(251 days)
No
The summary describes a dental implant abutment, a physical device, and there is no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is used to support and maintain prosthetic restored teeth, which directly addresses a health condition (loss of teeth) by restoring function and aesthetics, qualifying it as a therapeutic device.
No
The device is described as an abutment for dental implants, used to support and maintain prosthetic teeth. Its intended use is for restoration, not for diagnosis of a condition.
No
The device description explicitly states it is a "material for dental surgery" and an "abutment," which are physical components, not software. The performance studies also focus on material properties and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Oneday Implant Abutment is a physical material used in dental surgery to support prosthetic teeth. It is implanted into the jawbone.
- Intended Use: The intended use is to support dental restorations in the mouth, not to analyze biological samples.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The performance studies focus on mechanical properties, sterilization, biocompatibility, and MRI compatibility, which are typical for implantable devices, not IVDs.
Therefore, based on the provided information, the Oneday Implant Abutment is a dental implant component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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. The subject abutments are provided non-sterile. All products are fabricated from Ti-6A1-4V of ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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 Test Data:
- 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.
- 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.
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.
Key results: The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device. Clinical testing was not necessary to establish substantial equivalency of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 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.
1
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.
2
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
3
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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4
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
5
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
6
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.
7
| 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.
8
| Name | Uses | Surface | Connection |
|---|---|---|---|
| Multiunit Straight | |||
| Abutment | It is an abutment used when manufacturing screw | ||
| retaining prosthesis in multiple cases. | N/A | Screw | |
| Retained, | |||
| Internal Hex | |||
| Multiunit Angled | |||
| Abutment | retaining prosthesis in multiple cases. | N/A | Internal Hex |
| Multiunit Temporary | |||
| Cylinder | This product is an abutment for casting | ||
| Use temporary | N/A | Multi | |
| abutment | |||
| Multiunit Ti Cylinder | It is an abutment for manufacturing combination | ||
| maintenance type prosthesis by taking an abutment | |||
| level impression | N/A | Screw | |
| Retained | |||
| Transfer Abutment | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function. | N/A | Internal Hex | |
| Angled Abutment | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function | N/A | Internal Hex | |
| Healing Abutment | The healing Abutment is used for protecting inner | ||
| hole of fixture and adjusting the appropriate height | |||
| during the healing period | N/A | Screw | |
| Retained | |||
| Abutment Screw | Connection body to connect abutment to fixture | N/A | Screw |
| Retained |
The Abutments have below featured:
The subject abutments are provided non-sterile.
Materials:
- All products are fabricated from Ti-6A1-4V of ASTM F136 .
9
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 in | |
| partially or fully edentulous mandibles and maxillae, | ||
| in support of single or multiple unit restorations | ||
| including; cemented retained, screw 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. | ZENEX 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, screw retained, or | ||
| overdenture restorations, and final or temporary | ||
| abutment support for fixed bridgework. It is intended | ||
| for delayed loading. Wide Fixture System is intended | ||
| to 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 indications | |
| for Use, general design, surface treatment, material, abutment connection, diameter, and | ||
| sterilization method. The differences between the two devices are abutment design and | ||
| lengths. 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 partially | |||
| or fully edentulous mandibles and maxillae, in support of | ||||
| single or multiple unit restorations including; cemented | ||||
| retained, screw 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. | ZENEX 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, screw | ||||
| retained, or overdenture restorations, and final or | ||||
| temporary abutment support for fixed | ||||
| bridgework. It is intended for delayed loading. | ||||
| Wide Fixture System is intended to be used in the | ||||
| molar 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, |
10
| 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 indications | |
| for Use, general design, surface treatment, material, abutment connection, and | ||
| sterilization method. The differences between the two devices are abutment design and | ||
| dimensions. 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 in | |
| partially or fully edentulous mandibles and maxillae, | ||
| in support of single or multiple unit restorations | ||
| including; cemented retained, screw 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. | ZENEX 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, | ||
