(333 days)
No
The document describes a physical dental abutment and its manufacturing process, which involves CAD/CAM design and milling. There is no mention of AI or ML being used in the design, manufacturing, or function of the device itself. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a component that provides support for prosthetic dental restorations; it is not described as having any therapeutic effect on the patient.
No
Explanation: The TruBase S is a titanium component designed to support prosthetic dental restorations. It is a structural component, not a device that collects, analyzes, or interprets data to diagnose a condition or disease. Its purpose is to provide mechanical support for dental prosthetics.
No
The device is a physical titanium component (dental abutment) and associated screw, not software. While it is used in conjunction with CAD/CAM design, the device itself is hardware.
No, 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 Function: The TruBase S is a titanium component used to support dental prosthetic restorations. It is a physical implant component that is placed in the mouth, not a device used to analyze biological samples.
- Intended Use: The intended use clearly states it's for providing support for custom prosthetic restorations connected to dental implants. This is a mechanical and structural function within the body.
- Device Description: The description details the physical composition and design of the titanium abutment and screw.
- Performance Studies: The performance studies focus on mechanical properties like fatigue strength and compatibility with dental implants, not on analyzing biological samples or diagnostic accuracy.
The information provided describes a dental implant component, which falls under the category of medical devices, but not specifically in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)
All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruBase S is compatible with the following devices:
NobelActive (K102436, K071370, K133731)
Implant Body Diameter 3.0 / Implant Platform 3.0 / Connection Type: Internal Hex
Implant Body Diameter 3.5 / Implant Platform NP / Connection Type: Internal Hex
Implant Body Diameter 4.3 / Implant Platform RP / Connection Type: Internal Hex
Implant Body Diameter 5.0 / Implant Platform RP / Connection Type: Internal Hex
Implant Body Diameter 5.5 / Implant Platform WP / Connection Type: Internal Hex
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase S Screw for fixation to the implant body.
TruBase S abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (NobelActive 3.0, NP, RP, WP). The TruBase S Screws are composed of titanium alloy per ASTM F136.
They also feature:
- cylindrical shape
- hexagonal indexing at the apical end of the connection
- indexing guide in the cementable portion for coping fitting
CAD/CAM customized superstructure that composes the final abutmentis intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase S.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and mandible
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)
Mechanical performance testing was performed according to ISO 14801:2016. For compatible OEM implant lines, worst-case constructs were subjected to static compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.
Non-clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
-
Fatigue Test according to ISO 14801:2016
Below tests were performed for predicate device (K201197) and leveraged for the subject device: -
End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
-
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device.
Comparative fatigue testing of the subject and predicate devices was conducted in accordance with ISO 14801 and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing.
Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
Clinical testing was not necessary to establish substantial equivalency of the device.
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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614
Re: K201842
Trade/Device Name: TruBase S Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 22, 2021 Received: May 4, 2021
Dear Chris Choi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name TruBase S
Indications for Use (Describe)
TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)
All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutmentvalidated milling center for manufacture.
TruBase S is compatible with the following devices:
NobelActive (K102436, K071370, K133731)
Implant Body Diameter 3.0 / Implant Platform 3.0 / Connection Type: Internal Hex
Implant Body Diameter 3.5 / Implant Platform NP / Connection Type: Internal Hex
Implant Body Diameter 4.3 / Implant Platform RP / Connection Type: Internal Hex
Implant Body Diameter 5.0 / Implant Platform RP / Connection Type: Internal Hex
Implant Body Diameter 5.5 / Implant Platform WP / Connection Type: Internal Hex
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is written in white letters on a blue background. The letters "ru" are written in a larger, blue font and are placed below the word "Abutment". To the left of the letters "ru" is a blue image of a screw.
510(k) Summary
K201842
Submitter TruAbutment Inc. HoSu Lee 17742 Cowan, Irvine, CA 92614 USA Email: hosu.lee@truabutment.com Phone: 1-714-956-1488
Official Correspondent
TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: chris.choi(@truabutment.com Phone: 1-714-956-1488
- Trade Name: TruBase S
- Common Name: Endosseous dental implant abutment
- Classification Name: Abutment, Implant, Dental, Endosseous
- Product Code: NHA
- Panel: Dental .
