(275 days)
No
The summary describes a CAD/CAM system for designing and manufacturing dental abutments and bases. While it uses digital design and milling, there is no mention of AI or ML being used in the design process or any other aspect of the device's function. The focus is on compatibility with existing implant systems and mechanical performance testing.
No
The device, TruAbutment DS, is intended for prosthetic rehabilitation as an aid directly connected to dental implants. It provides support for patient-specific prosthetic restorations but does not directly treat a disease or condition.
No
The device is described as a patient-specific CAD/CAM abutment and titanium component for prosthetic rehabilitation, providing support for crowns or copings. Its intended use is mechanical support for restorations, not diagnosis. The performance studies focus on mechanical strength and compatibility, not diagnostic accuracy.
No
The device description explicitly details physical components made of titanium alloy (patient-specific abutments, abutment screws, TruBase, TruBase screws) and mentions manufacturing processes at a milling center. While CAD/CAM is used for design, the final product is a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended use of TruAbutment DS and TruBase is for prosthetic rehabilitation, specifically as components that connect to dental implants to support crowns or other restorations. This is a mechanical function within the oral cavity.
- Device Description: The device description details the materials (titanium alloy) and how the abutments are designed and manufactured to fit dental implants and support prosthetics. There is no mention of analyzing biological specimens.
- Anatomical Site: The anatomical site is the Oral Cavity, which is where the device is physically placed, not where biological samples are collected for analysis.
- Performance Studies: The performance studies described focus on mechanical properties like fatigue strength and dimensional compatibility with dental implants. These are not studies related to the accuracy of diagnostic tests.
The device is a dental prosthetic component, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
- · MIS C1 Conical Connection Implant (K172505, K112162)
- : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536)
- : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357)
- : 3.3(NNC)
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific 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:
- · MIS C1 Conical Connection Implant (K172505, K112162)
- : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536)
- : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357)
- : 3.3(NNC)
All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase 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 screw for fixation to the implant body. TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. The TruBase screws are composed of titanium alloy per ASTM F136. CAD/CAM customized superstructure that composes the final abutment is 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 in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.
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 the reference device (K152559, K200817) 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.
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.
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: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems.
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.
K172505, K112162, K163194, K180536, K050258, K173961, K181703, K191256, K111357, K152559, K200817
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 for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services seal on the left. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 15, 2021
TruAbutment Inc. Chris Choi Director 17666 Fitch Irvine, California 92614
Re: K203649
Trade/Device Name: TruAbutment DS, TruBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 26, 2021 Received: August 16, 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,
for Andrew 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
2
Indications for Use
510(k) Number (if known) K203649
Device Name TruAbutment DS, TruBase
Indications for Use (Describe)
TruAbutment DS
TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
- · MIS C1 Conical Connection Implant (K172505, K112162)
- : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536)
- : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357)
- : 3.3(NNC)
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
Indications for Use
510(k) Number (if known) K203649
Device Name TruAbutment DS, TruBase
Indications for Use (Describe) TruBase
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patientspecific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cementretained single tooth and bridge restorations. It is compatible with the following systems:
- · MIS C1 Conical Connection Implant (K172505, K112162)
- : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536)
- : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357)
- : 3.3(NNC)
All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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 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."
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Image /page/4/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is blue and features the word "Abutment" in a large, bold font. Below the word "Abutment" is the letters "ru" in a similar font. To the left of the word "Abutment" is a graphic of a screw.
