The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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.

Indications for Use for Mini Straight, Angled Abutment and screws:

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.

Indications for Use for Helix Short Attachment:

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

Device Description

All the subject devices are intended for single use;
The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10-9;
The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the Neodent Implant System - Helix Short Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly present a table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it describes what was tested and states that the results "met the acceptance criteria" or demonstrated "equivalent performance." We can infer the general acceptance criterion from the study descriptions.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Testing:
Dynamic Fatigue Test (per ISO 14801): Equivalent fatigue strength to predicate devices.	The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
Torsion Test (static torsional loading): Meet acceptance criteria.	The results met the acceptance criteria.
Insertion Test: Evaluate insertion torque in various bone types.	Performed to evaluate the insertion torque of the Helix Short System when it is inserted in bones type I, II, III, and IV. (No explicit "met criteria" statement, but implied by successful evaluation).
Implant Surface Area Simulation and Pull Out Test: Demonstrate acceptable BIC rate and pull out resistance.	Results demonstrated that the subject devices, despite having a slightly smaller surface area than the reference devices, presented a higher BIC rate and pull out resistance upon placement. Thus, the subject devices exhibit a level of benchtop performance equivalent to that reviewed for the reference device.
MR Compatibility Testing:
Not configure a new worst case compared to reference devices, allow safe scanning under established parameters.	An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.
Surface Treatment:
Identical or similar chemical processes to predicate/reference devices to achieve roughness.	The surface treatments applied to subject devices are identical to these applied and previously evaluated for primary predicate devices. Although some reference devices have a surface with different nomenclature, the chemical processes applied to the surface are similar to create the roughness surface. Acqua implants are submitted to an additional step in order to increase their hydrophilicity, as already cleared for primary predicate device.
Sterilization Validation:
Implants (Gamma Irradiation): Minimum Sterility Assurance Level (SAL) of 1 x 10^-6.	A minimum Sterility Assurance Level (SAL) of 1 x 10^-6 has been validated based on ISO 11137-1 and ISO 11137-2.
Abutments (Ethylene Oxide): Minimum Sterility Assurance Level (SAL) of 1 x 10^-6.	A minimum Sterility Assurance Level (SAL) of 1 x 10^-6 has been validated based on ISO 11135-1.
Endotoxin Testing (LAL):
Meet pyrogen limit specifications (acceptance criteria for endotoxin levels).	Subject devices meet the acceptance criteria for endotoxin levels as well as the primary predicate and reference devices.
Shelf Life Validation:
Packaging integrity maintained; established expiration date.	The shelf life for devices provided sterile is 5 years, except Helix Short Acqua Implants that have a shelf life of 4 years. The expiration date was determined considering product integrity and packaging tests.
Biocompatibility:
No new issues compared to predicate/reference devices.	No new issues of biocompatibility are raised for the subject devices when compared to primary predicate and reference devices. Therefore, no additional biocompatibility testing was required.

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

The document does not explicitly state the numerical sample size for the test sets in the mechanical, MR compatibility, or other in-vitro studies. It refers to "tested subject devices" or "representative samples."

Data Provenance: The studies described (mechanical testing, MR compatibility, surface treatment, sterilization, endotoxin, shelf life, biocompatibility) are all benchtop/laboratory studies (in vitro). There is no mention of human subject data, animal data, or clinical retrospective/prospective data for these specific performance criteria. The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) based in Curitiba, Paraná, Brazil.

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

Not applicable. As these are benchtop/laboratory performance studies, "ground truth" is established by adherence to recognized standards (e.g., ISO 14801, ISO 11137, ISO 11135, ISO 10993) and scientific methods, not by expert consensus in the typical sense for clinical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical images or patient outcomes, not for objective benchtop performance data against engineering 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

Not applicable. This device is an endosseous dental implant system, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

Adherence to International Standards: Performance measured against specifications outlined in standards like ISO 14801 (dynamic fatigue), ISO 11137 and ISO 11135 (sterilization), ISO 10993 series (biocompatibility).
Benchtop Test Results: Direct measurements and observations from the mechanical, physical, chemical, and biological laboratory tests performed on the device.
Comparison to Predicate Devices: Performance is frequently established by demonstrating equivalence or superiority to already legally marketed predicate devices, which serve as a benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concepts of "training set" and "validation set" are primarily used for machine learning and AI, not for the regulatory approval of physical implants based on benchtop testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as point 8.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K223638

