Legacy3 6mm Length consists of two-picce implants for one-stage on 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.

Device Description

The Legacy3 6mm length implants consists of 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.

The Legacy3 6mm length implants have a taper body to facilitate insertion in an undersized socket and gradual expansion of bone to increase initial stability. The body has double-lead buttress threads and quadruple-lead threads in the coronal region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components.

The Legacy3, 6mm length implants are a line extension to the previously cleared Legacy implants (K090234) having identical prosthetic interface compatibility. The addition is not due to recall, customer complaint, corrective action, or labeling and it does not affect its intended use. The addition provides a shorter version of the predicate implant in order to allow for a restoration option in areas of the mouth where an 8mm implant will not work.

The shorter version required minor changes to the outer body design taper and threads depth to allow for adequate thread engagement when using existing surgical protocol and have a surface area that is equal or greater than the predicate devices. The shorter 6mm length implants are equivalent to the existing SwishPlant 6mm implants (K081396) with clinically proven safety and efficacy.

The Legacy3 6mmL implants offer six body diameters (3.7, 4.2, and 4.7, 5.2, 5.7 and 7.0 mm) in 6mm length with the platform diameter of 3.5, 4.5 and 5.7mm. The Legacy3 6mmL implants are available with two surface coatings: SBM Blast and HA Coating. The Legacy3 6mm implants are surgically and functionally compatible with the previously cleared prosthetic components (K060063, K081101, K090234 and K061319), and currently marketed laboratory components and surgical armamentaria.

AI/ML Overview

The provided text describes a 510(k) submission for the "Legacy3 6mm Length Implants." This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. Therefore, the "acceptance criteria" are typically the demonstration of substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "study" refers to the non-clinical performance testing conducted to support this claim of substantial equivalence.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Substantial Equivalence to Predicate Devices)	Reported Device Performance (Legacy3 6mm Implants)
Intended Use	Must be the same as or very similar to predicate devices: Use in partially and fully edentulous upper and lower jaws for single or multiple-unit restorations, fixed bridgework, and immediate loading with good primary stability and appropriate occlusal loading.	"Legacy3 6mm Length 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." This matches the predicate devices' intended use.
Material	Must be comparable to predicate devices. (Titanium Alloy (Ti 6AL-4V ELI) or Commercially pure Titanium)	Titanium Alloy (Ti 6AL-4V ELI) - same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices).
General Design	Threaded, root-form implant design.	Threaded, root-form implant - same as Legacy 8mm, SwissPlant 6mm, and Straumann (Own Predicate/Reference Devices and Predicate Device).
Placement Method	Dual or single-stage surgery.	Dual or single-stage surgery - same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices).
Implant Surface	SBM (Soluble Blasted Media) or other roughened surface.	SBM (Soluble Blasted Media) or SBM with HA-coating. SBM is the same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices).
Surface Roughness	SBM = 1.5-2.3μm.	SBM = 1.5-2.3μm - same as Legacy 8mm and SwissPlant 6mm (Own Predicate/Reference Devices).
Mechanical Strength	Equivalent mechanical safety (strength) to predicate devices, meeting FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 standards (static compression bending, fatigue, implant driving torque, abutment/screw torque to failure). Able to withstand loads higher than functional masticatory loads.	Laboratory testing was conducted following FDA guidance and ISO 14801 for worst-case devices. Components "have shown to exhibit equivalent mechanical strength as the predicate devices and the implant/abutment combinations were able to withstand loads that were higher than the functional masticatory loads."
Surface Area Analysis	Demonstrate substantial equivalence in external osseointegration surface area compared to predicate devices.	"Comparative surface area analysis was performed to demonstrate substantial equivalence by creating 3D models of the implants and obtaining the total external osseointegration surface area using three dimensional CAD measurement function." The text implies this analysis supported substantial equivalence.
Pull-out Testing	Demonstrate substantial equivalence in pull-out strength in simulated bone, considering potential bone loss.	"Furthermore, comparative pull-out testing was conducted to demonstrate substantial equivalence by inserting the implants into simulated bone taking into account 3mm of potential bone loss." The text implies this testing supported substantial equivalence.
Sterilization	Validation in accordance with ISO 11137-2 and AAMI TIR-33 for gamma radiation.	"Sterilization Validation was carried out in accordance with ISO 11137-2 and AAMI TIR-33 for gamma radiation." The method is validated.
Device Dimensions	While the length is new (6mm), other dimensions (body diameter, platform diameter) should be comparable to existing product lines or justified as variations.	The device offers six body diameters (3.7, 4.2, 4.7, 5.2, 5.7, and 7.0 mm) and three platform diameters (3.5, 4.5, and 5.7 mm). The 6mm length is specifically cited as a line extension to allow for restoration options where an 8mm implant would not work, and the shorter version required minor changes to the outer body design taper and thread depth to maintain adequate thread engagement and surface area equal to or greater than predicate devices. This demonstrates that variations are justified and performance is maintained.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical performance testing, primarily mechanical and physical characterization, to demonstrate substantial equivalence.

