(303 days)
No
The summary describes a CAD/CAM system for designing and manufacturing dental abutments and bases. While it uses digital design and manufacturing, there is no mention of AI or ML being used in the design process, analysis, or manufacturing. The focus is on patient-specific design based on intra-oral indications and standard mechanical testing.
No
The device, TruAbutment DS and TruBase, is described as a patient-specific CAD/CAM abutment and a titanium component, respectively, both directly connected to endosseous dental implants to support prosthetic restorations. Their purpose is to aid in prosthetic rehabilitation by providing structural support for crowns or copings, rather than directly treating a disease or condition. They are reconstructive or restorative devices, not therapeutic ones.
No
The device is described as a patient-specific CAD/CAM abutment for prosthetic rehabilitation, and it provides support for prosthetic restorations. It is a restorative device, not one that is used to diagnose a medical condition.
No
The device description clearly outlines physical components (patient-specific abutments, screws, titanium bases) and manufacturing processes involving milling and cementation, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" and providing "support for patient-specific prosthetic restorations." This describes a device used in vivo (within the body) to replace or support anatomical structures.
- Device Description: The description details physical components (abutments, screws, titanium bases) that are directly connected to dental implants within the patient's mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Anatomical Site: The anatomical site is the "Oral Cavity," which is where the device is physically placed and functions.
- Performance Studies: The performance studies focus on mechanical properties (fatigue, compression) and compatibility with dental implants, which are relevant to the structural integrity and function of an implant-supported prosthesis in vivo.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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:
· 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)
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:
• 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)
- · PrimaConnexTM 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)
• 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 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 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.
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.
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 (Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro: X-small, Large and Dentium Company Limited Implantium: Regular and PrimaConnex™ Internal Connection Implant System: 3.5, 4.1, 5.0 and Straumann Ø2.9 mm Bone Level Tapered Implants: Small Crossfit (SC) and Straumann® Bone Level Tapered Implants: Narrow Crossfit (NC), Regular Crossfit (RC) and Xpeed AnyRidge Internal Implant System: 4.0, 4.4, 4.9, 5.4, 5.9 (3.5).
CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, 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.
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
Authorized healthcare provider, dental laboratory
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. (leveraged from predicate devices K152559, K170259)
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. (leveraged from predicate devices K152559, K170259)
Key results:
- 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.
K024111, K101732, K041368, K051614, K140091, K162890, K140878
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 08, 2021
TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614
Re: K202579
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: April 26, 2021 Received: June 7, 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 Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
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:
· 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)
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) |
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3
Indications for Use
510(k) Number (if known) K202579
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:
• 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)
- · PrimaConnexTM 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)
• 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 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) |
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 is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" is larger than the other letters and is placed above the rest of the word. Below the word "Abutment" is a graphic that resembles a screw or bolt. The logo is simple and eye-catching, and it effectively communicates the company's name and brand.
510(k) Summary K202579
Submitter
TruAbutment Inc. Eunjin Jang 17742 Cowan, Irvine, CA 92614 USA Email: Eunjin.jang@truabutment.com Phone: 1-714-956-1488
Official Correspondent
TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488
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: 07/07/2021 ●
Primary Predicate:
- TruAbutment DS, TruBase S (K201197) by TruAbutment Inc.
Reference Devices:
- Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111) by Astra Tech, Inc.
- Astra Tech Implant System (K101732) by Astra Tech AB.
- Dentium Company Limited Implantium (K041368) by Dentium Co., Ltd.
- Lifecore PrimaConnexTM Internal Connection Implant System(K051614) by Lifecore Biomedical, Inc.
- Xpeed AnyRidge Internal Implant System (K140091) by MegaGen Implant Co., Ltd.
- Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) by ● Straumann USA, LLC.
- Straumann® Bone Level Tapered Implants (K140878) by Straumann USA, LLC.
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Image /page/5/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 design that resembles a screw or bolt, also in blue. The logo is simple and modern, with a focus on the company name and a visual element related to engineering or construction.
General Description
TruAbutment DS
TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for 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.
The following table shows the subject device abutment platform sizes for each of the OEM implant lines and sizes.
| TruAbutment Platform Diameter /
Compatible Implant System | TruAbutment DS
Engaging | TruAbutment DS
Non-Engaging |
|--------------------------------------------------------------|----------------------------|--------------------------------|
| Astra Tech OsseoSpeed (K101732, K024111) | | |
| X-small | o | o |
| Small | o | o |
| Large | o | o |
| Dentium SuperLine (K041368) | | |
| Regular | o | o |
| Keystone PrimaConnex (K051614) | | |
| 3.5 (SD) | o | o |
| 4.1 (RD) | o | o |
| 5.0 (WD) | o | o |
| Straumann Bone Level (K162890) (K140878) | | |
| SC | o | o |
| NC | o | o |
| RC | o | o |
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Image /page/6/Picture/0 description: The image is a logo for Abutment. The logo is blue and white. The word "Abutment" is written in white letters on a blue background. Below the word "Abutment" is a blue image that looks like a screw.