Trade/Device Name: Neodent Implant System - Helix Short Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 17, 2023 Received: May 25, 2023

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 -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223638

Device Name

Neodent Implant System - Helix Short Implant System

Indications for Use (Describe)

Indications for Use for Helix Short Implant:

Indications for Use for Mini Straight, Angled Abutment and screws:

Indications for Use for Helix Short Attachment:

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for Helix Short Healing Abutment:

Indications for Use for Helix Short Cover Screw:

Indications for Use for Temporary Abutment for Helix Short Implant

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary
ADMINISTRATIVE INFORMATION
Sponsor	JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Paraná, 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	22/June/2023
Preparer / Alternate Contact	Bárbara UzaeRegulatory Affairs AnalystE-mail: barbara.uzae@neodent.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary NameCommon Name	Neodent Implant System – Helix Short Implant SystemEndosseous dental implant
Classification Name	Endosseous dental implant
Classification RegulationsProduct Code	21 CFR 872.3640, Class II / 21 CFR 872.3630, Class IIDZE/NHA
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K163194, Neodent Implant System - GM Line, JJGCIndústria e Comércio de Materiais Dentários S.A
Reference Devices	K200586 - Straumann TLX Implant System, InstitutStraumann AGK123022 - Neodent Implant System, JJGC Indústria eComércio de Materiais Dentários S.A

510(k) Summary

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K202942 - Straumann® 4 mm Short Implants, Straumann USA, LLC

K203309 – NUVO CF Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

K220251 - Neodent Implant System - Narrow Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

K182620 - MRI Compatibility For Existing Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A

INDICATIONS FOR USE

Indications for Use for Helix Short Implant:

Indications for Use for Mini Straight, Angled Abutment and screws:

Indications for Use for Helix Short Attachment:

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.

Indications for Use for Helix Short Healing Abutment:

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Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The seating of the Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

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. Temporary Abutments are indicated to be installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium Base is a titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cementretained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

SUBJECT DEVICE DESCRIPTIONS

. All the subject devices are intended for single use;
The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10-9;
. The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
. The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
. The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

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The various materials that can be used to create top halves for titanium bases and cements were already evaluated and cleared by FDA. Please find below a table with all clearance information for these materials:

Material	Raw material	510(k) of the material
Ticon	Titanium	Exempt according to CFR872.3710 (subpart E): Dental BaseMetal Alloys.
Coron	CoCr alloy
Zerion LT	Zirconia	K061804
IPS e.max	Lithium Dissilicate	K132209
Polycon ae	PMMA	K071548
Panavia-Kuraray cement	Chemically-active resin	K183537
Ivoclar Multilink cement	Lithium Dissilicate	K130436

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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