Sample Size for Test Set: Specific sample sizes for each mechanical test (static compression bending, fatigue, driving torque, screw torque) are not explicitly stated in the provided text. However, the testing was done for "worst-case devices," implying a selection of implants representing the range of sizes or configurations most likely to fail.
Data Provenance: The data provenance is from laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, which is based in Calabasas Hills, CA, USA. This is an experimental/testing type of data. It is not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the ground truth was established through non-clinical engineering and laboratory testing in accordance with recognized standards (FDA guidance, ISO 14801, ISO 11137-2, AAMI TIR-33). Ground truth in this context refers to the measured performance against established engineering benchmarks rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no human reader interpretation or clinical adjudication involved in the non-clinical performance testing. The "ground truth" was derived from direct physical and chemical measurements against defined engineering specifications and regulatory standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (dental implant), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence for the Legacy3 6mm Length Implants was based on:

Engineering Specifications and Standardized Test Results: Compliance with established mechanical and physical performance benchmarks defined by FDA guidance ("Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (ISO 14801 for mechanical testing, ISO 11137-2 and AAMI TIR-33 for sterilization).
Comparative Analysis: Demonstrating that the new device's performance (e.g., mechanical strength, surface area, pull-out strength) is equivalent to or better than that of already legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary

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510(K) Summary (21CFR 807.92(c))

1. Submitter's Information: Company Name: Implant Direct Sybron Manufacturing LLC 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Address: Telephone: 818-444-3300 818-444-3406 Fax: 3001617766 Registration No .: Ines Aravena Contact: May 15, 2013 Date Prepared:
1. Device Name and Classification: Device Trade Name: Legacy3 6mm Length Implants Classification Names: Implant, Endosseous, Root-Form Endosseous Dental Implant Common Names: Requlation Number: 872.3640 Product Codes: DZE Regulatory Class: Il

AUG 2 2 2013

3. Predicate Device(s):

Spectra Dental Implant System (K061319) Implant Direct Legacy Dental Implants with HA Coating (K073033) Implant Direct Spectra-System Implants 2008 (K090234) Implant Direct SwissPlant Implants (K081396) Bicon Implants with a 2.5mm Internal Connection (K092035) The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (K073368) ITI Dental Implant System (K030007)

4. Device Description:

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K131097

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510(K) Submission

region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components.

5. Intended Use:

Legacy3 6mm Length implants consist of 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.

Device Comparison (Technological Characteristics): 6.

This submission is comprised of devices whose physical dimensions, material composition, indications for use and methods of manufacture were previously cleared and have the same principles of operation as the cited predicate devices. The following Tables summarize the predicate device comparison analyses with the devices within the Legacy3 6mmL Implants. The subject device and the predicate devices have the same intended, the same technological characteristics, implant/abutment interface, similar material and surface treatment.

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Image /page/2/Picture/1 description: The image contains two distinct text blocks. The first block features the logo of "Implant Direct," accompanied by smaller text underneath. The second block reads "Legacy3 6mmL Implants", indicating a specific product or model. The text is clear and legible, suggesting a label or product description.

The table below compares the Legacy3 6mm Length Implants with currently marketed products. The comparison analysis consisted of the products' technological characteristics and intended use to support the substantial equivalency to their corresponding predicate devices.

