(447 days)
No
The summary describes a CAD/CAM system for designing and manufacturing patient-specific dental abutments. While it uses digital design and manufacturing, there is no mention of AI or ML being used in the design process or any other aspect of the device's function. The focus is on the physical abutment and its compatibility with existing implant systems.
No
Explanation: The device is an abutment for dental implants, described as an "aid in prosthetic rehabilitation" that supports a prosthetic restoration, not providing a direct therapeutic effect itself.
No
Explanation: The device is described as a patient-specific CAD/CAM abutment intended for prosthetic rehabilitation, providing support for prosthetic restorations in dental implants. Its function is to physically connect a prosthesis to a dental implant, not to diagnose medical conditions or diseases.
No
The device description clearly states that the TruAbutment DS system includes physical, patient-specific abutments made of Titanium, which are manufactured at a milling center. While CAD/CAM is mentioned for design, the final product is a physical medical device.
Based on the provided text, the TruAbutment DS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" by connecting to dental implants. This is a mechanical and structural function within the oral cavity.
- Device Description: The device is a physical abutment made of titanium, designed to support a dental prosthesis. It is placed directly into the patient's mouth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Use in a laboratory setting for testing biological samples.
The TruAbutment DS is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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:
· Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm
· BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
The available range of diameters is summarized below:
Tapered Internal / Laser-Lok 3.0
Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal
Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of 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.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Fatigue Test: according to ISO 14801:2016. Testing was performed for the smallest diameter with maximum angulation (worst-case scenario) through fatigue testing of finished assembled implant/abutment systems. Results met standards and demonstrated substantial equivalence with the predicate device.
End User Steam Sterilization Test: according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. Results met standards and demonstrated substantial equivalence with the predicate device.
Biocompatibility tests: according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-. 10:2010. Results met standards and demonstrated substantial equivalence with the predicate device.
Dimensional analysis and reverse engineering: performed on the implant-to-abutment connection platform, including assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant body, the OEM implant abutment, and the OEM abutment screw. Testing demonstrated implant to abutment compatibility and established substantial equivalency of the proposed device with predicate devices.
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 (K172304)
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.
TruAbutment DS (K152559), BioHorizons Tapered Internal Implant System (K071638), BioHorizons Tapered Internal Implants (K143022), BioHorizons Laser-Lok 3.0 Implant System (K093321)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
January 29, 2020
TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614
Re: K183106
Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 3, 2020 Received: January 3, 2020
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 (OS) 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 Srinivas Nandkumar, Ph.D. 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
Enclosure
2
Indications for Use
Device Name TruAbutment DS
Indications for Use (Describe)
The 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:
· Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm
- · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
The available range of diameters is summarized below:
Tapered Internal / Laser-Lok 3.0
Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal
Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex
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) |
---|---|
------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
510(k) Summary
Submitter
TruAbutment Inc. Kiyoon Nam 17742 Cowan, Irvine, CA 92614 USA Email: kiyoon.nam@truabutment.com Phone: 1-714-956-1488
Device Information
Official Correspondent
TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488
- Trade Name: TruAbutment DS
- 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: 01/29/2020 ●
Predicate Devices/Reference Devices
The subject device is substantially equivalent to the following predicate/reference devices:
Primary Predicate
- TruAbutment DS (K172304) ●
Reference Devices
- TruAbutment DS (K152559) ●
- BioHorizons Tapered Internal Implant System (K071638)
- BioHorizons Tapered Internal Implants (K143022)
- BioHorizons Laser-Lok 3.0 Implant System (K093321) .
Device Description
The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of 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.
4
Mechanical resistance of the implant-abutment connection is essential to ensure 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 proposed patient-specific abutments are available in internal connections and are compatible with:
| Implant System | Implant Ø
(mm) | Implant Platform (mm) | Type of Implant-
Abutment Connection |
|-------------------------------------|-------------------|-----------------------|-----------------------------------------|
| Tapered Internal /
Laser-Lok 3.0 | 3.0 | 3.0 | |
| Tapered Internal | 3.4 | 3.0 | |
| | 3.8 | 3.5 | Internal Hex |
| | 4.6 | 4.5 | |
| | 5.8 | 5.7 | |
Indication for Use
The 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:
- · Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm
- BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
The available range of diameters is summarized below:
Tapered Internal / Laser-Lok 3.0
Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal
Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex
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.
