(149 days)
No
The summary describes a digitally designed and manufactured dental abutment using CAD/CAM software, but there is no mention of AI or ML being used in the design or manufacturing process. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a prosthetic abutment that provides support for dental restorations, rather than actively treating a disease or condition.
No
Explanation: The device described is a customized prosthetic abutment designed to provide support for dental restorations. Its purpose is to physically support a prosthetic, not to diagnose a condition or disease.
No
The device is a physical dental abutment made of titanium alloy, not a software-only device. While its design process involves CAD/CAM software, the device itself is a manufactured hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the device as a "customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations." This is a physical implantable device used in the mouth for structural support of dental prosthetics.
- Lack of Mention of Biological Specimens: There is no mention of the device being used to test or analyze any biological specimens from the patient.
- Focus on Mechanical and Biocompatibility Testing: The performance studies described (dynamic fatigue, torsion, sterilization, MR compatibility, biocompatibility) are all related to the physical properties, safety, and performance of an implantable medical device, not an IVD.
Therefore, the Custom Abutment Ti with Screw and the Custom Abutment with Angled Screw Channel are dental prosthetic devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Custom Abutment Ti with Screw (milled):
The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.
Custom Abutment Ti with Angled Screw Channel (milled):
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Custom Abutments subject to this submission are similar to the devices already cleared in previous Neodent and Nuvo Implant System submissions, per the predicate and reference devices described above. This submission intends to expand the portfolio of digital abutments for the Grand Morse (GM), Narrow Grand Morse (NGM) and Helix Short (HS) lines, to provide more treatment options for customers. These abutments are composed of a unique body with two regions: the upper region is the customized portion, while the end region presents the prosthetic interface that fits with the implant, which does not allow customization.
They are intended for single use and provided non-sterilization recommended before installation in the mouth.
All proposed abutments are delivered to the final user already customized in a validated milling center, with a straight channel solution. For the GM line, the abutments could also be milled with a new angled channel solution for the screw access. All subject devices must be used with their corresponding prosthetic interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants
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:
Assessment regarding dynamic fatigue testing was 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 equivalent to that reviewed for the presented predicate devices.
Torsion tests were 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 of 2.0 N-cm over the indicated installation torque.
Sterilization Validation:
Sterilization validation was performed according to ISO 17665-1 "Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices" and ISO 17665-2 "Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1, as provided in K180536. A minimum Sterility Assurance Level (SAL) of 1x10-6 has been validated for this method. The subject devices are not represented to be "non-pyrogenic".
MR Compatibility Testing:
The MR compatibility was performed to assess the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.
Biocompatibility Testing:
A biological assessment was 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:
- Biocompatibility sample preparation was made according to ISO 10993-12.
- Biological Safety Assessment guided 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.
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.
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 contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
May 2, 2024
Re: K233857
Trade/Device Name: Neodent Implant System - Custom Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 2, 2024 Received: April 2, 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.
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233857
Device Name
Neodent Implant System - Custom Abutments
Indications for Use (Describe)
Custom Abutment Ti with Screw (milled):
The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.
Custom Abutment Ti with Angled Screw Channel (milled):
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.
| Type of Use (Select one or both, as applicable) |
|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
K233857 Traditional 510(k) Submission
Neodent Implant System – Custom Abutments
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| On the behalf of: | |
| | JJGC Indústria e Comércio de Materiais Dentários AS (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 |
| Prepared By &
Alternate Contact: | Leticia Milani
Regulatory Affairs Analyst
JJGC Indústria e Comércio de Materiais Dentários SA
E-mail: leticia.milani@neodent.com |
| Date Prepared: | May 2, 2024 |
| Name of the Device | |
| Trade Names: | Neodent Implant System – Custom Abutments |
| Trade Names: | Needent Implant System - Custom Abutment |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630, Class II |
| Device Classification: | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental Products Panel |
5
K233857 Traditional 510(k) Submission
Neodent Implant System – Custom Abutments
510(k) Summarv
Predicate Device(s)
Primary Predicate:
-
. K203309 – Nuvo CF Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A)
Reference Devices: -
. K150367 – Neodent Implant System – CM Preface Abutment (JJGC Indústria e Comércio de Materiais Dentários S.A)
-
K162890 Straumann SC CARES Abutment (Straumann USA, LLC) ●
-
. K182620 – MRI Compatibility For Existing Neodent Implant System
Device Description
The Custom Abutments subject to this submission are similar to the devices already cleared in previous Neodent and Nuvo Implant System submissions, per the predicate and reference devices described above. This submission intends to expand the portfolio of digital abutments for the Grand Morse (GM), Narrow Grand Morse (NGM) and Helix Short (HS) lines, to provide more treatment options for customers. These abutments are composed of a unique body with two regions: the upper region is the customized portion, while the end region presents the prosthetic interface that fits with the implant, which does not allow customization.
