Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Implants can be indicated for immediate loading when good primary stability has been achieved 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 and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

. Fixture-mounts as an abutment for narrow (3.2mmD) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments.

Manufacturer	Abutment Line	Platform Diameter
Implant Direct	Legacy	3.0mm, 3.5mm, 4.5mm, 5.7mm

Device Description

The Legacy2, Legacy4, and simplyLegacy2 implants have implant body and are supplied in similar dimensions. This 510(k) notice includes the Legacy3 dimensions previously cleared in K090234 and K131097; the Legacy3 (7.0mmD) is the same as the previously cleared Legacy3, but in a wider diameter.

The top approximate one-third of the implant body is straight, and the lower approximate two-thirds is tapered with progressively deeper buttress-threads. The Legacy3 implant body also features progressively deeper buttress threads, with quadruple-lead micro-threads at the coronal aspect; this implant body is evenly tapered. Each implant features a color-coded internal hex with a lead-in bevel. The simplyLegacy2 and simplyLegacy3 implants are identical to the Legacy3 implants, respectively, except that they are supplied without the corresponding fixturemount/abutment.

The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for dental implants. It details the device description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.

The performance data presented in the document solely pertains to physical and biological properties of the dental implants, such as fatigue testing, biocompatibility, surface area and bone-to-implant contact analysis, pull-out testing, insertion torque testing, sterilization validation, endotoxin testing, shelf-life validation, and distribution validation.

Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission for traditional dental implants.

The document explicitly states on page 7: "No animal or clinical studies were performed in support of this 510(k) notice." This further confirms the absence of the type of studies implied by your questions, which are typically found in submissions for diagnostic or AI-powered devices.

Summary

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June 25, 2020

Implant Direct Sybron Manufacturing, LLC % Kelliann Payne Partner Hogan & Lovells US LPP 1735 Market Street Floor 23 Philadelphia, Pennsylvania 19103

Re: K192221

Trade/Device Name: Legacy2, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 27, 2020 Received: May 27, 2020

Dear Kelliann Payne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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542 of the Act); 21 CFR 1000-1050.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K192221

Device Name

Legacy2, Legacy4, simplyLeaacy2, simplyLegacy3 dental implants; Legacy2, Legacy4 fixture-mounts Indications for Use (Describe)

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants for one-stage of two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors), multiple-tooth replacements or denture stabilization.
. Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

The Legacy 2. Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental mplants (Legacy3. and Legacy4. respectively). The fixture-mounts can furction as an abutment. fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for edentulous or partially edentulous patients.

Fixture-mounts as an abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and ● maxillary central and lateral incisors.

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Leqacy4 implants are compatible with the following abutments.

Manufacturer	Abutment Line	Platform Diameter
Implant Direct	Legacy	3.0mm, 3.5mm, 4.5mm, 5.7mm

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Implant Direct LLC's

Legacy2, Legacy3, Legacy4, simplyLegacy2, and simplyLegacy3 Dental Implants; Legacy2, Legacy3, and Leqacy4 Fixture-mounts

Submitter:Address:	Implant Direct Sybron Manufacturing LLC3050 East Hillcrest DriveThousand Oaks, CA 91362
Phone:Contact Person:	818-444-3306Reina Choi, Regulatory Affairs Manager
Date Prepared:	June 25, 2020
Name of Device:	Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dentalimplants; Legacy2, Legacy3, Legacy4 fixture-mounts
Common or Usual Name:Classification Name:Regulatory Class:Primary Product Code:Secondary Product Code:	Endosseous dental implants21 C.F.R. § 872.3640 (Endosseous dental implants);Class IIDZENHA
Predicate Device:	Implant Direct LLC's Spectra-System Dental Implants 2008 (nowLegacy3 Dental Implant) (K090234)
Reference Devices:	lmplant Direct LLC's Legacy3 Implants (6mm Length) (K131097);Implant Direct LLC's Legacy Abutment System (K060063);Implant Direct LLC's Custom Legacy and Custom InterActiveTitanium Abutments (K192218)

Device Description

The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.

