(89 days)
NeoConvert Solution: 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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Direct Screw to MUA: 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. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.
GM Attachment TiN 30°: 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. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.
The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.
The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.
Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.
{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.
December 4, 2024
JJGC Indústria e Comércia de Materiais Dentários S.A. % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K242686
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 6, 2024 Received: September 6, 2024
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
{2}------------------------------------------------
For comprehensive regulatory information about mediation-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242686
Device Name Neodent Implant System
Indications for Use (Describe)
NeoConvert Solution:
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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Direct Screw to MUA:
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. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.
GM Attachment TiN 30°:
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. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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Neodent Implant System
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810, USARegistration No.: 1222315 Owner/Operator No.: 9005052 |
|---|---|
| On the behalf of: | |
| JJGC Indústria e Comércio de Materiais Dentários S.A (dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Paraná, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702 | |
| Contact Person: | Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023Email: jennifer.jackson@straumann.com |
| Prepared By & | Leticia Milani |
| Alternate Contact: | Regulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SA |
| Date Prepared: | December 2, 2024 |
| Name of the Device | |
| Trade Names: | Neodent Implant System |
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |
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Neodent Implant System
510(k) Summary
Predicate Device(s)
NeoConvert Solution:
Primary Predicate:
K163194 Neodent Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A)
Reference Devices:
| K101945 | Neodent Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A. |
|---|---|
| --------- | ------------------------------------------------------------------------------- |
K193234 Nuvo IF Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A)
Direct Screw to MUA:
Primary Predicate:
K163194 Neodent Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A)
Reference Devices:
| K162890 | Straumann SC Variobase Abutments (Straumann USA, LLC) |
|---|---|
| K180536 | Neodent Implant System - GM Line (JJGC Indústria e Comércio de Materiais Dentários S.A) |
| K192229 | GM Titanium Base for Bridge (JJGC Indústria e Comércio de Materiais Dentários S.A) |
| K202452 | NobelProcera Zirconia Implant Bridge (Nobel Biocare AB) |
| K203309 | NUVO CF Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) |
| K203542 | Mini Abutment 60°(JJGC Indústria e Comércio de Materiais Dentários S.A) |
| K220251 | GM Narrow Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) |
| K223638 | Helix Short Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) |
GM Attachment TiN 30°:
Primary Predicate:
- K163194 Neodent Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A)
Reference Devices:
Neodent Implant System – GM Line (JJGC Indústria e Comércio de Materiais Dentários S.A) K173902
- K192229 GM Titanium Base for Bridge (JJGC Indústria e Comércio de Materiais Dentários S.A)
MRI:
K182620 MRI Compatibility for Existing Neodent Implant System
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Neodent Implant System
510(k) Summary
Device Description
This premarket notification includes the following additions to the Neodent Implant System:
- . NeoConvert Solution
- . Direct Screw to MUA
- GM Attachment TiN 30° .
The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers.
The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis.
The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function.
The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible.
Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.
Intended Use
NeoConvert Solution:
Instruments and components used to perform the procedure of converting removable prostheses into temporary fixed prostheses on GM line implants installed in the maxilla and/or mandible.
Direct Screw to MUA:
The Direct Screw to MUA is suitable for attaching the multiple restoration milled from a CAD/CAM library to the prosthetic abutment (mini or micro abutments).
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Neodent Implant System
510(k) Summary
GM Attachment TiN 30°:
This product is used to stabilize implant-mucosa supported removable full prostheses (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandibula. It can be used in immediate or conventional rehabilitation procedures.
Indications for Use
NeoConvert Solution:
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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Direct Screw to MUA:
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. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.