Device Comparison Table: Legacy3 6mmL Dental Implants

Characteristics	Proposed:Legacy3 6mm	Own PredicateDevice: Legacy8mm(K073033,K090234)	Own ReferenceDevice:SwissPlant 6mm(K081396)	PredicateDevice:BiconImplants(K073368andK092035)	PredicateDevice:Straumann(K030007)	SubstantialEquivalence
PartNumbers	853706, 854206,854706, 855206,855706, 857008,863706, 864206,864706, 865206,865706, 867008	853208, 853708,854208, 854708,855208, 855708,857008	904106, 904806,904806W,905706	260-340-255	043.051S	√
IntendedUse	The LegacyDental Implant isa dental implantfixture that is apart of a two-piece implantsystem. TheLegacy implantsare intended foruse in themandible andmaxilla, insupport of singleor multiple-unitcement or screwreceiving fixedrestorations andfor retention andsupport ofoverdentures.The implants areintended forimmediateplacement and	The LegacyDental Implant isa dental implantfixture that is apart of a two-piece implantsystem. TheLegacy implantsare intended foruse in themandible andmaxilla, insupport of singleor multiple-unitcement or screwreceiving fixedrestorations andfor retention andsupport ofoverdentures.The implants areintended forimmediateplacement and	The SwissPlantDental Implantsystem consistsof two-pieceimplants for oneor two-stagesurgicalprocedures thatare intended foruse in partially orfully edentulousmandibles andmaxillae, insupport of singleor multiple-unitrestorationsincluding: cementretained, screwretained oroverdenturerestorations andin terminal orimmediateabutment support	Intended forsurgicalimplantationin edentulousmandibles ormaxillae forattachment ofcompletedentureprostheses,or as aterminal orintermediaryattachmentfor fixed orremovablebridgework,or as afreestandingsingle toothreplacement	Intended forimmediateplacementand functionon single-tooth and/ormultiple toothapplicationswhen goodprimarystability isachieved andwithappropriateocclusalloading, torestorechewingfunction.Multiple toothapplicationsmay berigidlysplinted. In	√
					510(K) Submission
	function forsupport of singletooth and/ormultiple toothrestorations,recognizing bonestability andappropriateocclusal loadrequirements.	function forsupport of singletooth and/ormultiple toothrestorations,recognizing bonestability andappropriateocclusal loadrequirements.	for fixedbridgework. TheSwissPlant dentalimplants areintended forimmediateplacement andfunction on singletooth and/ormultiple toothapplicationsrecognizing initialimplant stabilityand appropriateocclusal loading,to restore normalmasticatoryfunction.		case ofedentulouspatients 4 ormoreimplantsmust be used
Indication	Immediate Load	Immediate Load	Immediate Load	Unknown	Unknown	√
GeneralDesign	Threaded, rootform implant	Threaded, rootform implant	Threaded, rootform implant	Groove typeimplant	Threaded,root formimplant	√
PlacementMethod	Dual or single-stage surgery	Dual or single-stage surgery	Dual or single-stage surgery	Two or singlestage surgery	Single stagesurgery	√
Material	Titanium Alloy (Ti6AL-4V ELI)	Titanium Alloy (Ti6AL-4V ELI)	Titanium Alloy (Ti6AL-4V ELI)	Commerciallypure Titanium	Commerciallypure Titanium	√
ImplantBody	Threaded bodywithout gingivalcollar	Threaded bodywithout gingivalcollar	Threaded bodywith gingivalcollar	Groovedbody withoutgingival collar	Threadedbody withgingival collar	√
BodyDiameter	3.7, 4.2, 4.7, 5.2,5.7, 7.0mm	3.2, 3.7, 4.2, 4.7,5.2, 5.7, 7.0mm	4.1, 4.8, 5.7mm	4.0, 5.0,6.0mm	4.1, 4.8mm	√
Length	6mm	8mm	6mm	5mm	6mm	√
PlatformDiameter	3.5, 4.5, 5.7mmD853706, 863706,854206 & 864206- Ø3.5 platform854706, 864706,855206 & 865206- Ø4.5 platform855706, 865706,857006 & 867006- Ø5.7 platform	3.0,3.5, 4.5,5.7mmD853208 =Ø3.0 platform853708 & 854208- Ø3.5 platform854708 & 855208- Ø4.5 platform855708 & 857008- Ø5.7 platform	4.8, 6.5mmD904106 & 904806-Ø4.8mm platform904806W &905706-Ø6.5mm platform	2.5 - 3.0mm	4.8 and6.5mm	√
ImplantSurface	SBM	SBM	SBM	Integra-Tiand Integra-CP	SLA andSLActive	√
level	Roughened	Roughened	Roughened orDual Roughened	Unknown	Unknown
SurfaceRoughness	SBM =1.5-2.3μm	SBM =1.5-2.3μm	SBM =1.5-2.3μm	Unknown	Unknown	√
Packaging	Inner sleeve tosuspend theimplant/fixture-mount assemblyinside an outervial sealed with acap. Packagingalso includessurgical coverscrew, extenderand temporarycoping	Inner sleeve tosuspend theimplant/fixture-mount assemblyinside an outervial sealed with acap. Packagingalso includessurgical coverscrew, extenderand temporarycoping	Inner sleeve tosuspend theimplant/fixture-mount assemblyinside an outervial sealed with acap. Packagingalso includessurgical coverscrew, extenderand temporarycoping	Implants arepackaged ina sealedplasticcontainerwith a Tyvektype sealedbarrier andwith a plasticcarrier.	Double vialsystem.Inner sleeveto suspendthe implantinside anouter vialsealed with acap.Packagingalso includessurgicalcover screw	√
Sterilization	GammaIrradiation	GammaIrradiation	GammaIrradiation	Unknown	Unknown	√
510(k)Number		K073033 K090234	K081396	K073368 K092035	K030007	√

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K131097

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The Legacy3 6mmL implants were shown to be substantially equivalent to the predicate devices: Legacy 8mmL (K073033 and K090234), SwissPlant 6mmL Implants (K081396), Bicon Implants (K073368 and K092035), and Straumann Implants (K030007).

