(186 days)
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.
The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.
The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.
Here's a breakdown of the acceptance criteria and study information for the Omni-Directional Multi-unit Abutment System (Omnibut™), based on the provided FDA 510(k) summary:
Description of the Device
The Omnibut™ is a pre-manufactured prosthetic component directly connected to endosseous dental implants. It is intended for use as an aid in prosthetic rehabilitation, specifically for supporting screw-retained prostheses on four or more implants. The system includes a ball abutment attached to an implant, with a retention attachment allowing for angle corrections of up to 30° off the implant axis. It supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. The device is made from Ti-6Al-4V alloy and is provided non-sterile, requiring user sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Description of Test | Reported Device Performance (Results) |
|---|---|---|
| Biological Evaluation | ||
| ISO 10993-1:2018; FDA Guidance on the Use of ISO 10993-1, 2023 | Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | PASS – All biological endpoint testing performed on the device, along with the analysis on the physical and chemical information, returned passing results. All biological endpoint testing suggests that the Omnibut is biocompatible and does not present a foreseen biological risk to those patient populations it is intended for. |
| ISO 10993-5 (2009) | Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity | PASS – The test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test since the grade was grade 0 (no reactivity). |
| Sterilization Validation | ||
| AAMI TIR12:2020; ANSI/AAMI/ISO 17665-1:2026/(R)2013; ANSI/AAMI ST79:2017 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers, Overkill method according to Section 5.7 | PASS – Results from testing have demonstrated that the Omnibut was able to achieve a 10-6 SAL when using the recommended parameters in the Instructions for Use (IFU). |
| Mechanical Performance | ||
| ISO 14801:2016; FDA Guidance Document, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) Section 8 | Dentistry — Implants — Dynamic loading test for endosseous dental implants | PASS – The results conclude that when evaluated in a manner consistent with ISO 14801:2016, the Omnibut met all predetermined acceptance criteria. |
| No specific standard (Compatibility) | Reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws were performed to demonstrate that the Omnibut abutments are compatible with the noted implant systems. Compatibility must be demonstrated to ensure proper device functionality. | PASS – The engineering and dimensional analysis concluded that each Omnibut design is compatible with the applicable implant connection. PASS - Omnibut prosthetic side components were demonstrated to be compatible. |
| No specific standard (Retention Force Testing) | The Omnibut has a retention attachment. Retention Force testing was performed via tensile push-out to ensure that the attachment will not detach during clinical use. | PASS – The Omnibut retention attachment did not detach at a predetermined acceptable force. |
| No specific standard (Simulated-Use Testing) | Simulated Use of four Omnibuts with components connected to a Titanium Bar under a clinically relevant cyclic load. | PASS – The Omnibut and components did not yield, deform, or fracture after fatigue testing. |
| No specific standard (Simulated Cleaning Testing) | Simulated cleaning of Omnibuts in a fixture with a clinically worst case cleansibility construction. | PASS – All parts of the Omnibuts were clean of soil indicators after six soilage and cleaning cycles. |
| MR Safety | ||
| FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 2021) | Non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795). | The analysis addressed parameters per the FDA guidance, including magnetically induced displacement force and torque. The document does not explicitly state the results (e.g., "MR Safe" or "MR Compatible"), but implies that the analysis was sufficient to support safety in the MR environment based on the scientific rationale and literature used. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each individual non-clinical test (e.g., number of abutments tested for dynamic fatigue, retention force, simulated use, or cleaning). It refers to the testing as "non-clinical" bench testing.
- Test Set Provenance: The data is generated from bench testing (laboratory studies), not from clinical data involving human patients. Therefore, information like "country of origin of the data" or "retrospective/prospective" is not applicable in the typical sense of clinical trials. The testing was performed in vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are non-clinical bench tests. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 14801), biological evaluation standards (ISO 10993), and internal company protocols for mechanical and cleaning validation, not on expert clinical interpretation of patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the studies are non-clinical bench tests. Adjudication methods are typically employed in studies involving human interpretation or clinical endpoints to resolve discrepancies in assessment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers/interpreters, which is not the case for this dental implant abutment. The device is a physical component, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This question is relevant for AI/software devices; this device is a physical medical device. The "standalone" performance here refers to the device's mechanical and biological performance on its own, which is what the bench tests evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance evaluations relies on:
- Established engineering and biological standards: e.g., ISO 14801:2016 for dynamic fatigue, ISO 10993 for biocompatibility, ANSI/AAMI/ISO for sterilization.