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Dimensions of Subject Implants

Subject Implants	BodyDiameter	PlatformDiameter	Implant Length
Legacy2,simplyLegacy2,Legacy3,simplyLegacy3,Legacy4	3.2mmD	3.0mmD	8, 10, 11.5, 13, 16mm
	3.7mmD	3.5mmD	8, 10, 11.5, 13, 16mm
	4.2mmD	3.5mmD	8, 10, 11.5, 13, 16mm
	4.7mmD	4.5mmD	6 (only simplyLegacy), 8, 10, 11.5, 13, 16mm
	5.2mmD	4.5mmD	6 (only simplyLegacy), 8, 10, 11.5, 13, 16mm
Legacy2,simplyLegacy2,Legacy3,simplyLegacy3,Legacy4	5.7mmD	5.7mmD	6 (only simplyLegacy), 8, 10, 11.5, 13, 16mm
Legacy2,simplyLegacy2,Legacy3,simplyLegacy3,Legacy4	7.0mmD	5.7mmD	6 (only simplyLegacy), 8, 10, 11.5, 13mm

The Legacy2 and Legacy3 implants have a one-piece fixture-mount, and the Legacy4 implant has a two-piece fixture-mount. The Legacy fixture-mounts serve (1) as a transfer, to carry the implant to the ostectory and help with placement if desired; (2) to take an impression after implant placement, to guide fabrication of the patient-specific dental restoration; and (3) as an abutment.

All of the subject devices are made of Titanium alloy, are single-use, and come into contact with patient tissue/bone for a long-term or permanent duration. The implants are supplied with one of two surface modifications/coatings:

. Soluble Blast Media (SBM);
Hydroxyapatite (HA) per ASTM F1185. ●

Legacy2, Legacy3, and Legacy4 implants are available with either surface modification/coating; simplyLegacy2 and simplyLegacy3 are only available with SBM.

The devices are supplied sterile; the fixture-mounts, if modified for use as abutments, must also be sterilized by the end user prior to intra-oral use.

Intended Use / Indications for Use

Implants can be indicated for immediate loading when good primary stability has been achieved 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 and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

. Fixture-mounts as an abutment for narrow (3.2mmD) Implants: Indicated for single-tooth

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replacement of mandibular central and lateral incisors and maxillary lateral incisors.

Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments.

Manufacturer	Abutment Line	Platform Diameter
Implant Direct	Legacy	3.0mm, 3.5mm, 4.5mm, 5.7mm

Summary of Comparison to Predicate Device

The minor differences in indications between the subject and predicate devices are not critical to the intended therapeutic use of the products and do not raise different questions of safety or effectiveness when the products are used as labeled, because they merely limit the scope of use and clarify the appropriate conditions of use. Relatedly, this submission updates the indications for use statement for the previously cleared Legacy3 implant models (K090234 and K131097) to align with the indications for the other subject Legacy models.

Both the subject and predicate implants function in support of single- and multi-unit restorations to help rehabilitate partially and fully edentulous patients' chewing function. Both implants are indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The underlying technological principle is mechanical load-bearing of the forces imparted in the patient's mouth in order to provide stability. While the devices differ slightly in specific features of the implant body, the core design and how it functions are the same. Similarly, the subject fixturemounts and the predicate Legacy3 straight abutment are made of the same materials and function in the same way to support dental restorations in conjunction with a corresponding implant. The minor differences in certain dimensions of the subject fixture-mounts and to incorporate the additional class l, exempt functionalities (implant carrier and transfer) do not alter the principles of operation of the system or the related safety and efficacy considerations.

A table comparing the key features of the subject and predicate devices is provided below.