Table 1 - Technological Characteristic Comparison Table – Helix Short Implants

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	Neodent Implant System - HelixShort Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K163194Neodent Implant System - GMLineJJGC Indústria e Comércio deMateriais Dentários S.A.	K200586Straumann TLX Implant SystemInstitut Straumann AG	K123022Neodent Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K202942Straumann® 4 mm ShortImplantsStraumann USA, LLC	EquivalenceDiscussion
Indications forUse	The Neodent ImplantSystem is recommendedfor surgical procedures onmaxilla or mandible bones.It provides support forprosthetic componentssuch as artificial teeth, thusrestoring the chewingfunction. It may be usedwith single-stage or two-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusalloading.	The Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.	Straumann TLX Implants aresuitable for endostealimplantation in the upper andlower jaws and for thefunctional and esthetic oralrehabilitation of edentulousand partially edentulouspatients. TLX Implants can beplaced with immediatefunction on single-tooth andmultiunit restorations whengood primary stability isachieved and with appropriateocclusal loading to restorechewing function. Theprosthetic restorations areconnected to the implantsthrough the correspondingabutment components.			EquivalentAlthough thelanguage is slightlydifferent, theindications for useof the subjectdevices is the sameas the primarypredicate device(K163194) andequivalent to theindications for useof referencepredicate device(K200586). Thesubject andpredicate devicesare intended to besurgically placed inthe bone of theupper or lower jawto provide supportfor prostheticdevices such asartificial teeth, torestore chewingfunction.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	Neodent Implant System - HelixShort Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K163194Neodent Implant System – GMLineJJGC Indústria e Comércio deMateriais Dentários S.A.	K200586Straumann TLX Implant SystemInstitut Straumann AG	K123022Neodent Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K202942Straumann® 4 mm ShortImplantsStraumann USA, LLC	EquivalenceDiscussion
Implant-Abutmentinterface	Internal Hex	Morse taper	TorcFit (with conical fitting)	Morse taper	Internal octagon	EquivalentThe subject andpredicate deviceshave internalimplant toabutmentconnection.
Design	Cylindrical bodyTissue level	Conical body (Helix)Bone level	Tapered bodyTissue level	Cylindrical bodyBone level	Cylindrical bodyTissue level	IdenticalCylindrical shape andtissue level as thereference devices.
Reusable	No	No	No	No	No	IdenticalThe subjectdevices and thepredicate devicesare indicated forsingle use.
Length (mm)	4.0 / 5.5 / 7.0 / 8.5	8 / 10 / 11.5 / 13 / 16 / 18(GM Helix)	6.0 / 8.0 / 10 / 12 / 14 / 16 / 18	- 5.0 / 6.0 (WS)	4.0	EquivalentSubject implantlengths are withinthe range of thepredicate devices.
Collar length(mm)	1.8	N/A	1.8	N/A	1.8	IdenticalSubject implant andreference devices withtissue level have acollar neck of 1.8mm.
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	REFERENCE DEVICE
	Neodent Implant System - HelixShort Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K163194Neodent Implant System – GMLineJJGC Indústria e Comércio deMateriais Dentários S.A.	K200586Straumann TLX Implant SystemInstitut Straumann AG	K123022Neodent Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K202942Straumann® 4 mm ShortImplantsStraumann USA, LLC	EquivalenceDiscussion
Diameter (Ø)(mm)	3.75 / 4.0 / 5.0 / 6.0 / 7.0	3.5 / 3.75 / 4.0 / 4.3 / 5.0(GM Helix)	3.75 / 4.0 / 4.5 / 5.0 / 5.5 / 6.5	4.0 / 5.0 / 6.0 (WS)	4.1 / 4.8	EquivalentSubject devicediameters arewithin the range ofdiameters of thepredicates devicesor larger (Ø 7.0).Larger diametersdo not represent aworst case interms ofperformance.
Material	Commercially pureTitanium grade 4 (ASTMF67)	Commercially pure Titaniumgrade 4 (ASTM F67)	Titanium-13 Zirconium alloy	Commercially pure titaniumgrade 4 (ASTM F67)	Titanium-13 Zirconiumalloy	IdenticalIdentical to theprimary predicatedevice and theNeodent referencedevices (K123022)
SterilizationMethod	Gamma irradiation to anSAL of 1x10-6	Gamma irradiation to an SAL of1x10-6	Gamma irradiation to an SAL of1×10-6	Gamma irradiation to an SAL of1×10-6	Gamma irradiation to an SALof 1x10-6	IdenticalSubjectdevicesandpredicatedevicesareprovided sterile bythesamesterilizationmethod.
Surfacetreatment	NeoPorosAcqua	NeoporosAcqua	SLActive®	NeoPoros	SLActive®	IdenticalIdenticalto theprimarypredicatedevice.

