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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

Device Description

Intended for single use;
The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
. All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
. The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
. Implant and Cover Screw delivered sterile via Gamma Radiation;
Sterile Abutments provided sterile via Ethylene Oxide;
The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
. The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
. The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
. The implant to abutment interface is a Grand Morse (GM) connection.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental implant system. It does not describe a study involving an AI/Machine Learning (AI/ML) device, nor does it present acceptance criteria or performance data for such a device.

The document discusses the substantial equivalence of the Neodent Implant System - Easy Pack to previously cleared predicate devices (K163194, K191191, K182620, K193592). The data presented is related to the physical and biological characteristics of the dental implants and abutments.

Therefore, I cannot extract the information required in your request regarding acceptance criteria and performance data for an AI/ML device, as the document does not pertain to such a device. All the acceptance criteria mentioned and the "results" describe testing for traditional medical device characteristics such as sterilization, shelf life, biocompatibility, pyrogenicity, MRI compatibility, and mechanical properties (torsion, insertion) of the implants and abutments.

Specifically, points 2 through 9 of your request are not applicable to the content of this document, as they relate to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance).

Summary

{0}------------------------------------------------

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 S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K203382

Trade/Device Name: Neodent Implant System-Easy Pack Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 11, 2021 Received: February 12, 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.

{1}------------------------------------------------

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 531-542 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 Steen Assistant 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203382

Device Name Neodent Implant System - Easy Pack

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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	15/Mar/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 Name	Neodent Implant System – Easy Pack
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Name	Implant, Endosseous, Root-formEndosseous dental implant abutment
Classification Regulations	21 CFR 872.3640, Class II
Product Code	Primary: DZESecondary: NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate Device	K163194	- Neodent Implant System - GM Line, JJGC Indústria eComércio de Materiais Dentários S.A
Reference Predicate Device	K191191	- Neodent Implant System - Temporary Abutments, JJGCIndústria e Comércio de Materiais Dentários S.A
Reference Predicate Device	K182620	- MRI Compatibility for Existing Neodent Implant System, JJGCIndústria e Comércio de Materiais Dentários S.A
Reference Predicate Device	K193592	- Change in the Shelf Life for Neodent Acqua Implants, JJGCIndústria e Comércio de Materiais Dentários S.A

{4}------------------------------------------------

INDICATIONS FOR USE

SUBJECT DEVICE DESCRIPTIONS

Intended for single use;
The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
. All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
. The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
. Implant and Cover Screw delivered sterile via Gamma Radiation;
Sterile Abutments provided sterile via Ethylene Oxide;
The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
. The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
. The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
. The implant to abutment interface is a Grand Morse (GM) connection.

The compatibility table for both GM Helix implants and GM Smart abutments is presented below (all combinations available within each row):

Implant Diameter	Implant Length	Abutment diameter	Abutment Gingival Heights
3.5 mm	8, 10, 11.5, 13 mm	3.5 and 4.5 mm	1.5, 2.5, 3.5 mm
3.75 mm	8, 10, 11.5, 13 mm	3.5 and 4.5 mm	1.5, 2.5, 3.5 mm
4.0 mm	8, 10, 11.5, 13 mm	3.5 and 4.5 mm	1.5, 2.5, 3.5 mm
4.3 mm	8, 10, 11.5, 13 mm	4.5 mm	1.5, 2.5, 3.5 mm

