(474 days)
No
The summary describes a physical dental implant component and its use with standard CAD/CAM software and milling units, with no mention of AI or ML.
Yes
The device is a titanium component that provides support for prosthetic dental restorations, thus restoring the function of a missing tooth.
No
The TruBase S is a titanium component designed to support prosthetic dental restorations. Its function is to provide structural support for crowns or copings, not to diagnose medical conditions or analyze patient health data.
No
The device is a titanium component (hardware) used in dental implants, not solely software. While it interacts with CAD/CAM software for design, the core device is a physical implant component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for patient-specific prosthetic restorations (copings or crowns) connected to dental implants. This is a structural and mechanical function within the body.
- Device Description: The device is a titanium component designed to be physically connected to a dental implant and support a dental prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information about a disease or condition.
- Focus on Mechanical and Structural Properties: The performance studies mentioned (fatigue testing, sterilization, biocompatibility) are related to the device's physical integrity, safety for implantation, and compatibility with the body, not its ability to diagnose.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples to provide diagnostic information. This device is an implantable medical device used for prosthetic support in vivo (within the body).
N/A
Intended Use / Indications for Use
The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
• Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
TruBase S abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:
- cylindrical shape
- hexagonal indexing at the apical end of the connection
- indexing guide in the cementable portion for coping fitting
The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.
TruBase S is compatible with the following devices:
Dental Implant
- Zimmer TSV - 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes) cleared under K133339, K113753, K112160, K111889, K101880, K101977, and K072589.
Raw material blank - InCoris Zi (ZrO2) by Sirona Dental Systems GmbH. L size blanks, cleared under K123664.
Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.
No change has been made in the software, its settings or configuration, as well as any modification in the workflow. Sirona inLab software or Sirona CEREC® Software are to be used to design the prosthesis structure according to the previous prosthetic planning. Therefore, the users are required to use the device models (3D models) and the workflow defined and validated by Sirona through K111421, according to the Instruction for Use of TruBase S.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 14801:2016
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 standard, and demonstrated the substantial equivalence with the predicate device.
Mechanical Testing:
Mechanical 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. The fatigue limit demonstrates the substantial equivalence. The results of the fatigue test have met the criteria of the standard, ISO 14801:2016, and demonstrated the substantial equivalence with the predicate device.
Dimensional analysis and reverse engineering:
Dimensional analysis and reverse engineering the OEM implant body, OEM implant abutment and OEM abutment fixation screw including all the connection platforms (implant-to-abutment-to-mesostructure) 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-to-mesostructure compatibility and has established substantial equivalency of the proposed device with predicate devices.
Software Verification and Validation Testing:
The recommended software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator. Therefore, the subject TruBase S was verified and validated with respect to its functionality and design using the Sirona validated workflow. The recommended CAD/CAM System is the same used for the primary predicate device and the validation performed was based on the validation presented by the manufacturer of the primary predicate 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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2018
TruAbutment Inc. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K171532
Trade/Device Name: TruBase S Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 4, 2018 Received: September 10, 2018
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 of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for 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
Indications for Use
510(k) Number (if known) K171532
Device Name TruBase S
Indications for Use (Describe)
The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for serew-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
- · Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.
| 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
Official Correspondent
Phone: 1-909-274-9971 Fax: 1-909-460-8122
Email: withus6664@gmail.com
Withus Group Inc.
Irvine, CA 92620
April Lee
USA
106 Superior,
Submitter
TruAbutment Inc. Brandon Kim 17742 Cowan, Irvine, CA 92614 USA Email: Brandon.kim@truabutment.com Phone: 1-714-956-1488
Device Information
- Trade Name: TruBase S
- 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: 09/04/2018 ●
Predicate Devices
The subject device is substantially equivalent to the following predicate device:
- Primary Predicate
- O Straumann® Variobase® for CEREC® (K151324)
- Reference Predicate
Device Description
TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
TruBase S abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:
- cylindrical shape
- hexagonal indexing at the apical end of the connection ●
4
- indexing guide in the cementable portion for coping fitting ●
The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.
TruBase S is compatible with the following devices:
Dental Implant
- . Zimmer TSV - 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes) cleared under K133339, K113753, K112160, K111889, K101880, K101977, and K072589.