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix ShortImplants SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	EquivalenceDiscussion
Indications for Use	Mini Straight and Angled Abutment:The Neodent Implant System isrecommended for surgical procedureson maxilla or mandible bones. Itprovides support forprostheticcomponents such as artificial teeth,thus restoring the chewing function. Itmay be used in one- or two-stageprocedures, multiple restorations, aswell as immediate loading when thereis good primary stability and adequateocclusal load. Multiple rehabilitationsmay be splinted rigidly.	GM Mini Conical and GM Exact MiniConical Abutments:The Neodent Implant System isintended to be surgically placed in thebone of the upper or lower jaw toprovide support for prosthetic devicessuch as artificial teeth, to restorechewing function. It may be used withsingle stage or two-stage proceduresfor single or multiple unit restorationsand may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.	Multi-Unit Screw Retained AbutmentCF (Straight/Angled):The Implant System is intended to besurgically placed in the maxilla ormandible to provide support forprosthetic devices such as artificialteeth in order to restore chewingfunction. It may be used with single-stage or two-stage procedures, forsingle or multiple unit restorations,and may be loaded immediately whengood primary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.	EquivalentAlthough thelanguage is slightlydifferent, the indications for use of thesubject devices is included into theindications of the predicate devices. Thesubject and predicate device intended tobe surgically placed in the bone of theupper or lower jaw to provide supportfor prosthetic devices such as artificialteeth, to restore chewing function. Itmay be used with single stage or two-stage procedures, for single or multipleunit restorations, and may be loadedimmediately when good primary stabilityis achieved and with appropriate occlusalloading.
Abutment Design	Surface:MachinedwithpinkelectrolysisMini Straight Abutment:Gingival height: 0.2, 1.5, 2.5, 3.5, 4.5Mini angled abutment:Gingival height: 0.6, 1.5, 2.5, 3.5Angulation: 17°	Surface: MachinedGM Mini Conical Abutments:Gingival height: 0.8; 1.5, 2.5, 3.5, 4.5,5.5GM Exact Mini Conical Abutments:Gingival height: 1.5, 2.5, 3.5Angulation: 17° and 30°	Surface: Machined and electrolysisStraight Abutment:Gingival height: 1.0, 2.0, 3.0, 4.0 and 5.0mm;Angled Abutment:Gingival height: 2.0 and 3.0 mmAngulation: 17° and 30°	EquivalentThe subject device have the same surface ofreference predicate device and similargeometry and range of dimensions andangulation of primary predicate device.
Single Use	Yes	Yes	Yes	IdenticalThe subject devices and predicatesdevices are indicated for single use.

Table 2 - Technological Characteristic Comparison Table – Mini Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

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K223638 - Neodent Implant System – Helix Short Implant System

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix ShortImplants SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de MateriaisDentários S.A.	EquivalenceDiscussion
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	IdenticalThe subject devices and predicatesdevices are manufactured of the sameraw material.
SterilizationMethod	Provided sterile via Ethylene Oxideto an SAL of 10-6	Provided sterile via Ethylene Oxide toan SAL of 10-6	Provided sterile via Ethylene Oxide to anSAL of 10-6	IdenticalThe subject devices and the primarypredicate devices are provided in sterilecondition to an SAL of 1 x 10-6 by the samesterilization method.

Table 3 - Technological Characteristic Comparison Table – Attachments

	SUBJECT DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix Short ImplantsSystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K220251Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A	EquivalenceDiscussion
Indications for Use	Helix Short Attachment:The Neodent Implant System isrecommended for surgical procedures onmaxilla or mandible bones. It providessupport for prosthetic components such asartificial teeth, thus restoring the chewingfunction. It may be used in one- or two-stageprocedures, multiple unit restorations, aswell as immediate loading when there isprimary stability and adequate occlusal load.	NGM AttachmentsThe Neodent Implant System is intended to besurgically placed in the bone of the upper or lowerjaw to provide support for prosthetic devices, suchas artificial teeth, to restore chewing function. It maybe used with single stage or two-stage proceduresfor single or multiple unit restorations, and may beloaded immediately when good primary stability isachieved and with appropriate occlusal loading.	EquivalentAlthough the language is slightly different, the indicationsfor use of the subject devices is the same of the indicationsof the predicate devices. The subject and predicate deviceare intended to be surgically placed in the bone of theupper or lower jaw to provide support for prostheticdevices such as artificial teeth, to restore chewingfunction. It may be used with single stage or two-stageprocedures, for single or multiple unit restorations, andmay be loaded immediately when good primary stability isachieved and with appropriate occlusal loading.

JJGC Indústria e Comércio de Materiais Dentários S.A.

