TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20, or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.

Device Description

The purpose of this submission is to obtain marketing clearance for TRI-matrix X-Force implants, a line extension of the TRI-matrix implant line previously cleared in K203660. TRI-matrix X-Force implants are tissue-level endosseous dental implants that are an adaptation of the TRI-matrix Tissue Level implants cleared in K203660, with the same prosthetic interface, but with modified external features. They are intended for use in the mandible or maxilla to restore chewing function. This submission includes only implants, and they are compatible with prosthetic components previously cleared in K203660 as part of the TRI-matrix implant line, including the TRI-matrix Crown Abutment.

TRI-matrix X-Force implants have a tapered body, double-lead threads and self-cutting flutes. A gritblasted and acid-etched surface, named the TRI SBA Surface, is applied to the endosseous portion of the implant. TRI-matrix X-Force implants incorporate a pink anodized, machined, 1.8 mm transgingival collar that is not treated with the TRI SBA Surface. Compared with TRI-matrix implants previously cleared in K203660, TRI-matrix X-Force implants have a modified thread design more suited to immediate placement and restoration, a more tapered apical portion (smaller apical diameter for a given coronal diameter), and more aggressive apical cutting flutes.

AI/ML Overview

This document describes the marketing clearance for medical devices and does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics or clinical outcomes.

The document discusses the substantial equivalence of the TRI-matrix® X-Force Implants to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. This type of submission (510(k)) generally does not require proof of meeting specific performance acceptance criteria through the kind of studies you've outlined.

Specifically, the "PERFORMANCE DATA" section states:

"Non-clinical data submitted to demonstrate substantial equivalence included: Referenced from the primary predicate device K203660: sterilization validation according to ISO 17665-1 and ISO 17665-2; . Provided in this submission: biocompatibility evaluation according to ISO 10993-5 and ISO 10993-12 worst-case analysis and static and dynamic testing according to ISO 14801 on subject devices to demonstrate that static and dynamic testing referenced from the primary predicate device K203660 demonstrates the subject implants do not create a new worst-case as compared to this predicate device with identical connection platform. No clinical data were included in this submission."

Therefore, I cannot provide the requested information for the following reasons:

Table of acceptance criteria and reported device performance: This document does not specify general "acceptance criteria" for clinical performance or report clinical performance data. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and design comparisons.
Sample size used for the test set and data provenance: No clinical test set was used or described. The non-clinical testing involved "worst-case analysis and static and dynamic testing according to ISO 14801," but specific sample sizes for these engineering tests are not detailed.
Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set or ground truth determination by experts is mentioned.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical studies were included.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device (dental implant), not an AI algorithm.
Type of ground truth used: Not applicable, as no clinical data or ground truth determination is described.
Sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TRI Dental Implants Int. AG % Floyd Larson President PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130

January 8, 2025

Re: K242661

Trade/Device Name: TRI-matrix® X-Force Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 30, 2024 Received: December 16, 2024

Dear Floyd Larson:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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

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Indications for Use

Submission Number (if known)

K242661

Device Name

TRI-matrix® X-Force Implants

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 TRI Dental Implants Int. AG TRI-matrix® X-Force Implants

January 7, 2024

ADMINISTRATIVE INFORMATION

Manufacturer Name	TRI Dental Implants Int. AG
	Boesch 80A/Postfach 419
	CH-6331, Huenenberg, Switzerland
	Telephone:	+41-32-510-1606
	Fax:	+41-32-510-1606
Official Contact	Sandro Venanzoni, Chief Technology Officer
Representative/Consultant	Floyd G. Larson, MS, MBA
	Kevin Thomas, PhD
	PaxMed International, LLC
	1925 Palomar Oaks Way, Suite 210
	Carlsbad, CA 92008
	Telephone:	+1-858-792-1235
	Fax:	+1-858-792-1236
	Email:	flarson@paxmed.com
		kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	TRI-matrix® X-Force Implants
Common Name	Dental implant
Regulation Number	21 CFR 872.3640
Regulation Name	Endosseous dental implant
Regulatory Class	Class II
Product Code	DZE
Classification Panel	Dental
Reviewing Office	Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices)
Reviewing Division	Division of Health Technology 1 B (Dental Devices)

