(254 days)
No
The summary describes a CAD/CAM system for designing and manufacturing custom dental abutments, 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 in the document.
No
The device is a custom abutment for dental implants, described as an aid in prosthetic rehabilitation, rather than a device that treats or diagnoses a disease or condition.
No
Explanation: The device is described as a patient-specific custom abutment that supports a prosthetic restoration, not a device used to identify the nature or cause of a disease or condition.
No
The device description explicitly states that the system includes custom abutments made of Titanium grade Ti-6A1-4V ELI and supplied with screws, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" by providing support for a dental restoration. This is a direct clinical application within the oral cavity, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical component (custom abutment and screw) placed into a dental implant. It's a structural element for supporting a prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze biological samples (blood, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties (fatigue), biocompatibility, and sterilization, which are relevant for a medical device intended for implantation and structural support, not for diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.
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
NHA
Device Description
The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titamium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36) for Osstem TS Fixture System (K121995) which consists of both Mini and Regular interface sizes. Each custom 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 custom 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.
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 custom abutments are available in internal hex connection, and are compatible with the Osstem TS Fixture System implant bodies. The Osstem TS Fixture System consists of two interface hex sizes which are 2.08mm (Mini) and 2.48mm (Regular). The available range of diameters is summarized below:
- Osstem TS Fixture System: 3.5mm, 4.0mm, 4.5mm (2.08 mm Mini Platform Connection Size)
- Osstem TS Fixture System: 5.0mm (2.48 mm Regular Platform Connection Size)
- Osstem TS Fixture System (Ultra Wide): 6.0mm, 7.0mm (2.48 mm Regular Platform Connection Size)
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)
Non-clinical Testing:
- 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.
- Fatigue Test according to ISO 14801:2007
Results: Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The result 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 abutment and implant body. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
TruAbutment, Inc. % Ms. April Lee Consultant WithUS Group Inc 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K152559
Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 15, 2016 Received: April 20, 2016
Dear Ms. Lee:
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. 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
Page 2 - Ms. April Lee
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152559
Device Name TruAbutment DS
Indications for Use (Describe)
The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.
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. Brandon Kim 300 S. Harbord Blvd #520 Anaheim, CA 92805 USA Email: Brandon.kim@truabutment.com Phone: 1-714-956-1488
Official Correspondent
WithUS Group Inc April Lee 2531 Pepperdale Drive, Rowland Heights, CA 9174 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- 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: 5/18/2016 ●
General Description
The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titamium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36) for Osstem TS Fixture System (K121995) which consists of both Mini and Regular interface sizes. Each custom 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 custom 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.
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 custom abutments are available in internal hex connection, and are compatible with the Osstem TS Fixture System implant bodies. The Osstem TS Fixture System consists of two interface hex
4
| Implant System | Implant Diameter (mm) | Platform Connection Size
(mm) | Type of Implant-
Abutment Connection |
|---------------------------------------------|-----------------------|----------------------------------|-----------------------------------------|
| Osstem TS
Fixture System | 3.5 | 2.08 (Mini) | Internal Hex |
| | 4.0 | | Internal Hex |
| | 4.5 | | Internal Hex |
| | 5.0 | 2.48 (Regular) | Internal Hex |
| Osstem TS
Fixture System
(Ultra Wide) | 6.0 | | Internal Hex |
| | 7.0 | | Internal Hex |
sizes which are 2.08mm (Mini) and 2.48mm (Regular). The available range of diameters is summarized below:
Indication for Use
The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.
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.
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.
Non-clinical Testing
- . 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.
- . Fatigue Test according to ISO 14801:2007
5
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The result 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 abutment and implant body. 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.
Predicate Devices:
The subject device is substantially equivalent to the following predicate device:
- . ET SmartFit Abutment K123627
Comparison between Predicate and Proposed Device
| Attributes | Proposed Device | Predicate Device |
|---|---|---|
| TruAbutment DS | ET SmartFit Abutment (K123627) | |
| Indications for Use | The TruAbutment DS is a patient- | |
| specific CAD/CAM custom abutment, | ||
| directly connected to endosseous dental | ||
| implants and is intended for use as an | ||
| aid in prosthetic rehabilitation. It is | ||
| compatible with all diameters of the | ||
| Osstem TS Fixture System which | ||
| consists of Mini (2.08mm) and Regular | ||
| (2.48mm) interface sizes. | ||
| 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. | ET SmartFit Abutment is intended for use | |
| with a dental implant to provide support | ||
| for prosthetic restorations such as crowns, | ||
| bridges, or overdentures. | ||
| Dimensions | Interface Hex Size: | |
| Mini (2.08 mm) and Regular (2.48 | ||
| mm) | Interface Hex Size: | |
| Mini (2.08 mm) and Regular (2.48 mm) | ||
| Connection | Internal Hex | Internal Hex |
| Sterility | Packaged Non-sterile | Packaged Non-sterile |
| Material | Ti-6AI-4V ELI | Ti-6AI-4V ELI |
| Picture of Abutment | (Milled from rods) | (Milled from puck) |
| Mini | Mini | |
| Image: Regular abutment | Image: Regular abutment | |
| Image: Regular abutment | Image: Regular abutment | |
| Picture of Screw | Image: Mini screw | Image: Mini screw |
| Image: Regular screw | Image: Regular screw | |
| Image: Regular screw | Image: Regular screw | |
| Abutment Angle ° | 0~25 | 0~30 |
| Abutment Seat | Sits on Taper | Sits on Taper |
| Screw 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. |
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Substantial Equivalence Discussion
TruAbutment DS incorporates the same material, similar indications for use, dimension, 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 feature different language or wording. However, both the subject and predicate device share intended use, namely to serve as an aid in prosthetic reconstructions, such as crowns, bridges or overdentures. Also both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.
7
The only other difference between the subject device and primary predicate is the manufacturing process and the maximum angulation of the abutment design. While the industry standard for CAD/CAM abutment is usually 30°, TruAbutment placed limitation on the abutment design at 25°in order to limit instances of having to re-design extraordinarily long abutments where the head protrudes from of the 14 mm () titanium rods. Other than this difference, there aren't any further variations between the two devices which would anyway impede the substantially equivalent decision.
Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.
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.