(89 days)
No
The document describes mechanical components for dental implants and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to restore chewing function by providing support for prosthetic devices (artificial teeth), which is considered a therapeutic purpose.
No
The device is described as an implant system and prosthetic components used to support artificial teeth and restore chewing function, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states that the submission includes "additions to the Neodent Implant System" which are described as "prosthetic components" and a "technique comprised by some abutments". The performance studies also detail bench testing, MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf life, all of which are associated with physical medical devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is surgically placed in the bone to support prosthetic devices for restoring chewing function. This describes a surgical implant and its components, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details the components as additions to an implant system, specifically abutments and screws used in dental procedures. It describes their function in supporting prosthetic restorations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties (fatigue, torsion), MRI compatibility, biocompatibility, sterilization, and shelf life – all relevant to a surgically implanted device and its components, but not to an IVD.
In summary, the device is a dental implant system and its associated prosthetic components, which are used in surgical procedures to restore oral function. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K101945, K193234, K162890, K180536, K192229, K202452, K203309, K203542, K220251, K223638, K173902, K182620
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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.
1
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
3
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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4
Neodent Implant System
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810, USA
Registration 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, 3291
Curitiba, Paraná, Brazil 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 |
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023
Email: jennifer.jackson@straumann.com |
| Prepared By & | Leticia Milani |
| Alternate Contact: | Regulatory Affairs Analyst
JJGC 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 |
5
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
6
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).
7
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.
8
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 | K242686 | |||
| Neodent Implant System | K163194 | |||
| Neodent Implant System | K101945 | |||
| Neodent Implant System | K193234 | |||
| Nuvo IF Implant System | ||||
| Indications | ||||
| for Use | 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. | The Neodent Implant System is intended to | |||
| be surgically placed in the bone of the upper | ||||
| or lower jaw to provide support for prosthetic | ||||
| devices, such as artificial teeth, to restore | ||||
| chewing function. It may be used with single- | ||||
| stage or two-stage procedures, for single or | ||||
| multiple unit restorations, and may be loaded | ||||
| immediately when good primary stability is | ||||
| achieved and with appropriate occlusal | ||||
| loading. | The 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. | ||||
| Multiple tooth applications may be rigidly | ||||
| splinted. | The Implant System is intended to be | |||
| surgically placed in the maxilla or mandible to | ||||
| provide support for prosthetic devices such | ||||
| as artificial teeth in order 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. Multiple tooth applications may be | ||||
| rigidly 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. |
| Overall | ||||
| dimensions | NeoConvert Screw: | |||
| ● Laying diameter: 1.4 mm | ||||
| ● Height: 3.7 mm |
NeoConvert Coping:
● Laying diameter: 4.8 mm
● Height: 5.0 and 6.0 mm
NeoConvert 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 |
| Commercially
Supplied | NeoConvert Coping and Screw:
One cavity blister with five units.
NeoConvert Distal Bar:
Two cavity blister with one unit and one
screw. | 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 one
screw. |
| Single use | Yes | Yes | Yes | Yes |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| K Number | K242686
Neodent Implant System | K163194
Neodent Implant System | K101945
Neodent Implant System
K193234
Nuvo IF Implant System | |
| Sterilization
Method | Provided sterile via Ethylene Oxide. The
coping and screw, if opened and not
used, must be terminally sterilized by
user via moist heat with cycle parameters
validated to a SAL of 1x10-6. | Provided sterile via Ethylene Oxide. | Provided sterile via Ethylene Oxide. Terminally
sterilized by user via moist heat with cycle
parameters validated to a SAL of 1x10-6.