- Predetermined acceptance criteria: For retention force, simulated use, and cleaning efficacy, the "ground truth" is defined by specific pass/fail criteria established during the test design based on expected clinical performance and safety.
- Dimensional accuracy and compatibility models: For compatibility testing, the "ground truth" is established by the dimensions and specifications of OEM implant bodies and abutments.
8. The Sample Size for the Training Set
This information is not applicable because the device is a physical medical component, not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
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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.
January 17, 2025
Smart Denture Conversions, LLC % Azary Joseph Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K242064
Trade/Device Name: Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 12, 2024 Received: December 19, 2024
Dear Azary Joseph:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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3
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,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242064
Device Name
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
Indications for Use (Describe)
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
| Compatible Implant System(Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Neodent Helix(Morse taper GM) | 3.5,3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM (3.0) |
| NobelActive®(Conical Connection) | 3.5 | NP (3.5) |
| 4.3, 5.0 | RP (3.9) | |
| Straumann BLX(TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Tapered Screw-Vent®(Zimmer Internal Hex) | 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6 | 5.7 |
| Table 1 - Compatible Implant Systems |
|---|
| 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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510(k) Summary
K242064
Smart Denture Conversions, LLC
Omni-Directional Multi-Unit Abutment System
January 14, 2025
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Smart Denture Conversions, LLC |
|---|---|
| 1800 N. Salem St., Suite 104 | |
| Apex, NC 27523 | |
| FDA Registration | 3015527825 |
| Telephone | (855) 550-0707 |
| Representative/Consultant | Joseph Azary |
| Aztech Regulatory & Quality LLC | |
| 543 Long Hill Ave | |
| Shelton, CT 06484 | |
| Telephone (203) 242-6670 | |
| Email jazary@rcn.com |
DEVICE NAME AND CLASSIFICATION
| Proprietary Name: | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) |
|---|---|
| Common/Usual Name: | Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Regulation Name: | Endosseous dental implant abutment |
| Regulatory Class: | Class II |
| Product code: | NHA |
| Classification Panel: | Dental |
| Reviewing Office: | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT, andDental Devices |
| Reviewing Division: | Division of Dental and ENT Devices |
PREDICATE AND REFERENCE DEVICE INFORMATION
Primary Predicate: K161416, NobelActive Multi Unit Plus Abutment, Nobel Biocare AB
Reference Devices:
K192614, Meg-Ball Attachment System, Meg-Magnet Abutment, Meg-Magnet Abutment, MegaGen Implant CO., Ltd. K240208, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices for OEM Implant Body Clearances K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K180536, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A. K201225, Neodent Implant System – GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais S.A. K071370, Nobelactive Internal Connection Implant, Nobel Biocare AB K083205, Nobelactive 8.5 Mm & 18.0 Mm, Nobel Biocare AB K142260, NobelActive®, Nobel Biocare AB K173961, Straumann® BLX Implant System, Institut Straumann AG
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510(k) Summary Page 2 of 8
K181703, Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments, Institut Straumann AG
K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG
K210855, Straumann BLX Implant System, Institut Straumann AG
K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG
K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc.
K061410, Screw-Vent Implant System, SV, Tapered Screw-Vent Implant System TSV. Advent Implant System AV, Zimmer One Piece Implant, Zimmer Dental (includes 3.7, 4.7 and 6.0mm diameters)
INTENDED USE/INDICATIONS FOR USE STATEMENT
Indications for Use:
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
| Compatible Implant System(Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Neodent Helix(Morse taper GM) | 3.5,3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM (3.0) |
| NobelActive®(Conical Connection) | 3.5 | NP (3.5) |
| NobelActive®(Conical Connection) | 4.3, 5.0 | RP (3.9) |
| Straumann BLX(TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| Straumann BLX(TorcFit™ Internal Hexalobular) | 5.0, 5.5, 6.5 | WB |
| Tapered Screw-Vent ®(Zimmer Internal Hex) | 3.7, 4.1 | 3.5 |
| Tapered Screw-Vent ®(Zimmer Internal Hex) | 4.7 | 4.5 |
| Tapered Screw-Vent ®(Zimmer Internal Hex) | 6 | 5.7 |
Table 1 - Compatible Implant Systems
Intended Use:
Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function with four or more endosseous implants, are indicated for multiple unit reconstructions when screw-retained prosthetics are preferred.