510(k) Summary K203649
| Submitter | Official Correspondent |
|---|---|
| TruAbutment Inc. | TruAbutment Inc. |
| Eunjin Jang | Chris Choi |
| 17666 Fitch, | 17666 Fitch, |
| Irvine, CA 92614 | Irvine, CA 92614 |
| USA | USA |
| Email: eunjin.jang@truabutment.com | Email: chris.choi@truabutment.com |
| Phone: 1-714-956-1488 | Phone: 1-714-956-1488 |
Device Information
- Trade Name: TruAbutment DS, TruBase ●
- Common Name: Endosseous dental implant abutment
- . Classification Name: Abutment, Implant, Dental, Endosseous
- . Product Code: NHA
- Panel: Dental ●
- Regulation Number: 21 CFR 872.3630
- Device Class: Class II
- Date prepared: 09/14/2021
Primary Predicate / Reference Devices:
Primary Predicate:
- TruAbutment DS, TruBase (K202579) by TruAbutment Inc. .
Reference Devices:
- MIS C1 Narrow Platform Conical Connection Implant System (K172505) by MIS Implants Technologies Ltd.
- . MIS C1 Standard, Wide Platform Conical Connection Implants (K112162) by MIS Implants Technologies Ltd.
- Neodent Implant System GM Helix (K163194) by Straumann USA, LLC. ●
- Neodent Implant System GM Helix (K180536) by PaxMed International, LLC. ●
- Nobel Biocare Groovy Implants (K050258) by Nobel Biocare AB.
- Straumann BLX Implant System (K173961) by Straumann USA, LLC.
- Straumann BLX Line Extension - Implants (K181703) by Straumann USA, LLC.
- . Straumann BLX Ø3.5 Mm Implants (K191256) by Straumann USA, LLC.
- Straumann Narrow Neck CrossFit (NNC) Ø3.3mm Dental Implant System (K111357) by ● Straumann USA.
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Image /page/5/Picture/0 description: The image shows a logo for a company or organization called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font, stacked above the letters "ru", which are also in blue but in a different, more stylized font. To the left of the "ru" is a design that resembles a gear or cogwheel, also in blue, which adds a mechanical or technical element to the logo.
General Description
TruAbutment DS
TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
Mechanical resistance of the implant-abutment connection is essential to ensure the correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The TruAbutment DS is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
| Design Parameter | Design Limit |
|---|---|
| Minimum and Maximum abutment angle(°) | 0 ~ 25 |
| Minimum and Maximum cuff height(mm) | 0.5 ~ 6.0 |
| Minimum and Maximum diameter at abutment/implant interface(Ø,mm) | 3.8 ~ 8.0 |
| Minimum thickness(mm) | 0.4 |
| Minimum and Maximum length of abutment post | |
| (length above the abutment collar / gingival height) (mm) | 4.0 ~ 7.0 |
Design Limitation for TruAbutment DS
TruBase
TruBase 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 screw for fixation to the implant body.
TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (MIS C1 Narrow Platform
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Image /page/6/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font stacked above the letters "ru", which are also in blue. The "A" in "Abutment" is larger than the other letters, and the left side of the "r" in "ru" is stylized to resemble the threads of a screw or bolt.
Conical Connection Implant (K172505, K112162): 3.3 (NP), 3.75, 4.2, 5.0 (SP,WP), Neodent Implant System - GM Helix (K163194, K180536): 3.5, 3.75, 4.0, 4.3, 5.0 (3.0), Nobel Biocare Groovy Implants (K050258): 3.5.4.3, 5.0, 6.0 (NP, RP, WP, 6.0), Straumann BLX Implant System (K173961, K181703, K191256): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB), Straumann Tissue Level (K111357): 3.3 (NNC). The TruBase screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment is 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 in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.
TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.
The TruBase is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
Raw material blanks
-
InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.
Cement -
RelyX Unicem 2Automix by 3M ESPE, cleared under K100756. .
Design Limitation for Zirconia superstructure
| Design Parameter | Design Limit |
|---|---|
| Minimum and Maximum angulation(°) | 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 |
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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, stacked above the letters "ru", which are connected and stylized to resemble a screw or bolt. The overall design is modern and suggests a connection to engineering or construction.