Raw material blank
- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH. L size blanks, cleared under K123664. ●
Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.
No change has been made in the software, its settings or configuration, as well as any modification in the workflow. Sirona inLab software or Sirona CEREC® Software are to be used to design the prosthesis structure according to the previous prosthetic planning. Therefore, the users are required to use the device models (3D models) and the workflow defined and validated by Sirona through K111421, according to the Instruction for Use of TruBase S.
Indication for Use
The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
- Zimmer TSV 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes) ●
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.
5
Summary of Technological Characteristics
Both the subject and the reference devices have the same indication of providing support for prostheses. All devices are pre-manufactured titanium bases made of titanium (Ti-6AI-4V ELI), designed to be used as a base when fabricating a CAD/CAM patient-specific superstructure and are compatible with the same CAD/CAM system and blocks of raw material. A clinician or dental laboratory equipped with the Sirona Dental CAD/CAM System will design and mill the patient-specific superstructure, which composes the final medical device after the bonding to TruBase S.
The subject devices differ from the primary predicate devices cleared under K151324 only in the portion of implant connection, which is specific for each manufacturer. The cementable portion is identical and compatible with the Sirona Dental CAD/CAM System and the blocks of raw material. In the end of this section a comparison between the features of subject device and its predicate devices is shown in a tabular format.
6
Comparison between Proposed Device and Predicates
| Attributes | Proposed Device | Predicate Device | Reference Device #1 | Reference Device #2 | EQUIVALENCE |
|---|---|---|---|---|---|
| Trade Name | TruBase S | Straumann® Variobase® for | |||
| CEREC® (K151324) | Neodent Implant System | ||||
| Titanium Base for | |||||
| CEREC® (K160964) | Link Abutment for CEREC® | ||||
| (K160519) | DISCUSSION | ||||
| Indications for | |||||
| Use | The TruBase S is a titanium | ||||
| component that is directly | |||||
| connected to endosseous dental | |||||
| implants to provide support for | |||||
| patient-specific prosthetic | |||||
| restorations, such as copings or | |||||
| crowns. It is indicated for screw- | |||||
| retained single tooth or cement- | |||||
| retained single tooth and bridge | |||||
| restorations. It is compatible with | |||||
| the following systems: | |||||
| · Zimmer TSV - 3.7, 4.1, 4.7, 6.0 | |||||
| mm (3.5, 4.5, 5.7mm platform | |||||
| sizes) | |||||
| All digitally designed abutments | |||||
| and/or coping for use with the | |||||
| TruBase S are to be designed using | |||||
| Sirona inLab software or Sirona | |||||
| CEREC Software and manufacture | |||||
| using a Sirona CEREC or inLab | |||||
| MCX or MC XL milling unit. | The Straumann® Variobase® | ||||
| for CEREC® are titanium alloy | |||||
| abutments placed onto | |||||
| Straumann dental implants to | |||||
| provide support for customized | |||||
| prosthetic restorations. | |||||
| Straumann® Variobase® for | |||||
| CEREC® abutments are | |||||
| indicated for screw-retained | |||||
| single tooth or cement-retained | |||||
| single tooth and bridge | |||||
| restorations. | |||||
| All digitally designed copings | |||||
| and/or crowns for use with the | |||||
| Straumann® Variobase® for | |||||
| CEREC® abutments are to be | |||||
| designed using Sirona inLab | |||||
| software (Version 3.65) or | |||||
| Sirona CEREC Software | |||||
| (Version 4.2) and manufactured | |||||
| using a Sirona CEREC or inLab | |||||
| MC X or MC XL milling unit. | The Titanium Base for | ||||
| CEREC is a titanium | |||||
| component that is placed | |||||
| over Neodent Implants to | |||||
| provide support for custom | |||||
| prosthetic restorations, such | |||||
| as copings or crowns. It is | |||||
| indicated for single-tooth | |||||
| screw-retained restorations. | |||||
| All digitally designed | |||||
| copings and/or crowns for | |||||