{5}------------------------------------------------

TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLES

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Neodent Implant System - Easy Pack SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de Materiais Dentários S.A.	EquivalenceDiscussion
Indications for Use	The Neodent Implant System is intended to besurgically placed in the bone of the upper or lower jawto provide support for prosthetic devices, such asartificial teeth, to restore chewing function. It may beused with single-stage or two-stage procedures, forsingle or multiple unit restorations, and may beloaded immediately when good primary stability isachieved and with appropriate occlusal loading. TheGM Easy Pack System is indicated to be used onNeodent implants to provide temporary support forprosthesis structure for up to 6 months.	for GM implants and conventional abutments:The Neodent Implant System is intended to besurgically placed in the bone of the upper or lower jawto provide support for prosthetic devices such asartificial teeth, to restore chewing function. It may beused with single-stage or two-stage procedures, forsingle or multiple unit restorations, and may beloaded immediately when good primary stability isachieved and with appropriate occlusal loading.for GM Titanium Base abutments:Titanium Base Abutment is a titanium base placedonto Neodent dental implants to provide support forcustomized prosthetic restorations. It is used with acoping and crown, or crown alone, and is indicated forcement-retained single or multi-unit restorations, orscrew-retained single restorations. All digitallydesigned copings and/or crowns for use with theNeodent Titanium Base Abutment System areintended to be sent to Straumann for manufacture ata validated milling center.for GM Pro Peek Abutments:The Pro PEEK Abutments are indicated to be used onNeodent implants to provide temporary support forprosthesis structure for up to 6 months. They can beused in one or two stage procedures and alsoimmediate load when there is good primary stability.	SimilarSubject devices and predicate devices share the sameindications for use. The predicate for the subjectimplants and cover screw is the GM implants andconventional abutments of K163194. The temporaryindication is covered by the GM Pro Peek Abutments ofK163194.
Implant-Abutmentinterface	GM Morse Taper	GM Morse Taper	IdenticalSubject devices and predicate devices present thesame Implant-to-abutment interface.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
	Neodent Implant System - Easy Pack SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de Materiais Dentários S.A.	EquivalenceDiscussion
Implant Design	Conical shape, double threads with trapezoidalprofile, rounded apex	Conical shape, double threads with trapezoidalprofile, rounded apex	IdenticalSubject devices and predicate devices present thesame design
Cover Screw Design	One end with a slot for the recommendeddriver/connection and the other end with aninterface compatible with the GM prostheticinterface	One end with a slot for the recommendeddriver/connection and the other end with an interfacecompatible with the GM prosthetic interface	IdenticalSubject devices and predicate devices present thesame design
Reusable	No	No	IdenticalThe subject devices and the predicate devices areindicated for single use.
Implant Diameter (Ø)(mm)	3.5, 3.75, 4.0 and 4.3 mm	3.5, 3.75, 4.0, 4.3 and 5.0 mm	EquivalentDiameter of subject devices is within the range ofdiameters for the primary and reference predicatedevices, so the subject devices do not represent a worstcase in terms of performance.
Implant Length (mm)	8, 10, 11.5 and 13 mm	8, 10, 11.5, 13, 16 and 18 mm	EquivalentRange of lengths for subject devices is within therange of lengths for the primary and referencepredicate devices.
Material	Implant - Titanium grade 4 conforming to ASTM F67Cover Screw - Titanium alloy conforming to ASTMF136	Implant - Titanium grade 4 conforming to ASTM F67Cover Screw - Titanium alloy conforming to ASTMF136	IdenticalSubject devices and predicate devices aremanufactured of the same raw material
Surface	NeoporosAcqua	NeoporosAcqua	IdenticalSubject devices and predicate devices present thesame surface
Sterilization Method	Provided sterile via Gamma Radiation to an SAL of1x10-6	Implant - Provided sterile via Gamma Radiation to anSAL of 1x10-6Cover Screw - Provided sterile via Ethylene Oxide to anSAL of 1x10-6	EquivalentSubject devices and predicate devices are providedsterile by the same sterilization method.The subject Cover Screw provided along with the Implantis delivered sterile via Gamma Irradiation and whencommercialized separately, provided sterile via EthyleneOxide. Detailed information are provided in Section 14.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE	EquivalenceDiscussion
	Neodent Implant System - Easy Pack SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K191191Neodent Implant System - TemporaryAbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.
Indicationsfor Use	The Neodent Implant System is intended to besurgically placed in the bone of the upper orlower jaw to provide support for prostheticdevices, such as artificial teeth, to restorechewing function. It may be used with single-stage or two-stage procedures, for single ormultiple unit restorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusalloading. The GM Easy Pack System is indicatedto be used on Neodent implants to providetemporary support for prosthesis structure forup to 6 months.	for GM implants and conventional abutments:The Neodent Implant System is intended to besurgically placed in the bone of the upper orlower jaw to provide support for prostheticdevices such as artificial teeth, to restorechewing function. It may be used with single-stage or two-stage procedures, for single ormultiple unit restorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusalloading.for GM Titanium Base abutments:Titanium Base Abutment is a titanium baseplaced onto Neodent dental implants toprovide support for customized prostheticrestorations. It is used with a coping andcrown, or crown alone, and is indicated forcement-retained single or multi-unitrestorations, or screw-retained singlerestorations. All digitally designed copingsand/or crowns for use with the NeodentTitanium Base Abutment System are intendedto be sent to Straumann for manufacture at avalidated milling center.for GM Pro Peek Abutments:The Pro PEEK Abutments are indicated to beused on Neodent implants to providetemporary support for prosthesis structure forup to 6 months. They can be used in one ortwo stage procedures and also immediateload when there is good primary stability.	The Neodent Implant System is intended to besurgically placed in the bone of the upper orlower jaw to provide support for prostheticdevices, such as artificial teeth, to restorechewing function. It may be used with single-stage or two-stage procedures, for single ormultiple unit restorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusalloading. The Neodent Implant System -Temporary Abutments are indicated to beused on Neodent implants to providetemporary support for prosthesis structure forup to 6 months.	SimilarSubject devices and predicate devicesshare similar indications for use. Subjectdevices present the same indications foruse as reference predicate devices(K191191).
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE
	Neodent Implant System - Easy Pack SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K191191Neodent Implant System - TemporaryAbutmentsJJGC Indústria e Comércio de MateriaisDentários S.A.	EquivalenceDiscussion
Intended Use	GM Smart Abutment: Hybrid component thathas three functions. It can be used as ascanbody, conventional closed tray transfer ortemporary component. With scanbodyfunction, the product is used to transfer theposition and orientation of the implants to thedigital model (scan) or plaster model(conventional). For use as a temporarycomponent, the GM Smart Abutment is usedfor temporary rehabilitation (up to 180 days)with screw retrained single-unit protheses.The GM Smart Abutment is only used withimplants placed straight (i.e no divergence)and is available in the GM prosthetic interfaceand must be used only with implants ofcorresponding interface.		The Temporary Abutment is used fortemporary rehabilitation (up to 180 days) withscrew retained single-unit (antirotationalabutment) or multi-unit (rotational abutment)prostheses.Temporary Abutments are only to be usedwith implants placed straight (i.e. nodivergence).This product is available in the GM prostheticinterface and must be used only with implantsof corresponding interface.	SimilarThe scanbody and conventional closedtray transfer applications are exempt ofregistration, so it is not beingconsidered in the comparison. The GMSmart Abutment application astemporary abutment is similar to theTemporary Abutment of K191191.
Implant-Abutmentinterface	GM Morse Taper	GM Morse Taper	GM Morse Taper	IdenticalSubject devices and predicate devicespresent the same Implant-to-abutmentinterface.
Reusable	No	No	No	IdenticalThe subject devices and the predicatedevices are indicated for single use.
Gingival Height(mm)	GM Healing Abutment - 1.5, 2.5 and 3.5mmGM Smart Abutment - 1.5, 2.5 and 3.5mm	GM Healing Abutment - 0.8, 1.5, 2.5,3.5, 4.5, 5.5 mm	GM Temporary Abutments - 0.8; 1.5; 2.5and 3.5 mm	EquivalentRange of size of gingival heights torsubject devices is within the range ofsizes for the primary and referencepredicate devices.
Material	Titanium alloy conforming to ASTMF136	Titanium alloy conforming to ASTMF136	Titanium alloy conforming to ASTM F136	IdenticalSubject devices and predicate devicesare manufactured of the same rawmaterial
SterilizationMethod	Provided sterile via Ethylene Oxide toan SAL of 1x10-6	Provided sterile via Ethylene Oxide to anSAL of 1x10-6	Provided sterile via Ethylene Oxide to anSAL of 1x10-6	IdenticalSubject devices and predicate devices areprovided sterile by the same sterilizationmethod.