Design Limitation for TruAbutment DS
| Design parameter | Design Limit |
|---|---|
| Minimum and Maximum abutment angle | 0~25° |
| Minimum and Maximum Cuff Height | 0.5~6.0mm |
| Minimum and Maximum diameter at the | |
| abutment/implant interface | Ø3.8mm~Ø8.0mm |
| Minimum Thickness | 0.4 mm |
| Minimum and Maximum length of | |
| abutment post (length above the abutment | |
| collar/gingival height) | 4~7 mm |
TruBase S
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.
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 (Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro: X-small, Large and Dentium Company Limited Implantium: Regular and PrimaConnex™ Internal Connection Implant System: 3.5, 4.1, 5.0 and Straumann Ø2.9 mm Bone Level Tapered Implants: Small Crossfit (SC) and Straumann® Bone Level Tapered Implants: Narrow Crossfit (NC), Regular Crossfit (RC) and Xpeed AnyRidge Internal Implant System: 4.0, 4.4, 4.9, 5.4, 5.9 (3.5).
CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, 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.
The following table shows the subject device abutment platform sizes for each of the OEM implant lines and sizes.
| TruAbutment Platform Diameter /
Compatible Implant System | TruBase
Engaging | TruBase
Non-Engaging |
|--------------------------------------------------------------|---------------------|-------------------------|
| Astra Tech OsseoSpeed (K101732, K024111) | | |
| X-small | o | o |
| Small | o | o |
| Large | o | o |
| Dentium SuperLine (K041368) | | |
| Regular | o | o |
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Image /page/7/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is the ".ru" domain name, also in blue. The logo has a screw-like design on the left side of the ".ru" domain name.
| TruAbutment Platform Diameter /
Compatible Implant System | TruBase
Engaging | TruBase
Non-Engaging |
|--------------------------------------------------------------|---------------------|-------------------------|
| Keystone PrimaConnex (K051614) | | |
| 3.5 (SD) | o | o |
| 4.1 (RD) | o | o |
| 5.0 (WD) | o | o |
| Straumann Bone Level (K162890) (K140878) | | |
| SC | o | o |
| NC | o | o |
| RC | o | o |
| Megagen AnyRidge (K140091) | | |
| 3.5 | o | o |
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.
Software
- 3Shape Abutment Designer Software by 3Shape A/S, cleared under K151455. ●
Instruments
- Screwdrivers (class I exempt devices) ●
- . Scanbodies (class I – exempt devices)
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 the | |
| abutment/implant interface | $\varnothing$ 5.0mm~ $\varnothing$ 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/8/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a sans-serif font, with the "A" slightly larger than the other letters. Below the word "Abutment" is the text ".ru" in a larger, stylized font. To the left of the text is a graphic that resembles a screw or bolt.
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 svstems:
- · 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)
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 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:
- · 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)
- · 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 a TruAbutment-validated milling center for manufacture.
9
Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a stylized font, also in blue. The left side of the logo has a jagged edge, resembling the threads of a screw.
