(118 days)
No
The summary describes a CAD/CAM system for designing and manufacturing patient-specific dental abutments. It mentions digital design and manufacturing processes but does not include any terms or descriptions indicative of AI or ML technology being used in the design or manufacturing process. The performance studies focus on mechanical testing and dimensional analysis, not algorithmic performance.
No
The device is described as an aid in prosthetic rehabilitation to support a prosthetic restoration. It replaces a missing body part and supports a prosthesis, which classifies it as a prosthetic device rather than a therapeutic one.
No
This device is described as a patient-specific CAD/CAM abutment intended for use in prosthetic rehabilitation, specifically to provide support for a prosthetic restoration. Its function is to interface between a dental implant and a prosthesis, not to diagnose a condition.
No
The device description explicitly states that the TruAbutment DS system includes patient-specific abutments and abutment screws made of Titanium, which are physical hardware components. The summary also describes manufacturing processes at a milling center and non-clinical testing involving fatigue testing of assembled implant/abutment systems.
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 providing support for a dental prosthesis. This is a structural and mechanical function within the oral cavity.
- Device Description: The device is a physical abutment made of titanium, designed to connect to a dental implant. It's a manufactured component for a dental restoration.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, or other fluids) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in a laboratory setting or point-of-care setting for these purposes.
- Anatomical Site: While the oral cavity is involved, the device's function is mechanical support, not diagnostic testing of biological samples from the oral cavity.
The device is clearly a medical device, specifically a dental implant abutment, but its function is therapeutic and restorative, not diagnostic.
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:
• Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm
All digitally designed abutments and/or coping for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.
Product codes
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-I 36). 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.
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 connection, and are compatible with Zimmer Screw Vent and Tapered Screw Vent.
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
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 OEM implant body as well as the OEM implant abutment and OEM fixation 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, or a bird in flight, composed of three overlapping profiles.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2017
TruAbutment Inc. c/o April Lee Consultant WithUS Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K170259
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: April 21, 2017 Received: April 27, 2017
Dear April 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
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Image /page/1/Picture/9 description: The image contains a signature and the name "Tina Kiang". The signature is a complex series of loops and lines, and it is positioned to the left of the name. Below the name is the character sequence "-s", which is smaller in size compared to the name.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170259
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: · Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
Submitter
TruAbutment Inc. Brandon Kim 300 S. Harbor 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 91748 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: 04/21/2017 ●
General 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-I 36). 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.
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 connection, and are compatible with Zimmer Screw Vent and Tapered Screw Vent. The available range of diameters is summarized below:
4
| Implant System | Implant Ø (mm) | Implant Platform (mm) | Type of Implant-Abutment Connection |
|---|---|---|---|
| Zimmer | |||
| Screw Vent / | |||
| Tapered Screw Vent | 3.7 | 3.5 | Internal Hex |
| 4.1 | 3.5 | ||
| 4.7 | 4.5 | ||
| 6 | 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:
- · Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm
All digitally designed abutments and/or coping for use with the TruAbutment 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
The subject device was tested to evaluate its substantial equivalence according to the following standards.
-
. Fatigue Test according to ISO 14801:2007
Below tests were performed for predicate 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 criteria of the standard, and demonstrated the substantial equivalence with the predicate device.
5
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 OEM implant body as well as the OEM implant abutment and OEM fixation 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.
Predicate Devices:
The subject device is substantially equivalent to the following predicate device:
- . Primary Predicate
- TruAbutment DS (K152559) o
- Reference Predicate
- Zimmer® Patient Specific Abutment Internal Hex (K143505) o
Comparison between Predicate and Proposed Device
| Attributes | Proposed Device | Predicate Device | Reference Device |
|---|---|---|---|
| Trade Name | TruAbutment DS | TruAbutment DS (K152559) | Zimmer® Patient Specific |
| Abutment, Internal Hex | |||
| (K143505) | |||
| 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: | |||
| • Zimmer SV/TSV 3.7, 4.1, | |||
| 4.7, 6.0 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. | 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. | The Zimmer® Patient | ||
| Specific Abutment is used | |||
| as a terminal or | |||
| intermediate abutment for a | |||
| cemented prosthesis. The | |||
| abutment can be used for a | |||
| single or multiple-unit | |||
| restoration. | |||
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Sterility | Packaged Non-sterile | Packaged Non-sterile | Packaged Non-sterile |
| Material | Ti-6AI-4V ELI | Ti-6AI-4V ELI | Ti-6AI-4V |
| Abutment Angle ° | 0~25 | 0~25 | 0~30 |
6
| Dimensions | Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm | Osstem TS Fixture System 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 mm | Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm |
|---|---|---|---|
| Abutment Seat | Sits on Taper | Sits on Taper | Sits on Taper |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Construction | Machined | 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. | Screw-retained to the implant. The prosthesis can be cement-retained to the |
Substantial Equivalence Discussion
TruAbutment DS incorporates the same material, 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 are identical other than the compatible implant bodies. This difference is mitigated by fatigue testing, reverse engineering, dimensional analysis, and identification of reference predicate for compatible implant bodies. 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.
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. TruAbutment DS and its predicate are substantially equivalent.