| screw retained, or overdenture restorations, and | ||
| final or temporary abutment support for fixed | ||
| bridgework. It is intended for delayed loading. | ||
| Wide Fixture System is intended to be used in | ||
| the 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 as | |
| indications for Use, general design, diameter, surface treatment, material, abutment | ||
| connection, and sterilization method. The differences between the two devices are | ||
| abutment design and length. The differences don't impact product's fundamental | ||
| technologies; therefore, subject device and predicate device are substantially | ||
| equivalent. |
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 in | |
| partially or fully edentulous mandibles and maxillae, | ||
| in support of single or multiple unit restorations | ||
| including; cemented retained, screw 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. | ZENEX 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, screw | ||
| retained, or overdenture restorations, and final or | ||
| temporary abutment support for fixed | ||
| bridgework. It is intended for delayed loading. | ||
| Wide Fixture System is intended to be used in the | ||
| molar region. |
11
| 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 as | |
| indications for Use, general design, diameter, surface treatment, material, abutment | ||
| connection, and sterilization method. The differences between the two devices are | ||
| abutment design and length. The differences don't impact product's fundamental | ||
| technologies; therefore, subject device and predicate device are substantially | ||
| equivalent. |
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 in | |
| partially or fully edentulous mandibles and maxillae, | ||
| in support of single or multiple unit restorations | ||
| including; cemented retained, screw 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 OSSTEM Implant System -Abutment is intended | |
| for use with a dental implant to provide support for | ||
| prosthetic restorations such as crowns, bridges, or | ||
| overdentures. | ||
| 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 indications | |
| for Use, general design, diameter, material, abutment connection, and sterilization | ||
| method. The differences between the two devices are abutment design and length. The | ||
| differences don't impact product's fundamental technologies; therefore, subject device | ||
| and predicate device are substantially equivalent. |
12
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-MERGED | |
| IMPLANT | |||
| Model | Angled Abutment | Angled Abutment | |
| Indications 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, screw | |||
| 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 DIO UF HAS Internal Sub-Merged Implant System is | ||
| indicated for surgical placement in the upper and lower jaw | |||
| arches, to provide a root form means for single or multiple | |||
| units' prosthetic attachment to restore a patient's chewing | |||
| function. The smaller ( $Ø$ 3.8- $Ø$ 5.5) implants ca be placed | |||
| with a conventional two stage surgical process with an | |||
| option for transmucosal healing or they can be placed in a | |||
| single stage surgical process for immediate loading when | |||
| good primary stability is achieved with appropriate occlusal | |||
| loading. The larger ( $Ø$ 5.0- $Ø$ 7.0) implants can be placed | |||
| with a conventional two stage surgical process with an | |||
| option for transmucosal healing and are indicated for the | |||
| molar 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 as | ||
| indications for Use, design, material, and sterilization method. | |||
| The difference between two devices is design and dimensions. These differences do | |||
| not impact product's fundamental technologies; therefore, subject device and | |||
| predicate 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 in | |
| partially or fully edentulous mandibles and maxillae, | ||
| in support of single or multiple unit restorations | ||
| including; cemented retained, screw 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. | ZENEX 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, | ||
| screw retained, or overdenture restorations, and | ||
| final or temporary abutment support for fixed | ||
| bridgework. It is intended for delayed loading. | ||
| Wide Fixture System is intended to be used in | ||
| the 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 | - |
13
| 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 | |
| indications for Use, general design, material, abutment connection, surface treatment | ||
| and sterilization method. The differences between the two devices are abutment | ||
| design and dimensions. The differences don't impact product's fundamental | ||
| technologies; therefore, subject device and predicate device are substantially | ||
| equivalent. |
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 in | |
| partially or fully edentulous mandibles and maxillae, | ||
| in support of single or multiple unit restorations | ||
| including; cemented retained, screw 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 OSSTEM Implant System -Abutment is | |
| intended for use with a dental implant to | ||
| provide support for prosthetic restorations such | ||
| as 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 as | |
| indications for Use, general design, material, abutment connection, surface treatment | ||
| and sterilization method. The differences between the two devices are abutment | ||
| design and dimensions. The differences don't impact product's fundamental | ||
| technologies; therefore, subject device and predicate device are substantially | ||
| equivalent. |
14
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.