The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

Device Description

Intended for single use;
Provided sterile via Ethylene Oxide;
. All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
. The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
ZiLock prosthetic interface with internal indexer;
Apically tapered implant with trapezoidal thread profile;
Implant provided with sand-blasted, acid etched surface finish;
. The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
. The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

AI/ML Overview

This document describes the Neodent Implant System - Zirconia Implant System (K210336), which includes Zirconia Implants and CR Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly refer to "acceptance criteria" in the traditional sense of numerical thresholds for a study endpoint. Instead, the performance data presented aims to demonstrate equivalence to predicate devices through various tests.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 and ISO 10993-18. Not representing a new worst-case compared to K201491.	Biological Safety Assessment guided by ISO 10993-1 performed. Chemical characterization per ISO 10993-18 performed. Subject devices do not represent a new worst-case, relying on results from K201491.
Dynamic Fatigue Test	Equivalent fatigue strength to predicate devices per ISO 14801 and FDA Guidance.	Performed according to ISO 14801. Devices exhibit a level of performance equivalent to that reviewed for the predicate devices. SEM images after fatigue show similar wear to K201491.
Torsion Test	Sufficient resistance to static torsional loading.	Performed to evaluate the Zirconia Implant System under static torsional loading. (Specific quantitative results not provided in this summary).
Insertion Test	Acceptable insertion torque into different bone types.	Performed to evaluate insertion torque into sawbones material representing bone types I, II, III, and IV. (Specific quantitative results not provided in this summary).
Screw Torque Testing	No visible failure after torque application and removal.	Performed with torque application and visual analysis. No visible failure identified after applying torque and removing items. Subject screws considered equivalent to those cleared per K201491.
Sterilization Validation	Sterility Assurance Level (SAL) of 1x10^-6 via Ethylene Oxide (ISO 11135-1). Not representing a new worst-case compared to K201491.	Sterilized by Ethylene Oxide per ISO 11135-1 (over-kill method). Achieved an SAL of 1x10^-6. Subject devices do not represent a new worst-case, adopting the method from K201491.
Bacterial Endotoxin Testing	Results < 0.05 EU/device per ANSI/AAMI ST72:2011.	Performed on representative samples. Obtained results were <0.05 EU/device.
MR Conditional Labeling	Leveraging of existing K182620 labeling.	MR Conditional Labeling was leveraged from K182620.
Shelf Life	5 years of product and package stability.	Validated per ASTM F1980. Shelf life determined to be 5 years.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific numerical sample sizes for each individual test conducted for the subject device. It refers to "representative samples" for biocompatibility and bacterial endotoxin testing, and studies conducted based on "FDA Guidance" and ISO standards.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, JJGC Indústria e Comércio de Materiais Dentários SA, is located in Curitiba, Parana, Brazil.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided in the document. The document describes engineering and laboratory testing for device performance, not a clinical study involving diagnosis or interpretation by experts to establish ground truth.

4. Adjudication Method:

This information is not applicable and not provided in the document. As mentioned above, it's not a clinical study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

No, this question is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is derived from established engineering standards, material specifications, and regulatory guidance. For example:

Biocompatibility: ISO 10993 standards and a comparison to previously cleared (predicate) device data.
Mechanical Testing: ISO 14801 standard and comparison to predicate device performance.
Sterilization: ISO 11135-1 standard achieving a specific SAL.
Bacterial Endotoxin: ANSI/AAMI ST72:2011 standard.
Shelf Life: ASTM F1980 standard.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as the device is a physical medical device, not an AI/ML algorithm.

Summary

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

JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K210336

Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 14, 2021 Received: July 16, 2021

Dear Jennifer Jackson:

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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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 (QS) 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 531-542 of the Act); 21 CFR 1000-1050.

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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210336

Device Name

Neodent Implant System - Zirconia Implant System

Indications for Use (Describe) Indications for Use for Zirconia Implants:

Indications for Use for CR Abutment for Zirconia System:

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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K210336 510(k) Summary

ADMINISTRATIVE INFORMATION

Sponsor	JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	13/Aug/2021
Preparer / Alternate Contact	Mariana Soares HartmannRegulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SAE-mail: mariana.hartmann@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	Neodent Implant System – Zirconia Implant SystemEndosseous dental implantEndosseous dental implant abutment
Classification Name	Implant, Endosseous, Root-FormEndosseous dental implant abutment
Classification RegulationsProduct Code	21 CFR 872.3640 / 21 CFR 872.3630, Class IIDZE/NHA
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K201491 – Neodent Implant System – Zirconia ImplantSystem, JJGC Indústria e Comércio de MateriaisDentários S.A
Reference Predicate Devices	K151328 - PURE Ceramic Implants - Institut StraumannAGK101945 - Neodent Implant System – CM Line, JJGCIndústria e Comércio de Materiais Dentários S.AK182620 - MRI Compatibility For Existing NeodentImplant System, JJGC Indústria e Comércio de MateriaisDentários S.A

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INDICATIONS FOR USE

Indications for Use for Zirconia Implants:

Indications for Use for CR Abutment for Zirconia System:

SUBJECT DEVICE DESCRIPTIONS

Intended for single use;
Provided sterile via Ethylene Oxide;
. All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
. The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
ZiLock prosthetic interface with internal indexer;
Apically tapered implant with trapezoidal thread profile;
Implant provided with sand-blasted, acid etched surface finish;
. The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
. The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

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Neodent Implant System – Zirconia Implant System

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K201491Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K151328PURE Ceramic ImplantsInstitut Straumann AG	EquivalenceDiscussion
Indications forUse	The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower jaw to provide support forprosthetic devices, such as artificial teeth, torestore chewing function. It may be usedwith single-stage or two-stage surgicalprocedures, for single or multiple unitrestorations,andmaybeloadedimmediately when good primary stability isachieved and with physiological occlusalloading. Multiple teeth applications can berigidly splinted.	The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower jaw to provide support forprosthetic devices, such as artificial teeth, torestore chewing function. It may be usedwith single-stage or two-stage surgicalprocedures, for single or multiple unitrestorations,andmaybeloadedimmediately when good primary stability isachieved and with physiological occlusalloading. Multiple teeth applications can berigidly splinted.	The Straumann® PURE Ceramic Implant(Monotype) is indicated for restoration insingle tooth gaps and in an edentulous orpartially edentulous jaw. The prostheticrestorations used are single crowns, fixedpartial or full dentures, which are connectedto the implants through the correspondingcomponents.The Ø3.3 mm reduced diameter implantsare recommended for central and lateralincisors only.	IdenticalThe Indications for Use of the subjectdevices are the same as for the primarypredicate devices.
Implant-Abutmentinterface	Straight internal connectionindexing features (Zilock)	Straight internal connectionindexing features (Zilock)		IdenticalSubject devices and Primary Predicatedevices present the same implant-abutment interface.
Design	Apically Tapered formatTrapezoidal threads profile	Apically Tapered formatTrapezoidal threads profile		IdenticalSubject devices and Primary Predicatedevices present the same design.
Reusable	No	No	No	IdenticalThe subject devices and the predicate devicesare indicated for single use.

Table 1. Technological Characteristic Comparison Table - Zirconia Implants

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Traditional 510(k) Submission

Neodent Implant System - Zirconia Implant System
--------------------------------------------------	--	--	--	--

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K201491Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K151328PURE Ceramic ImplantsInstitut Straumann AG	EquivalenceDiscussion
Length (mm)	10; 11.5; 13	8; 10; 11.5; 13	8; 10; 12; 14 mm	EquivalentRange of lengths for subject devices iswithin the range of lengths for the predicatedevices.
Diameter (Ø)(mm)	3.75 mm	4.3 mm	3.3; 4.1 mm	EquivalentThe diameter of the subject devices issmaller than the diameter of the primarypredicate devices, but greater than thereference predicate devices. DynamicFatigue Testing were performed to ensurethe system strength.
Material	Yttrium-stabilized zirconium dioxide(Y-TZP).	Yttrium-stabilized zirconium dioxide(Y-TZP).	Yttrium-stabilized zirconium dioxide(Y-TZP).	IdenticalSubject devices and predicate devices aremanufactured of the same raw material.
SterilizationMethod	Provided sterile via Ethylene Oxide to anSAL of 10-6.	Provided sterile via Ethylene Oxide to an SAL of10-6.	Provided sterile via Ethylene Oxide to an SALof 10-6.	IdenticalSubject devices and predicate devices aprovided sterilized by the same method.

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Traditional 510(k) Submission

Neodent Implant System – Zirconia Implant System

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE	EQUIVALENCE DISCUSSION
	Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K201491Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de MateriaisDentários S.A.	K101945Neodent Implant System - CM LineJJGC Indústria e Comércio de MateriaisDentários S.A.
Indications forUse	The CR Abutment is an abutment placedover Neodent Zirconia Implants in order toprovide support for prosthetic restorations,such as copings or crowns. It may be usedfor single-unit restorations that are cement-retained in esthetical areas over implantsinstalled in maxilla or mandible.	The Zirconia Base is an abutment placedover Neodent Zirconia Implants in order toprovide support for custom-madeprosthetic restorations, such as copings orcrowns. It may be used for cement- orscrew-retained single unit restorations. Alldigitally designed copings and/or crowns tobe used with the Neodent Zirconia BaseAbutment System are intended to be sent toStraumann for manufacture at a validatedmilling center.	The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. It may be usedwith single-stage or two-stage procedures,for single or multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading.	EquivalentThe Indications for the subject devices areincluded within the scope of Indications for theprimary predicate devices. Both are indicated tobe placed over implants to support prostheticrestorations such as copings or crowns and thedifferences between the Indications for Use aredue to the fact that the predicate device isdigitally designed while the subject device is astock abutment.
Implant-Abutmentinterface	Straight internal connectionindexing features (Zilock)	Straight internal connectionindexing features (Zilock)	Cone morse internal connection	IdenticalSubject devices and Primary Predicate devicespresent the same implant-abutment interface.