Device Information
- Regulation Number: 21 CFR 872.3630
- Device Class: Class II ●
- Date prepared: 06/03/2021 ●
Primary Predicate Device/ Reference Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate Device:
- TruAbutment DS, TruBase S (K201197) by TruAbutment Inc. ●
Reference Devices:
- . Nobelactive 3.0 (K102436) By NobelBiocare.
- Nobelactive Internal Connection Implant (K071370) By Nobel Biocare.
- Nobelactive Wide Platform (Wp) (K133731) By Nobel Biocare.
4
Image /page/4/Picture/0 description: The image shows a logo for a company called "Abutmentru". The logo is primarily blue and white. The word "Abutment" is written in white at the top of the logo, and the letters "ru" are written in a large blue font below the word "Abutment". The "r" in "ru" is stylized to look like a screw.
General Description
TruBase S
TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase S Screw for fixation to the implant body.
TruBase S abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (NobelActive 3.0, NP, RP, WP). The TruBase S Screws are composed of titanium alloy per ASTM F136.
They also feature:
- . cylindrical shape
- hexagonal indexing at the apical end of the connection ●
- indexing guide in the cementable portion for coping fitting ●
CAD/CAM customized superstructure that composes the final abutmentis intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase S.
The following table shows the subject device abutment platform sizes for each of the OEM implant lines and sizes.
| Implant System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
|--------------------------------------------------|-------------------------------------|---------------------------|-----------|-----------------------------------------|-----------------------------------------|
| NobelActive
(K102436,
K071370,
K133731) | 3.0 | 10 | 36769 | 3.0 | |
| | | 11.5 | 36770 | | |
| | | 13 | 36771 | | |
| | | 15 | 36772 | | |
| | 3.5 | 10 | 34125 | 3.5
(NP) | |
| | | 11.5 | 34126 | | |
| | | 13 | 34127 | | |
| | | 15 | 34128 | | |
| | 4.3 | 10 | 34131 | 3.9
(RP) | Internal Hex |
| | | 11.5 | 34132 | | |
| | | 13 | 34133 | | |
TruBase S is compatible with the following devices:
5
Image /page/5/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized, sans-serif font. The letters are in a bright blue color. The "T" in "ABUTMENT" extends downward, forming a visual element that resembles a screw thread. The letters "RU" are placed to the right of the "T" and are also in blue.
TruAbutmentInc. 17742 Cowan, Irvine, CA 92614
ાર 34134
6
Image /page/6/Picture/0 description: The image shows a logo for a company called "Abutment Tru". The word "Abutment" is written in white letters on a blue background. The word "Tru" is written in large, blue letters, with a design that looks like a screw on the left side of the word. The logo has a modern and professional look.
TruAbutmentInc. 17742 Cowan, Irvine, CA 92614
| Implant System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
|----------------|-------------------------------------|---------------------------|-----------|-----------------------------------------|-----------------------------------------|
| | 5.0 | 10 | 34137 | | |
| | | 11.5 | 34138 | 3.9
(RP) | |
| | | 13 | 34139 | | |
| | | 15 | 34140 | | |
| | 5.5 | 7 | 37806 | | |
| | | 8.5 | 37807 | 5.1
(WP) | |
| | | 10 | 37808 | | |
| | | 11.5 | 37809 | | |
| | | 13 | 37810 | | |
Raw material blanks
- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, (same as K201197). ●
Cement
- RelyX Unicem 2Automix by 3M ESPE, (same as K201197). .
- Design Limitation for Zirconia .
superstructure
| Design parameter | Design Limit |
|---|---|
| Minimum and Maximum abutment angle (°) | 0~15 |
| Minimum and Maximum Cuff Height (mm) | 0.5~5.0 |
| Minimum and Maximum diameter at abutment/implant interface | |
| (Ø, mm) | 5.0~8.0 |
| Minimum Thickness (mm) | 0.4 |
| Minimum and Maximum length of abutment post | |
| (length above the abutment collar/gingival height) (mm) | 4.0~6.0 |
7
Image /page/7/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a stylized font at the top. Below "Abutment", the letters "ru" are displayed in a larger, bolder font, with a design resembling the threads of a screw or bolt on the left side of the letters. The overall design is simple and modern, with a focus on the company name and a visual element suggesting engineering or construction.