Provided sterile via Ethylene Oxide. | |
Table 1 – Table of Substantial Equivalence NeoConvert
9
Neodent Implant System
510(k) Summary
10
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 | K242686 | |||||||||||||||
| Neodent Implant System | K163194 | |||||||||||||||
| Neodent Implant System | K202452 | |||||||||||||||
| NobelProcera Zirconia Implant Bridge | K203542 | |||||||||||||||
| Mini Abutment 60° | ||||||||||||||||
| Indications | ||||||||||||||||
| for Use | 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. | The Neodent Implant System is intended to | |||||||||||||||
| be surgically placed in the bone of the upper | ||||||||||||||||
| or lower jaw to provide support for prosthetic | ||||||||||||||||
| devices, such as artificial teeth, to restore | ||||||||||||||||
| chewing function. It may be used with single- | ||||||||||||||||
| stage or two-stage procedures, for single or | ||||||||||||||||
| multiple unit restorations, and may be loaded | ||||||||||||||||
| immediately when good primary stability is | ||||||||||||||||
| achieved and with appropriate occlusal | ||||||||||||||||
| loading. | The NobelProcera Zirconia Implant Bridge | |||||||||||||||
| are indicated for use as a bridge anatomically | ||||||||||||||||
| shaped and/or framework in the treatment of | ||||||||||||||||
| partially or totally edentulous jaws for the | ||||||||||||||||
| purpose of restoring chewing function. | The Mini Conical Abutments are indicated for | |||||||||||||||
| use with Zygomatic Implants, in case of | ||||||||||||||||
| severe jaw resorption, in order to restore | ||||||||||||||||
| patient aesthetics and chewing function. It | ||||||||||||||||
| 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. | ||||||||||||||||
| 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. | ||||||||||||
| Overall | ||||||||||||||||
| dimensions | Diameter of the screw head: 2.2 mm | |||||||||||||||
| Height of screw head: 1.7 mm | ||||||||||||||||
| Total height: 4.1 mm | Diameter of the screw head: 1.9 mm | |||||||||||||||
| Diameter of the external thread: 1.4 mm | ||||||||||||||||
| Height of screw head: 1.7 mm | ||||||||||||||||
| Total height: 3.7 mm | Diameter of the screw head: 2.0 mm | |||||||||||||||
| Total height: 4.0 mm | ||||||||||||||||
| Commercially | ||||||||||||||||
| Supplied | One cavity blister with five units. | One cavity blister with one units. | ||||||||||||||
| Single Use | Yes | Yes | Yes | Yes | ||||||||||||
| Sterilization | ||||||||||||||||
| Method | Provided non-sterile. Must be sterilized | |||||||||||||||
| before installation via moist heat (steam), | ||||||||||||||||
| using either gravity or vacuum, with an | ||||||||||||||||
| exposure time of 3 minutes at 132°C | ||||||||||||||||
| (270°F). | Provided non-sterile. Must be sterilized | |||||||||||||||
| before installation via moist heat (steam), | ||||||||||||||||
| using either gravity or vacuum, at 132°C | ||||||||||||||||
| (270°F) or 134°C (273°F). | ||||||||||||||||
| Top Half | ||||||||||||||||
| Material | 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 |
11
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 | K242686 | |||
| Neodent Implant System | K163194 | |||
| Neodent Implant System | K192229 | |||
| GM Titanium Base for Bridge | ||||
| K203309 | ||||
| NUVO CF Implant System | ||||
| Indications | ||||
| for Use | 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. | 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. | Titanium Base Abutment is a titanium base | |||
| placed onto Neodent dental implants to provide | ||||
| support for customized prosthetic restorations. | ||||
| It is used with a coping and crown, or crown | ||||
| alone, and is indicated for cement-retained | ||||
| single or multi-unit restorations or screw- | ||||
| retained single restorations. All digitally | ||||
| designed copings and/or crowns to be used | ||||
| with the Neodent Titanium Base Abutment | ||||
| System are intended to be sent to Straumann | ||||
| for manufacture at a validated milling center. | ||||
| The GM Titanium Base for Bridge is indicated | ||||
| for cement or screw-retained multi-unit | ||||
| restorations. | The CF Titanium Base for Bridge is a | |||
| titanium abutment placed onto dental | ||||
| implants to provide support for customized | ||||