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	SUBJECT DEVICE	REFERENCE DEVICE
	Neodent Implant System - Helix Short ImplantsSystemJJGC Indústria e Comércio de MateriaisDentários S.A.	K220251Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A	EquivalenceDiscussion
Abutment Design	HS Attachments:Gingival height: 0.2, 1.5, 2.5, 3.5Surface Treatment: TiN Coating	NGM Attachments:Gingival height: 0.8; 1.5, 2.5, 3.5 and 4.5Surface Treatment: TiN Coating	EquivalentThe subject devices and predicates devices have the samesurface treatment and similar geometry and range ofdimensions.
Single Use	Yes	Yes	IdenticalThe subject devices and predicates devices are indicated forsingle use.
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	IdenticalThe subject devices and predicates devices aremanufactured of the same raw material.
Sterilization Method	Provided sterile via Ethylene Oxide to anSAL of 10-6.	Provided sterile via Ethylene Oxide to an SAL of10-6	IdenticalThe subject devices and the primary predicate devices areprovided in sterile condition to an SAL of 1 x 10 -6 by thesame sterilization method.

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - HelixShort Implants SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A	K203309NUVO CF Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	EquivalenceDiscussion
Indications for Use	Helix Short Healing Abutmentand Cover Screw:This product is used for themaintenance of soft tissue,during the bone integration stageof Neodent implants to berehabilitated with the lateloading technique.The Healing Abutment may beused in the implant installationsurgery or the reopening surgery(second surgical stage).The Cover Screw must remainintragingival, preventing thegrowth of tissue over the implantplatform. The seating of theCover Screw takes place in theconical region of the implantinterface.	GM Healing abutment and CoverScrew:The Neodent Implant System isintended to be surgically placed inthe bone of the upper or lowerjaw to provide support forprosthetic devices, such asartificial teeth, to restore chewingfunction. It may be used withsingle stage or two-stageprocedures, for single or multipleunit restorations, and may beloaded immediately when goodprimary stability is achieved andwith appropriate occlusal loading.	NUVO CF Healing Abutments andCover Screws:The Implant System is intended tobe surgically placed in the maxillaor mandible to provide supportfor prosthetic devices such asartificial teeth in order to restorechewing function. It may be usedwith single-stage or two-stageprocedures, for single or multipleunit restorations, and may beloaded immediately when goodprimary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications maybe rigidly splinted.	EquivalentAlthough the language isdifferent, the indications for useof the subject devices are thesame of predicate devices. Thesubject and the predicate devicesare used to the maintenance ofsoft tissue, during the boneintegration stage of implants tobe rehabilitated with the lateloading technique. Theindications for use are writtendifferently because those for thepredicate devices are talkingabout the implant system as awhole and not the healingabutment and cover screwsspecifically.

Table 4 - Technological Characteristic Comparison Table – Healing Abutment and Cover Screw

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	Neodent Implant System - HelixShort Implants SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio deMateriais Dentários S.A	K203309NUVO CF Implant SystemJJGC Indústria e Comércio deMateriais Dentários S.A.	EquivalenceDiscussion
Abutment Design	Surface: Machined with pinkelectrolysis.HS Healing Abutment:Gingival height: 1.5, 2.5, 3.5, 4.5,5.5Cover Screw:0.35 mm height above the implantplatform level	Surface: MachinedGM Healing abutment:Gingival height: 0.8, 1.5, 2.5, 3.5, 4.5,5.5Cover Screw:Gingival height: at the bone level,or with a height of 2 mm	Surface: Machined with pinkelectrolysis.NUVO CF Healing Abutments andCover Screws:Gingival height: 1.0, 2.0, 3.0, 4.0 and5.0Cover Screw: 0.3, 2. 0 mm	EquivalentThe subject devices and thereference predicate devices havethe same surface treatment. Thesubject and predicate devices havesimilar geometry and dimensions.
Single Use	Yes	Yes	Yes	IdenticalThesubjectdevicesandpredicates devices are indicatedfor single use.
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	IdenticalThe subject devices and predicatedevices are manufactured of thesame raw material.
SterilizationMethod	Provided sterile via EthyleneOxide to an SAL of 10-6.	Provided sterile via EthyleneOxide to an SAL of 10-6.	Provided sterile via EthyleneOxide to an SAL of 10-6.	IdenticalThe subject devices and thepredicate devices are provided insterile condition to an SAL of 1 x 10-6by the same sterilizationmethod.

