(251 days)
Oneday Implant Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.
The Oneday Implant Abutment is a material for dental surgery and is an abutment used to support and maintain prosthetic restored teeth in case of partial or total loss of teeth. It is used in combination with a fixture implanted in the jawbone.
This document describes a 510(k) premarket notification for the "Oneday Implant Abutment," a dental device. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.
The provided text details the device description, indications for use, comparison to predicate devices, and non-clinical test data. It is crucial to understand that this document does NOT describe the acceptance criteria and a study proving a device meets those criteria in the context of clinical performance or AI/software validation. Instead, it describes mechanical, material, and biocompatibility testing for a physical dental implant component to demonstrate its substantial equivalence to an existing device.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for AI systems, training set sample size) are not applicable to this type of device submission. This is a traditional medical device submission, not a submission for a software-as-a-medical-device (SaMD) or an AI/ML-driven device that would involve performance metrics related to diagnostic accuracy or clinical outcomes.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria here are standards for mechanical performance, biocompatibility, and sterilization, rather than performance metrics for an AI algorithm.
| Test Type | Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|---|
| Fatigue Testing | ISO 14801:2016 (Implies meeting the fatigue strength requirements defined by the standard for dental implants/abutments) | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." Specifically, "The Fatigue Testing was performed under worst case scenario according to ISO 14801." (The exact quantitative performance is not provided in a summary table but is stated to meet the standard.) |
| End User Sterilization Validation | ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 (Implies demonstrating that the proposed sterilization method effectively sterilizes the device and maintains its properties) | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." "The end user sterilization test was performed on abutment that is not cleared but it can be leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of the both products are exactly same." |
| Biocompatibility Testing | ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010, and ISO 10993-11:2006 (Implies demonstrating the device is safe for biological contact according to the specified parts of the ISO 10993 series) | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." "The Biocompatibility Test was conducted on abutment made of Ti-6AI-4V ELI and leveraged for the subject device because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate." |
| Dimensional Tolerance | Within ± 1% range (for stated dimensions of various components like abutments, cylinders, etc.) | Not explicitly stated as a 'reported performance' for the device itself, but assumed to be met for the manufactured products as part of quality control and design specifications. The document lists dimensions but not measured ranges. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., number of abutments tested for fatigue, sterilization, or biocompatibility). This information is typically detailed in the full test reports referenced in the submission, not summarized in the 510(k) summary letter.
- Data Provenance: The tests are non-clinical (laboratory-based) performed on "subject device" or "worst-case test article" samples. There is no patient data involved for these tests. The country of origin for the data generation (the testing laboratories) is not specified in this summary. These are prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for mechanical testing, sterilization, and biocompatibility is based on established ISO and ANSI standards. There are no "experts" establishing a "ground truth" in the clinical imaging or diagnostic sense. The evaluations are objective measurements against predefined thresholds.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments (e.g., image interpretation). These are objective non-clinical tests.
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:
- This is not applicable. The device is a physical dental implant abutment, not an AI-powered diagnostic or assistive tool. No MRMC study would be performed for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. There is no algorithm or software for which standalone performance would be relevant for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria specified by the referenced ISO/ANSI standards for mechanical properties, sterility assurance levels, and biocompatibility endpoints. There is no clinical "ground truth" in the sense of pathology or outcomes data for this specific submission, as it relies on non-clinical testing for substantial equivalence.
8. The sample size for the training set:
- This is not applicable. This is a physical medical device, not a software/AI product requiring a training set for model development.
9. How the ground truth for the training set was established:
- This is not applicable. See point 8.
In summary: The provided document is a 510(k) summary for a physical medical device, the Oneday Implant Abutment. It demonstrates substantial equivalence primarily through comparisons of design, materials, intended use, and adherence to established performance standards through non-clinical (laboratory) testing. It does not involve AI/ML technology or associated validation studies typically seen in software medical device submissions, and therefore, many of the detailed questions regarding AI performance criteria and study design are not relevant to this specific document.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Oneday Biotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
February 21, 2024
Re: K231753
Trade/Device Name: Oneday Implant Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 24, 2024 Received: January 24, 2024
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 (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.