GM Attachment TiN 30°:
The Neodent Implant System is intended to be surqically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
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Neodent Implant System
510(k) Summary
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|---|
| K Number | K242686Neodent Implant System | K163194Neodent Implant System | K101945Neodent Implant System | K193234Nuvo IF Implant System |
| Indicationsfor Use | The Neodent Implant System is intendedto be surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function.TheNeoConvert Solution may be used withsingle-stage or two-stage procedures, fortemporary multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. | The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower 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 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 occlusal loading.Multiple tooth applications may be rigidlysplinted. | The Implant System is intended to besurgically placed in the maxilla or mandible toprovide support for prosthetic devices suchas artificial teeth in order to restore chewingfunction. It may be used with single-stage ortwo-stage procedures, for single or multipleunit restorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusalloading. Multiple tooth applications may berigidly splinted. |
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. |
| Overalldimensions | NeoConvert Screw:● Laying diameter: 1.4 mm● Height: 3.7 mmNeoConvert Coping:● Laying diameter: 4.8 mm● Height: 5.0 and 6.0 mmNeoConvert Distal Bar:● Laying diameter: 4.8 mm● Height: 5 mm | Mini Conical Abutment Coping Screw:● Laying diameter: 1.4 mm● Height: 3.7 mm | Mini Conical Abutment Coping:● Laying diameter: 4.8 mm● Height: 12 mm | Nuvo Distal Bar:● Laying diameter: 5.2 mm● Height: 10 mm |
| CommerciallySupplied | NeoConvert Coping and Screw:One cavity blister with five units.NeoConvert Distal Bar:Two cavity blister with one unit and onescrew. | Mini Conical Abutment Coping Screw:One cavity blister with one unit. | Mini Conical Abutment Coping:Two cavity blister with one unit and one screw. | Nuvo Distal Bar:Two cavities blister with one unit and onescrew. |
| Single use | Yes | Yes | Yes | Yes |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| K Number | K242686Neodent Implant System | K163194Neodent Implant System | K101945Neodent Implant SystemK193234Nuvo IF Implant System | |
| SterilizationMethod | Provided sterile via Ethylene Oxide. Thecoping and screw, if opened and notused, must be terminally sterilized byuser via moist heat with cycle parametersvalidated to a SAL of 1x10-6. | Provided sterile via Ethylene Oxide. | Provided sterile via Ethylene Oxide. Terminallysterilized by user via moist heat with cycleparameters validated to a SAL of 1x10-6.Provided sterile via Ethylene Oxide. |
Table 1 – Table of Substantial Equivalence NeoConvert
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Neodent Implant System
510(k) Summary
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Neodent Implant System
510(k) Summary
Table 2 – Table of Substantial Equivalence Direct Screw to MUA (Zygomatic Implants)
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| K Number | K242686Neodent Implant System | K163194Neodent Implant System | K202452NobelProcera Zirconia Implant Bridge | K203542Mini Abutment 60° | ||||||||||||
| Indicationsfor Use | The Neodent Implant System is intended tobe surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. The DirectScrew to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may beloaded immediately when good primarystability is achieved and with appropriateocclusal loading. All digitally designedpersonalized copings to be used with theDirect to Multi Unit Abutment Screw areintended to be sent to Straumann formanufacture at a validated milling center. | The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower 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 NobelProcera Zirconia Implant Bridgeare indicated for use as a bridge anatomicallyshaped and/or framework in the treatment ofpartially or totally edentulous jaws for thepurpose of restoring chewing function. | The Mini Conical Abutments are indicated foruse with Zygomatic Implants, in case ofsevere jaw resorption, in order to restorepatient aesthetics and chewing function. Itmay be used with single-stage or two-stageprocedures, for multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. | ||||||||||||
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | ||||||||||||
| Overalldimensions | Diameter of the screw head: 2.2 mmHeight of screw head: 1.7 mmTotal height: 4.1 mm | Diameter of the screw head: 1.9 mmDiameter of the external thread: 1.4 mmHeight of screw head: 1.7 mmTotal height: 3.7 mm | Diameter of the screw head: 2.0 mmTotal height: 4.0 mm | |||||||||||||
| CommerciallySupplied | One cavity blister with five units. | One cavity blister with one units. | ||||||||||||||
| Single Use | Yes | Yes | Yes | Yes | ||||||||||||
| SterilizationMethod | Provided non-sterile. Must be sterilizedbefore installation via moist heat (steam),using either gravity or vacuum, with anexposure time of 3 minutes at 132°C(270°F). | Provided non-sterile. Must be sterilizedbefore installation via moist heat (steam),using either gravity or vacuum, at 132°C(270°F) or 134°C (273°F). | ||||||||||||||