Table 1. Technological Characteristic Comparison Table – Implants and Cover Screw

{6}------------------------------------------------

{7}------------------------------------------------

Table 2. Technological Characteristic Comparison Table - Abutments

{8}------------------------------------------------

{9}------------------------------------------------

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

Subject and predicate devices have the same implant-to-abutment interfaces. They present the same sterile barrier system and same sterilization methods. The subject devices and predicate devices are manufactured of the same materials.

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

NON-CLINICAL PERFORMANCE DATA

Sterilization

. Gamma Radiation
The Gamma Radiation validation is based on the ISO 11137-2 Parts 1, 2 and 3. The purpose of this validation is to define the minimum dose Validation and Refer the Maximum dose approved by the client. The subject devices present the same sterilization method already validated for the predicate devices in K163194. The acceptance criteria is SAL of 10° with a Dose of 25 kGy and the result of the validation is passed.

● Ethylene Oxide

The Ethylene Oxide validation is based on the ISO 11135:2014 Part 1. The purpose of this validation is to verify the maintenance of the effectiveness of the validated ethylene oxide sterilization process. The subject devices present the same sterilization method already validated for the predicate devices in K163194 and K191191.

The acceptance criteria is SAL of 10° and the result of the validation is passed.

EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 - Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.

● Steam Sterilization

The moist heat sterilization cycle (Dynamic air removal – 132 C, 3 mins, unwrapped) have been validated by the overkill method to a sterility assurance level (SAL) of 10° according to ISO 17665-1 (Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO 17665-2 (Sterilization of health care products -Moist heat – Part 2: Guidance on the application of ISO 17665-1). The subject devices present the same sterilization method already validated for the predicate devices in K163194. The acceptance criteria is SAL of 106 and the result of the validation is passed.

{10}------------------------------------------------

Shelf Life

. Sealing Strength

The Sealing Strength test is based on ASTM F88 and the purpose of this test is to validated the packaging. The acceptance criteria is resistance between 1.5 N and 15 N for specimens with width of 15 ± 1 mm and the result of the test is passed.

● Dye Penetration

The Dye Penetration test is based on ASTM F1929 and the purpose of this test is to validated the packaging. The acceptance criteria is no dye solution leakage through the blister sealing and the result of the test is passed.