| prosthetic restorations (multiple structures). | ||||
| It is indicated for multi-unit restorations, | ||||
| cement-retained or screw-retained in | ||||
| aesthetic areas on implants installed in the | ||||
| maxilla 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. |
| Overall | ||||
| dimensions | Diameter of the screw head: 2.2 mm | |||
| Height of screw head: 1.7 mm | ||||
| Total height: 4.1 mm | Diameter of the screw head: 1.9 mm | |||
| Diameter of the external thread: 1.4 mm | ||||
| Height of screw head: 1.7 mm | ||||
| Total height: 3.7 mm | Diameter: 3.5mm | |||
| Cementable area height 4.0mm | ||||
| Gingival Height: 0.8 mm | Diameter: 3.5 mm | |||
| Cementable area height: 4.5 mm | ||||
| Gingival height: 0.5 mm | ||||
| Commercially | ||||
| Supplied | 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 one |
| screw. | ||||
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | ||||
| Method | Provided non-sterile. Must be sterilized | |||
| before installation via moist heat (steam), | ||||
| using either gravity or vacuum, with an | ||||
| exposure time of 3 minutes at 132°C (270°F). | Provided sterile by Ethylene Oxide. Must be | |||
| sterilized before installation via moist heat | ||||
| (steam), using either gravity or vacuum, at | ||||
| 132°C (270°F). | Provided sterile by Ethylene Oxide. Must be | |||
| sterilized before installation via moist heat | ||||
| (steam), using either gravity or vacuum, at | ||||
| 132°C (270°F). | ||||
| Top Half | ||||
| Material | 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 the | ||||
| mouth 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 the | ||||
| mouth only for up to 180 days | ||||
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
| K Number | K242686 | |||
| Neodent Implant System | K163194 | |||
| Neodent Implant System | K223638 | |||
| Helix Short Implant System | ||||
| Indications | ||||
| for Use | 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. | The Neodent Implant System is intended to be surgically placed | |||
| in the bone of the upper or lower jaw to provide support for | ||||
| prosthetic devices, such as artificial teeth, to restore chewing | ||||
| function. It may be used with single-stage or two-stage | ||||
| procedures, for single or multiple unit restorations, and may be | ||||
| loaded immediately when good primary stability is achieved and | ||||
| with appropriate occlusal loading. | The 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 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. | ||||
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | |
| Overall | ||||
| dimensions | Diameter of the screw head: 2.2 mm | |||
| Height of screw head: 1.7 mm | ||||
| Total height: 4.1 mm | Diameter of the screw head: 1.9 mm | |||
| Diameter of the external thread: 1.4 mm | ||||
| Height of screw head: 1.7 mm | ||||
| Total height: 3.7 mm | Diameter: 4.8 mm | |||
| Cementable area height 4.5 mm | ||||
| Gingival Height: 0.2 mm | ||||
| Commerciall | ||||
| y Supplied | One cavity blister with five units. | One cavity blister with one units. | ||
| Single Use | Yes | Yes | Yes | |
| Sterilization | ||||
| Method | Provided non-sterile. Must be sterilized before installation | |||
| via moist heat (steam), using either gravity or vacuum, with | ||||
| an exposure time of 3 minutes at 132°C (270°F). | Provided sterile by Ethylene Oxide. Must be sterilized before | |||
| installation via moist heat (steam), using either gravity or | ||||
| vacuum, at 132°C (270°F). | ||||
| Top Half | ||||
| Material | 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 to | ||||
| 180 days |
12
Neodent Implant System
510(k) Summary
Table 4 – Table of Substantial Equivalence Direct Screw to MUA (HS Implants)
13
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 | K242686 | |||||
| Neodent Multi-Unit Abutments | K163194 | |||||
| Neodent Implant System | K162890 | |||||
| Straumann SC Variobase Abutments | K220251 | |||||
| Narrow Implant System | ||||||
| Indications for | ||||||
| Use | 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 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. | 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. | Straumann® Variobase® abutments are | |||||
| indicated to be placed into Straumann® | ||||||