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 |
|-----------------------------------------------------------------------|-------------------------------------|---------------------------|--------------------|-----------------------------------------|-----------------------------------------|
| Astra Tech
OsseoSpeed
TX
(K101732)
(K024111) | 3.0 S | 11 | 24982 | 3.0
(X-small) | Image: Internal double hexagon. |
| | | 13 | 24983 | | |
| | | 15 | 24984 | | |
| | 3.5 S | 8 | 24930 | 3.5/4.0
(Small) | |
| | | 9 | 24931 | | |
| | | 11 | 24932 | | |
| | | 13 | 24933 | | |
| | | 15 | 24934 | | |
| | 4.0 S | 17 | 24935 | 4.5/5.0
(Large) | |
| | | 8 | 24930 | | |
| | | 9 | 24931 | | |
| | | 11 | 24932 | | |
| | | 13 | 24933 | | |
| | 4.5 | 15 | 24934 | | |
| | | 17 | 24935 | | |
| | | 9 | 24951 | | |
| | | 11 | 24952 | | |
| | 13 | 24953 | | | |
| | 15 | 24954 | | | |
| | 17 | 24955 | | | |
| 5.0 | 9 | 24961 | 4.5/5.0
(Large) | | |
| | 11 | 24962 | | | |
| | 13 | 24963 | | | |
| | 15 | 24964 | | | |
| | 17 | 24965 | | | |
| 5.0 S | 2 | 24971 | | | |
| | 11 | 24972 | | | |
| | 13 | 24973 | | | |
| | 15 | 24974 | | | |
| | 17 | 24975 | | | |
| Dentium
SuperLine
(K041368) | 3.4 | 8 | FX3608SWC | Regular | |
| | | 10 | FX3610SWC | | |
| | | 12 | FX3612SWC | | |
| | | 14 | FX3614SWC | | |
| | 3.8 | 8 | FX4008SWC | | |
| | | 10 | FX4010SWC | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 4.3 | 12 | FX4012SWC | | Internal Hex |
| | | 14 | FX4014SWC | | |
| | | 8 | FX4508SWC | | |
| | | 10 | FX4510SWC | | |
| | | 12 | FX4512SWC | | |
| | | 14 | FX4514SWC | | |
| | 4.8 | 8 | FX5008SWC | | |
| | | 10 | FX5010SWC | | |
| | | 12 | FX5012SWC | | |
| | | 14 | FX5014SWC | | |
| | | 8 | FX6008SWC | | |
| | | 10 | FX6010SWC | | |
| | 4.8 | 12 | FX6012SWC | | |
| | 3.5 | 10 | 15413K | 3.5
(SD) | Internal TiLobe |
| | | 11.5 | 15414K | | |
| | | 13 | 15415K | | |
| | | 15 | 15416K | | |
| Keystone
PrimaConnex
(K051614) | 4.1 | 10 | 15417K | 4.1
(RD) | |
| | | 11.5 | 15418K | | |
| | | 13 | 15419K | | |
| | | 15 | 15415K | | |
| | 5.0 | 10 | 15421K | 5.0
(WD) | |
| | | 11.5 | 15422K | | |
| | | 13 | 15423K | | |
| | | 15 | 15424K | | |
| Straumann
Bone Level
Tapered
Implants
SC
(K162890) | 2.9 | 10 | 021.0010 | Small
Crossfit
(SC) | Internal Cross Fit® |
| | | 12 | 021.0112 | | |
| | | 14 | 021.0114 | | |
| Straumann
Bone Level
Tapered
Implants
NC, RC
(K140878) | 3.3 | 8 | 021.3508 | Narrow
Crossfit
(NC) | |
| | | 10 | 021.3510 | | |
| | | 12 | 021.3512 | | |
| | | 14 | 021.3514 | | |
| | | 16 | 021.3516 | | |
| | | 18 | 021.3518 | | |
| | 4.1 | 8 | 021.5508 | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| Megagen
AnyRidge®
(K140091) | 4.8 | 10 | 021.5510 | Regular
Crossfit
(RC) | |
| | | 12 | 021.5512 | | |
| | | 14 | 021.5514 | | |
| | | 16 | 021.5516 | | |
| | | 18 | 021.5518 | | |
| | | 8 | 021.7508 | | |
| | | 10 | 021.7510 | | |
| | | 12 | 021.7512 | | |
| | | 14 | 021.7514 | | |
| | | 16 | 021.7516 | | |
| | | 18 | 021.7518 | | |
| | | 7 | FANIHX3507C | | |
| 4.0 | 8 | FANIHX3508C | 3.5 | Image: Internal Hex | |
| | 10 | FANIHX3510C | | | |
| | 11.5 | FANIHX3511C | | | |
| | 13 | FANIHX3513C | | | |
| | 15 | FANIHX3515C | | | |
| | 7 | FANIHX4007C | | | |
| 4.4 | 8 | FANIHX4008C | | | |
| | 10 | FANIHX4010C | | | |
| | 11.5 | FANIHX4011C | | | |
| | 13 | FANIHX4013C | | | |
| | 15 | FANIHX4015C | | | |
| | 7 | FANIHX4508C | | | |
| 4.9 | 8 | FANIHX4508C | | | |
| | 10 | FANIHX4510C | | | |
| | 11.5 | FANIHX4511C | | | |
| | 13 | FANIHX4513C | | | |
| | 15 | FANIHX4515C | | | |
| | 7 | FANIHX5007C | | | |
| 5.4 | 8 | FANIHX5008C | | | |
| | 10 | FANIHX5010C | | | |
| | 11.5 | FANIHX5011C | | | |
| | 13 | FANIHX5013C | | | |
| | 15 | FANIHX5015C | | | |
| | 7 | FANIHX5507C | | | |
| 5.9 | 8 | FANIHX5508C | | | |
| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length
(mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | | 10 | FANIHX5510C | | |
| | | 11.5 | FANIHX5511C | | |
| | | 13 | FANIHX5513C | | |
| | | 15 | FANIHX5515C | | |
10
Image /page/10/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The letter "A" is larger than the other letters, and the letters "ru" are connected and larger than the rest of the word.
