screw type | Same |
| Rotation | 60° | 60° | Same |
| Surface | Sand Blasted and acid etched | Sand Blasted and acid etched | Same |
| Packaging | Double packaging | Double packaging | Same |
| Sterilization | Gamma Radiation | Gamma Radiation | Same |
| Material | Titanium | Titanium | Same |
| Abutments | | | |
| Abutment Type | - Straight and angled abutments - Temporaty cylinder abutments
- Ball Abutments
- Multi esthetic abutments | - Straight and angled abutments
- Ti bases abutments
- Temporaty cylinder abutments
- Ball Abutments
- Multi esthetic abutments | Substantially equivalent, the range of abutment types of GMI Frontier Dental Implant System is within the range of abutment types of MIS Dental Implant System. |
| Angulation | Straight or Angled up to 30°: - 17° and 30° for ME | Straight
Angled up to 30° | Same |
| Manufacturer | IlerImplant | MIS - Implant
Technologies, LTD. | Significant Differences |
| Trade Name | GMI Frontier Dental
Implant System | MIS Dental Implant
System | |
| | abutment - 15° and 20° for the
angled abutments | | |
| Material | Titanium
PEEK | Titanium
PEEK | Same |
| Platforms | RP / WP | NP / RP / WP | Substantially Equivalent, the abutment platforms are suitable to the implant platforms. Fatigue and/or static mechanical strength for the abutments of GMI Frontier Dental Implant System is higher than the anatomical loads that can be applied and is comparable to the predicate device. |
| Model | Straight (S)
Anatomic (A)
Esthetic (E)
Non-Esthetic (NE) | Straight (S)
Anatomic (A)
Esthetic (E)
Non-Esthetic (NE) | Same |
| Gingival Height (mm) | 1 to 6 mm | 1 to 8 mm | Substantially Equivalent, the range of height for abutments of GMI Frontier Dental Implant System is within the range of height for abutments of MIS Dental Implant System. |
| Length (mm) | 6.25 to 12.9 mm | 6 to 13mm | Substantially Equivalent, the range of length for abutments of GMI Frontier Dental Implant System is within the range of length for abutments of MIS Dental Implant System. |
| Connection | Internal hex | Internal hex | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Clinic screws | | | |
| Angulation | Straight | Straight | Same |
| Manufacturer | IlerImplant | MIS – Implant
Technologies, LTD. | Significant Differences |
| Trade Name | GMI Frontier Dental
Implant System | MIS Dental Implant
System | |
| Material | Titanium | Titanium | Same |
| Size | M1.8 | U-72 UNF SAE | Substantially Equivalent,
the two threads only differ on
the diameter (difference: 0.05
mm) and on the pitch (0.003
mm). |
| Connection | Internal hex | Internal hex | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Multi esthetic abutments accessories | | | |
| Angulation | Straight | Straight | Same |
| Material | Titanium | Titanium | Same |
| Platform diameter
(mm) | 4.8 / 6.0 | 4.5 | Substantially Equivalent,
a longer accessory do not
change the functionality of GMI
Frontier Dental Implant System
compared to the predicate
device. |
| Connection | Conical (Multi-Unit
Cone) | Conical | Substantially Equivalent,
a reference device cleared by
the FDA includes the same
conical connection with multi-
unit cone as GMI Frontier
Dental Implant System. |
| Sterility | Non-sterile | Non-sterile | Same |
Table 5A – Comparison of Characteristics with MIS Dental Implant System
7
8
9
10
9. Non-Clinical Performance Data
As part of demonstrating the GMI Frontier Dental Implant System substantial equivalence to the predicate devices that are subject to this 510(k) submission, llerImplant completed a number of nonclinical performance tests. The GMI Frontier Dental Implant System meets all the requirements for overall design, sterilization, and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.
The GMI Frontier Dental Implant System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility evaluation (ISO 10993-1:2009 and ISO 7405:2008):
11
- Cytotoxiticy test (ISO 10993-5:2009) O
- Intracutaneous Reactivity Test (ISO 10993-10:2010) O
- Delayed Hypersensitivity Test (ISO 10993-10:2010) O
- O Acute Systemic Toxicity Test (ISO 10993-11:2006)
- Bacterial Reverse Mutation Assay Test (ISO 10993-3:2014) O
- Mouse Lymphoma Test (ISO 10993-3:2014) O
- Bone Implantation Test (ISO 10993-6:2007) O
- Surface analysis (SEM/EDX) for the implants as required by FDA guidance Class II Special Controls . Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments
- . Evaluation of functional and mechanical properties, through a combination of physical testing and finite element analysis for implants and abutments:
- o Bending Compression Static and Fatigue Testing (ISO 14801:2007)
- o Torsional Testing are intended to determine the static torsion strength of hexagonal connection. The torsional testing is applicable to implants, clinic screws, cover screw, healing abutments and ball abutments and consists of applying an incremental torsional stress to the hexagonal connection until rupture and recording the rupture torque value (N.cm).
- o Retention Testing is intended to determine the retention force that occurs between the ball abutments and the different retention caps. The retention testing is applicable to ball abutments and consists of applying an incremental tension force on the ball abutment assembled with the retention caps until both components are dismounted. The retention testing also consists of 4000 mounting-dismounted cycles (1Hz) to determine the final retention force.
- Cleaning and Sterilization Testing (ISO 11137-1:2006, ISO 11137-2:2006, ISO 17665-1:2006 and ISO/TS 17665-2:2009)
- . LAL Pyrogen Testing (USP 38-NF33:2015, )
- . Shelf Life Testing (ASTM F1980-07:2011):
- O Dye Testing (European Pharmacopoeia 3.2.9)
- O Sterility testing (ISO 11737-2:2009)
- Transport Testing (ASTM D4169-14)
10. Clinical Performance Data
12
None
11. Statement of Substantial Equivalence
Based on the similar intended use and the supporting non-clinical performance testing, the GMI Frontier Dental Implant System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).