Performance Data

The company performed the following bench testing in support of the subject devices' safety and effectiveness:

. Fatigue Testing
The subject devices were subjected to cyclic fatique testing in accordance with ISO 14801:2016 and FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, and also leveraged fatigue testing conducted on representative devices (submitted in K192218). Results were favorable compared to the predicate and reference device and demonstrate that the subject devices can withstand foreseeable mastication forces in accordance with their specifications when used as intended.

. Biocompatibility Testing

Representative, worst-case subject devices were successfully tested for biocompatibility in accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 and FDA's corresponding June 2016 quidance. The following endpoints were tested: cytotoxicity; sensitization; systemic toxicity; implantation (considered to also

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cover sub-acute/sub-chronic and chronic toxicity); and genotoxicity/mutagenicity.

. Surface Area and Bone-to-Implant Contact Analysis
Both surface area and bone-to-implant contact comparisons were made between the subject implants and reference device (K131097) 6mm length implants. Results show that the subject devices are substantially equivalent with respect to surface area and bone-to-implant contact.
. Pull-out Testing
Osteotomies were made in simulated soft bone. The subiect and reference device 6mmL implants were inserted to a depth of 3mm below the bone level. Results show that the force required to pull out the 6mmL subject implants was substantially equivalent to that for the reference device.

. Insertion Torque Testina

Osteotomies were made in simulated soft and dense bone; subject and reference device 6mmL implants were inserted. Results show that the subject 6mmL devices have comparable insertion torque as the reference 6mmL device.

. Sterilization Validation Testing

Sterilization validation testing was performed on worst-case representative subject devices in accordance with ISO 11137-2. The validation successfully demonstrated a sterility assurance level (SAL) of 10th for the subject devices.

. Endotoxin Testina

Bacterial endotoxin (LAL) testing was performed per ANSI/AAMI ST72 on worst-case representative subject devices to verify that the subject implants, upon terminal sterilization, meet established endotoxin release limits. Results were well below the maximum thresholds set by FDA and USP, confirming that the devices are acceptably non-pyrogenic.

. Shelf Life Validation

The subject devices after 5 years of real time aging were subjected to microbial aerosol challenge and sterility testing in accordance with ISO 11737-2. Results were passing in support of the labeled shelf life - the device label remained attached and legible, there was no damage to the device or packaging due to aging, and the sterile barrier remained intact.

. Distribution Validation

To determine any impact distribution would have on the subject device, worst-case implants underwent simulated shipping following ASTM D4169, DC 13, Assurance Level II. Tests include handling, stacking, loose load vibration, and concentrated impact. All tested implants passed post-simulation quality and sterile barrier inspection.

. Sterilization Validation

Sterilization validation performed for K192218 on devices representing worst-case compared to the subject fixture-mount/abutments in accordance with ANSI/AAMI/ISO_14937 and ISO 17665 was relied upon. This testing confirmed the adequacy of the steam sterilization process (performed by the end user on the fixture-mount/abutment per instructions/parameters provided in the device's labeling) to achieve a sterility assurance level (SAL) of 10 ° for the subject fixture-mount/abutments.

All results confirmed the devices' adequacy for their intended use and equivalent safety and effectiveness to the predicate device.

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No animal or clinical studies were performed in support of this 510(k) notice.

Conclusions

The Legacy2, Legacy3, Legacy4, simplyLegacy2, and simplyLegacy3 dental implants and the Legacy2, Legacy3, and Legacy4 fixture-mounts are as safe and effective as the predicate Legacy3 implant system (K090234). The subject devices have intended uses and similar indications, technological characteristics, and principles of operation as the predicate device. The minor differences in indications do not alter the intended therapeutic use of the devices and do not affect their safety and effectiveness when used as labeled. In addition, the minor technological differences between the subject devices and their predicate raise no new issues of safety or effectiveness. Performance data demonstrate that the subject devices are as safe and effective as the predicate. Thus, the subject Legacy dental implants and fixture-mount/abutments are substantially equivalent.