5
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.
Attributes | Subject Device | Primary Predicate Device | Equivalence Discussion |
---|---|---|---|
Trade Name | TruAbutment DS (K183106) | TruAbutment DS (K172304) | |
Indications for | |||
Use | The 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: | |||
Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm BioHorizons Laser-Lok Implant System (K093321) 3.0 mm The available range of diameters is summarized below: | |||
Tapered Internal / Laser-Lok 3.0 | |||
Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / | |||
Type of Implant-Abutment Connection : Internal Hex | |||
Tapered Internal | |||
Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / | |||
Type of Implant-Abutment Connection : Internal Hex | |||
Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / | |||
Type of Implant-Abutment Connection : Internal Hex | |||
Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / | |||
Type of Implant-Abutment Connection : Internal Hex | |||
Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / | |||
Type of Implant-Abutment Connection : Internal Hex | |||
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. | The TruAbutment DS is a patient-specific | ||
CAD/CAM patient-specific 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 OsseoSpeedTM EV 3.0. 3.6, 4.2, 4.8, 5.4 mm Nobel ActiveTM 3.5, 4.3, 5.0, 5.5 mm Straumann® Bone Level 3.3, 4.1, 4.8 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. | Equivalent | ||
The basic indication of | |||
providing support for | |||
prostheses is identical. | |||
The subject devices are | |||
compatible with the same | |||
CAD/CAM System as the | |||
primary predicate device. |
6
Attributes | Subject Device | Primary Predicate Device | Equivalence Discussion |
---|---|---|---|
Trade Name | TruAbutment DS (K183106) | TruAbutment DS (K172304) | Equivalent |
Connection | Internal Connections | Internal Connections | Equivalent |
Sterility | Packaged Non-sterile | Packaged Non-sterile | Equivalent |
Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Equivalent |
Abutment Angle | 0~25 | 0~25 | Equivalent |
Dimensions | Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm BioHorizons Laser-Lok Implant System (K093321) 3.0 mm | Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8, 5.4 mm Nobel Active™ 3.5, 4.3, 5.0, 5.5 mm Straumann® Bone Level 3.3, 4.1, 4.8 mm | Equivalent |
Abutment Seat | Sits on Taper | Sits on Taper | Equivalent |
Anatomical Site | Oral Cavity | Oral Cavity | Equivalent |
Construction | Machined | Machined | Equivalent |
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. | Equivalent | ||
Principle | |||
Operation | The proposed device is manufactured components utilized for | ||
digital prosthetic solutions as an aid in prosthetic restoration. | |||
The abutments are fixed to the underlying implant with an | |||
abutment screw, upon which a CAD/CAM designed | |||
restoration may be processed to complete a dental prosthesis. | The proposed device is manufactured components | ||
utilized for digital prosthetic solutions as an aid in | |||
prosthetic restoration. The abutments are fixed to | |||
the underlying implant with an abutment screw, | |||
upon which a CAD/CAM designed restoration may | |||
be processed to complete a dental prosthesis. | Equivalent |
TruAbutment DS incorporates the same material, indication, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the predicate device.
The Indications for Use of the subject and predicate devices are identical other than the compaitble implant bodies. This difference is mirigated by fatigue testing, reverse engineering, dimensional analysis, and identification of reference predicate for compatible implant bodies. Both the predicate and subject devices are intended into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.
Any differences in technology characteristics are accompanied by information that device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.
7
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 reference device. K152559 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 standard, and demonstrated the substantial equivalence with the predicate device.
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing.
Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant body, the OEM implant abutment, and the OEM abutment screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The TruAbutment DS 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 and its predicate are substantially equivalent.