Indication for Use
TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screwretained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
- . NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)
All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruBase S is compatible with the following devices:
NobelActive (K102436, K071370, K133731)
Implant Body Diameter 3.0 / Implant Platform 3.0 / Connection Type: Internal Hex Implant Body Diameter 3.5 / Implant Platform NP / Connection Type: Intemal Hex Implant Body Diameter 4.3 / Implant Platform RP / Connection Type: Intemal Hex Implant Body Diameter 5.0 / Implant Platform RP / Connection Type: Intemal Hex Implant Body Diameter 5.5 / Implant Platform WP / Connection Type: Intemal Hex
8
Image /page/8/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The logo also includes a graphic element that resembles a screw or bolt, suggesting a connection to engineering or construction.
Summary of Technological Characteristics
The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each diameter and connection type. Comparison demonstrating Substantial Equivalence follows at the end of this section.
| Attributes | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade Name | TruBase S | TruBase S (K201197) |
| Indications for | ||
| Use | TruBase S is a titanium component | |
| that is directly connected to | ||
| endosseous dental implants to | ||
| provide support for custom | ||
| prosthetic restorations, such as | ||
| copings or crowns. It is indicated for | ||
| a screw-retained single tooth or | ||
| cement-retained single tooth and | ||
| bridge restorations. It is compatible | ||
| with the following systems: | ||
| NobelActive (K102436, | ||
| K071370, K133731): 3.0, 3.5, 4.3, | ||
| 5.0, 5.5 (3.0, NP, RP, WP) All digitally designed abutments | ||
| and/or copings for use with TruBase | ||
| S are intended to be sent to a | ||
| TruAbutment-validated milling | ||
| center for manufacture. | ||
| TruBase S is compatible with the | ||
| following devices: | TruBase S is a titanium component | |
| that is directly connected to | ||
| endosseous dental implants to | ||
| provide support for custom | ||
| prosthetic restorations, such as | ||
| copings or crowns. It is indicated for | ||
| screw-retained single tooth or | ||
| cement-retained single tooth and | ||
| bridge restorations. It is compatible | ||
| with the following systems: | ||
| Zimmer 3.1mmD Dental Implant | ||
| System (K142082) Screw Vent® and Tapered Screw | ||
| Vent® (K013227) TruBase S is intended to be sent to a | ||
| TruAbutment-validated milling | ||
| center for manufacture. | ||
| TruBase S is compatible with the | ||
| Attributes | Proposed Device | Primary Predicate Device |
| Trade Name | TruBase S | TruBase S (K201197) |
| NobelActive (K102436, K071370, | ||
| K133731) | ||
| Implant Body Diameter 3.0 / Implant | ||
| Platform 3.0 / Connection Type: | ||
| Internal Hex | ||
| Implant Body Diameter 3.5 / | ||
| Implant Platform NP / Connection | ||
| Type: Internal Hex | ||
| Implant Body Diameter 4.3 / | ||
| Implant Platform RP / Connection | ||
| Type: Internal Hex | ||
| Implant Body Diameter 5.0 / Implant | ||
| Platform RP / Connection Type: | ||
| Internal Hex | ||
| Implant Body Diameter 5.5 / Implant | ||
| Platform WP / Connection Type: | ||
| Internal Hex | following devices: | |
| Zimmer 3.1mmD Dental Implant | ||
| System(K142082) | ||
| Implant Body Diameter 3.1/ | ||
| Implant Platform Diameter 2.9 / | ||
| Internal Hex | ||
| Screw Vent® and Tapered Screw | ||
| Vent® (K013227) | ||
| Implant Body Diameter 3.7/ | ||
| Implant Platform Diameter 3.5 / | ||
| Internal Hex | ||
| Implant Body Diameter 4.1/ | ||
| Implant Platform Diameter 3.5 / | ||
| Internal Hex | ||
| Implant Body Diameter 4.7/ | ||
| Implant Platform Diameter 4.5 / | ||
| Internal Hex | ||
| Implant Body Diameter 6.0/ Implant | ||
| Platform Diameter 5.7 / Internal Hex | ||
| CAD Design | ||
| Limits | Maximum Angulation 0~15° | |
| Maximum Cuff Height 0.5~5mm | ||
| Minimum Diameter Ø 5.0~ Ø 8.0mm | ||
| Minimum Thickness 0.4mm | ||
| Minimum Post Height 4~6mm | Maximum Angulation 0~15° | |
| Maximum Cuff Height 0.5~5mm | ||
| Minimum Diameter Ø 5.0~Ø 8.0mm | ||
| Minimum Thickness 0.4mm | ||
| Minimum Post Height 4~6mm | ||
| Attributes | Proposed Device | Primary Predicate Device |
| Trade Name | TruBase S | TruBase S (K201197) |
| Abutment | ||
| Diameter (s) | Engaging: 3.5, 4.0, 4.5, 4.6, 5.5mm | |
| Non-Engaging: 3.5, 4.0, 4.5, 4.6, | ||
| 5.5mm | Engaging: 3.5, 3.8, 4.5, 5.7mm | |
| Non-Engaging: 3.5, 4.3, 4.5, 5.3, 5.7, | ||
