(338 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 compatibility with existing implant systems and standard testing.
Yes
The device is described as an "aid in prosthetic rehabilitation" and is intended to be "directly connected to endosseous dental implants" to "provide support for a prosthetic restoration." This function of aiding in the restoration of dental function and structure makes it a therapeutic device.
No
The device is described as a patient-specific CAD/CAM abutment intended for use as an aid in prosthetic rehabilitation, providing support for a prosthetic restoration. It performs a functional role in treatment rather than a diagnostic one.
No
The device description explicitly states that the TruAbutment DS system includes custom abutments made of Titanium, which are physical components placed into dental implants. The summary also details non-clinical testing related to the physical properties of the abutments (fatigue, sterilization, biocompatibility). While CAD/CAM is mentioned for design and manufacturing, the final product is a physical medical device.
Based on the provided text, the TruAbutment DS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" by connecting to dental implants. 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 (an abutment and screw) made of titanium, designed to be placed into a dental implant. It's a structural component for supporting a dental 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.) or provide information for diagnostic purposes.
- Focus on Mechanical and Biocompatibility Testing: The performance studies described focus on mechanical properties (fatigue) and biocompatibility, which are relevant for implantable medical devices, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The TruAbutment DS does not fit this description.
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:
- · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
- · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
- Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
- · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm
The available range of diameters is summarized below:
Biomet 3i Certain® (K130949)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex
DIO UF(II) Internal Submerged (K161987, K170608, K173975)
Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Megagen AnyRidge® (K140091)
Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Neoss ProActive® (K083561)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / 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 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 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 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.
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: The subject device was tested to evaluate its substantial equivalence according to the following standards:
- Fatigue Test according to ISO 14801:2007. Comparative fatigue testing of the subject and predicate devices was conducted which consisted of testing finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation) through fating. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.
- End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. (Leveraged from predicate K152559, K170259)
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. (Leveraged from predicate K152559, K170259)
Dimensional analysis and reverse engineering: Performed on the implant-to-abutment connection platform, 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, OEM abutment, and OEM fixation screw.
Clinical testing: Not necessary to establish substantial equivalency of the device.
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.
K152559, K143505, K130949, K161987, K170608, K173975, K140091, K083561
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.)
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 seal 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. The full name reads "U.S. Food & Drug Administration".
June 19, 2020
TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614
Re: K191913
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: May 19, 2020 Received: May 19, 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
510(k) Number (if known) K191913
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:
- · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
- · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
- Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
- · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm
The available range of diameters is summarized below:
Biomet 3i Certain® (K130949)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Megagen AnyRidge® (K140091) Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Neoss ProActive® (K083561) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / 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.
3
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Submitter
TruAbutment Inc. Kiyoon Nam 17742 Cowan, Irvine, CA 92614 USA Email: kiyoon.nam@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,
- 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: 06/19/2020 .
