(206 days)
TruAbutment DS (K203649)
No
The summary describes a CAD/CAM system for designing and manufacturing dental abutments and bases, which is a standard digital workflow in dentistry and does not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts like image processing or training/test sets.
Yes
Explanation: The device is a patient-specific abutment intended for prosthetic rehabilitation by connecting directly to dental implants and supporting prosthetic restorations. This directly aids in restoring a missing body part and its function, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a patient-specific CAD/CAM abutment and a titanium component for prosthetic restorations, used to support crowns or copings. Its intended use is for prosthetic rehabilitation, not for diagnosing any medical condition.
No
The device description clearly states that the device includes physical components made of titanium alloy (abutments, screws, and bases) and is intended for physical implantation and connection to dental implants. While CAD/CAM design is mentioned, the core device is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the TruAbutment DS and TruBase are components used in dental prosthetic rehabilitation. They are physical devices that connect to dental implants to support crowns or bridges. They do not involve testing samples from the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. The focus is entirely on the mechanical and structural function of the dental components.
Therefore, the TruAbutment DS and TruBase are medical devices, but they fall under the category of dental prosthetics/components, not in vitro diagnostics.
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:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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 patientspecific 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:
- · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
- · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
- · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
- · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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 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 a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136. CAD/CAM customized superstructure that composes the final abutment 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)
TruAbutment-validated milling center
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)
Non-clinical Testing:
- Fatigue Test according to ISO 14801:2016
- 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.
Non-clinical worst-case MRI review was performed to evaluate the metallic TruAbutment and TruBase devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque."
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.
TruAbutment DS (K203649)
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.
Osstem TS Fixture System(K121995), Astra OsseoSpeed EV (K120414), Biohorizons Laser-Lok 3.0 Implant System (K093321), Biohorizons Tapered Internal Implants (K143022), Biohorizons Tapered Internal Implant System (K071638), Straumann Tissue Level Implant (K122855), Straumann 4mm Short Implants (K202942)
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.)
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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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TruAbutment Inc. Chris Choi Director 17666 Fitch Irvine, California 92614
Re: K213961
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: June 10, 2022 Received: June 17, 2022
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) K213961
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:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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) |
|---|
| ------------------------------------------------- |
| 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.
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*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
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Indications for Use
510(k) Number (if known) K213961
Device Name TruAbutment DS, TruBase
Indications for Use (Describe)
TruBase
TruBase is a titanium component that is directly connected to endosseous dental implants to patientspecific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cementretained single tooth and bridge restorations. It is compatible with the following systems:
- · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
- · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
- · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
- · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed zirconia superstructure for use with the TruBase 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 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 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 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 shows a logo for a company called "Abutment". The logo is primarily blue and features the word "Abutment" in a stylized font, with the "A" in uppercase and the rest of the word in lowercase. Below "Abutment", there is a stylized image of a screw or bolt, also in blue. The logo has a modern and professional look.
510(k) Summary K213961
Submitter TruAbutment Inc. Kiyoon Nam 17666 Fitch, Irvine, CA 92614 USA Email: kiyoon.nam@truabutment.com Phone: 1-714-956-1488
Official Correspondent
TruAbutment Inc. Chris Choi 17666 Fitch, Irvine, CA 92614 USA Email: chris.choi@truabutment.com 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: 07/13/2022 ●
Predicate Devices/ Reference Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate:
- TruAbutment DS (K203649) by TruAbutment Inc. ●
Reference Devices for OEM Compatibilities:
- Osstem TS Fixture System(K121995) by Osstem Implant Co., Ltd.
- Astra OsseoSpeed EV (K120414) by Astra. ●
- Biohorizons Laser-Lok 3.0 Implant System (K093321) by Biohorizons Implant Systems, Inc. ●
- Biohorizons Tapered Internal Implants (K143022) by Biohorizons Implant Systems, Inc.
- Biohorizons Tapered Internal Implant System (K071638) by Biohorizons Implant Systems, Inc.
- . Straumann Tissue Level Implant (K122855) by Straumann USA.
- Straumann 4mm Short Implants (K202942) by Straumann USA. ●
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Image /page/5/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is in blue and white. The word "Abutment" is in white letters on a blue background. The letters "ru" are in blue and are larger than the word "Abutment". The logo has a stylized image of a screw.
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 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.
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 Limitation for TruAbutment DS
| 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) | 5.2 ~ 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 |
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Image /page/6/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in white text with a blue outline, and the letters are capitalized. Below the word "Abutment" is the word "ru" in a large, stylized blue font. To the left of the word "ru" is a graphic of a tooth.
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 a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment 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 abutment angle | 0~15° |
| Minimum and Maximum Cuff Height | 0.5~5 mm |
| Minimum and Maximum diameter at | |
| abutment/implant interface | $Ø$ 6.5mm~ $Ø$ 8.0mm |
| Minimum Thickness | 0.4 mm |
| Minimum and Maximum length of | |
| abutment post (length above the abutment | |
| collar/gingival height) | 4 ~6 mm |
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Image /page/7/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is in blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a graphic that resembles a screw or bolt. The logo is simple and modern, and the blue color gives it a professional look.