| Top HalfMaterial | Material Minimum thickness N!ce® HT 0.4 mm N!ce® LT 0.4 mm N!ce® XT 0.4 mm Ticon® 0.4 mm Coron® 0.4 mm |
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Neodent Implant System
510(k) Summary
Table 3 – Table of Substantial Equivalence Direct Screw to MUA (GM Implants)
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
|---|---|---|---|---|
| K Number | K242686Neodent Implant System | K163194Neodent Implant System | K192229GM Titanium Base for BridgeK203309NUVO CF Implant System | |
| Indicationsfor Use | The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower jaw to provide support for prostheticdevices, such as artificial teeth, to restorechewing function. The Direct Screw to MUAmay be used with single-stage or two-stageprocedures, for screw-retained multi-unitrestorations, and may be loaded immediatelywhen good primary stability is achieved andwith appropriate occlusal loading. All digitallydesigned personalized copings to be usedwith the Direct to Multi Unit Abutment Screware intended to be sent to Straumann formanufacture at a validated milling center. | The Neodent Implant System is intended tobe surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. It may be usedwith single-stage or two-stage procedures,for single or multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. | Titanium Base Abutment is a titanium baseplaced onto Neodent dental implants to providesupport for customized prosthetic restorations.It is used with a coping and crown, or crownalone, and is indicated for cement-retainedsingle or multi-unit restorations or screw-retained single restorations. All digitallydesigned copings and/or crowns to be usedwith the Neodent Titanium Base AbutmentSystem are intended to be sent to Straumannfor manufacture at a validated milling center.The GM Titanium Base for Bridge is indicatedfor cement or screw-retained multi-unitrestorations. | The CF Titanium Base for Bridge is atitanium abutment placed onto dentalimplants to provide support for customizedprosthetic restorations (multiple structures).It is indicated for multi-unit restorations,cement-retained or screw-retained inaesthetic areas on implants installed in themaxilla or mandible. |
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. |
| Overalldimensions | Diameter of the screw head: 2.2 mmHeight of screw head: 1.7 mmTotal height: 4.1 mm | Diameter of the screw head: 1.9 mmDiameter of the external thread: 1.4 mmHeight of screw head: 1.7 mmTotal height: 3.7 mm | Diameter: 3.5mmCementable area height 4.0mmGingival Height: 0.8 mm | Diameter: 3.5 mmCementable area height: 4.5 mmGingival height: 0.5 mm |
| CommerciallySupplied | One cavity blister with five units. | One cavity blister with one units. | Two cavity blister with one unit and one screw. | Two cavity blister with one unit and onescrew. |
| Single Use | Yes | Yes | Yes | Yes |
| SterilizationMethod | Provided non-sterile. Must be sterilizedbefore installation via moist heat (steam),using either gravity or vacuum, with anexposure time of 3 minutes at 132°C (270°F). | Provided sterile by Ethylene Oxide. Must besterilized before installation via moist heat(steam), using either gravity or vacuum, at132°C (270°F). | Provided sterile by Ethylene Oxide. Must besterilized before installation via moist heat(steam), using either gravity or vacuum, at132°C (270°F). | |
| Top HalfMaterial | Material | Minimum thickness | Material | Minimum thickness |
| N!ce® HT | 0.4 mm | N!ce® | 1.0 mm | |
| N!ce® LT | 0.4 mm | Zerion LT | 0.5 mm | |
| N!ce® XT | 0.4 mm | Ticon® | 0.4 mm | |
| Ticon® | 0.4 mm | Coron® | 0.3 mm | |
| Coron® | 0.4 mm | Polycon® ae | 1.0 mm | |
| Polycon® ae | 1.0 mm | *Polycon ae is indicated to remain in the mouth only for up to 180 days | ||
| *Polycon ae is indicated to remain in themouth only for up to 180 days | Zerion LT | 0.5 mm | ||
| Ticon® | 0.4 mm | |||
| Coron® | 0.3 mm | |||
| Polycon® ae | 1.0 mm | |||
| *Polycon ae is indicated to remain in themouth only for up to 180 days | ||||
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
| K Number | K242686Neodent Implant System | K163194Neodent Implant System | K223638Helix Short Implant System | |
| Indicationsfor Use | The Neodent Implant System is intended to be surgicallyplaced in the bone of the upper or lower jaw to providesupport for prosthetic devices, such as artificial teeth, torestore chewing function. The Direct Screw to MUA maybe used with single-stage or two-stage procedures, forscrew-retained multi-unit restorations, and may be loadedimmediately when good primary stability is achieved andwith appropriate occlusal loading. All digitally designedpersonalized copings to be used with the Direct to MultiUnit Abutment Screw are intended to be sent toStraumann for manufacture at a validated milling center. | The Neodent Implant System is intended to be surgically placedin the bone of the upper or lower jaw to provide support forprosthetic devices, such as artificial teeth, to restore chewingfunction. It may be used with single-stage or two-stageprocedures, for single or multiple unit restorations, and may beloaded immediately when good primary stability is achieved andwith appropriate occlusal loading. | The Helix Short Implant Titanium Base is a titanium base thatis placed over Neodent dental implants to provide support forcustomized prosthetic restorations, such as copings andcrowns. It is indicated for single- and multiple-structurerestorations, screw- or cement-retained on implants installedin the maxilla or mandible. All digitally designed copingsand/or crowns to be used with the Neodent Titanium BaseSystem must be sent to Straumann for manufacture at avalidated milling center. | |