TruAbutment Inc. 17742 Cowan, Irvine, CA 92614
11
Image /page/11/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The letter "A" is larger than the other letters, and the letters "ru" are connected and stylized to look like a single shape.
TruAbutment Inc. 17742 Cowan, Irvine, CA 92614
12
Image /page/12/Picture/0 description: The image shows a logo for a company called "ABUTMENT". The logo is blue and white, with the word "ABUTMENT" in a stylized font. The letter "A" is larger than the other letters, and the letters "ru" are connected and stylized to look like a screw. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants or other dental products.
TruAbutment Inc. 17742 Cowan, Irvine, CA 92614
13
Image /page/13/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The logo also includes a graphic element that resembles a screw or bolt head, also in blue. 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 individual 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 (K201197) |
| 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: | 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) | Zimmer 3.1mmD Dental Implant System (K142082) | |
| Screw Vent® and Tapered Screw Vent® (K013227) | ||
| Nobel Active 3.0 (K102436) | ||
| Nobel Active Internal Connection Implant (K071370) | ||
| Dentium Company Limited Implantium (K041368): 3.4, 3.8, | ||
| 4.3, 4.8 (Regular) | 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. | ||
| PrimaConnex™ Internal Connection Implant | ||
| System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD) | TruAbutment DS is compatible with the following | |
| devices: | ||
| Zimmer 3.1mmD Dental Implant System(K142082) | ||
| Implant Body Diameter 3.1/ Implant Platform Diameter | ||
| 2.9 / Internal Hex |
Screw Vent® and Tapered Screw Vent® (K013227) |
| | 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) | |
| | 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. | |
| Attributes | Proposed Device | Primary Predicate Device |
| Trade Name | TruAbutment DS | TruAbutment DS (K201197) |
| | | Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex |
| | | Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex |
| | | Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex |
| | | Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex |
| | | Nobel Active 3.0 (K102436)
Implant Body Diameter 3.0/ Implant Platform Diameter 3.0/ Internal Hex |
| | | Nobel Active Internal Connection Implant (K071370)
Implant Body Diameter 3.5/ Implant Platform Diameter NP / Internal Hex |
| | | Implant Body Diameter 4.3/ Implant Platform Diameter RP / Internal Hex |
| | | Implant Body Diameter 5.0/ Implant Platform Diameter RP / Internal Hex |
| | | Implant Body Diameter 5.5/ Implant Platform Diameter WP / Internal Hex |
| CAD Design Limits | Minimum and Maximum abutment angle: 025°6.0mm
Minimum and Maximum Gingival (Cuff) Height: 0.5
Minimum and Maximum diameter at abutment/implant interface:
$Ø3.8Ø8.0$11mm
Minimum and Maximum length of abutment: 6
Minimum wall thickness at the abutment/implant interface: 0.4mm
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height): 48mm | Minimum and Maximum abutment angle: 025°
Minimum and Maximum Gingival (Cuff) Height: 0.54.0mmØ5.5$
Minimum and Maximum diameter at abutment/implant interface:
$Ø3.8
Minimum and Maximum length of abutment: 611mm7mm |
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
| Attributes | Proposed Device | Primary Predicate Device |
| Trade Name | TruAbutment DS | TruAbutment DS (K201197) |
| 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 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 the word "ABUTMENT" in a stylized font. The word is written in all capital letters and is in a blue color. The letter "A" is larger than the other letters and has a jagged edge on the left side.
15
Image /page/15/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" is a graphic that resembles a tooth implant. The logo is in a light blue color.