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:
- Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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
TruBase 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 screwretained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
- Osstem TSIII SA (K121995): 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular)
- Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
- BioHorizons Tapered Internal (K093321, K143022, K071638) 3.0, 3.4, 3.8, 4.6, 5.8 mm ●
- Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm ●
All digitally designed zirconia superstructure for use with TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
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Image /page/8/Picture/0 description: The image features a logo with the word "ABUTMENT" in white, set against a blue background. The "ru" is stylized in a cursive font and is also in blue. To the left of the text, there is a graphic of a screw, also in blue, which adds a visual element related to construction or engineering.
TruAbutment DS and TruBase are compatible with the following devices:
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
|-------------------------------------------------------------------------|-------------------------------------|------------------------|-----------|-----------------------------------------|-----------------------------------------|
| OSSTEM
TSIII
SA (K121995) | 3.5 (3.7) | 8.5mm | TS3M3508S | 2.1
(Mini) | Image: Internal Hex |
| | | 10mm | TS3M3510S | | |
| | | 11.5mm | TS3M3511S | | |
| | | 13mm | TS3M3015S | | |
| | 4.0 (4.2) | 7mm | TS3S4007S | 2.5
(Regular) | |
| | | 8.5mm | TS3S4008S | | |
| | | 10mm | TS3S4010S | | |
| | | 11.5mm | TS3S4011S | | |
| | 4.5 (4.6) | 13mm | TS3S4013S | | |
| | | 7mm | TS3S4507S | | |
| | | 8.5mm | TS3S4508S | | |
| | | 10mm | TS3S4510S | | |
| | 5.0 (5.1) | 11.5mm | TS3S4511S | | |
| | | 13mm | TS3S4513S | | |
| | | 7 mm | TS3S5007S | | |
| | | 8.5 mm | TS3S5008S | | |
| | 10 mm | TS3S5010S | | | |
| | 11.5 mm | TS3S5011S | | | |
| 13 mm | TS3S5013S | | | | |
| 6.0 (6.0) | 7 mm | TS3S6007S | | Image: Internal Spline | |
| | 8.5 mm | TS3S6008S | | | |
| | 10 mm | TS3S6010S | | | |
| | 11.5 mm | TS3S6011S | | | |
| 13 mm | TS3S6013S | | | | |
| 7.0 (6.8) | 7 mm | TS3S7007S | | | |
| | 8.5 mm | TS3S7008S | | | |
| | 10 mm | TS3S7010S | | | |
| | 11.5 mm | TS3S7011S | | | |
| 13 mm | TS3S7013S | | | | |
| Astra
OsseoSpeed
EV
(K120414) | 3.6 | 6mm | 25221 | 3.6 | |
| | | 8mm | 25222 | | |
| | | 9mm | 25223 | | |
| | | 11mm | 25224 | | |
| | | 13mm | 25225 | | |
| | | 15mm | 25226 | | |
| | | 17mm | 25227 | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 4.2 | 6mm | 25231 | 4.2 | |
| | | 8mm | 25232 | | |
| | | 9mm | 25233 | | |
| | | 11mm | 25234 | | |
| | | 13mm | 25235 | | |
| | | 15mm | 25236 | | |
| | | 17mm | 25237 | | |
| | 4.8 | 6mm | 25241 | 4.8 | |
| | | 8mm | 25242 | | |
| | | 9mm | 25243 | | |
| | | 11mm | 25244 | | |
| | | 13mm | 25245 | | |
| | | 15mm | 25246 | | |
| | | 17mm | 25247 | | |
| | 5.4 | 6mm | 25251 | 5.4 | |
| | | 8mm | 25252 | | |
| | | 9mm | 25253 | | |
| | | 11mm | 25254 | | |
| | | 13mm | 25255 | | |
| | | 15mm | 25256 | | |
| | 3.0 | 10.5mm | TLX3010 | 3.0 | |
| | | 12mm | TLX3012 | | |
| | | 15mm | TLX3015 | | |
| BioHorizons
Tapered
Internal
(K093321,
K143022,
K071638) | 3.4 | 9mm | TLX3409 | 3.0 | |
| | | 10.5mm | TLX3410 | | |
| | | 12mm | TLX3412 | | |
| | | 15mm | TLX3415 | | |
| | 3.8 | 18mm | TLX3418 | 3.5 | |
| | | 9mm | TLX3809 | | |
| | | 10.5mm | TLX3810 | | |
| | | 12mm | TLX3812 | | |
| | | 15mm | TLX3815 | | |
| | 4.6 | 18mm | TLX3818 | 4.5 | |
| | | 7.5mm | TLX4607 | | |
| | | 9mm | TLX4609 | | |
| | | 10.5mm | TLX4610 | | |
| | | 12mm | TLX4612 | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 5.8 | 15mm | TLX4615 | 5.7 | |
| | | 18mm | TLX4618 | | |
| | | 7.5mm | TLX5807 | | |
| | | 9mm | TLX5809 | | |
| | | 10.5mm | TLX5810 | | |
| | | 12mm | TLX5812 | | |
| | | 15mm | TLX5815 | | |
| | | 18mm | TLX5818 | | |
| | 4.1 | 6mm | 033.560S | Regular Neck
(RN) | Internal octagon |
| | | 8mm | 033.561S | | |
| | | 10mm | 033.562S | | |
| | | 12mm | 033.563S | | |
| | | 14mm | 033.564S | | |
| Straumann
Tissue Level
(K122855,
K202942) | 4.8 | 6mm | 033.590S | | |
| | | 8mm | 033.591S | | |
| | | 10mm | 033.592S | | |
| | | 12mm | 033.593S | | |
| | | 14mm | 033.594S | | |
| | 6.5 | 6mm | 033.610S | Wide Neck
(WN) | |
| | | 8mm | 033.611S | | |
| | | 10mm | 033.612S | | |
| | | 12mm | 033.613S | | |
9
Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The letters are stylized, with the "A" being larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a similar blue color and font. The "r" is designed to look like a screw.