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) K231753
Device Name Oneday Implant Abutment
Indications for Use (Describe)
Oneday Implant Abutment is indicated for use in partially or fully edentulous mandbles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.
| 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
Submitter
Oneday Biotech Co., Ltd. Kim Jinhwan 135 Seongseodong-ro, Dalseo-gu Daegu, 42721 Korea Email: jimbol2002@hotmail.com Tel. +82-53-581-2835 Fax. +82-53-584-3835
Device Information
- Trade Name: Oneday Implant Abutment
- Common Name: Dental Implant Abutment
- Classification Name: Abutment, Implant, Dental, Endosseous
- . Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3630 ●
- Device Class: Class II
- . Date Prepared: 02/21/2024
Predicate Devices:
Primary Predicate
-
K211090, ZENEX Implant system
Reference devices -
K192294, I Do by I Do Biotech Co., Ltd.
-
. K122519, DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM by DIO CORPORATION
-
. K161689, OSSTEM Implant System - Abutment by OSSTEM IMPLANT Co., Ltd.
Indication for Use:
Oneday Implant Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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Device Description:
The Oneday Implant Abutment is a material for dental surgery and is an abutment used to support and maintain prosthetic restored teeth in case of partial or total loss of teeth. It is used in combination with a fixture implanted in the jawbone.
| K number | Device Component | Diameters (Ø) | Lengths (mm) |
|---|---|---|---|
| K192294 | Fixture-S | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | ||
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | ||
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | ||
| 5.5 | 7.3/8.5/10.0/11.5 | ||
| 6.0 | 7.3/8.5/10.0 | ||
| 7.0 | 7.3/8.5/10.0 | ||
| Fixture-MT ACTIVE | 3.8 | 8.5/10.0/11.5/13.0/15.0 | |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | ||
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | ||
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | ||
| 5.5 | 7.3/8.5/10.0/11.5 | ||
| 6.0 | 7.3/8.5/10.0 | ||
| 7.0 | 7.3/8.5/10.0 |
The compatible Fixture with the subject abutment system is below:
The dimensions of abutments are as following:
Ø4.8
Multiunit Straight Abutment
Image /page/5/Figure/7 description: The image shows a technical drawing of a "Multiunit Straight Abutment" along with a table of its dimensions. The drawing includes side and top views, labeled with dimensions such as L, H, H1, and ØD. The table specifies that ØD is 4.8, GH ranges from 0.8 to 4.8 mm, H is 2.3 mm, L ranges from 8.1 to 12.1 mm, L1 is 1.8 mm, and H1 is 3.3 mm.
2.3
8.6/9.6/10.6/11.6/12.6
2.0
3.3
| Device Name | Ø D | GH (mm) | H(mm) | Angle (°) | L(mm) | H1(mm) |
|---|---|---|---|---|---|---|
| Multiunit Angled Abutment | Ø 4.9 | 2.3/2.8/3.3/3.8/4.8 | 2.3 | 17,30 | 6.856-9.276 | 2.08/2.48 |
0.8/1.8/2.8/3.8/4.8
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Image /page/6/Figure/2 description: The image shows a technical drawing of a "Multiunit Temporary Cylinder" along with a table of its dimensions. The drawing includes a side view and an end view of the cylinder, with labels indicating the length (L), height (H), and diameter (ΦA). The table provides specific measurements: the diameter (ØD) is 4.8, the height (H) is 11.8 mm, and the length (L) is 13.3 mm.
Image /page/6/Figure/3 description: The image shows a technical drawing of a multiunit Ti cylinder, along with a table of specifications. The drawing includes two views of the cylinder, a top view and a side view, with labels indicating the dimensions L, H1, and ØD. The table lists the device name, ØD, L(mm), and H1(mm) for two types of cylinders: Multiunit Ti Cylinder (Hex) and Multiunit Ti Cylinder (Non-Hex). Both cylinders have a ØD of 4.8 and an L(mm) of 7, while the H1(mm) is 3.31 for the Hex cylinder and not specified for the Non-Hex cylinder.