Non-clinical Performance Testing: 7.

The devices in this submission have mechanical safety (strength) equivalent to the predicate devices. Laboratory testing was conducted for the worst-case devices following FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 in static compression bending and fatigue, as well as implant driving torque and abutment/screw torque to failure tests. The components have shown to exhibit equivalent mechanical strength as the predicate devices and the implant/abutment combinations were able to withstand loads that were higher than the functional masticatory loads.

In addition, comparative surface area analysis was performed to demonstrate substantial equivalence by creating 3D models of the implants and obtaining the total external osseointegration surface area using three dimensional CAD measurement function. Furthermore, comparative pull-out testing was conducted

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	Concession Company of Children
: Com	Legacy3 6mmL Implants

to demonstrate substantial equivalence by inserting the implants into simulated bone taking into account 3mm of potential bone loss.

Lastly, sterilization Validation was carried out in accordance with ISO 11137-2 and AAMI TIR-33 for gamma radiation.

8. Clinical Performance Testing

No clinical testing was performed. The clinical evaluation was used to support the decision of safety and effectiveness.

9. Conclusion:

The information submitted in this 510(k) for the Legacy3 6mmL Implants have shown that the devices are substantial equivalent to the device systems identified as predicates and it is considered that the new devices are as safe and effective for its indication for use, compatible and performs as well the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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August 22, 2013

Implant Direct Sybron Manufacturing LLC Ms. Ines Aravena Senior Director of Product Design and Regulatory Affairs 27030 Malibu Hills Road CALABASAS HILLS CA 91301

K131097 Re:

Trade/Device Name: Legacy3 6mm Length Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 23, 2013 Received: July 24, 2013

Dear Ms. Aravena:

We have reviewed your Section 510(k) premarket notification of intent to referenced above and have determined the device is substantially equivale for use stated in the enclosure) to legally marketed predicate devices mark commerce prior to May 28, 1976, the enactment date of the Medical Device devices that have been reclassified in accordance with the provisions of the and Cosmetic Act (Act) that do not require approval of a premarket appro You may, therefore, market the device, subject to the general controls pro general controls provisions of the Act include requirements for annual reg devices, good manufacturing practice, labeling, and prohibitions against n International Places not ... CDD11 dage not sucluate information ralatad to

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Please be advised that FDA's issuance of a substantial equivalence determ that FDA has made a determination that your device complies with other r or any Federal statutes and regulations administered by other Federal agen comply with all the Act's requirements, including, but not limited to: regis CFR Part 807); labeling (21 CFR Part 801); medical device reporting (rep device-related adverse events) (21 CFR 803); good manufacturing practice forth in the quality systems (QS) regulation (21 CFR Part 820); and if app product radiation control provisions (Sections 531-542 of the Act); 21 CFI

If you desire specific advice for your device on our labeling regulation (21 contact the Division of Small Manufacturers, International and Consumer free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ht the regulation entitled. "Misbranding by reference to premarket notificatio 807.97). For questions regarding the reporting of adverse events under the CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm f of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under t Division of Small Manufacturers, International and Consumer Assistance (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ht

Sincerely yours,

Image /page/7/Picture/5 description: The image shows the name "Mary S. Ru". The text is in a bold, sans-serif font. The letters are black, and the background is white. The letters are slightly distorted, especially the "S" and "Ru".

Y II VIA

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Image /page/8/Picture/0 description: The image contains two logos. The first logo is for "Implant Direct Sybron Dental Specialties". The second logo is for "Legacy3 6mmL Implants".

Indications for Use

510(k) Number (if known): K131097

Device Name: Legacy3 6mm Length_Implants

Indications for Use:

Legacy3 6mm Length consists of two-picce implants for one-stage on two-stage surgical Legacy3 bmm Lengin consists of Norpheee napitally and fully edentulous upper
procedures. These implants are intended for use in partially and fully as any procedures. These miffams are miended this are restorations and serminal or intermediate abutment support for fixed bridgework. Implants can be indicated for intermediate abutifiem support for fixed bridgeworks aspirities and with appropriate occlusal loading.

Prescription Use _ メ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S-2013.08.21 08:05:01 -04'00'

Division Sign-Off) ·ivision of Anesthesiology, General Hospital rection Control, Dental Devices

Page | of |

510(k) Number: 长13(0分7

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.