SUBJECT DEVICE DESCRIPTION
The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.
The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.
The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.
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PERFORMANCE DATA
Non-clinical testing performed on the subject device to demonstrate substantial equivalence included:
- provided in this submission is reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate the subject device abutments are compatible with the Neodent GM Helix (Morse Taper GM connection) implants, the Nobel Internal (Conical Connection) implants, Straumann BLX (TorcFit™ Internal Hexalobular connection) implants, and Zimmer Internal (Internal Hex connection) implants;
- provided in this submission is dynamic load testing conducted according to ISO 14801:2016 to support the performance of the subject device abutments with the Neodent GM Helix (Morse Taper GM connection) implants, the Nobel Internal (Conical Connection) implants, Straumann BLX (TorcFit™ Internal Hexalobular connection) implants, and Zimmer Internal Hex connection) implants;
- provided in this submission was non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
- . provided in this submission is moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 10° by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- Verification of biocompatibility of the final device in accordance with ISO 10993-1 and ISO 10993-5;
- Bench testing included Retention Force Testing and Simulated Use Testing.
- Simulated cleaning testing to show the cleanability of the Omnibut vs a predicate device.
| Table 2 – Summary of Performance Data | ||
|---|---|---|
| Standard | Description of Test | Results |
| Biological Risk AssessmentISO 10993-1:2018FDA Guidance on the Use ofISO 10993-1, 2023 | Biological Evaluation of MedicalDevices – Part 1: Evaluation andTesting within a RiskManagement Process | All biological endpoint testing performedon the device, along with the analysis onthe physical and chemical information,returned passing results. All biologicalendpoint testing suggests that the Omnibutis biocompatible and does not present aforeseen biological risk to those patientpopulations it is intended for. |
| CytotoxicityISO 10993-5 (2009) | Biological Evaluation of MedicalDevices – Part 5: Tests for invitro cytotoxicity | The test article showed no evidence ofcausing cell lysis or toxicity. The test articlemet the requirements of the test since thegrade was grade 0 (no reactivity). |
| Sterilization ValidationTesting per standards:• AAMI TIR12:2020• ANSI/AAMI/ISO 17665-1:2026/(R)2013• ANSI/AAMI ST79:2017 | AAMI TIR12:2020 Designing,Testing, And Labeling MedicalDevices Intended For ProcessingBy Health Care Facilities: A GuideFor Device Manufacturers,Overkill method according toSection 5.7 | PASS – Results from testing havedemonstrated that the Omnibut was ableto achieve a 10-6 SAL when using therecommended parameters in theInstructions for Use (IFU). |
| Dynamic Fatigue Testing | Dynamic Fatigue testing per: | PASS – The results conclude that when |
| Testing per ISO 14801:2016FDA Guidance Document,"Class II Special ControlsGuidance Document: Root-form Endosseous DentalImplants and EndosseousDental Abutments" (May 12, 2004) | ISO 14801:2016: Dentistry —Implants — Dynamic loading testfor endosseous dental implantsRoot-form Endosseous DentalImplants and Endosseous DentalAbutments - Class II SpecialControls Guidance Document forIndustry and FDA Staff Section 8 | evaluated in a manner consistent with ISO14801:2016, the Omnibut met allpredetermined acceptance criteria. |
| Compatibility | Reverse engineering dimensionalanalysis of OEM implant bodies,OEM abutments, and OEMabutment screws wereperformed to demonstrate thatthe Omnibut abutments arecompatible with the notedimplant systems.Compatibility must bedemonstrated to ensure properdevice functionality. | PASS – The engineering and dimensionalanalysis concluded that each Omnibutdesign is compatible with the applicableimplant connection.PASS - Omnibut prosthetic sidecomponents were demonstrated to becompatible. |
| FDA Guidance Document,"Class II Special ControlsGuidance Document: Root-form Endosseous DentalImplants and EndosseousDental Abutments" (May 12, 2004) | ||
| Retention Force Testing | The Omnibut has a retentionattachment. Retention Forcetesting was performed viatensile push-out to ensure thatthe attachment will not detachduring clinical use. | PASS - The Omnibut retention attachmentdid not detach at a predeterminedacceptable force. |
| No standard | ||
| Simulated-Use Testing | Simulated Use of four Omnibutswith components connected to aTitanium Bar under a clinicallyrelevant cyclic load. | PASS - The Omnibut and components didnot yield, deform, or fracture after fatiguetesting. |
| No standard | ||
| Simulated Cleaning Testing | Simulated cleaning of Omnibutsin a fixture with a clinically worstcase cleansibility construction. | PASS - All parts of the Omnibuts wereclean of soil indicators after six soilage andcleaning cycles. |
| No standard |
of Dorform
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Clinical performance data is not required to establish substantial equivalence for the subject devices.