Image /page/6/Figure/4 description: This image shows a table with the dimensions of two types of transfer abutments, Hex and Non-Hex. The table lists the outer diameter (ØD) as Ø 4/4.5/5/5.5/6/7/8 for all abutments. The table also includes the gingiva level (G1) in mm, the total length (L1) in mm, the post height (P1) in mm, and the height (H1) in mm for each abutment type.
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| Device Name | Ø D | G1 (mm) | L1(mm) | P1(mm) | H1(mm) | Angle (°) |
|---|---|---|---|---|---|---|
| Angled Abutment (Hex) | Ø4/4.5/5/5.5/6/7/8 | 0.8/1.8/2.8/3.8 | 9.7/10.7/11.7/12.7 | 6 | 2.495 | 15,25 |
| Angled Abutment (Non-Hex) | Ø4/4.5/5/5.5/6/7/8 | 0.8/1.8/2.8/3.8 | 9.7/10.7/11.7/12.7 | 6 | - | 15,25 |
Image /page/7/Figure/3 description: The image shows technical drawings of a "Healing Abutment" and an "Abutment Screw" along with a table of their dimensions. The table lists the device names, "Healing Abutment" and "Abutment Screw", along with their corresponding diameters (Ø D), lengths (L1 in mm), and heights (H1 in mm). The "Healing Abutment" has a diameter ranging from Ø4 to Ø8, a length ranging from 7 to 17 mm, and a height of 1.2 mm, while the "Abutment Screw" has a diameter of Ø2.3, a length of 8.3 mm, and a height of 1.2 mm.
Image /page/7/Figure/4 description: The image shows a technical drawing of an abutment screw with labeled dimensions. The drawing includes a top view, a side view, and an end view of the screw. According to the table, the screw has a diameter of 2.3 mm, a total length (L1) of 8.3 mm, and a height (H1) of 1.2 mm.
Tolerance of dimension shall be within ± 1% range.
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| Name | Uses | Surface | Connection |
|---|---|---|---|
| Multiunit StraightAbutment | It is an abutment used when manufacturing screwretaining prosthesis in multiple cases. | N/A | ScrewRetained,Internal Hex |
| Multiunit AngledAbutment | retaining prosthesis in multiple cases. | N/A | Internal Hex |
| Multiunit TemporaryCylinder | This product is an abutment for castingUse temporary | N/A | Multiabutment |
| Multiunit Ti Cylinder | It is an abutment for manufacturing combinationmaintenance type prosthesis by taking an abutmentlevel impression | N/A | ScrewRetained |
| Transfer Abutment | The Abutment is connected with fixture and itsupports prosthesis which restores tooth function. | N/A | Internal Hex |
| Angled Abutment | The Abutment is connected with fixture and itsupports prosthesis which restores tooth function | N/A | Internal Hex |
| Healing Abutment | The healing Abutment is used for protecting innerhole of fixture and adjusting the appropriate heightduring the healing period | N/A | ScrewRetained |
| Abutment Screw | Connection body to connect abutment to fixture | N/A | ScrewRetained |
The Abutments have below featured:
The subject abutments are provided non-sterile.
Materials:
- All products are fabricated from Ti-6A1-4V of ASTM F136 .