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | |
| Overalldimensions | Diameter of the screw head: 2.2 mmHeight of screw head: 1.7 mmTotal height: 4.1 mm | Diameter of the screw head: 1.9 mmDiameter of the external thread: 1.4 mmHeight of screw head: 1.7 mmTotal height: 3.7 mm | Diameter: 4.8 mmCementable area height 4.5 mmGingival Height: 0.2 mm | |
| Commercially Supplied | One cavity blister with five units. | One cavity blister with one units. | ||
| Single Use | Yes | Yes | Yes | |
| SterilizationMethod | Provided non-sterile. Must be sterilized before installationvia moist heat (steam), using either gravity or vacuum, withan exposure time of 3 minutes at 132°C (270°F). | Provided sterile by Ethylene Oxide. Must be sterilized beforeinstallation via moist heat (steam), using either gravity orvacuum, at 132°C (270°F). | ||
| Top HalfMaterial | Material | Minimum thickness | ||
| N!ce® HT | 0.4 mm | |||
| N!ce® LT | 0.4 mm | |||
| N!ce® XT | 0.4 mm | |||
| Ticon® | 0.4 mm | |||
| Coron® | 0.4 mm | |||
| Polycon® ae | 1.0 mm | |||
| Material | Minimum thickness | |||
| IPS e.max CAD | 0.9 mm | |||
| Ticon® | 0.4 mm | |||
| Coron® | 0.3 mm | |||
| Polycon® ae | 1.0 mm | |||
| *Polycon ae is indicated to remain in the mouth only for up to180 days |
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Neodent Implant System
510(k) Summary
Table 4 – Table of Substantial Equivalence Direct Screw to MUA (HS Implants)
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Neodent Implant System
510(k) Summary
Table 5 – Table of Substantial Equivalence Direct Screw to MUA (NGM Implants)
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |||
|---|---|---|---|---|---|---|
| K Number | K242686Neodent Multi-Unit Abutments | K163194Neodent Implant System | K162890Straumann SC Variobase Abutments | K220251Narrow Implant System | ||
| Indications forUse | The Neodent Implant System is intended tobe surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. It may be usedwith single-stage or two-stage procedures,for screw-retained multi-unit restorations,and may be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. All digitallydesigned personalized copings to be usedwith the Direct to Multi Unit Abutment Screware intended to be sent to Straumann formanufacture at a validated milling center. | The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower 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. | Straumann® Variobase® abutments areindicated to be placed into Straumann®dental implants to provide a support structurefor the functional and esthetic oralrehabilitation of edentulous or partiallyedentulous patients with crowns, bridges, orfull-arch prostheses. | The Neodent Implant System is intended tobe surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. It may be usedwith one or two-stage procedures, for singleor multiple unit restorations, and may beloaded immediately when good primarystability is achieved and with appropriateocclusal loading. | ||
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium-vanadium alloy. | Titanium alloy, according to ASTM F136. | ||
| Overalldimensions | Diameter of the screw head: 2.2 mmHeight of screw head: 1.7 mmTotal height: 4.1 mm | Diameter of the screw head: 1.9 mmDiameter of the external thread: 1.4 mmHeight of screw head: 1.7 mmTotal height: 3.7 mm | Diameter: 3.3 - 4.3 mmGingival Height: 3.0 mmTotal height: 6.7 – 8.7 mm | Diameter: 3.5 mmGingival height: 3.5 mm | ||
| CommerciallySupplied | One cavity blister with five units. | One cavity blister with one units. | One cavity blister with one unit. | |||
| Single Use | Yes | Yes | Yes | Yes | ||
| SterilizationMethod | Provided non-sterile. Must be sterilizedbefore installation via moist heat (steam),using either gravity or vacuum, with anexposure time of 3 minutes at 132°C(270°F). | Provided sterile by Ethylene Oxide. Must besterilized before installation via moist heat(steam), using either gravity or vacuum, at132°C (270°F). | ||||
| Top HalfMaterial | Material | Minimum thickness | Material | Minimum thickness | ||
| N!ce® HT | 0.4 mm | N!ce® HT | 0.4 mm | Ticon® | 0.4 mm | |
| N!ce® LT | 0.4 mm | N!ce® LT | 0.4 mm | Coron® | 0.4 mm | |
| N!ce® XT | 0.4 mm | N!ce® XT | 0.5 mm | *Polycon ae is indicated to remain in the | ||
| Ticon® | 0.4 mm | Polycon® ae | 0.5 mm | mouth only for up to 180 days | ||
| Coron® | 0.4 mm | *Polycon ae is indicated to remain in the | ||||
| Polycon® ae | 1.0 mm | mouth only for up to 180 days | ||||
| *Polycon ae is indicated to remain in themouth only for up to 180 days |
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Neodent Implant System
510(k) Summary
Table 6 – Table of Substantial Equivalence GM Attachment TiN 30°
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
|---|---|---|---|---|
| K Number | K242686Neodent Implant System | K163194Neodent Implant System | K173902Neodent Implant System -GM Line | K192229GM Titanium Base for Bridge |