Predicate Devices/Reference Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- TruAbutment DS (K170259) .
Reference Device
- TruAbutment DS (K152559) ●
- Zimmer® Patient Specific Abutment (K143505) ●
- Biomet 3i Certain® (K130949) ●
- . DIO UF(II) Internal Submerged (K161987, K170608, K173975)
- Megagen AnyRidge® (K140091
- Neoss ProActive® (K083561) ●
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 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 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.
5
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 abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant. The available range of diameters is summarized below:
| Implant System | Implant
Ø (mm) | Implant
Length (mm) | Model
Number
(mm) | Implant
Platform (mm) | Type of Implant-
Abutment
Connection |
|---------------------------------------------------------------------------------------|-------------------|------------------------|-------------------------|--------------------------|--------------------------------------------|
| Biomet 3i
Certain®
(K130949) | 3.25 | 8.5 | IFNT3285 | 3.4 | Internal Hex |
| | | 10 | IFNT3210 | | |
| | | 11.5 | IFNT3211 | | |
| | | 13 | IFNT3213 | | |
| | | 15 | IFNT3215 | | |
| 4.0 | 8.5 | IFNT485 | 4.1 | | |
| | 10 | IFNT410 | | | |
| | 11.5 | IFNT411 | | | |
| | 13 | IFNT413 | | | |
| | 15 | IFNT415 | | | |
| 5.0 | 8.5 | IFNT585 | | | |
| | 10 | IFNT510 | 5.0 | | |
| | 11.5 | IFNT511 | | | |
| | 13 | IFNT513 | | | |
| | 15 | IFNT515 | | | |
| 6.0 | 8.5 | IFNT685 | | 6.0 | |
| | 10 | IFNT610 | | | |
| | 11.5 | IFNT611 | | | |
| | 13 | IFNT613 | | | |
| | 15 | IFNT615 | | | |
| DIO UF(II)
Internal
Submerged
Implant
(K161987)
(K170608)
(K173975) | 3.3 | 8.5 | UF(II)N3308 | Narrow
(K161987) | Internal Hex |
| | | 10 | UF(II)N3310 | | |
| | | 11.5 | UF(II)N3311 | | |
| | | 13 | UF(II)N3313 | | |
| | | 15 | UF(II)N3315 | | |
| | 3.8 | 8.5 | UF(II)3808S | Regular
(K170608) | |
| | 10 | UF(II)3810S | | | |
| | | 11.5 | UF(II)3811S | | |
| | | 13 | UF(II)38013 | | |
| | | 15 | UF(II)38015 | | |
| | | 16 | UF(II)3816S | | |
| Implant System | Implant
Ø (mm) | Implant
Length (mm) | Model
Number
(mm) | Implant
Platform (mm) | Type of Implant-
Abutment
Connection |
| | 4.0 | 7 | UF(II)4007S | | |
| | | 8.5 | UF(II)4008S | | |
| | | 10 | UF(II)4010S | | |
| | | 11.5 | UF(II)4011S | | |
| | | 13 | UF(II)4013S | | |
| | | 15 | UF(II)4015S | | |
| | | 16 | UF(II)4016S | | |
| | 4.5 | 7 | UF(II)4507S | | |
| | | 8.5 | UF(II)4508S | | |
| | | 10 | UF(II)4510S | | |
| | | 11.5 | UF(II)4511S | | |
| | | 13 | UF(II)4513S | | |
| | | 15 | UF(II)4515S | | |
| | | 16 | UF(II)4516S | | |
| | 5.0 | 7 | UF(II)5007S | | |
| | | 8.5 | UF(II)5008S | | |
| | | 10 | UF(II)5010S | | |
| | | 11.5 | UF(II)5011S | | |
| | | 13 | UF(II)5013S | | |
| | | 15 | UF(II)5015S | | |
| | | 16 | UF(II)5016S | | |
| | 5.5 | 7 | UF(II)5507S | | |
| | | 8.5 | UF(II)5508S | | |
| | | 10 | UF(II)5510S | | |
| | | 11.5 | UF(II)5511S | | |
| | | 13 | UF(II)5513S | | |
| | | 15 | UF(II)5515S | | |
| | | 16 | UF(II)5516S | | |
| | 6.0 | 7 | UF(II)6007S | | |
| | | 8.5 | UF(II)6008S | | |
| | | 10 | UF(II)6010S | | |
| | | 11.5 | UF(II)6011S | Wide
(K173975) | |
| | | 13 | UF(II)6013S | | |
| | 6.5 | 7 | UF(II)6507S | | |
| | | 8.5 | UF(II)6508S | | |
| | | 10 | UF(II)6510S | | |
| | | 11.5 | UF(II)6511S | | |
| | | 13 | UF(II)6513S | | |
| | 7.0 | 7 | UF(II)7007S | | |
| | | 8.5 | UF(II)7008S | | |
| Implant System | Implant Ø (mm) | Implant Length (mm) | Model Number (mm) | Implant Platform (mm) | Type of Implant-Abutment Connection |
| | | 10 | UF(II)7010S | | |
| | | 11.5 | UF(II)7011S | | |
| | | 13 | UF(II)7013S | | |
| | | 3.5 | 8 | FANIHX3508 | |
| | | | 10 | FANIHX3510 | |
| | | | 11.5 | FANIHX3511 | |
| | | | 13 | FANIHX3513 | |
| | | 15 | FANIHX3515 | | |
| | | 18 | FANIHX3518 | | |
| | 4.0 | 8 | FANIHX4008 | | |
| | | 10 | FANIHX4010 | | |
| | | 11.5 | FANIHX4011 | | |
| | | 13 | FANIHX4013 | | |
| | | 15 | FANIHX4015 | | |
| | | 18 | FANIHX4018 | | |
| Megagen
AnyRidge®
(K140091) | 4.5 | 7 | FANIHX4508 | 3.1 | Internal Hex |
| | | 8 | FANIHX4508 | | |
| | | 10 | FANIHX4510 | | |
| | | 11.5 | FANIHX4511 | | |
| | | 13 | FANIHX4513 | | |
| | | 15 | FANIHX4515 | | |
| | | 18 | FANIHX4518 | | |
| | 5.0 | 7 | FANIHX5007 | | |
| | | 8 | FANIHX5008 | | |
| | | 10 | FANIHX5010 | | |
| | | 11.5 | FANIHX5011 | | |
| | | 13 | FANIHX5013 | | |
| | | 15 | FANIHX5015 | | |
| | | 18 | FANIHX5018 | | |
| | 5.5 | 7 | FANIHX5507 | | |
| | | 8 | FANIHX5508 | | |
| | | 10 | FANIHX5510 | | |
| | | 11.5 | FANIHX5511 | | |
| | | 13 | FANIHX5513 | | |
| | | 15 | FANIHX5515 | | |
| | | 18 | FANIHX5518 | | |
| Neoss
ProActive®
(K083561) | 3.25 | 9 | 21176 | 3.5 | Internal Hex |
| | | 11 | 21177 | | |
| | | 13 | 21178 | | |
| | | 15 | 21179 | | |
| Implant System | Implant
Ø (mm) | Implant
Length (mm) | Model
Number
(mm) | Implant
Platform (mm) | Type of Implant-
Abutment
Connection |
| | 3.5 | 7 | 21181 | | |
| | | 9 | 21182 | | |
| | | 11 | 21183 | | |
| | | 13 | 21184 | | |
| | | 15 | 21185 | | |
| | | 17 | 21186 | | |
| | 4.0 | 7 | 21187 | | |
| | | 9 | 21188 | | |