PREDICATE DEVICE INFORMATION

Primary Predicate Device

K203660, TRI-matrix® Implant Line, TRI Dental Implants Int. AG

Reference Devices

K151916, TRI® Dental Implant System, TRI Dental Implants Int. AG

K212785, Blue Sky Bio Implant System, Blue Sky Bio, LLC

K230108, Straumann® BLC and TLC Implants, Straumann USA, LLC (on behalf of Institut Straumann AG)
K192221, Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts, Implant Direct Sybron Manufacturing, LLC

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INDICATIONS FOR USE STATEMENT

TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20 or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.

SUBJECT DEVICE DESCRIPTION

TRI-matrix X-Force 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix X-Force 3.7 mm and 4.1 mm diameter implants are available in two (2) platform diameters: 3.7 mm and 4.5 mm. TRI-matrix X-Force 4.7 mm diameter and 5.7 mm diameter implants have a platform diameter of 4.5 mm. The combinations of subject device implant body and platform diameters and implant lengths are summarized in Table 1 Summary of Subject Device TRI-matrix X-Force Implant Sizes.

BodyØ,mm	Platform Ø,(Implant/Abutmentconnection),mm	Length, mm
3.3	3.7	8	10	12	14	16
3.7	3.7, 4.5	8	10	12	14	16	18	20	22
4.1	3.7, 4.5	8	10	12	14	16	18	20	22
4.7	4.5	8	10	12	14	16
5.7	4.5	8	10	12	14	16

Table 1. Summary of Subject Device TRI-matrix X-Force Implant Sizes

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PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included:

Referenced from the primary predicate device K203660:
sterilization validation according to ISO 17665-1 and ISO 17665-2; .

Provided in this submission:

biocompatibility evaluation according to ISO 10993-5 and ISO 10993-12 ●
worst-case analysis and static and dynamic testing according to ISO 14801 on subject devices to . demonstrate that static and dynamic testing referenced from the primary predicate device K203660 demonstrates the subject implants do not create a new worst-case as compared to this predicate device with identical connection platform.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and reference devices.

The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K203660. Slight differences in the language of the subject device and primary predicate device IFUS do not affect the intended use as an endosseous dental implant for support of a prosthesis to restore chewing function. Minor differences between the IFUS for the subject device and the primary predicate include the specific device names and special requirements for implants with lengths of 18 mm, 20 mm and 22 mm. Substantial equivalence of the latter is supported by the reference device K212785. The minor differences do not impact substantial equivalence both IFUS express equivalent intended use to facilitate dental prosthetic restorations and are expressed equivalently using different specific wording.

The designs of the subject TRI-matrix X-Force implants, the primary predicate implants (K203660) and implants of reference device K151916 also are substantially equivalent in terms of endosseous thread form designs, prosthesis attachment (screw-retained), restorations (single-unit or multi-unit), abutmentimplant interface (internal connection), material, and surface treatment. The ranges of dimensions of body diameter, platform diameter and endosseous length, for the TRI-matrix X-Force implants are within the ranges of the primary predicate device K203660 and the reference device K151916 except that the subject device includes longer implants (18 mm, 20 mm and 22 mm) for Ø 3.7 and Ø 4.1, and one shorter implant (8 mm) for Ø 3.3. In both cases, suitable reference devices have been identified. Long implants are substantially equivalent in diameter and length, and in Indications for Use, to reference device K212785. The range of implant lengths for Ø 3.3 subject device implants is substantially equivalent to that of Straumann TLC implants cleared in reference device K230108.

