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.

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.

AI/ML Overview

I'm sorry, but this document (K161593 510(k) Premarket Notification for the GMI Frontier Dental Implant System) relates to a dental implant system and does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, I cannot provide the specific details you requested regarding the acceptance criteria and study proving a digital health or AI/ML device meets those criteria. The provided text details the substantial equivalence of a physical medical device (dental implants) to existing predicate devices based on non-clinical performance data (biocompatibility, mechanical properties, sterilization, etc.).

No mention of AI, machine learning, deep learning, algorithms for image analysis, or any form of digital diagnostic assistance is present in this document.

To provide the requested information, I would need a document related to an AI/ML medical device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K161593

Device Name GMI Frontier Dental Implant System

Indications for Use (Describe)

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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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

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

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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.

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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

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 – ImplantTechnologies, LTD.	Significant Differences
Trade Name	GMI Frontier DentalImplant System	MIS Dental ImplantSystem
510(k) Number	K161593	K040807	NA
Product Code	DZE, NHA	DZE, NHA	Same
RegulationNumber	872.3640	872.3640	Same
Regulation Name	Endosseous dental	Endosseous dental	Same
Manufacturer	IlerImplant	MIS - ImplantTechnologies, LTD.	Significant Differences
Trade Name	GMI Frontier DentalImplant System	MIS Dental ImplantSystem
	implant	implant
Indications for Use	GMI Frontier DentalImplant System modelis intended to be usedfor surgical placementin upper or lower jawto provide a supportfor prosthetic devicessuch as artificial teeth,in order to restore thepatient's chewingfunction. The GMIFrontier DentalImplants System isintended for delayedloading.	The MIS Dental ImplantSystem is indicated foruse in surgical andrestorative applicationsfor placement in thebone of the upper orlower jaw to providesupport for prostheticdevices, such asartificial teeth, in orderto restore the patient'schewing function.	Substantially Equivalent,the indications for use are bothfor surgical placement in upperor lower jaw to provide asupport for prosthetic devicesto restore the patient's chewingfunction.
ImplantLoading	Delayed	Immediate and delayed	Substantially Equivalent,both are used for delayedloading.
Thread	Threaded	Threaded	Same
Implant Type	Root form endosseousimplant	Root form endosseousimplant	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 ofGMI Frontier Dental ImplantSystem is within the range ofbody diameter of MIS DentalImplant System.
Platform Ø (mm)	RP: 3.30 / WP: 4.30	NP: 3.30 / RP: 3.75 /WP: 4.50	Substantially equivalent,fatigue and static mechanicalstrength of GMI Frontier DentalImplant System is higher thanthe anatomical loads that canbe applied and is comparableto the predicate device
Manufacturer	IlerImplant	MIS – ImplantTechnologies, LTD.	Significant Differences
Trade Name	GMI Frontier DentalImplant System	MIS Dental ImplantSystem
Length (mm)	8, 10, 11.5, 13, 15, 17Note: 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, 16Note: 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	StraightAngled up to 30°	Same
Manufacturer	IlerImplant	MIS - ImplantTechnologies, LTD.	Significant Differences
Trade Name	GMI Frontier DentalImplant System	MIS Dental ImplantSystem
	abutment- 15° and 20° for theangled abutments
Material	TitaniumPEEK	TitaniumPEEK	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 – ImplantTechnologies, LTD.	Significant Differences
Trade Name	GMI Frontier DentalImplant System	MIS Dental ImplantSystem
Material	Titanium	Titanium	Same
Size	M1.8	U-72 UNF SAE	Substantially Equivalent,the two threads only differ onthe diameter (difference: 0.05mm) and on the pitch (0.003mm).
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 notchange the functionality of GMIFrontier Dental Implant Systemcompared to the predicatedevice.
Connection	Conical (Multi-UnitCone)	Conical	Substantially Equivalent,a reference device cleared bythe FDA includes the sameconical connection with multi-unit cone as GMI FrontierDental Implant System.
Sterility	Non-sterile	Non-sterile	Same

Table 5A – Comparison of Characteristics with MIS Dental Implant System

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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):

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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, <85>)
. 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

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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).

Regulation Number and Section

§ 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.