EQUIVALENCE TO MARKETED DEVICES
The subject device abutments are substantially equivalent in intended use to the primary predicate device K161416, and the reference devices K192614 and K240208. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.
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The primary predicate device K161416 and the reference devices K192614 and K240208 are in support of the substantial equivalence of the subject device designs, material, manufacturing, and biocompatibility.
All subject device abutments have identical materials as the predicate device is different in technology compared to the predicate, as it has a variable angulation and differently designed components. The device has many common characteristics with the predicate and reference devices as found in 510(k)sK161416, K192614, and K240208. The subject submission, K161416, K192614, and K240208 all include abutments manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The scientific data described above demonstrates that the subject device has equivalent performance compared to the predicate device.
The subject device abutments have similar or identical ranges of abutment-implant platform diameter, prosthetic platform diameter, and angulation as the components cleared in K161416, K192614, and K240208.
The subject device abutments and the reference device K240208 include abutments compatible with the Reference Devices for OEM Implant Body Clearances above.
The subject device abutments and the reference device K240208 include non-sterile provided devices.
The risks associated with the use of the subject device abutment angulation with the compatible implants are mitigated by the mechanical testing as described in the performance testion of this summary.
CONCLUSION
Any differences in the technological characteristics between the subject device, the predicate device, and reference devices do not raise different questions of safety or effectiveness. The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.
Overall, the subject devices have the following similarities to the primary predicate and reference devices:
- Have similar intended use,
- Use similar operating principles,
- Incorporate identical materials,
- Are sterilized using similar materials and processes,
- And have similar packaging
The basis for the belief of Smart Denture Conversions, LLC that the subject device is substantially equivalent to the predicate devices is summarized in the following Table 3, Substantial Equivalence.
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Table 3 – Substantial Equivalence
| DescriptiveInformation | Subject Device | Primary Predicate | Reference Device #1 | Reference Device #2 | Comparison |
|---|---|---|---|---|---|
| Omni-Directional Multi-Unit Abutment SystemSmart DentureConversions | K161416Multi-unit Abutment PlusNobel Biocare AB | K192614Meg-Ball Attachment System,Meg-Loc Abutment, Meg-MagnetAbutmentMegaGen Implant CO., Ltd. | K240208DESS Dental Smart SolutionsTerrats Medical SL | N/A | |
| Regulatory Classification | |||||
| Registration # | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Registration Title | Endosseous DentalImplant Abutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Identical |
| Regulation Class | II | II | II | II | Identical |
| Product Code | NHA | NHA | NHA | NHA | Identical |
| Reason forpredicate orreference | N/A | Indications, function, systemcompatibility, retention testing,general technologicalcharacteristics | Technological comparison | Implant System Compatibility | N/A |
| Subject Device | Primary Predicate | Reference Device #1 | Reference Device #2 | Comparison | |
| 510(k) Number | N/A | K161416 | K192614 | K240208 | N/A |
| Device Name | Omni-Directional Multi-UnitAbutmentFor Omni-Directional Multi-UnitAbutment System | Multi-unit Abutment PlusFor NobelActive | Meg-Ball AbutmentFor Meg-Ball Attachment System | Multi-Unit AbutmentFor DESS Dental Smart Solutions | N/A |
| Intended UseStatement | Dental implant abutments areintended to be used in theupper or lower jaw and used forsupporting tooth replacementsto restore chewing function.Omnibuts, in combination withfour or more endosseousimplants, are indicated formultiple unit reconstructionswhen screw-retainedprosthetics are preferred. | Dental implant abutments areintended to be used in theupper or lower jaw and usedfor supporting toothreplacements to restorechewing function. Multi-unitAbutment in combination withendosseous implants areindicated for multiple unitreconstructions when screwretained prosthetics ispreferred. | Meg-Ball Attachment System is asuperstructure of a dental implantsystem to provide support forprosthetic restorations. It isintended to be used in implant-retained and removableoverdenture restorations wherethe patient is fully edentulous. | Functional and esthetic rehabilitationof the edentulous mandible or maxilla. | Similar IntendedUse expressedthrough a similarchoice of words. |