The subject device implants are manufactured from titanium alloy conforming to ASTM F136, using the identical material and processing used for titanium alloy components cleared in the primary predicate K203660 and the reference device K151916. They are grit-blasted and acid-etched, as are the implants of the primary predicate K203660 and the reference device K151916. The subject device implants have a pink collar that is anodized using a standard anodization process that is identical to the anodization process used on tissue level implants cleared in K203660.

All subject device implants are provided sterile by gamma irradiation, the identical sterilization method used for sterile components in K203660.

Risks associated with the subject device implant designs are mitigated by engineering analysis demonstrating that they are not a new worst-case relative to implants of the primary predicate K203660

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510(k) Summary K242661

and by mechanical testing of implants and prosthetic components provided in in K203660. The mechanical testing data and engineering rationale demonstrate that the subject device implants in combination with compatible TRI Dental Implants angled abutments have sufficient strength for their intended use.

Minor differences in the designs, dimensions or sizes among the subject device, the primary predicate device and the reference devices do not affect substantial equivalence. These minor differences do not impact safety or effectiveness because these differences are mitigated by the engineering analysis.

CONCLUSION

The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device and the reference devices encompass the same range of physical dimensions, are packaged in the same materials, and are sterilized using the same methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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	Indications for Use Statement
Subject Device
TRI-matrix® X-ForceImplant LineTRI Dental ImplantsInt. AG	TRI-matrix® X-Force implants are intended for placement in the bone of the maxillaryor mandibular arch for the rehabilitation of edentulous and partially edentulouspatients. TRI-matrix® X-Force implants allow for one and two stage surgicalprocedures. When a one-stage surgical procedure is applied, the implant may beimmediately loaded when good primary stability is achieved and with appropriateocclusal loading.. TRI-matrix® X-Force implants with lengths of 18, 20, 22, or 24 mm,when placed in the maxilla, are indicated only for multiple unit restorations in splintedapplications that utilize at least two implants.
Primary Predicate Device
K203660TRI-matrix® ImplantLineTRI Dental ImplantsInt. AG	The TRI-matrix® Implant Line is intended for placement in the bone of the maxillaryor mandibular arch for the rehabilitation of edentulous and partially edentulouspatients. TRI-matrix® Implant Line allows for one and two-stage surgical procedures.When a one-stage surgical procedure is applied, the implant may be immediatelyloaded when good primary stability is achieved and with appropriate occlusal loading.TRI-matrix® Implant Line 6.5 mm implants are intended for delayed loading only.
	The TRI-matrix® Crown Abutment is intended for use with an endosseous implant tofunction as a substructure that also serves as the final restoration, in a partially orcompletely edentulous patient. The abutment screw is intended to secure the TRI-matrix® Crown Abutment to the endosseous implant.
Reference Device
K151916TRI® Dental ImplantSystemTRI Dental ImplantsInt. AG	The TRI® Dental Implant System is intended for placement in the bone of themaxillary or mandibular arch for the rehabilitation of edentulous and partiallyedentulous patients. TRI® Dental Implant System allows for one and two-stage surgicalprocedures. When a one-stage surgical procedure is applied, the implant may beimmediately loaded when good primary stability is achieved and with appropriateocclusal loading.TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.
Reference Device
K212785Blue Sky Bio ImplantSystemBlue Sky Bio, LLC	Blue Sky Bio Long Implant System is intended for surgical placement in the bone ofthe upper jaw to provide support for prosthetic devices, such as artificial teeth, torestore chewing function. Implants may be used with single-stage or two-stageprocedures, and may be loaded immediately when good primary stability is achievedand with appropriate occlusal loading. Blue Sky Bio Long implants can be placedbicortically in cases of reduced bone density. Blue Sky Bio Long implants are onlyindicated for multiple unit restorations in splinted applications that utilize at least twoimplants. Blue Sky Bio Long Implant System with a 45° angulation are indicated forsurgical installation in the pterygoid region only, in cases of severe jaw resorption, inorder to restore patient esthetics and chewing function.