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	SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	EquivalenceDiscussion
	Neodent Implant System - Helix Short Implants SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A.	K220251Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A
Indications forUse	Temporary Abutment:The Implant System is indicated for surgicalprocedures on maxilla or mandible bones, providingsupport for dental prostheses with the purpose ofrestoring the chewing function as well as aesthetics.It may be used in one- or two-stage procedures, singleor multiple restorations, and immediate loadingwhen there is good primary stability and adequateocclusal load. Temporary Abutments are indicated tobe installed over Helix Short Implants and to providesupport for prosthetic structures for up to 6 months.	Temporary Abutments:The Implant System is intended to be surgicallyplaced in the maxilla or mandible to providesupport for prosthetic devices such as artificialteeth in order to restore chewing function. Itmay be used with single-stage or two-stageprocedures, for single or multiple unitrestorations, and may be loaded immediatelywhen good primary stability is achieved andwith appropriate occlusal loading. Multipletooth applications may be rigidly splinted.	Temporary Abutments:Prosthetic component to be installed in theNarrow GM Implant, providing support forprosthetic structures. Indicated for temporaryrestorations with unitary structures, screwed,on implants installed in the maxilla or mandible.Temporary Abutments Narrow GM have amaximum duration of usage of 180 days.	EquivalentAlthough the language isslightly different, theindications for use of thesubject devices is included intothe indications of thepredicate devices. The subjectand predicate devices areintended to be surgicallyplaced in the maxilla ormandible to provide supportfor prosthetic devices such asartificial teeth in order torestore chewing function. Itmay be used in one- or two-stage procedures, single ormultiple restorations, andimmediate loading when thereis good primary stability andadequate occlusal load. All areindicated to be used for up to6 months.
AbutmentDesign	Temporary Abutments:Gingival height: 0.2; 1.5; 2.5; 3.5Surface: Machined with pink electrolysis.	Temporary Abutments:Gingival height: 0.5, 1.0 and 3.0 mmSurface: Machined with pink electrolysis.	Temporary Abutments:Gingival height: 0,8; 1.5, 2.5, 3.5 and 4.5Surface: Machined	EquivalentThe subject devices and theprimary predicate devices havethe same surface treatment. Thesubject and predicate deviceshave similar geometry anddimensions.

Table 5 - Technological Characteristic Comparison Table – Temporary Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

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	SUBJECT DEVICE	REFERENCE DEVICE	REFERENCE DEVICE	EquivalenceDiscussion
	Neodent Implant System - Helix Short Implants SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.	K220251Neodent Implant System - Narrow Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A
Single Use	Yes	Yes	Yes	IdenticalThe subject devices andpredicates devices areindicated for single use.
Raw material	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	Titanium alloy ASTM F136.	IdenticalThe subject devices andpredicates devices aremanufactured of the same rawmaterial.
SterilizationMethod	Provided sterile via Ethylene Oxide to an SAL of 10-6	Provided sterile via Ethylene Oxide to an SALof 10-6	Provided sterile via Ethylene Oxide to an SALof 10-6	IdenticalThe subject devices and theprimary predicate devices areprovided in sterile condition toan SAL of 1 x 10 -6 by the samesterilization method.

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	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE DEVICE
COMPARISON	SubjectNeodent Implant System - Titanium Bases forHelix Short Implant LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de Materiais DentáriosS.A.	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A.	EQUIVALENCE DISCUSSION
Indications for Use	The Helix Short Implant Titanium Base is atitanium base that is placed over Neodentdental implants to provide support forcustomized prosthetic restorations, such ascopings and crowns. It is indicated forsingle- and multiple-structure restorations,screw- or cement-retained on implantsinstalled in the maxilla or mandible. Alldigitally-designed copings and/or crowns tobe used with the Neodent Titanium BaseSystem must be sent to Straumann formanufacture at a validated milling center.	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- or screw-retained single or multi-unitrestorations single. All digitally designedcopings and/or crowns to be used with theNeodent Titanium Base Abutment System areintended to be sent to Straumann formanufacture at a validated milling center. TheGM Titanium Base for Bridge is indicated forcement or screw-retainedmulti-unitrestorations.	Titanium Base for Bridge:CF Titanium Base for Bridge is a titaniumabutment placed onto dental implants toprovide support for customized prostheticrestorations. The CF Titanium Base for Bridgeis indicated for cement or screw-retainedmulti-unit restorations. All digitally designedcopings and/or crowns to be used with theTitanium Base Abutment System are intendedto be sent to Straumann for manufacture at avalidated milling center.Titanium Base for Crown:CF Titanium Base for Crown is a titaniumabutment placed onto dental implants toprovide support for customized prostheticrestorations, as copings or crowns. It isindicated for single-unit restorations, cement-retained or screw-retained in aesthetic areason implants installed in the maxilla ormandible. All digitally designed copings and/orcrowns to be used with the Titanium BaseAbutment System are intended to be sent toStraumann for manufacture at a validatedmilling center.	EquivalentAlthough the language isslightly different, theindications for use of thesubject and predicate devicesare the same. The subject andpredicate devices areintended to place onto dentalimplants to provide supportfor customized prostheticrestorations, such as copingsand crowns.