● Bubble Test

The Bubble test is based on the ASTM F2096 and the purpose of this test is to validated the packaging. The acceptance criteria is no constant flow of bubbles in the sealed area of the blister indicating a failure area and the result of the test is passed.

The subject devices present the same shelf life already validated for the reference predicate devices in K193592 - Change in the Shelf Life for Neodent Acqua Implants. The shelf life for the Easy Pack System is 4 years.

Biocompatibility

● Chemical Characterization

The Chemical Characterization is a test based on the ISO 10993-12 and ISO 10993-18 to identify extractable/leachable chemicals. The acceptance criteria is MOS > 1 or HI < 1 and the result of the test is passed.

. Toxicological Analysis of Extractables

The Toxicological Analysis of Extractables is test based on the ISO 10993-17 to complement the Chemical Characterization test. The acceptance criteria is MOS > 1 or HI < 1 and the result of the test is passed.

. Cytotoxicity

The Cytotoxicity is a test based on the ISO 10993-12 and 10993-5 to identify any substance with cytotoxicity potential. The acceptance criteria is cell viability ≤ 30 % and the result of the test is passed.

● Corrosion Resistance

The Corrosion Resistance is a test based on ISO 10993-12 and ISO 10993-15 to evaluate the corrosion resistance. The acceptance criteria is the breakdown potential ≥ 0.8 V for implantable devices and the result of the test is passed.

● Genotoxicity

The Genotoxicity is a test based on ISO 10993-12 and ISO 10993-3 to identify any substance with genotoxicity potential. The acceptance criteria is no biologically relevant increases in revertant colony numbers and the result of the test is passed.

The subject devices do not present a new worst case for Biocompatibility. We are, therefore, relying upon testing performed previously on devices considered to be representative of the subject devices, already cleared per K163194.

{11}------------------------------------------------

Pyrogenicity

The pyrogenicity is a test based on ANSI/AAMI ST72:2011 to evaluate the pyrogenicity. The acceptance criteria is ≤ 0.5 EU/ml and the result of the test is passed.

The sampling frequencies were defined based on the criticality of the products and on historical results, as shown below:

Products	Quantity	Pool tested?	Frequency
Implants	10	Yes	Monthly
Abutments	10	Yes	Quarterly

The test is performed according to the turbidimetric kinetic method described in Chapter 85>Bacterial Endotoxins Test by United States Pharmacopeia and ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Method, Routine Monitoring and Alternatives to Batch Testing.

The quantity of samples is defined by the two standards above. The reports are being provided within this submission.

MRI

The MRI test is based on ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119. The test has the purpose of characterization and behavior of the metallic implant system when subjected to the energy of a MRI scan. This study assesses magnetic migration, magnetic torsion, image aberration and RF-induced heating.

The acceptance criteria of each standard are as follow:

. ASTM F2052: maximum deflection angle, measured at the entrance of the bore of a 3T MRI of 45°
ASTM F2213: the maximum MR induced torque must be less than the maximum torque induced by the force of gravity
. ASTM F2182: the mathematic model shall have a maximum deviation of ± 20% from the real measurement to confirm the model and the maximum temperature rise shall be less than 6°C.
ASTM F2119: This test is for the purpose of characterization.

The results of the MRI is that a patient with an implant from a Straumann Group Implant System can be scanned safely in a MR System under the following conditions:

Static magnetic field of 1.5T and 3T, only
Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode. Under the scan conditions defined, the implants, as well as clinically relevant implant constructs, from a dental implant system of a Straumann Group company are expected to produce a maximum temperature rise of 4.9°C after 15-minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the implants from a dental implant system for a Straumann Group company extends approximately 10 mm from this device when imaged with a gradient echo pulse sequence and a 3T MR system.

The subject devices have been assessed to determine whether the previously conducted studies related to the MR compatibility of the devices of the Neodent Implant System also apply to the subject devices. It has been determined that the subject devices do not result in new worst-case constructs for the purpose of assessing MR compatibility and they can be leveraged from the preciously cleared K182620.

{12}------------------------------------------------

Mechanical Tests

. Torsion
The Torsion test is based on ISO/TS 13498:2011 and the purpose is to evaluate the static torsional loading. The acceptance criteria is 2.0 safety factor on the indicated torque on the IFU and the result of the test is passed.

. Insertion

The Insertion test is based on ASTM F1839-08 and the purposed is to evaluate the implant presents minimum insertion torque in different situations.

The complete reports regarding mechanical tests (Dynamic Fatigue Test, Torsion Test and Insertion Test) are being provided within this submission.

CONCLUSION

The subject devices and the predicate devices have equivalent Indications for Use, design and technological characteristics. Equivalent range of overall dimensions and sterilization methods. 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.