Indication for Use
TruAbutment DS
TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
- · MIS C1 Conical Connection Implant (K172505, K112162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258) : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
- · Straumann BLX Implant (K173961, K181703, K191256) : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357) : 3.3(NNC)
All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruBase
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific 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:
- · MIS C1 Conical Connection Implant (K172505, K112162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
- · Neodent Implant System GM Helix (K163194, K180536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
- · Nobel Biocare Groovy Implants (K050258)
- : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
- · Straumann Tissue Level Implant (K111357) : 3.3(NNC)
All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
8
Image /page/8/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a cursive font. The logo is in a bright blue color. The left side of the "A" in "Abutment" has a jagged edge, resembling a screw.
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-Abutment
Connection |
|-------------------------------------------------------|-------------------------------------|---------------------------|-----------|-----------------------------------------|----------------------------------------|
| MIS C1
(K172505,
K112162) | 3.3 | 10 | C1-10330 | Narrow
Platform
(NP) | Image: Conical connection |
| | 3.3 | 11.5 | C1-11330 | | |
| | 3.3 | 13 | C1-13330 | | |
| | 3.3 | 16 | C1-16330 | | |
| | 3.75 | 8 | C1-08375 | Standard
Platform
(SP) | |
| MIS C1
(K172505,
K112162) | 3.75 | 10 | C1-10375 | | |
| MIS C1
(K172505,
K112162) | 3.75 | 11.5 | C1-11375 | | |
| MIS C1
(K172505,
K112162) | 3.75 | 13 | C1-13375 | | |
| MIS C1
(K172505,
K112162) | 3.75 | 16 | C1-16375 | | |
| MIS C1
(K172505,
K112162) | 4.2 | 8 | C1-08420 | Standard
Platform
(SP) | |
| MIS C1
(K172505,
K112162) | 4.2 | 10 | C1-10420 | | |
| MIS C1
(K172505,
K112162) | 4.2 | 11.5 | C1-11420 | | |
| MIS C1
(K172505,
K112162) | 4.2 | 13 | C1-13420 | | |
| MIS C1
(K172505,
K112162) | 4.2 | 16 | C1-16420 | Standard
Platform
(SP) | |
| MIS C1
(K172505,
K112162) | 5.0 | 8 | C1-08500 | | |
| MIS C1
(K172505,
K112162) | 5.0 | 10 | C1-10500 | | |
| MIS C1
(K172505,
K112162) | 5.0 | 11.5 | C1-11500 | | |
| MIS C1
(K172505,
K112162) | 5.0 | 13 | C1-13500 | Wide
Platform
(WP) | |
| MIS C1
(K172505,
K112162) | 5.0 | 16 | C1-16500 | | |
| Neodent GM
(K163194,
K180536) | 3.5 | 8 | 109.943 | | 3.0 |
| | 3.5 | 10 | 109.944 | | |
| | 3.5 | 11.5 | 109.945 | | |
| | 3.5 | 13 | 109.946 | | |
| | 3.5 | 16 | 109.947 | | |
| | 3.5 | 18 | 109.988 | | |
| Neodent GM
(K163194,
K180536) | 3.75 | 8 | 109.976 | 3.0 | |
| | 3.75 | 10 | 109.977 | | |
| | 3.75 | 11.5 | 109.978 | | |
| | 3.75 | 13 | 109.979 | | |
| | 3.75 | 16 | 109.980 | | |
| | 3.75 | 18 | 109.981 | | |
| Neodent GM
(K163194,