| use with the Neodent | |||||
| Titanium Base for CEREC | |||||
| are to be designed using | |||||
| Sirona inLab software or | |||||
| Sirona CEREC Software | |||||
| and manufactured using a | |||||
| Sirona CEREC or inLab | |||||
| MC X or MC XL milling | |||||
| unit. | The Link Abutment for CEREC | ||||
| is titanium alloy abutments | |||||
| placed onto HIOSSEN dental | |||||
| implants to provide support for | |||||
| customized prosthetic | |||||
| restorations. Link Abutment for | |||||
| CEREC is indicated for screw- | |||||
| retained single tooth or cement- | |||||
| retained single tooth and bridge | |||||
| restorations. | |||||
| • Link abutment for CEREC | |||||
| All digitally designed copings | |||||
| and/or crowns for use with the | |||||
| Link abutment for CEREC is to | |||||
| be scanned using Sirona CEREC | |||||
| AC or CEREC AF or CEREC | |||||
| AI, designed using Sirona inLab | |||||
| software (Version 3.65) or | |||||
| Sirona CEREC Software | |||||
| (Version 4.2) and manufactured | |||||
| using a Sirona CEREC or inLab | |||||
| MC X or MC XL milling unit. | |||||
| CAD/CAM | |||||
| manufacturing/milling occurs at | |||||
| dental laboratories per the design | |||||
| limitations of the Sirona | |||||
| CEREC. | Equivalent | ||||
| The basic indication of | |||||
| providing support for | |||||
| prostheses is identical. All | |||||
| devices are CAD/CAM | |||||
| abutment design to be | |||||
| used as a base when | |||||
| fabricating a patient- | |||||
| specific superstructure. | |||||
| The subject devices are | |||||
| compatible with the same | |||||
| CAD/CAM System as the | |||||
| primary predicate device. | |||||
| Abutment | |||||
| Diameter(s) | 4.3, 5.3, 6.5 mm | 4.5 to 7.0 mm | 4.65 mm | 4.5 mm | Equivalent |
| Subject devices diameter is | |||||
| within the range of diameters | |||||
| for the primary predicate | |||||
| devices and does not | |||||
| represent a worst case in | |||||
| terms of performance. | |||||
| Abutment | |||||
| Height(s) | 4.7 mm | 4.7 mm | 4.7 mm | 4.7 mm | Identical |
| Material of | |||||
| Abutment | Ti-6Al-4V ELI | Titanium-AluminumNiobium | |||
| alloy (Ti-6Al-7Nb) | Titanium- | ||||
| aluminumvanadium alloy | |||||
| Ti-6Al-4V | Titanium Alloy | Equivalent | |||
| The subject and reference | |||||
| devices are made of the same | |||||
| titanium alloy; the titanium | |||||
| alloy of the primary predicate | |||||
| device differs, but the | |||||
| strength of the materials is | |||||
| demonstrated via dynamic | |||||
| fatigue testing. Also, all | |||||
| materials are shown to be | |||||
| biocompatible. | |||||
| Implant-to- | |||||
| Abutment | |||||
| Connection(s) | • Internal hex | RN (Regular Neck), WN (Wide | |||
| Neck), NC (Narrow CrossFit), and | |||||
| RC (Regular CrossFit) | Morse taper (CM) interface | Morse taper internal connection | |||
| Mini (Hex, non-Hex) | |||||
| Regular (Hex, non-Hex) | Equivalent | ||||
| The implant-to-abutment | |||||
| connections of TruBase S | |||||
| and Straumann devices are | |||||
| not identical, but equivalent | |||||
| because of the compatibility | |||||
| with the identified Zimmer | |||||
| implant body. | |||||
| Compatibility | Zimmer 3.5mm, 4.5mm, 5.7mm | ||||
| platform sizes | Straumann implant lines, as | ||||
| indicated by the implant-to | |||||
| abutment interfaces. | Morse taper (CM) implant | ||||
| lines of Neodent Implant | |||||
| System. | HIOSSEN dental implants; ETIII | ||||
| SA Fixture ETIII SA Ultra-Wide | |||||
| Fixture ETIII SA Fixture | Equivalent | ||||
| The implant-to-abutment | |||||
| connections of TruBase S | |||||
| and Straumann devices are | |||||
| not identical, but equivalent | |||||
| because of the compatibility | |||||
| with the identified Zimmer | |||||
| implant body. | |||||
| Retention | Screw-retained | Screw-retained or cement retained | Screw-retained | Screw-retained | Equivalent |
| Subject device mode of | |||||
| attachment is more restrictive | |||||
| and is within the scope of the | |||||
| primary predicate device's | |||||
| mode of attachment. | |||||
| Restorative | |||||
| Range of | |||||
| Angulation | Up to 20° | Up to 20° | Up to 20° | Up to 20° | Identical |
| The restoration angulation is | |||||
| identical among the devices | |||||
| that use Sirona Dental | |||||