| 6.5mm | ||
| Abutment | ||
| Height (s) | 6.7~10.7mm | 4.7mm |
| Material of | ||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Implant-to- | ||
| Abutment | ||
| Connection(s) | Screw-retained to the implant. The | |
| prosthesis can be cement-retained to the | ||
| abutment. | Screw-retained to the implant. | |
| The | ||
| prosthesis can be cement-retained to the | ||
| abutment. | ||
| Type of | ||
| Retention | Screw-retained | Screw-retained |
| Material of | ||
| Superstructure | InCoris Zi | InCoris ZI |
| Manufacturing | ||
| processes | TruAbutment-validated milling center | TruAbutment-validated milling center |
| End-User | ||
| Sterilization | Moist steam sterilization | Moist steam sterilization |
9
Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a large, stylized font, also in blue. The left side of the logo has a jagged edge, resembling the teeth of a gear or screw.
10
Image /page/10/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letters are white, set against a blue background. The bottom of the image has a jagged edge, resembling the teeth of a gear or a screw thread, adding a mechanical or engineering element to the design.
11
Image /page/11/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and white. The word "Abutment" is written in white letters with a blue outline at the top of the logo. Below "Abutment", the letters "ru" are written in a larger, stylized blue font. To the left of the "ru" is a graphic of a screw.
Substantial Equivalence Discussion
TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM-designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device and the primary predicate device.
The Indications for Use Statement (IFUS) for the subject device (TruBase S) is substantially equivalent in intended use to the primary predicate device (K201197). All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.
The Indications for Use Statement (IFUS) for the subject device (TruBase S) is substantially equivalent to that of the primary predicate device (K201197). Slight differences in the language of the subject device and primary predicate device Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function.
The other minor differences are related to the compatible OEM implant lines. None of these minor differences impact substantial equivalence because all IFUS express equivalent intended to use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
Also, the primary predicate device follows the same digital workflow and utilizes the same materials (Ti-6Al-4V ELI) and inCoris ZI, as the subject device system.
| Design parameter | Subject Device
(K201842) | Predicate Device
(K201197) |
|-----------------------------------------------------------------------------|-----------------------------|-------------------------------|
| Minimum and Maximum
abutment angle (°) | 015 | 015 |
| Minimum and Maximum
Cuff Height (mm) | 0.55.0 | 0.55.0 |
| Minimum and Maximum
diameter at
abutment/implant interface
(Ø, mm) | 5.08.0 | 5.08.0 |
The subject device and the predicate device design parameter are substantially equivalent.
12
Image /page/12/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is in blue and white, with the word "Abutment" in a sans-serif font. The logo also includes a stylized image of a screw or bolt. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells screws, bolts, or other fasteners.
| Design parameter | Subject Device
(K201842) | Predicate Device
(K201197) |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------|
| Minimum Thickness (mm) | 0.4 | 0.4 |
| Minimum and Maximum
length of abutment post
(length above the abutment
collar/gingival height)
(mm) | 4.06.0 | 4.06.0 |
Mechanical performance testing was performed according to ISO 14801:2016. For compatible OEM implant lines, worst-case constructs were subjected to static compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.
Non-clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
-
Fatigue Test according to ISO 14801:2016
Below tests were performed for predicate device (K201197) and leveraged for the subject device: -
End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
-
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device.
Comparative fatigue testing of the subject and predicate devices was conducted in accordance with ISO 14801 and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing.
Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The TruBase S constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, TruBase S and its predicate are substantially equivalent.