K180536) | 4.0 | 8 | 109.982 | 3.0 | |
| | 4.0 | 10 | 109.983 | | |
| | 4.0 | 11.5 | 109.984 | | |
| | 4.0 | 13 | 109.985 | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-Abutment
Connection |
| | 4.3 | 16 | 109.986 | | |
| | | 18 | 109.987 | | |
| | | 8 | 109.948 | | |
| | | 10 | 109.949 | | |
| | | 11.5 | 109.950 | | |
| | | 13 | 109.951 | | |
| | | 16 | 109.952 | | |
| | | 18 | 109.989 | | |
| | 5.0 | 8 | 109.953 | | |
| | | 10 | 109.954 | | |
| | | 11.5 | 109.955 | | |
| | | 13 | 109.956 | | |
| | | 16 | 109.957 | | |
| | | 18 | 109.990 | | |
| | | 8 | 109.1009 | | |
| | | 10 | 109.1010 | | |
| | | 11.5 | 109.1011 | | |
| | | 13 | 109.1012 | | |
| | 3.5 | 8 | 32211 | Narrow
Platform
(NP) | Image: Internal tri-channel connection |
| | | 10 | 32212 | | |
| | | 11.5 | 36100 | | |
| | | 13 | 32213 | | |
| | | 16 | 32214 | | |
| Nobel Biocare
Groovy
Implants
(K050258) | 4.3 | 8 | 32215 | Regular
Platform
(RP) | |
| | | 10 | 32216 | | |
| | | 11.5 | 36101 | | |
| | | 13 | 32217 | | |
| | | 16 | 32218 | | |
| | 5.0 | 8 | 32219 | Wide
Platform
(WP) | |
| 10 | | 32220 | | | |
| 11.5 | | 36102 | | | |
| 13 | | 32221 | | | |
| 16 | | 32222 | | | |
| | 6.0 | 8 | 32223 | 6.0 | |
| | | 10 | 32224 | | |
| | | 11.5 | 36103 | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-Abutment
Connection |
| | | 13 | 32225 | | |
| | | 16 | 32226 | | |
| | | | 3.5 | | |
| 10 | 061.3310 | | | | |
| 12 | 061.3312 | | | | |
| 14 | 061.3314 | | | | |
| 16 | 061.3316 | | | | |
| 18 | 061.3318 | | | | |
| | 3.75 | 6 | 061.4306 | | |
| | | 8 | 061.4308 | | |
| | | 10 | 061.4310 | | |
| | | 12 | 061.4312 | | |
| | | 14 | 061.4314 | | |
| | | 16 | 061.4316 | | |
| | | 18 | 061.4318 | Regular
Base
(RB) | Image: TorcFit connection |
| Straumann
BLX
(K173961,
K181703,
K191256) | 4.0 | 6 | 061.5306 | | |
| | | 8 | 061.5308 | | |
| | | 10 | 061.5310 | | |
| | | 12 | 061.5312 | | |
| | | 14 | 061.5314 | | |
| | | 16 | 061.5316 | | |
| | | | 18 | 061.5318 | |
| | 4.5 | 6 | 061.6306 | | |
| | | 8 | 061.6308 | | |
| | | 10 | 061.6310 | | |
| | | 12 | 061.6312 | | |
| | | 14 | 061.6314 | | |
| | | 16 | 061.6316 | | |
| | | 18 | 061.6318 | | |
| | 5.0 | 6 | 061.7306 | Wide Base
(WB) | |
| | | 8 | 061.7308 | | |
| | | 10 | 061.7310 | | |
| | | 12 | 061.7312 | | |
| | | 14 | 061.7314 | | |
| | | 16 | 061.7316 | | |
| | | 18 | 061.7318 | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-Abutment
Connection |
| | 5.5 | 6 | 061.8306 | | |
| | | 8 | 061.8308 | | |
| | | 10 | 061.8310 | | |
| | | 12 | 061.8312 | | |
| | 6.5 | 6 | 061.9306 | | |
| | | 8 | 061.9308 | | |
| | | 10 | 061.9310 | | |
| | | 12 | 061.9312 | | |
| Straumann
Tissue Level
(K111357) | 3.3 | 8 | 033.416S | Narrow
Neck
Crossfit
(NNC) | Image: CrossFit connection |
| | | 10 | 033.417S | | |
| | | 12 | 033.418S | | |
| | | 14 | 033.419S | | |
TruAbutment DS and TruBase are compatible with the following OEM devices:
9
Image /page/9/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a cursive font. To the left of the letters "ru" is a graphic of a screw.