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Characteristic	Legacy2, Legacy4, simplyLegacy2,Legacy3, and simplyLegacy3 Implants;Legacy2, Legacy3, Legacy4 Fixture-mounts	Predicate (K090234):Spectra-System DentalImplants 2008	Reference (K131097):Legacy3 Implants(6mmL)	Reference (K060063):Legacy AbutmentSystem	Reference (K192218):Custom Legacy andCustom InterActiveTitanium Abutments
Classification	21 C.F.R. § 872.3640; DZE21 C.F.R. § 872.3630; NHA		21 C.F.R. § 872.3640; DZE	21 C.F.R. § 872.3630;NHA	21 C.F.R. § 872.3630; NHA
Intended Use /Indications forUse	Legacy2, simplyLegacy2, Legacy3,simplyLegacy3, and Legacy4 dental implantsare two-piece implants for one-stage or two-stage surgical procedures. These implantsare intended for use in partially and fullyedentulous upper and lower jaws in supportof single or multiple-unit restorations andterminal or intermediate abutment support forfixed bridgework.Implants can be indicated for immediateloading when good primary stability hasbeen achieved and with appropriateocclusal loading.• Narrow (3.2mmD) implants: Indicated forsingle-tooth replacement (mandibularcentral and lateral incisors; maxillarylateral incisors), multiple-toothreplacements or denture stabilization.• Short (<10mm) 3.7mm implants:Indicated for single-tooth (mandibularand maxillary 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 are intendedfor use with dental implants in the maxillaryand/or mandibular arches to provide supportfor crowns or bridges for edentulous orpartially edentulous patients.• Fixture-mounts as an abutment fornarrow (3.2mmD) implants: Indicated forsingle-tooth replacement of mandibularcentral and lateral incisors and maxillarylateral incisors.• Fixture-mounts as an abutment for short(8mm) 3.7mmD implants: Not intendedfor tooth replacement of canines, pre-	The Spectra-SystemDental Implant 2008system is comprised ofdental implant fixturesand prosthetic devicesthat compose a two-piece implant system.The Dental Implants areintended for use in themandible and maxilla, insupport of single unit ormultiple unit cement orscrew-receivingrestorations and for theretention and support ofoverdentures. Theimplants are intendedfor immediateplacement and functionfor the support of single-tooth or multiple-toothrestorations,recognizing bonestability and appropriateocclusal loadrequirements.	Legacy3 6mm Lengthimplants consist of two-piece implants for one-stage or two-stagesurgical procedures.These implants areintended for use inpartially and fullyedentulous upper andlower jaws in support ofsingle or multiple-unitrestorations andterminal or intermediateabutment support forfixed bridgework.Implants can beindicated for immediateloading when goodprimary stability hasbeen achieved and withappropriate occlusalloading.	The Legacy AbutmentSystem is intended foruse with dental implantsin the maxillary and/ormandibular arches toprovide support forcrowns, bridges, oroverdentures foredentulous or partiallyedentulous patients.The Legacy AbutmentSystem is compatiblewith implants that havemating diameters, lead-inbevels, internal hex sizes,and 1-72UNF internalthreads, as shown in theZimmer Dental TaperedScrew-Vent SurgicalManual.Implant Direct LLC willmonitor the compatibleimplants for modificationsto ensure futurecompatibility. In the eventof any modification,Implant Direct LLC willeither modify the Legacyabutment to ensurecompatibility, or ceaseclaiming compatibility tothe modified ZimmerDental Screw-Ventimplants.	