Table 6 - Technological Characteristic Comparison Table – Helix Short Titanium Bases

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		SUBJECT DEVICES		PRIMARY PREDICATE			REFERENCE DEVICE
COMPARISON	SubjectNeodent Implant System – Titanium Bases forHelix Short Implant LineJJGC Indústria e Comércio de MateriaisDentários S.A.			K163194Neodent Implant System - GM LineJJGC Indústria e Comércio de Materiais DentáriosS.A.		K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A.			EQUIVALENCE DISCUSSION
Abutment Design	Cylindrical format provided in differentgingival heights.Angulation: 0°Gingival Heights: 0.2; 1.5, 2.5 and 3.5 mmSurface: Machined and ElectrolysisCementable portion height: 6.0 and 4.5mm			Cylindrical format provided in differentgingival heights.Angulation: 0°Gingival Heights: 0.8; 1.5; 2.5; 3.5; 4.5 mmSurface: MachinedCementable portion height: 6.0 and 4.0		Conical format provided in different gingivalheights.Angulation: 0°Gingival Heights: 0.5; 1.0; 3 mmSurface: Machined and ElectrolysisCementable portion height: 6.0 and 4.5 mm			EquivalentThe subject devices and thereference predicate devicesshare the same surface finish,similar geometry and rangeof dimensions.
Single Use	Yes			Yes		Yes			IdenticalSubject and predicate devicesare not reusable.
Raw material	Titanium Alloy (Ti-6Al-4V) – according toASTM F136.			Titanium Alloy (Ti-6Al-4V) – according toASTM F136.		Titanium Alloy (Ti-6Al-4V) – according to ASTMF136.			IdenticalThe subject and predicatedevices are manufactured ofthe same raw material.
Top Half Materials	Material	Minimumthickness	Maximumallowableangulation	Material	Minimumthickness	Maximumallowableangulation	Material	Minimumthickness	Maximumallowableangulation	EquivalentThe top half materials of thesubject devices are containedwithin the scope of the tophalf materials of thepredicate device. Themaximum allowableangulation of subject deviceis smaller than the maximumangulation of the predicatedevices, therefore it is lesscritical.
	Coron(CoCr)	0.3		Coron (CoCr)	0.3		Coron (CoCr)	0.3
	Ticon(Titanium)	0.4	16°	Ticon (Titanium)	0.4
	IPS e.max	0.9		Zerion LT	0.5	30°	Zerion LT	0.5
	Zerion LT	0.5		IPS e.max CAD	0.9		IPS e.max CAD	0.9	30°
	Polyconae*(PMMA)	1.0		3M ESPE LavaPlus Zirconia	0.7		Polyconae*(PMMA)	1.0
	* Polycon ae material is only recommendedfor temporary/provisional prostheticrestorations.			Polyconae*(PMMA)	1.0			*Polycon ae is indicated to remain in the mouthonly for up to 180 days.

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	SUBJECT DEVICES	PRIMARY PREDICATE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
COMPARISON	SubjectNeodent Implant System – Titanium Bases forHelix Short Implant LineJJGC Indústria e Comércio de MateriaisDentários S.A.	K163194Neodent Implant System – GM LineJJGC Indústria e Comércio de Materiais DentáriosS.A.	K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais DentáriosS.A.
Sterilization Method	• Provided sterile via Ethylene Oxideto an SAL of 1x10-6The final prosthesis must be sterilized by theend used before installation in the mouthvia moist heat (steam), gravity displacementor dynamic air removal in 132°C (270°F) for3 minute exposure.	• Provided sterile via Ethylene Oxide toan SAL of 1x10-6To be sterilized by user after superstructurecementation, before placed in patient mouth(moist steam sterilization).	• Provided sterile via Ethylene Oxide toan SAL of 1x10-6If customized on the chairside, must be sterilizedbefore the installation via moist heat (steam),Gravity displacement or dynamic air removal in132°C (270°F) for 3 minute exposure.	IdenticalThe subject devices andpredicate devices share thesame sterilization method.