| | | 11 | 21189 | | |
| | | 13 | 21190 | | |
| | | 15 | 21191 | | |
| | | 17 | 21192 | | |
| | 4.5 | 7 | 21193 | 4.0 | |
| | | 9 | 21194 | | |
| | | 11 | 21195 | | |
| | | 13 | 21196 | | |
| | | 15 | 21197 | | |
| | | 17 | 21198 | | |
| | 5.0 | 7 | 21199 | | |
| | | 9 | 21200 | | |
| | | 11 | 21201 | | |
| | | 13 | 21202 | | |
| | | 15 | 21203 | | |
| | | 17 | 21205 | | |
| | 5.5 | 9 | 21206 | | |
| | | 11 | 21207 | | |
| | | 13 | 21208 | | |
| | | 15 | 21211 | | |
| | 6.5 | 9 | 21212 | | |
| | | 11 | 21213 | | |
| | | 13 | 21221 | | |
| | | 15 | 21222 | | |
6
7
8
9
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:
- · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
- · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
- • Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
- · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm
The available range of diameters is summarized below:
Biomet 3i Certain® (K130949)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Megagen AnvRidge® (K140091)
Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Neoss ProActive® (K083561)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / 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.
10
Summary of Technological Characteristics
The subject device is substantially equivalent to the creatingly equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Companison demonstating Substantial Equivalence follows at the end of this section.
| Attributes | Proposed Device | Primary Predicate Device | Equivalence Discussion |
|---|---|---|---|
| Trade Name | TruAbutment DS (K191913) | TruAbutment DS (K170259) | |
| 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 following systems: | |||
| • Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm | |||
| • DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, | |||
| 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm | |||
| • Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 | |||
| mm | |||
| • Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm | |||
| The available range of diameters is summarized below: | |||
| Biomet 3i Certain® (K130949) | |||
| Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| DIO UF(II) Internal Submerged (K161987, K170608, K173975) | |||
| Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex | |||
| Megagen AnyRidge® (K140091) | |||
| Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex | |||
| Neoss ProActive® (K083561) | |||
| Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex | |||
| Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / 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 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 / Zimmer SV/TSV 3.7, 4.1, | |||
| 4.7, 6.0 mm 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. | 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 | |||
| Attributes | Proposed Device | Primary Predicate Device | Equivalence Discussion |
| Trade Name | TruAbutment DS (K191913) | TruAbutment DS (K170259) | Equivalent |
| Connection | Internal Hex | Internal Hex | Equivalent |
| Sterility | Packaged Non-sterile | Packaged Non-sterile | Equivalent |
| Material | Ti-6AI-4V ELI | Ti-6AI-4V ELI | Equivalent |
| Abutment | 0~25 | 0~25 | Equivalent |
| Dimensions | Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm | ||
| DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, | |||
| 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm | |||
| Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, | |||
| 8.0 mm | |||
| Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 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 | Slightly difference | ||
| The Indications for Use of the | |||
| subject and predicate devices | |||
| are identical other than the | |||
| compatible implant bodies. | |||
| Abutment Seat | Sits on Taper | Sits on Taper | Equivalent |
| Anatomical | 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 |
11
Page 8 of 10
12
Substantial Equivalence Discussion
The subject device is substantially equivalent in indications and design principles to the predicate devices listed above. Provided tables are comparing the Indications for Use and the technological characteristics of the subject device, the primary predicate device.
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.
Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs, or are mitigated by the mechanical performance testing.
Mechanical performance testing was performed according to ISO 14801 and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". For each 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.
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.
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, 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 standard, and demonstrated the substantial equivalence with the predicate device.
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: 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 fating.
13
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, 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. 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.