TruAbutment Inc. 17666 Fitch, Irvine, CA 92614
10
Image /page/10/Picture/0 description: The image shows a logo for "Abutment ru". The word "Abutment" is in a sans-serif font, with the "A" being larger than the rest of the letters. The letters "ru" are in a smaller, cursive font and are placed below and to the right of "Abutment". To the left of the "ru" is a graphic of a screw.
TruAbutment Inc. 17666 Fitch, Irvine, CA 92614
11
Image /page/11/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is blue and features the company name in a stylized font. The "ru" portion of the name is larger and bolder than the "Abutment" portion. The logo also includes a graphic of a screw thread, which is likely related to the company's products or services.
TruAbutment Inc. 17666 Fitch, Irvine, CA 92614
12
Image /page/12/Picture/0 description: The image is a logo for a company called "Abutmentru". The logo is primarily blue and features the word "ABUTMENT" in a bold, sans-serif font. Below "ABUTMENT" is the letters "ru" in a similar font, but slightly smaller. The overall design is simple and modern.
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.
TruAbutment DS
| Attributes | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade Name | TruAbutment DS | TruAbutment DS (K202579) |
| Indications for Use | TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: |
MIS C1 Conical Connection Implant (K172505, K112162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
Neodent Implant System - GM Helix (K163194, K180536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0)
Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
Straumann BLX Implant (K173961, K181703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
Straumann Tissue Level Implant (K1113575)
: 3.3(NNC)
All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture. | TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
Astra Tech Implant System (K101732), Astra Tech
OsseoSpeed, Astra Tech Fixture MicroMacro (New
Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)
Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)
Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC)
Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC) |
13
Image /page/13/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is in a bright blue color. The word "Abutment" is written in a sans-serif font, with the "A" being larger than the other letters. Below the word "Abutment" is the letters "ru", also in a sans-serif font. To the left of the letters "ru" is a stylized image of a screw.
| Attributes | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade Name | TruAbutment DS | TruAbutment DS (K202579) |
| All digitally designed abutments and/or coping for use with | ||
| the TruAbutment DS abutments are intended to be sent to a | ||
| TruAbutment-validated milling center for manufacture. | ||
| CAD Design Limits | Minimum and Maximum abutment angle(°): 0~25 | |
| Minimum and Maximum gingival (cuff) height(mm): | ||
| 0.5~6.0 | ||
| Minimum and Maximum diameter at abutment/implant | ||
| interface( $Ø$ ,mm): 3.3~8.0 | ||
| Minimum and Maximum length of abutment(mm): 6.0~11.0 | ||
| Minimum wall thickness at the abutment/implant | ||
| interface(mm): 0.4~0.9 | ||
| Minimum and Maximum length of abutment post (length | ||
| above the abutment collar/gingival height)(mm): 4.0~7.0 | Minimum and Maximum abutment angle: 0~25° | |
| Minimum and Maximum Gingival (Cuff) Height: | ||
| 0.5~6.0mm | ||
| Minimum and Maximum diameter at abutment/implant | ||
| interface: $Ø$ 3.8~ $Ø$ 8.0 | ||
| Minimum and Maximum length of abutment: 6~11mm | ||
| Minimum wall thickness at the abutment/implant interface: | ||
| 0.4mm | ||
| Minimum and Maximum length of abutment post (length | ||
| above the abutment collar/gingival height): 4~7mm | ||
| Connection | Internal Connections | Internal Connections |
| Sterility | Packaged Non-sterile | Packaged Non-sterile |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Abutment Seat | Sits on Taper | Sits on Taper |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Construction | Machined | Machined |
| Type of Retention | 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. |
14
Image /page/14/Picture/0 description: The image shows a logo for a company called "Abutment.ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a cursive font. To the left of the "r" in "ru" is a jagged line that resembles the teeth of a gear or saw blade. The entire logo is in a light blue color.