They are intended for single use and provided non-sterilization recommended before installation in the mouth.
All proposed abutments are delivered to the final user already customized in a validated milling center, with a straight channel solution. For the GM line, the abutments could also be milled with a new angled channel solution for the screw access. All subject devices must be used with their corresponding prosthetic interface.
Intended Use
The Custom Abutments are used onto dental implants to provide support for customized prosthetic restorations (copings and crowns), indicated for screw-retained or cement-retained single restorations. They are indicated according to the interocclusal space available, existing transmucosal height and three-dimensional position of the implant. The subject devices are available in GM, NGM and HS prosthetics interfaces compatible with the implants of the prosthetic interface.
6
K233857 Traditional 510(k) Submission
Neodent Implant System – Custom Abutments
510(k) Summarv
Indications for Use
The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.
7
Neodent Implant System – Custom Abutments
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 PREDICATE DEVICE | REFERENCE PREDICATE DEVICE |
|---|---|---|---|---|
| K Number | Neodent Implant System | |||
| Customizable Abutments | K203309 | |||
| Nuvo CF Implant System | K162890 | |||
| Straumann SC CARES Abutment | K150367 | |||
| Neodent Implant System - CM Preface | ||||
| Abutment | ||||
| Indications | ||||
| for | ||||
| Use | The Custom Abutment Ti with Screw is a customized prosthetic | |||
| abutment, manufactured in titanium alloy, placed onto dental | ||||
| implants to provide support for customized prosthetic | ||||
| restorations. All abutments are only intended to be digitally | ||||
| designed and manufactured using specific CAD/CAM software | ||||
| according to digital dentistry workflow. Custom Abutments Ti | ||||
| with Screw are indicated for screw-retained single restorations | ||||
| or cemented-retained single or multiple restorations. All digitally | ||||
| designed abutments for use with the Custom Abutment Ti with | ||||
| Screw are intended to be sent to Straumann for manufacturing | ||||
| at a validated milling center. | ||||
| The Custom Abutment with Angled Screw Channel is a | ||||
| customized prosthetic abutment, manufactured in titanium | ||||
| alloy, placed onto dental implants to provide support for | ||||
| customized prosthetic restorations. All abutments are only | ||||
| intended to be digitally designed and manufactured using | ||||
| specific CAD/CAM software according to digital dentistry | ||||
| workflow. Custom Abutments with Angled Screw Channel are | ||||
| indicated for screw-retained single restorations or cemented- | ||||
| retained single or multiple restorations. All digitally designed | ||||
| abutments for use with the Custom Abutment Ti with Angled | ||||
| Screw Channel are intended to be sent to Straumann for | ||||
| manufacturing at a validated milling center. | The CARES® Abutment CF is a | |||
| customized prosthetic | ||||
| abutment, | ||||
| manufactured in titanium alloy, placed | ||||
| onto dental implants to provide support | ||||
| for customized prosthetic restorations | ||||
| (copings or crowns). It is indicated for | ||||
| screw-retained or cement-retained | ||||
| single-unit restorations. All digitally | ||||
| designed abutments for use with the | ||||
| CARES® Abutment are intended to be | ||||
| sent to Straumann for manufacturing at | ||||
| a validated milling center. | Straumann SC CARES® abutments | |||
| are indicated for | ||||
| single-tooth | ||||
| replacements and multiple tooth | ||||
| restorations. The | ||||
| prosthetic | ||||
| restoration can be cemented or | ||||
| directly veneered/screw-retained. | PreFace Abutment is a titanium | |||
| abutment to be used in fabricating a full | ||||
| custom abutment and placed onto | ||||
| Neodent dental implants to provide | ||||
| support | ||||
| for customized prosthetic | ||||