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The subject implants have equivalent indications for use and 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 similar implant-to-abutment interface. Both present the same surfaces, are manufactured of the same materials and are sterilized using the same sterilization method. Subject and reference predicate devices present the same range of sizes and similar overall design.

The subject conventional abutments have equivalent indications for use and overall design as the predicate devices. They also present the same sterilization method and raw materials.

The subject Base abutments have the equivalent indications for use and same sterilization method as the primary predicate devices. Both, subject and primary predicate devices, are made of the same material. The top half materials of the subject devices are contained within the scope of the top half materials of the predicate devices and all digitally designed copings and/or crowns for use with the subject Titanium Bases are intended to be sent to Straumann for manufacture at a validated milling center as the predicate devices. The subject devices and the reference predicate devices share the same surface finish, similar geometry and range of dimensions.

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

· same intended use,
· same operating principle,
· incorporate the equivalent basic design,
incorporate the same materials, and
are sterilized using the same materials and processes

PERFORMANCE DATA

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 Helix Short Implant under static torsional loading. The results met the acceptance criteria. Insertion test was performed to evaluate the insertion torque of the Helix Short System when it is inserted in bones type I, II, IIII and IV.

The Implant Surface Area simulation and Pull Out Test were also made to evaluate and represent the clinical use of the subject implants. Results demonstrated that the subject devices, despite having a slightly smaller surface area than the reference devices, presented a higher BIC rate and pull out resistance upon placement. Thus, the subject devices exhibit a level of benchtop performance equivalent to that reviewed for the reference device.

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MR Compatibility testing

The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.

Surface treatment

The surface treatments applied to subject devices are identical to these applied and previously evaluated for primary predicate devices. Although some reference devices have a surface with different nomenclature, the chemical processes applied to the surface are similar to create the roughness surface. Acqua implants are submitted to an additional step in order to increase their hydrophilicity, as already cleared for primary predicate device.

Sterilization validation

Sterilization of the subject implants via gamma irradiation according to ISO 11137-1 Sterilization of health care products -Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -Radiation -Part 2: Establishing the sterilization dose. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

Sterilization of the subject abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135-1 Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements For Development, Validation and Routine Control of a Sterilization Process For Medical Devices. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated.

Endotoxin testing (LAL)

The LAL Endotoxin Analysis is the method used to determine that the device meets pyrogen limit specifications, based in the referred FDA guidance (510(k) Submission for Devices Labeled as Sterile, issued on 21 January 2016). Routine endotoxin testing is performed with representative devices as an assessment of environmentally derived pyrogenicity. Subject devices meet the acceptance criteria for endotoxin levels as well as the primary predicate and reference devices. The subject devices are not represented to be "pyrogen free".

Shelf Life validation

The expiration date of the products was determined considering the integrity of the product and the packaging tests after shelf life testing. The packaging of the subject Helix Short Implant System is identical to the packaging of the primary predicate and reference devices. The shelf life for devices provided sterile is 5 years, except Helix Short Acqua Implants that have a shelf life of 4 years.

Biocompatibility

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

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Cytotoxicity testing was performed per ISO 10993-5. Chemical characterization was performed per ISO 10993-18.

Biocompatibility sample preparation was performed per ISO 10993-12. Biological Safety Assessment guided by ISO 10993-1.

EO Residuals evaluation was performed in accordance with 10993-7.

No new issues of biocompatibility are raised for the subject devices when compared to primary predicate and reference devices. Therefore, no additional biocompatibility testing was required.

CONCLUSION

The data included in this submission demonstrate that the subject system is substantially equivalent to the primary predicate and reference devices in terms of intended use, design, technological characteristics, mechanical properties, shelf life, sterilization method and material.

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.