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Summaries of Technological Characteristics & Substantial Equivalence Discussion
Multiunit Straight Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K231753 | K211090 |
| Manufacturer | Oneday Biotech Co., Ltd. | Izenimplant Co., Ltd. |
| Trade Name | Oneday Implant Abutment | ZENEX Implant System |
| Model | Multiunit Straight Abutment | Multi Abutment |
| Indications for Use | Oneday Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae,in support of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It is intendedfor delayed loading. Implants with diameters largerthan 5 mm are intended to be used in the molarregion. | ZENEX Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae, insupport of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It is intendedfor delayed loading. Wide Fixture System is intendedto be used in the molar region. |
| Design | Image: Abutment design | Image: Abutment design |
| Diameter(Ø) | 4.8 | 4.8 |
| Length(mm) | 8.1, 8.6, 9.1, 9.6, 10.1, 10.6, 11.1, 11.6,12.1, 12.6 | 8.5/ 10/11.5/13/15 |
| Angle | 0° | 0° |
| Surface Treatment | Non-Coating | Non-Coating |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such as indicationsfor Use, general design, surface treatment, material, abutment connection, diameter, andsterilization method. The differences between the two devices are abutment design andlengths. The differences don't impact product's fundamental technologies; therefore,subject device and predicate device are substantially equivalent. |
Multiunit Angled Abutment
| Subject Device | Primary Predicate | |||
|---|---|---|---|---|
| K number | K231753 | K211090 | ||
| Manufacturer | Oneday Biotech Co., Ltd. | Izenimplant Co., Ltd. | ||
| Trade Name | Oneday Implant Abutment | ZENEX Implant System | ||
| Model | Multiunit Angled Abutment | Multi Abutment | ||
| Indications for Use | Oneday Implant Abutment is indicated for use in partiallyor fully edentulous mandibles and maxillae, in support ofsingle or multiple unit restorations including; cementedretained, screw retained, or overdenture restorations, andfinal or temporary abutment support for fixed bridgework.It is intended for delayed loading. Implants with diameterslarger than 5 mm are intended to be used in the molarregion. | ZENEX Implant Abutment is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained, screwretained, or overdenture restorations, and final ortemporary abutment support for fixedbridgework. It is intended for delayed loading.Wide Fixture System is intended to be used in themolar region. | ||
| Hex | Non-Hex | Hex | Non-Hex | |
| Design | Image: Hex | Image: Non-Hex | Image: Hex | Image: Non-Hex |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex | ||
| Diameter(Ø) | 4.9 | 4.83 | ||
| Length (mm) | 6.856, 7.267, 7.276, 7.347, 7.356, 7.767,7.847, 8.282, 8.356, 8.847, 8.767, 8,776, 9.276 | 7.05, 7.52, 8.05, 8.52, 9.05, 9.52, 10.05,10.52, |
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| Angle | 17°, 30° | 17°, 30° |
|---|---|---|
| Surface Treatment | Non-Coating | Non-Coating |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such as indicationsfor Use, general design, surface treatment, material, abutment connection, andsterilization method. The differences between the two devices are abutment design anddimensions. The differences don't impact product's fundamental technologies; therefore,subject device and predicate device are substantially equivalent. |
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K231753 | K211090 |
| Manufacturer | Oneday Biotech Co., Ltd. | Izenimplant Co., Ltd. |
| Trade Name | Oneday Implant Abutment | ZENEX Implant System |
| Model | Multiunit Temporary Cylinder | Multi Temporary Cylinder |
| Indications for Use | Oneday Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae,in support of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It is intendedfor delayed loading. Implants with diameters largerthan 5 mm are intended to be used in the molar region. | ZENEX Implant Abutment is indicated for usein partially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained,screw retained, or overdenture restorations, andfinal or temporary abutment support for fixedbridgework. It is intended for delayed loading.Wide Fixture System is intended to be used inthe molar region. |
| Design | Image: Screw | Image: Screw |
| Diameter( $Ø$ ) | 4.8 | 4.8 |
| Length(mm) | 13.3 | 12 |
| Angle | 0° | 0° |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such asindications for Use, general design, diameter, surface treatment, material, abutmentconnection, and sterilization method. The differences between the two devices areabutment design and length. The differences don't impact product's fundamentaltechnologies; therefore, subject device and predicate device are substantiallyequivalent. |