| Indications forUse | The Omnibut is a pre-manufactured prostheticcomponent directly connectedto the endosseous dentalimplant and is intended for useas an aid in prostheticrehabilitation.[Table of Compatible Implant] | The Multi-unit Abutment Plusis a pre-manufacturedprosthetic component directlyconnected to the endosseousdental implant and is intendedfor use as an aid in prostheticrehabilitation. | The Meg-Ball Attachment Systemis intended to be used in the upperor lower jaw and used forsupporting tooth replacements torestore chewing function. Intendedfor fully edentulous jaw retaining atissue supported overdenture.The abutments in combinationwith endosseous implants are usedas the foundation for anchoringtooth replacements in either jaw.The attachments are used in fixedoverdenture restorations that canbe attached with a snap-in system. | DESS Dental Smart Solutionsabutments are intended to be used inconjunction with endosseous dentalimplants in the maxillary ormandibular arch to provide support forprosthetic restorations.[Table of Compatible Implant] | Similar Indicationsfor Use expressedthrough a similarchoice of words.Subject, Predicateand ReferenceDevice #2 used formulti-unit fixedrestorations. |
| Design | Image: Omni-Directional Multi-Unit Abutment Design | Image: Multi-unit Abutment Plus Design | Image: Meg-Ball Abutment Design | Image: Multi-Unit Abutment Design | N/A |
| Compatibility | Neodent Grand Morse,NobelActive®, Straumann BLXTorcFit™, Zimmer TaperedScrew-Vent® | NobelActive, NobelParallel andNobelReplace ConicalConnection | MegaGen AnyRidge InternalFixture, AnyRidge Octa 1 Fixture,ExFeel Internal Fixture | Astra Tech EV, Astra Tech OsseoSpeed,BioHorizons Internal, Biomet 3iOSSEOTITE®, Dentium Superline, DESSActive, PrimaConnex, Genesis, Molaris,Paltop, MIS Seven, MIS M4, MegaGenAnyRidge, Neodent Grand Morse,NobelActive®, NobelParallel Conical. | Similar connectionsas Predicate andReference Device#2. |
| ProsthesisAttachment | Screw Retained | Screw Retained | Snap Retained | Screw Retained | Similar to PrimaryPredicate |
| Restoration | Multi-Unit | Multi-Unit | Multi-unit | Single and Multi-Unit | Similar to PrimaryPredicate |
| AbutmentCollar Height | 2.3 mm | 1.5, 2.5, 3.5, 4.5 mm | 0-6.0mm | 1.0mm-5.5mm | Similar.Height is withincleared range ofPrimary Predicateand ReferenceDevices. |
| PlatformDiameter | 4.8mm | 4.8mm | 5mm | 4.8mm | Identical to PrimaryPredicate |
| Abutment Angle | Straight to 30° | Straight to 30° | 0°, 5°, 10°, 15° | Straight to 30° | Similar to PrimaryPredicate |
| AbutmentMaterial | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Identical to PrimaryPredicate |
| AbutmentFixation | Abutment fixation with anintegral screw | Abutment fixation with anintegral screw or retainingscrew | Abutment fixation with an integralscrew | Abutment fixation with integral screwor retaining screw | Identical to PrimaryPredicate |
| Abutment/Implant Interface | Internal | Internal | Internal | Internal, External | Identical to PrimaryPredicate |
| Sterility | Non-sterile | Sterile | Non-sterile | Non-sterile | Identical toReference Devices#1 and #2 |
| Usage | Single patient, single use | Single patient, single use | Single patient, single use | Single patient, single use | Identical to PrimaryPredicate |
| Performance Testing | |||||
| Fatigue Testing | Fatigue testing according to ISO14801 | Fatigue testing according to ISO14801 | Not performed per OEM 510(k) | Fatigue testing according to ISO 14801 | Identical toPrimary Predicate |
| Biocompatibility | Evaluated according to ISO10993-1: 2018 | Evaluated according toISO 10993-1: 2018 as thematerials were identical to thepredicate device in 510(k) | Evaluated according to ISO 10993-1: 2018 | Evaluated according to ISO 10993-1:2018 | Identical toreference devicesand similar toPrimary Predicate |
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510(k) Summary Page 7 of 8
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§ 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.)