| dental implants to provide a support structure | ||||||
| for the functional and esthetic oral | ||||||
| rehabilitation of edentulous or partially | ||||||
| edentulous patients with crowns, bridges, or | ||||||
| full-arch prostheses. | 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 one 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. | ||||||
| Material | Titanium alloy, according to ASTM F136. | Titanium alloy, according to ASTM F136. | Titanium-vanadium alloy. | Titanium alloy, according to ASTM F136. | ||
| Overall | ||||||
| dimensions | Diameter of the screw head: 2.2 mm | |||||
| Height of screw head: 1.7 mm | ||||||
| Total height: 4.1 mm | Diameter of the screw head: 1.9 mm | |||||
| Diameter of the external thread: 1.4 mm | ||||||
| Height of screw head: 1.7 mm | ||||||
| Total height: 3.7 mm | Diameter: 3.3 - 4.3 mm | |||||
| Gingival Height: 3.0 mm | ||||||
| Total height: 6.7 – 8.7 mm | Diameter: 3.5 mm | |||||
| Gingival height: 3.5 mm | ||||||
| Commercially | ||||||
| Supplied | One cavity blister with five units. | One cavity blister with one units. | One cavity blister with one unit. | |||
| Single Use | Yes | Yes | Yes | Yes | ||
| Sterilization | ||||||
| Method | Provided non-sterile. Must be sterilized | |||||
| before installation via moist heat (steam), | ||||||
| using either gravity or vacuum, with an | ||||||
| exposure time of 3 minutes at 132°C | ||||||
| (270°F). | Provided sterile by Ethylene Oxide. Must be | |||||
| sterilized before installation via moist heat | ||||||
| (steam), using either gravity or vacuum, at | ||||||
| 132°C (270°F). | ||||||
| Top Half | ||||||
| Material | 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 the | ||||||
| mouth only for up to 180 days |
14
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 | K242686 | |||
| Neodent Implant System | K163194 | |||
| Neodent Implant System | K173902 | |||
| Neodent Implant System -GM Line | K192229 | |||
| GM Titanium Base for Bridge | ||||
| Indications | ||||
| for Use | 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. | The Neodent Implant System is intended to | |||
| be surgically placed in the bone of the upper | ||||
| or lower jaw to provide support for prosthetic | ||||
| devices, such as artificial teeth, to restore | ||||
| chewing function. It may be used with single- | ||||
| stage or two-stage procedures, for single or | ||||
| multiple unit restorations, and may be loaded | ||||
| immediately when good primary stability is | ||||
| achieved and with appropriate occlusal | ||||
| loading. | The 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. | Titanium Base Abutment is a titanium base | |||
| placed onto Neodent dental implants to provide | ||||
| support for customized prosthetic restorations. It | ||||
| is used with a coping and crown, or crown alone, | ||||
| and is indicated for cement-retained single or | ||||
| multi-unit restorations or screw-retained single | ||||
| restorations. All digitally designed copings and/or | ||||
| crowns to be used with the Neodent Titanium | ||||
| Base Abutment System are intended to be sent to | ||||
| Straumann for manufacture at a validated milling | ||||
| center. The GM Titanium Base for Bridge is | ||||
| indicated for cement or screw-retained multi-unit | ||||
| restorations. | ||||
| 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. |
| Overall | ||||
| dimensions | Gingival height: 1.5, 2.5, 3.5, 4.5 and 5.5 | |||
| mm | ||||
| Angulation: 30° | Gingival height: 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 | |||
| mm | ||||
| Angulation: 0° | Gingival height: 0.8, 1.5, 2.5, 3.5, 4.5 and | |||
| 5.5 mm | ||||
| Angulation: 15° | Cementable area height: 4.0 mm | |||
| Gingival height: 0.8 mm | ||||
| Maximum angulation: 30° | ||||
| Commercially | ||||
| Supplied | 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 |
| Sterilization | ||||
| Method | Provided sterile by ethylene oxide. | Provided sterile by Ethylene Oxide. Must be | ||
| sterilized before installation via moist heat | ||||
| (steam), using either gravity or vacuum, at | ||||
| 132°C (270°F). | Provided sterile by ethylene oxide. | Provided sterile by ethylene oxide. |
15
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.
16
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.