Multiunit Temporary Cylinder
Multiunit Ti Cylinder
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K231753 | K211090 |
| Manufacturer | Oneday Biotech Co., Ltd. | Izenimplant Co., Ltd |
| Trade Name | Oneday Implant Abutment | ZENEX Implant System |
| Model | Multiunit Ti Cylinder | Multi Ti Link Cylinder |
| Indications for Use | Oneday Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae,in support of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It is intendedfor delayed loading. Implants with diameters largerthan 5 mm are intended to be used in the molar region. | ZENEX Implant Abutment is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained, screwretained, or overdenture restorations, and final ortemporary abutment support for fixedbridgework. It is intended for delayed loading.Wide Fixture System is intended to be used in themolar region. |
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| Design | Image: Abutment | Image: Abutment |
|---|---|---|
| Connection Type | Hex, Non-Hex | Non-Hex |
| Diameter(Ø) | 4.8 | 4.8 |
| Length (mm) | 7.0 | 12.0 |
| Angle | 0° | 0° |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such asindications for Use, general design, diameter, surface treatment, material, abutmentconnection, and sterilization method. The differences between the two devices areabutment design and length. The differences don't impact product's fundamentaltechnologies; therefore, subject device and predicate device are substantiallyequivalent. |
Transfer Abutment
| Transfer Abutment | ||
|---|---|---|
| Subject Device | Reference Device | |
| K number | K231753 | K161689 |
| Manufacturer | Oneday Biotech Co., Ltd. | Osstem Implant Co., Ltd. |
| Trade Name | Oneday Implant Abutment | Osstem Implant System - Abutment |
| Model | Transfer Abutment | Transfer Abutment |
| Indications for Use | Oneday Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae,in support of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It isintended for delayed loading. Implants withdiameters larger than 5 mm are intended to be usedin the molar region. | The OSSTEM Implant System -Abutment is intendedfor use with a dental implant to provide support forprosthetic restorations such as crowns, bridges, oroverdentures. |
| Design | Image: Abutment design | Image: Abutment design |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex |
| Diameter( $Ø$ ) | 4, 4.5, 5, 5.5, 6, 7, 8 | 4.6, 5.0, 6.0, 7.0 |
| Lengths (mm) | 7.7, 8.7, 9.2, 9.7, 10.2, 10.7, 11.2, 11.7,12.2, 12.7, 13.2, 13.7, 14.2, 14.7 | 7.5, 8.5, 9.0, 9.1, 9.5, 10.0, 10.6, 11.0,11.1, 11.5, 11.6, 12.0, 12.1, 12.5, 12.6,13.0, 13.1, 13.5, 13.6, 14.0, 14.5, 14.6 |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Surface Treatment | Non-Coating | Non-Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such as indicationsfor Use, general design, diameter, material, abutment connection, and sterilizationmethod. The differences between the two devices are abutment design and length. Thedifferences don't impact product's fundamental technologies; therefore, subject deviceand predicate device are substantially equivalent. |
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Angled Abutment
| Angled Abutment | |||
|---|---|---|---|
| Subject Device | Reference Device | ||
| K number | K231753 | K122519 | |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Coporation | |
| Trade Name | Oneday Implant Abutment | DIO UF HAS INTERNAL SUB-MERGEDIMPLANT | |
| Model | Angled Abutment | Angled Abutment | |
| Indications for Use | Oneday Implant Abutment is indicated foruse in partially or fully edentulousmandibles and maxillae, in support ofsingle or multiple unit restorationsincluding; cemented retained, screwretained, or overdenture restorations, andfinal or temporary abutment support forfixed bridgework. It is intended fordelayed loading. Implants with diameterslarger than 5 mm are intended to be usedin the molar region. | The DIO UF HAS Internal Sub-Merged Implant System isindicated for surgical placement in the upper and lower jawarches, to provide a root form means for single or multipleunits' prosthetic attachment to restore a patient's chewingfunction. The smaller ( $Ø$ 3.8- $Ø$ 5.5) implants ca be placedwith a conventional two stage surgical process with anoption for transmucosal healing or they can be placed in asingle stage surgical process for immediate loading whengood primary stability is achieved with appropriate occlusalloading. The larger ( $Ø$ 5.0- $Ø$ 7.0) implants can be placedwith a conventional two stage surgical process with anoption for transmucosal healing and are indicated for themolar region with delayed loading. | |
| Design | Image: Angled abutment design | Image: Angled abutment design | |
| Hex | Hex, Non-Hex | Hex, Non-Hex | |
| Diameter( $Ø$ ) | 4, 4.5, 5, 5.5, 6, 7, 8 | 4.5, 5.5 | |
| Length (mm) | 9.7, 10.7, 11.7, 12.7 mm | ||