TruAbutment Inc. 17666 Fitch, Irvine, CA 92614
TruBase
| Attributes | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade Name | TruBase | TruBase (K202579) |
| Indications for Use | TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific 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: | TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific 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: |
| MIS C1 Conical Connection Implant (K172505, K112162) | ||
| : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP) | ||
| Neodent Implant System - GM Helix (K163194, K180536) | ||
| : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0) | Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large) | |
| Nobel Biocare Groovy Implants (K050258) | ||
| : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) | Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular) | |
| Straumann BLX Implant (K173961, K181703, K191256) | ||
| : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) | PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD) | |
| Straumann Tissue Level Implant (K111357) | ||
| : 3.3(NNC) | Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC) | |
| All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture. | Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC) | |
| Xpeed AnyRidge Internal Implant System | ||
| (K140091): 4.0, 4.4, 4.9, 5.4, 5.9 (3.5) | ||
| All digitally designed zirconia superstructure for use | ||
| with the TruBase are intended to be sent to | ||
| TruAbutment-validated milling center for | ||
| manufacture. | ||
| CAD Design Limits | Maximum angulation(°): 0~15 | |
| Maximum cuff height(mm) 0.5~5.0 | ||
| Minimum and Maximum diameter at the | ||
| abutment/implant(Ø,mm): 5.0~8.0 | ||
| Minimum thickness(mm): 0.4 | ||
| Minimum post height(mm): 4~6 | Maximum Angulation 0~15° | |
| Maximum Cuff Height 0.5~5mm | ||
| Minimum Diameter Ø5.0~ Ø8.0mm | ||
| Minimum Thickness 0.4mm | ||
| Minimum Post Height 4~6mm | ||
| Abutment and Screw | ||
| Material | 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 (K123664) | InCoris ZI (K123664) |
| Patient-Specific | ||
| Design | CAD/CAM manufactured superstructures | CAD/CAM manufactured superstructures |
| End-User Sterilization | Moist steam sterilization | Moist steam sterilization |
15
Image /page/15/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a larger, bold, sans-serif font, stacked on top of the letters "ru", which are also in a bold, sans-serif font. To the left of the letters "ru" is a graphic of a screw.
16
Image /page/16/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font, stacked above the letters "ru", which are also in a bold, sans-serif font. To the left of the letters "ru" is a stylized image of a screw or bolt, also in blue, which adds a visual element related to construction or engineering.
Substantial Equivalence Discussion
The subject device (TruAbutment DS) is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. The provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device.
The Indications for Use Statement (IFUS) for the subject device (TruAbutment DS) is substantially equivalent in intended use to the primary predicate device (K202579). 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.
Slight differences in the language of the subject device (TruAbutment DS) and primary predicate (K202579) 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 minor differences between the subject device (TruAbutment DS) and the primary predicate device (K202579) are related to the compatible OEM implant lines and the implant platform diameter.
The following subject device (TruBase) is substantially equivalent in indications and design principles to the primary predicate device(K202579) listed above. The subject device (TruBase) and the primary predicate device(K202579) have internal implant interface connections and are made of Ti-6A1-4V ELI (abutments and abutment screws).
The subject devices (TruAbutment DS, TruBase) are to be sterilized by the end-user, the same as primary predicate devices (K202579).
Sterilization validation for the subject devices (TruAbutment DS, TruBase) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization method is the same as the primary predicate devices (K202579).
Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.
17
Image /page/17/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, with the "A" being larger than the other letters. Below "Abutment" is "ru" in a cursive font. To the left of the text is a graphic that resembles a screw or implant, further emphasizing the company's focus.
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 the reference device (K152559, K200817) 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.
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.
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: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems.
Conclusion
The TruAbutment DS, TruBase 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 devices. Therefore, TruAbutment DS, TruBase, and its predicate are substantially equivalent.