Custom Titanium Abutmentsare customizable devicesintended for use with dentalimplants in the maxillaryand/or mandibular arches toprovide support for crowns orbridges for edentulous orpartially edentulous patients.• Custom TitaniumAbutment for narrow(3.2mmD, 3.3mmD)implants: Indicated forsingle-tooth replacementof mandibular central andlateral incisors andmaxillary lateral incisors.Also indicated for multipletooth replacements.• Custom TitaniumAbutment for short (8mm)3.7mmD implants:Indicated for toothreplacement ofmandibular and maxillarycentral and lateralincisors.Custom Legacy TitaniumAbutments are compatible atthe implant-level withLegacy1, Legacy2, Legacy3,Legacy4, simplyLegacy2and simplyLegacy3implants, excluding 6mmlength implants.Custom InterActive TitaniumAbutments are compatible atthe implant-level withInterActive,simplyInterActive and
Characteristic	Legacy2, Legacy4, simplyLegacy2,Legacy3, and simplyLegacy3 Implants;Legacy2, Legacy3, Legacy4 Fixture-mounts	Predicate (K090234):Spectra-System DentalImplants 2008	Reference (K131097):Legacy3 Implants(6mmL)	Reference (K060063):Legacy AbutmentSystem	Reference (K192218):Custom Legacy andCustom InterActiveTitanium Abutments
	molars or molars.				SwishActive implants,
	Legacy2, simplyLegacy2, Legacy3,simplyLegacy3, and Legacy4 implants arecompatible with Legacy abutments (3.0mm,3.5mm, 4.5mm, 5.7mm platform).				excluding 6mm lengthimplants.
General Design	Threaded Root form implant	Threaded Root form implant	Threaded Root form implant	Screw- or cement-retainedroot form abutment	Cement-retained root formabutment
Body Diameters	3.2mm, 3.7mm, 4.2mm, 4.7mm, 5.2mm,5.7mm, 7.0mm	3.2mm, 3.7mm, 4.2mm,4.7mm, 5.2mm, 5.7mm	3.7mm, 4.2mm, 4.7mm,5.2mm, 5.7mm, 7.0mm	N/A	N/A
ImplantLengths	6mm (only simplyLegacy), 8mm, 10mm,11.5mm, 13mm, 16mm	8mm, 10mm, 11.5mm,13mm, 16mm	6mm	N/A	N/A
Cutting Flutes	3 (Legacy2/4); 2 (Legacy3)	N/A	2	N/A	N/A
lmplantPlatform	3.0mm, 3.5mm, 4.5mm, 5.7mm	3.0mm, 3.5mm, 4.5mm,5.7mm	3.5mm, 4.5mm, 5.7mm	Mates with 3.5mm,4.5mm, 5.7mm interfacediameter	Mates with 3.0mm, 3.4mm.3.5mm, 4.5mm, 5.7mminterface diameter
Connection Type	Internal hex	Internal hex	Internal hex	Internal hex	Internal hex
Screw Size	M1.6 and 1-72 UNF 2A	M1.6 and 1-72 UNF 2A	1-72 UNF 2A	M1.6, 1-72UNF	M1.6, M2, 1-72UNF
ImplantAssembly	lmplant is assembled with one-piece(Legacy2, 3) or two-piece (Legacy4)fixture-mount.simplyLegacy2, 3: No carrier or fixture-mount.	Implant is assembled with an abutment; carrier andtransfer.	Implant is assembled with an abutment; carrier andtransfer.	Abutment is assembledwith compatible implant(corresponding size)	Abutment is assembledwith compatible implant(corresponding size)
Sterilization	Supplied sterile; fixture-mounts sterilizedby end user when used as abutments.	Supplied sterile; prosthetic components sold non-sterile and steam sterilized by end user prior touse.	Supplied sterile; prosthetic components sold non-sterile and steam sterilized by end user prior touse.	Sterilized by end user	Sterilized by end user
Materials	Titanium 6AL4V ELI	Titanium 6AL4V ELI	Titanium 6AL4V ELI	Titanium 6AL4V ELI	Titanium 6AL4V ELI
Surface belowbone level	SBM implant: HA blasted;HA implant: HA blasted/HA coated	SBM implant: HA blasted;HA implant: HA blasted/HA coated	SBM implant: HA blasted;HA implant: HA blasted/HA coated	N/A	N/A

Substantial Equivalence Table

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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.