| Angle | 15°, 25° | 15°, 25° | |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Comparison | The Subject Device and primary predicate have same characteristics such asindications for Use, design, material, and sterilization method.The difference between two devices is design and dimensions. These differences donot impact product's fundamental technologies; therefore, subject device andpredicate device are substantially equivalent. |
Healing Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K231753 | K211090 |
| Manufacturer | Oneday Biotech Co., Ltd. | Izenimplant Co., Ltd. |
| Trade Name | Oneday Implant Abutment | ZENEX Implant System |
| Model | Healing Abutment | Healing Abutment |
| Indications for Use | Oneday Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae,in support of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It is intendedfor delayed loading. Implants with diameters largerthan 5 mm are intended to be used in the molar region. | ZENEX Implant Abutment is indicated for usein partially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained,screw retained, or overdenture restorations, andfinal or temporary abutment support for fixedbridgework. It is intended for delayed loading.Wide Fixture System is intended to be used inthe molar region. |
| Design | Image: Oneday Implant Abutment | Image: ZENEX Implant System |
| Diameter(Ø) | 4, 4.2, 4.5, 4.7, 5.5, 6, 6.5, 7, 7.5, 8 | 4.0~9.0 |
| Length (mm) | 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 | - |
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| Angle | 0° | 0° |
|---|---|---|
| Surface Treatment | Non-Coating | Non-Coating |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such asindications for Use, general design, material, abutment connection, surface treatmentand sterilization method. The differences between the two devices are abutmentdesign and dimensions. The differences don't impact product's fundamentaltechnologies; therefore, subject device and predicate device are substantiallyequivalent. |
Abutment Screw
| Subject Device | Reference Device | |
|---|---|---|
| K number | K231753 | K161689 |
| Manufacturer | Oneday Biotech Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Trade Name | Oneday Implant Abutment | OSSTEMImplant System -Abutment |
| Model | Abutment Screw | Abutment Screw |
| Indications for Use | Oneday Implant Abutment is indicated for use inpartially or fully edentulous mandibles and maxillae,in support of single or multiple unit restorationsincluding; cemented retained, screw retained, oroverdenture restorations, and final or temporaryabutment support for fixed bridgework. It is intendedfor delayed loading. Implants with diameters largerthan 5 mm are intended to be used in the molar region. | The OSSTEM Implant System -Abutment isintended for use with a dental implant toprovide support for prosthetic restorations suchas crowns, bridges, or overdentures. |
| Design | Image: Abutment Screw | Image: Abutment Screw |
| Diameter(Ø) | 2.3 | 2.0, 2.05, 2.2, 2.3, 2.5 |
| Length(mm) | 8.3 | 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) |
| Surface Treatment | Non-coating | Non-coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such asindications for Use, general design, material, abutment connection, surface treatmentand sterilization method. The differences between the two devices are abutmentdesign and dimensions. The differences don't impact product's fundamentaltechnologies; therefore, subject device and predicate device are substantiallyequivalent. |
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Non-Clinical Test Data
Below tests were performed on subject device:
- . Fatigue Testing under the worst-case scenario according to ISO 14801:2016
- End User Sterilization Validation Test Report on Abutments according to ANSVAAMI ST79. . ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
Below tests were performed on a worst-case test article with the same material composition, manufacturing, and sterilization and leveraged for the subject device:
- . Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The end user sterilization test was performed on abutment that is not cleared but it can be leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of the both products are exactly same.
The Biocompatibility Test was conducted on abutment made of Ti-6AI-4V ELI and leveraged for the subject device because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.
The Fatigue Testing was performed under worst case scenario according to ISO 14801.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition.
Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
Oneday Implant Abutment 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, Oneday Implant Abutment and its predicates are substantially equivalent.
§ 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.)