| Indicationsfor Use | The Neodent Implant System is intendedto be surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. The GMAttachment TiN 30° may be used withsingle-stage or two-stage procedures, formultiple unit restorations, and may beloaded immediately when good primarystability is achieved and with appropriateocclusal loading. | The Neodent Implant System is intended tobe surgically placed in the bone of the upperor lower 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 is intended tobe surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices such as artificial teeth, torestore chewing function. It may be usedwith single-stage or two-stage procedures,for single or multiple unit restorations, andmay be loaded immediately when goodprimary stability is achieved and withappropriate occlusal loading. | Titanium Base Abutment is a titanium baseplaced onto Neodent dental implants to providesupport for customized prosthetic restorations. Itis used with a coping and crown, or crown alone,and is indicated for cement-retained single ormulti-unit restorations or screw-retained singlerestorations. All digitally designed copings and/orcrowns to be used with the Neodent TitaniumBase Abutment System are intended to be sent toStraumann for manufacture at a validated millingcenter. The GM Titanium Base for Bridge isindicated for cement or screw-retained multi-unitrestorations. |
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. |
| Overalldimensions | Gingival height: 1.5, 2.5, 3.5, 4.5 and 5.5mmAngulation: 30° | Gingival height: 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5mmAngulation: 0° | Gingival height: 0.8, 1.5, 2.5, 3.5, 4.5 and5.5 mmAngulation: 15° | Cementable area height: 4.0 mmGingival height: 0.8 mmMaximum angulation: 30° |
| CommerciallySupplied | One cavity blister with one unit. | One cavity blister with one unit. | One cavity blister with one unit. | One cavity blister with one unit. |
| Single Use | Yes | Yes | Yes | Yes |
| SterilizationMethod | Provided sterile by ethylene oxide. | Provided sterile by Ethylene Oxide. Must besterilized before installation via moist heat(steam), using either gravity or vacuum, at132°C (270°F). | Provided sterile by ethylene oxide. | Provided sterile by ethylene oxide. |
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Neodent Implant System
Performance Testing
Performance Testing
Bench Testing
Assessments regarding dynamic fatigue testing were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants". For dynamic fatigue tests, the results demonstrated that in identical conditions, the subject devices exhibit a level of performance equal or better than the predicate and reference devices. Torsion tests were also performed to evaluate the strength of the screw used to fix all subject abutments against maximum twisting forces. The results prove that there is an adequate torsion strength in accordance with the installation torque recommended in IFU.
SEM images made after fatigue loading test were included to demonstrate that the personalized copings made from Zirconia and PMMA present acceptable levels of wear in the areas of the screw seating.
MRI Compatibility Testing
An assessment was made to demonstrate that the MR conditional labeling from K182620 is applicable to the subject devices, and a patient treated with them can be safely scanned observing the parameters previously established per reference devices.
Biocompatibility Testing
Assessments regarding biological compatibility were performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016".
Representative samples of the subject devices were subjected to the following:
- · Biological Safety Assessment quided by ISO 10993-1.
- Chemical characterization was performed per ISO 10993-18.
- Cytotoxicity testing was performed per ISO 10993-5.
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Neodent Implant System
Performance Testing
The subject devices are equivalent in material and manufacturing processes to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised and no additional biocompatibility testing was required.
Sterilization validation
For the proposed devices supplied sterile via Ethylene Oxide (EO), the method was validated to a sterility assurance level (SAL) of 1x10-6 in accordance with ISO 11135:2014, "Ethylene Oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices". 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".
For proposed devices that must be sterilized before installation in the mouth, the steam sterilization methos was validated 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", using the parameters described in IFU.
The sterilization of the subject device are identical to the sterilization already cleared for the primary and reference predicate devices.
Shelf Life
The expiration date of the devices was determined considering the integrity of the product and the packaging tests after shelf-life testing. The packaging of the Neodent Multi-Unit Abutments is identical to the packaging of the primary predicate and reference devices. The Shelf Life for Neodent Multi-Unit Abutments is 5 years.
Conclusion
The subject devices and the primary predicate device have similar indications for use, intended use, design, raw material and overall dimensions. Thus, all documentation submitted in this premarket notification demonstrate that the proposed devices are substantially equivalent to the primary predicate and reference devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)