Table 2. Technological Characteristic Comparison Table – Zirconia CR Abutments

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Traditional 510(k) Submission

Neodent Implant System – Zirconia Implant System

	SUBJECT DEVICENeodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de Materiais	PRIMARY PREDICATE DEVICEK201491Neodent Implant System - Zirconia ImplantSystemImplantsJJGC Indústria e Comércio de Materiais	REFERENCE PREDICATE DEVICEK101945Neodent Implant System - CM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	EQUIVALENCE DISCUSSION
	Dentários S.A.	Dentários S.A.
Design	Angulation: 0; 17°Gingival Height: 1.5; 2.5 mmPlatform: NP; SP	Angulation: 0Gingival Height: 1.5; 2.5 mmPlatform: NP; SP	Angulation: 0, 17 and 30°Gingival Height: 1.5; 2.5 and 3.5 mm	EquivalentThe angulation and gingival height of thesubject devices are within the range ofangulation and gingival height of thereference predicate device (K101945) theplatform is identical of the primarypredicate device.
Reusable	No	No	No	IdenticalThe subject devices and the predicate devicesare intended for single use.
Material	Abutment: Yttrium-stabilized zirconiumdioxide(Y-TZP).Screw: Titanium alloy ASTM F136.	Abutment: Yttrium-stabilized zirconiumdioxide(Y-TZP).Screw: Titanium alloy ASTM F136.	Abutment and Screw: Titanium alloy ASTMF136.	IdenticalThe subject devices have the same material ofconstruction as the primary predicate devices.
SterilizationMethod	Provided sterile via Ethylene Oxide to an SAL of$10^{-6}$	Provided sterile via Ethylene Oxide to an SAL of$10^{-6}$	Provided sterile via Ethylene Oxide to an SAL of$10^{-6}$	IdenticalThe subject devices have the same sterilizationmethod and same SAL as the predicatedevices.

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The subject implants have the same indications for use and an equivalent range of lengths as the primary predicate devices, being contemplated within the range of lengths of the predicate devices.

Subject and predicate implants have the same implant-to-abutment interface. Both present sand-blast and acid-etch surface finishes and same sterile barrier system. The subject implants are manufactured of the same materials and are sterilized using the same sterilization method as the primary predicate devices.

The subject CR Abutments have equivalent indications for use of the primary predicate devices and an equivalent range of gingival height and angulation as the reference predicate devices, being contemplated within the range of gingival height and diameter of the reference predicate devices. They also present the same sterilization method and are made of the same material as the primary predicate devices.

Overall, the subject devices are equivalent to the predicate devices as follows:

same intended use,
. same operating principle,
incorporate the same basic design,
incorporate the same materials, and
have same packaging and are sterilized using the same materials and processes

PERFORMANCE DATA

Biocompatibility

Representative samples of each of the subject devices was subjected to the following:

Biological Safety Assessment guided by ISO 10993-1,
Chemical characterization was performed per ISO 10993-18.

An assessment was made to define if new biocompatibility tests were needed or whether prior testing applies to the subject devices. The subject devices do not represent a new worst case and we are therefore relying on the results of the tests provided in K201491.

Mechanical testing

Dynamic fatigue test per ISO 14801 was performed to determine the fatigue strength for the dental implant system, according to FDA Guidance. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.

Torsion Test was performed to evaluate the Zirconia Implant System under static torsional loading.

Insertion test was performed to evaluate the insertion torque of the Zirconia Implant System when inserted into sawbones material representing bone type I, II, III and IV.

SEM images made after fatigue loading test were included to demonstrate that the subject devices present similar wear in the implant inner thread compared to the Zirconia Implant (K201491).

Screw torque testing was performed with torque application and visual analysis before and after use to assess whether the torque would damage the items. No visible failure was identified after applying torque

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and removing items from the implant. The subject screws are considered equivalent to those already cleared per K201491.

Sterilization validation

The subject devices are sterilized by Ethylene Oxide, according to ISO 11135-1 via the over-kill method. The method achieved a Sterility Assurance Level of 1x10-6.

An assessment was made to determine if the subject devices represent new worst-cases for sterilization validation and since they do not represent a new worst-case, they are being adopted into the already the same sterilization validation method already cleared under K201491.

The Subject devices are not represented to be "pyrogen free".

Bacterial Endotoxin Testing are performed on representative samples selected and tested based upon the raw material, manufacturing processes and sterilization process, according to ANSI/AAMI ST72:2011, Bacterial Endotoxins – Test Methods, Routine Monitoring and Alternatives to Batch Testing. The obtained results were <0,05 EU/device.

MR Conditional Labeling

The MR Conditional Labeling was leveraged from K182620.

Shelf Life

Product and package stability have been validated per ASTM F1980. The subject device's shelf life was determined to be 5 years.

CONCLUSION

The subject devices and the predicate devices have equivalent intended use, design, and technological characteristics. Equivalent range of overall dimensions and sterilization method. The data included in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.

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.