TruAbutment Inc. 17666 Fitch, Irvine, CA 92614
10
Image /page/10/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 larger and stylized. To the left of the "ru" is a graphic that resembles a screw or implant, possibly indicating the company's focus on dental implants or related products. The logo is in a bright blue color.
TruAbutment Inc. 17666 Fitch, Irvine, CA 92614
11
Image /page/11/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 bottom of the logo has a design that resembles the threads of a screw, also in blue.
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 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 (K203649) |
| 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: | ||
| Straumann Tissue Level Implant (K122855, K202942) | ||
| : 4.1(RN), 4.8(RN), 6.5(WN) mm | ||
| 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: | ||
| 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. |
12
Image /page/12/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters and is connected to a graphic that resembles a screw. The letters "ru" are also larger than the other letters in the word and are connected to the screw graphic. The text and graphic are all in a light blue color.
| Attributes | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade Name | TruAbutment DS | TruAbutment DS (K203649) |
| 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): 5.2~8.0 | ||
| Minimum wall thickness: 0.4 | ||
| 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(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 | ||
| Connection | Internal Connections | Internal Connections |
| Sterility | Packaged Non-sterile | Packaged Non-sterile |
| Material | Ti-6AI-4V ELI | Ti-6AI-4V ELI |
| Abutment | ||
| Seat | Sits on Taper | Sits on Taper |
| Anatomical | 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. | ||
| Attributes | Proposed Device | Predicate Device |
| Trade Name | TruBase | TruBase (K203649) |
| Indications | ||
| for Use | TruBase 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: | ||
| Osstem TSIII SA (K121995): 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 | ||
| (6.0), 7.0 (6.8) (Mini, Regular) Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm BioHorizons Tapered Internal (K093321, K143022, K071638) | ||
| 3.0, 3.4, 3.8, 4.6, 5.8 mm Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5 | ||
| (WN) mm All digitally designed zirconia superstructure for use with TruBase 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 | ||
| 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. | ||
| 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(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 4~6mm | ||
| Attributes | Proposed Device | Predicate Device |
| Trade Name | TruBase | TruBase (K203649) |
| Minimum post height(mm): 4~6 | ||
| Material of | ||
| Abutment | ||
| and Screw | 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 | ||
| Superstructu | ||
| re | InCoris Zi (K123664) | InCoris ZI (K123664) |
| Manufacturin | ||
| g processes | TruAbutment-validated milling center | TruAbutment-validated milling center |
| End-User | ||
| Sterilization | Moist steam sterilization | Moist steam sterilization |
13
Image /page/13/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in all caps, with the "A" slightly raised above the rest of the word. The letters are a light blue color. The bottom of the image has a jagged edge, resembling teeth.
TruBase
14
Image /page/14/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 font size and are also blue. The logo has a stylized image of a screw on the left side of the letters "ru".
15
Image /page/15/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white, with the letters slightly overlapping each other. Below the word "ABUTMENT" is the letter "ru" in a larger font size and in the same color as the background. To the left of the letter "r" is a graphic of a screw.
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 (K203649). 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 (K203649) 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 (K203649) 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(K203649) listed above. The subject device (TruBase) and the primary predicate device(K203649) have internal implant interface connections and are made of Ti-6AI-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 (K203649). Sterilization for the subject devices (TruAbutment DS, TruBase) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization validation method is the same as the primary predicate devices (K203649).
Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to their intended use.
16
Image /page/16/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is primarily blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a graphic that resembles a tooth with a screw-like design, also in blue. The overall design is simple and modern.
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 (K203649) 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.
Non-clinical worst-case MRI review was performed to evaluate the metallic TruAbutment and TruBase devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque."
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 device. Therefore, TruAbutment DS, TruBase and its predicate are substantially equivalent.