| restorations. PreFace Abutments are | ||||
| indicated | ||||
| for screw-retained single | ||||
| restorations or cement-retained single or | ||||
| multi-unit restorations. | ||||
| Material | Devices: Titanium alloy, according to ASTM F136. | |||
| Screw: Titanium alloy, according to ASTM F136 or TAN. | Devices: Titanium alloy, according to | |||
| ASTM F136. | ||||
| Screw: Titanium alloy, according to | ||||
| ASTM F136. | Devices: TAN | |||
| Screw: TAN | Devices: Titanium alloy, according to | |||
| ASTM F136. | ||||
| Screw: Titanium alloy, according to ASTM | ||||
| F136. | ||||
| Implant-Abutment | ||||
| Connection | Grand Morse and Narrow Grand Morse | |||
| HS: Internal Hex | Internal Hex | SC Internal Connection | Cone Morse | |
| Channel Solution | Straight and angled | Straight | Straight | Straight |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |
| K Number | Neodent Implant System | |||
| Customizable Abutments | K203309 | |||
| Nuvo CF Implant System | K162890 | |||
| Straumann SC CARES Abutment | K150367 | |||
| Neodent Implant System - CM Preface | ||||
| Abutment | ||||
| Minimum Wall | ||||
| Thickness | 0.4mm | 0.4mm | 0.4mm | 0.4mm |
| Gingival Height | NGM Customized abutment 0.6-5.8mm | |||
| HS Customized abutment 0.2-5.4mm** | ||||
| GM Customized abutment 0.6-5.8mm | ||||
| GM Customized abutment with angled screw channel | ||||
| 0.6-5.6mm | Minimum 0.8mm | Minimum 0.1mm | Min 0.6mm | |
| Maximum Gingival | ||||
| Height | NGM Customized abutment 5.8mm | |||
| HS Customized abutment 5.4mm | ||||
| GM Customized abutment with angled screw channel 5.6mm | ||||
| GM Customized abutment 5.8mm | 5.8mm | 3.5mm | ||
| Abutment Post | ||||
| Height* | Minimum 4.0mm | Minimum 4.0mm | Minimum 6mm | Minimum 4.0mm |
| Maximum Abutment | ||||
| Angulation | ||||
| Customization | 30° | 30° | 30° | 30° |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | ||||
| Method | Provided non-sterile. Terminally sterilized by user via moist | |||
| heat. Moist heat cycle parameters have been validated to a | ||||
| SAL of 1x10-6. | Provided non-sterile. Terminally | |||
| sterilized by user via moist heat. Moist | ||||
| heat cycle parameters have been | ||||
| validated to a SAL of 1x10-6. | Provided non-sterile. Terminally | |||
| sterilized by user via moist heat. Moist | ||||
| heat cycle parameters have been | ||||
| validated to a SAL of 1x10-6. | Provided non-sterile. Terminally sterilized | |||
| by user via moist heat. Moist heat cycle | ||||
| parameters have been validated to a SAL | ||||
| of 1x10-6. |
8
Traditional 510(k) Submission
Neodent Implant System – Custom Abutments
510(k) Summary
*Post height is the length above the abutment collar/gingival height.
**Helix Short (HS) Implant System, K223638, is a tissue level implant system.
9
Traditional 510(k) Submission
Neodent Implant System – Custom Abutments
Performance Testing
Performance Testing
Bench Testing
Assessment regarding dynamic fatigue testing was 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 equivalent to that reviewed for the presented predicate devices.
Torsion tests were 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 of 2.0 N-cm over the indicated installation torque.
Sterilization Validation
Sterilization validation was performed according to ISO 17665-1 "Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices" and ISO 17665-2 "Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1, as provided in K180536. A minimum Sterility Assurance Level (SAL) of 1x10° has been validated for this method. The subject devices are not represented to be "non-pyrogenic".
MR Compatibility Testing
The MR compatibility was performed to assess the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.
10
Biocompatibility Testing
A biological assessment was 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:
- Biocompatibility sample preparation was made according to ISO 10993-12.
- · Biological Safety Assessment guided 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.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.