| CAD/CAM System | |||||
| Material of | |||||
| Superstructure | inCoris ZI meso (K123664) | Zirconia | |||
| IPS e-max CAD | |||||
| PMMA | Zirconia | ||||
| IPS e-max CAD | Currently available: inCoris ZI | ||||
| meso (K123664) Ivoclar IPS e.max | |||||
| CAD (K132209) Ivoclar Telio CAD | |||||
| (K093708) | Equivalent | ||||
| The range of materials | |||||
| cleared for use with the | |||||
| primary predicate and | |||||
| reference devices is within | |||||
| the scope of materials | |||||
| indicated for the subject | |||||
| devices. | |||||
| Patient-Specific | |||||
| Design | CAD/CAM manufactured | ||||
| superstructures | CAD/CAM manufactured | ||||
| superstructures | CAD/CAM manufactured | ||||
| superstructures | CAD/CAM manufactured | ||||
| superstructures | Identical | ||||
| Manufacturing | |||||
| work-flow | Sirona Dental CAD/CAM System | Sirona Dental CAD/CAM System | Sirona Dental CAD/CAM | ||
| System | Per the Sirona CEREC MC X and | ||||
| MC XL milling systems | Equivalent | ||||
| The subject device | |||||
| manufacturing work-flow is | |||||
| the same of the primary | |||||
| predicate device workflow | |||||
| Sterility | Delivered non-sterile.; To be sterilized | ||||
| by user after superstructure | |||||
| cementation, before placed in patient | |||||
| mouth. | Delivered non-sterile.: To be | ||||
| sterilized by user after | |||||
| superstructure cementation, before | |||||
| placed in patient mouth. | Delivered sterile by EO | ||||
| exposure. To be sterilized by | |||||
| user after superstructure | |||||
| cementation, before placed in | |||||
| patient mouth. | Delivered non-sterile.; To be | ||||
| sterilized by user after superstructure | |||||
| cementation, before placed in | |||||
| patient mouth. | Equivalent | ||||
| Although TruBase S and one | |||||
| reference device is provided | |||||
| in different sterilization | |||||
| conditions, all final | |||||
| abutments must be sterilized | |||||
| by steam before be placed in | |||||
| patient mouth. | |||||
| End-User | |||||
| Sterilization | Moist steam sterilization | Moist steam sterilization | Moist steam sterilization | Moist steam sterilization | Identical |
7
8
Any differences in technology characteristics are accompanied by information that device is substantially equivalence as the predicate.
9
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 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.
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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.
Mechanical Testing
Mechanical 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. The fatigue limit demonstrates the substantial equivalence. The results of the fatigue test have met the criteria of the standard, ISO 14801:2016, and demonstrated the substantial equivalence with the predicate device.
Dimensional analysis and reverse engineering
Dimensional analysis and reverse engineering the OEM implant body, OEM implant abutment and OEM abutment fixation screw including all the connection platforms (implant-to-abutment-tomesostructure) 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 implantto-abutment-to-mesostructure compatibility and has established substantial equivalency of the proposed device with predicate devices.
Software Verification and Validation Testing
The recommended software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator. Therefore, the subject TruBase S was verified and validated with respect to its functionality and design using the Sirona validated workflow. The recommended CAD/CAM System is the same used for the primary predicate device and
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the validation performed was based on the validation presented by the manufacturer of the primary predicate device.
Note: TruAbutment makes no changes to the software, its setting or configuration, as well as no modification in the workflow defined and validated by Sirona per K111421. The Sirona software is recommended because of the compatibility of its existing 3D models with the subject device. Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion: TruBase S 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 devices. Therefore, TruBase S and its predicates are substantially equivalent.