Table 2. Substantial Equivalence – Indications for Use Statement

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Reference Device
K230108Straumann® BLCand TLC ImplantsStraumann USA,LLC	Straumann® dental implants are indicated for the functional and esthetic oralrehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.They can be used for immediate, early or late implantation following the extraction orloss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved andwith appropriate occlusal loading to restore chewing function.
Reference Device
K192221Legacy 2, Legacy3,Legacy4,simplyLegacy2,simplyLegacy3 dentalimplants;Legacy2, Legacy3,Legacy4 fixture-mountsImplant DirectSybronManufacturing, LLC	Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants aretwo-piece implants for one-stage or two-stage surgical procedures. These implants areintended for use in partially and fully edentulous upper and lower jaws in support ofsingle or multiple-unit restorations and terminal or intermediate abutment support forfixed bridgework.Implants can be indicated for immediate loading when good primary stability has beenachieved and with appropriate occlusal loading. Narrow (3.2mmD) implants: Indicated for single-tooth replacement(mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization. Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular andmaxillary central and lateral incisors), multiple tooth replacements or denturestabilization. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with thecorresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). Thefixture-mounts can function as an abutment. As an abutment, fixture-mounts areintended for use with dental implants in the maxillary and/or mandibular arches toprovide support for crowns or bridges for edentulous or partially edentulous patients. Fixture-mounts as an abutment for narrow (3.2mmD) implants: Indicated forsingle-tooth replacement of mandibular central and lateral incisors andmaxillary lateral incisors. Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicatedfor tooth replacement of mandibular and maxillary central and lateral incisors. Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants arecompatible with the following abutments.
	Manufacturer Abutment Line Platform Diameter Implant Direct Legacy 3.0mm, 3.5mm, 4.5mm, 5.7mm

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510(k) Summary K242661

TRI-matrix® X-Force Implants Page 7 of 8

Table 3. Substantial Equivalence – Technological Characteristics

Comparison	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
		K203660	K151916	K212785	K230108
	TRI-matrix®X-Force Implant Line	TRI-matrix® Implant Line	TRI® Dental Implant System	Blue Sky Bio Implant System	Straumann® BLC and TLC Implants
	TRI Dental Implants Int. AG	TRI Dental Implants Int. AG	TRI Dental Implants Int. AG	Blue Sky Bio, LLC	Straumann USA, LLC
Reason for Predicate /Reference Device	Not applicable	Implant designs, prostheticinterface	Implant designs	Long implants	Range of Ø 3.3 mm implant lengths
Implant Design
Tissue LevelBody Diameters x EndosseousLengths (mm)(Also see Table 4)	TRI-matrix® X-ForceØ 3.3 x 8, 10, 12, 14, 16Ø 3.7 x 8, 10, 12, 14, 16, 18, 20, 22Ø 4.1 x 8, 10, 12, 14, 16, 18, 20, 22Ø 4.7 x 8, 10, 12, 14, 16Ø 5.7 x 8, 10, 12, 14, 16	TRI-matrix® Tissue-LevelØ 3.3 x 10, 11.5, 13Ø 3.75 x 8, 10, 11.5, 13Ø 4.1 x 6.5, 8, 10, 11.5, 13Ø 4.7 x 6.5, 8, 10, 11.5, 13	TRI OctaØ 3.75 x 8, 10, 11.5, 13Ø 4.1 x 6.5, 8, 10, 11.5, 13Ø 4.7 x 6.5, 8, 10, 11.5, 13		Straumann TLC ImplantsØ 3.3 x 8, 10, 12, 14, 16, 18
Platform Diameters (mm) or names	3.7 (for 3.3, 3.7, and 4.1 mm body)4.5 (for 3.7, 4.1, 4.7, and 5.7 mm body)	3.7 (for 3.3, 3.75, and 4.1 mm body)4.5 (for 3.75, 4.1, and 4.7 mm body)	4.8		NT/RT
Bone LevelBody Diameters x Lengths (mm)		TRI-matrix® Bone-LevelØ 3.75 x 8, 10, 11.5, 13, 16Ø 4.1 x 6.5, 8, 10, 11.5, 13, 16Ø 4.7 x 6.5, 8, 10, 11.5, 13, 16	TRI-Vent, TRI NarrowØ 3.3 x 10, 11.5, 13, 16(TRI-Narrow)Ø 3.75 x 8, 10, 11.5, 13, 16Ø 4.1 x 6.5, 8, 10, 11.5, 13, 16Ø 4.7 x 6.5, 8, 10, 11.5, 13, 16	Blue Sky Bio Long ImplantSystemØ 3.7 x 20, 22.5, 25Ø 4.3 x 20, 22.5, 25Ø 5.0 x 20, 22.5, 25
Platform Diameters (mm)		3.7 (for 3.75 and 4.1 mm body)4.5 (for 4.7 mm body)	3.2 (for 3.3 mm body TRI-Narrow)3.5 (for 3.75, 4.1, and 4.7 mm body)	3.5
Connection	Internal	Internal	Internal	Internal, External	Internal
Material
Implant	Titanium alloy (Ti-6Al-4V ELI)	Titanium alloy (Ti-6Al-4V ELI)	Titanium alloy (Ti-6Al-4V ELI)	Titanium alloy (Ti-6Al-4V ELI)	Titanium-13 Zirconium alloy
Surface	Grit-blasted and acid-etched;Pink anodized collar	Grit-blasted and acid-etched;Pink anodized collar	Grit-blasted and acid-etched;Pink anodized collar	Not stated	SLActive® andSLA®
How Provided
Implant	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile by gamma irradiation
Usage	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use