TruBase
| Attributes | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade Name | TruBase | TruBase S (K201197) |
| 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 screw-retained single tooth or | ||
| cement-retained single tooth and bridge restorations. 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, | TruBase S is a titanium component that is directly | |
| connected to endosseous dental implants to provide | ||
| support for custom prosthetic restorations, such as | ||
| copings or crowns. It is indicated for screw-retained | ||
| single tooth or cement-retained single tooth and bridge | ||
| restorations. It is compatible with the following systems: | ||
| Zimmer 3.1mmD Dental Implant System (K142082) | ||
| Screw Vent® and Tapered Screw Vent® (K013227) | ||
| TruBase S is intended to be sent to a TruAbutment- | ||
| 4.3, 4.8 (Regular) | validated milling center for manufacture. | |
| PrimaConnex™ Internal Connection Implant | ||
| System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD) | TruBase S is compatible with the following devices: | |
| Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES | ||
| Abutments (K162890): 2.9 (SC) | Zimmer 3.1mmD Dental Implant System(K142082) | |
| Implant Body Diameter 3.1/ Implant Platform Diameter | ||
| 2.9 / Internal Hex | ||
| 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) | Screw Vent® and Tapered Screw Vent® (K013227) | |
| Implant Body Diameter 3.7/ Implant Platform Diameter | ||
| 3.5 / Internal Hex | ||
| Implant Body Diameter 4.1/ Implant Platform Diameter | ||
| 3.5 / Internal Hex | ||
| All digitally designed zirconia superstructure for use | ||
| with the TruBase are intended to be sent to a | ||
| TruAbutment-validated milling center for | ||
| manufacture. | Implant Body Diameter 4.7/ Implant Platform Diameter | |
| 4.5 / Internal Hex | ||
| Implant Body Diameter 6.0/ Implant Platform Diameter | ||
| 5.7 / Internal Hex | ||
| CAD Design Limits | Maximum Angulation 0~15° | |
| Maximum Cuff Height 0.5~5mm | ||
| Minimum Diameter Ø5.0~ Ø8.0mm | ||
| Minimum Thickness 0.4mm | ||
| Minimum Post Height 4~6mm | 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 | ||
| Material of | ||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Implant-to- | ||
| Abutment | ||
| Connection(s) | Screw-retained to the implant. The prosthesis can be cement- | |
| retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement- | |
| retained to the abutment. | ||
| Type of Retention | Screw-retained. | Screw-retained |
16
Image /page/16/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letter "A" is larger and bolder than the rest of the word. Below "ABUTMENT" is a design that resembles a screw or a gear, with a series of teeth or ridges. The color of the text and design is a bright, light blue.
17
Image /page/17/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letter "A" is larger and bolder than the rest of the word. Below "ABUTMENT" is a design that resembles a screw or a gear, with a series of teeth or ridges. The color of the text and design is a bright, light blue.
| 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 |
18
Image /page/18/Picture/0 description: The image is a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a sans-serif font, with the "A" slightly larger than the other letters. Below "Abutment" is the text ".ru" in a stylized, cursive font. To the left of the text is a graphic that resembles a tooth implant.
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. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The Indications for Use Statement (IFUS) for the subject device (TruAbutment DS) is substantially equivalent in intended use to the primary predicate device (K201197). All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.
Slight differences in the language of the subject device (TruAbutment DS) and primary predicate (K201197). 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 (K201197) are related to the compatible OEM implant lines and the implant platform diameter.
The difference between the two products (TruAbutment DS, K201197) in the design parameters are the same except for the minimum diameter. The minimum diameter of the product compatible with the subject device is larger than the Primary predicate device (K201197). The diameter of the primary predicate device (K201197) is Ø3.5mm ~ Ø8.0mm, while the subject device (TruAbutment DS) can be designed up Ø3.8mm~Ø8.0mm. The minor differences between the subject device (TruAbutment DS) and the primary predicate device (K201197) are related to the compatible OEM implant lines and the implant platform diameter.
| Design parameter | Subject Device
(TruAbutment DS)
Design Limit | Primary Predicate Device
(K201197)
Design Limit |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|
| Minimum and Maximum abutment
angle | 025° | 025° |
| Minimum and Maximum Gingival
(Cuff) Height | 0.56.0mm | 0.56.0mm |
| Minimum and Maximum diameter
at the abutment/implant interface | ⌀3.8mm~⌀8.0mm | ⌀3.5mm~⌀8.0mm |
| Minimum and Maximum length of
the abutment | 611mm | 611mm |
| Minimum wall thickness at
abutment/implant interface | 0.4 mm | 0.4 mm |
| Minimum and Maximum length of
abutment post (length above the
abutment collar/gingival height) | 47mm | 47mm |
The following subject device (TruBase) is substantially equivalent in indications and design principles to the primary predicate device(K201197). The subject device (TruBase) and the primary predicate device(K201197) have internal implant interface connections, and are made of Ti-6Al-4V (abutments and abutment screws).
19
Image /page/19/Picture/1 description: The image is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" in Abutment is larger than the other letters and has a jagged edge, resembling a screw. The rest of the word is in a smaller, sans-serif font.
The subject devices (TruAbutment DS, TruBase) are to be sterilized by the end-user, the same as primary predicate devices (K201197).
Sterilization validation 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 (K201197).
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.
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 predicate device (K152559, K170259) 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 device. TruAbutment DS, TruBase, and its predicate are substantially equivalent.