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Table 3. Substantial Equivalence – Technological Characteristics (continued)
Comparison	Subject Device	Reference Device
	TRI-matrix®X-Force Implant Line	K192221Legacy2, Legacy3, Legacy4, simplyLegacy2,simplyLegacy3 dental implants; Legacy2,Legacy3, Legacy4 fixture-mounts
	TRI Dental Implants Int. AG	Implant Direct Sybron Manufacturing, LLC
Reason for Predicate / Reference Device	Not applicable	Implant diameters and lengths
Implant Design
Tissue LevelBody Diameters xEndosseous Lengths (mm)(Also see Table 4)	TRI-matrix® X-ForceØ 3.3 x 8, 10, 12, 14, 16Ø 3.7 x 8, 10, 12, 14, 16, 18, 20, 22Ø 4.1 x 8, 10, 12, 14, 16, 18, 20, 22Ø 4.7 x 8, 10, 12, 14, 16Ø 5.7 x 8, 10, 12, 14, 16
Platform Diameters (mm) or names	3.7 (for 3.3, 3.7, and 4.1 mm body)4.5 (for 3.7, 4.1, 4.7, and 5.7 mm body)
Bone LevelBody Diameters xLengths (mm)		3.2 x 8, 10, 11.5, 13, 163.7 x 6, 8, 10, 11.5, 13, 164.2 x 6, 8, 10, 11.5, 13, 164.7 x 6, 8, 10, 11.5, 13, 165.2 x 6, 8, 10, 11.5, 13, 165.7 x 6, 8, 10, 11.5, 13, 167.0 x 6, 8, 10, 11.5, 13
Platform Diameters (mm)		3.0, 3.5, 4.5, 5.7
Connection	Internal	Internal
Material
Implant	Titanium alloy (Ti-6Al-4V ELI)	Titanium alloy (Ti-6Al-4V ELI)
Surface	Grit-blasted and acid-etched;Pink anodized collar	Grit-blasted and acid-etched;
How Provided
Implant	Sterile by gamma irradiation	Sterile by gamma irradiation
Usage	Single patient, single use	Single patient, single use

		Table 3. Substantial Equivalence - Technological Characteristics (continued)

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.