(330 days)
The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
-
The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
-
Immediate placement in extraction situations with a partially or completely healed alveolar ridge.
-
It is intended for delayed loading.
The Oneday Mini Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is two stage endosseous screw type implant with internal hexagonal connection. This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures. The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.
This document is a 510(k) summary for the Oneday Mini Implant System, primarily focused on demonstrating substantial equivalence to a predicate device (UF(II) Narrow Implant System by DIO Corporation, K161987) rather than proving performance against specific acceptance criteria for an AI/ML device.
Therefore, many of the requested details related to AI/ML device acceptance criteria, study design (like MRMC, training/test set ground truth, expert adjudication), and performance metrics (e.g., AUC, sensitivity, specificity) are not present in this document because it is for a traditional dental implant device, not an AI/ML powered device.
However, I can extract the information relevant to a traditional medical device's acceptance criteria and performance proof, focusing on the equivalence to a predicate device.
Acceptance Criteria and Study for the Oneday Mini Implant System (A Traditional Medical Device)
1. Table of Acceptance Criteria and Reported Device Performance:
For a traditional medical device like a dental implant, "acceptance criteria" are typically demonstrated through various non-clinical tests (mechanical, material, sterilization, biocompatibility) and comparison to a legally marketed predicate device. The performance is assessed by showing substantial equivalence to this predicate, meaning it is as safe and effective as the predicate.
| Acceptance Criteria Category | Specific Criteria (Implied by Substantial Equivalence Documentation) | Reported Device Performance/Comparison to Predicate |
|---|---|---|
| Indications for Use | Match the predicate device's Indications for Use. | Met: "The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading." This is identical to the predicate's indications. |
| Design Characteristics | Similar fundamental design, with acceptable differences that do not raise new questions of safety or effectiveness. | Met (with minor non-impactful differences): The subject device and primary predicate have the same characteristics such as indications for use, diameter, length, surface treatment, material, abutment connection, and sterilization method. The only stated difference is "fixture design", which the submitter claims "doesn't impact product's fundamental technologies." Minor dimensional differences are noted for some abutments (e.g., Cover Screw, Cemented Abutment, Healing Abutment, Abutment Screw), but these are deemed not to impact fundamental technologies. |
| Material Composition | Same or equivalent biocompatible materials as the predicate. | Met: Fixture: Pure Titanium of ASTM F67 (same as predicate). Other components (Cover Screw, Cemented Abutment, Solid Abutment, Angled Abutment, Healing Abutment, Abutment Screw): Ti-6Al-4V ELI (same as predicate). |
| Surface Treatment | Same or equivalent surface treatment. | Met: SLA (Sand-blasted, Large grit, Acid-etched surface) for fixtures (same as predicate). Surface roughness, surface composition analysis, and SEM imaging were provided (leveraged from K192294) to demonstrate substantial equivalence of the surface modification. |
| Sterilization Method | Same or equivalent sterilization method with validation data. | Met: Fixtures: Gamma Irradiation (same as predicate). Abutments: End User Sterilization (same as predicate). Validation for Gamma Sterilization (fixtures) was leveraged from K192294. Validation for End User Sterilization (abutments) was performed on the subject healing abutment and met standards (ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1). |
| Biocompatibility | Biocompatible materials and design, demonstrated through testing or leveraging predicate data. | Met: Biocompatibility testing for both fixture and abutment materials was leveraged from predicate devices (K192294) because the materials and manufacturing processes are the same. Standards included ISO 10993-1, -3, -5, -6, -10, -11. |
| Mechanical Performance (Fatigue) | Meet established mechanical performance standards (e.g., ISO for dental implants). | Met: Fatigue Testing performed under worst-case scenario according to ISO 14801:2016. Results met criteria. |
| Shelf-Life | Demonstrated stability and integrity over the claimed shelf-life. | Met: Shelf-Life Test on Fixtures leveraged from K192294 (ASTM F1980), as materials, sterilization, packaging, and manufacturing process are the same. |
| Bacterial Endotoxin | Meet limits for Bacterial Endotoxins. | Met: Bacterial Endotoxin Test Report on Fixtures leveraged from K192294 (ANSI/AAMI ST72:2011, USP <161>, and USP <85>). |
| MRI Safety (if applicable) | Assessment of safely in MRI environments. | Met: Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment". The assessment covered all compatible implant bodies, dental abutments, and fixation screws, and material compositions. |
2. Sample Size for the Test Set and Data Provenance:
- Test Set (for performance evaluation): For a traditional device showing substantial equivalence, there isn't a "test set" in the sense of a distinct dataset used to calculate performance metrics like sensitivity/specificity for an algorithm. Instead, the "testing" involves performing specific engineering and biological tests (e.g., fatigue testing on a sample of implants, sterilization validation on a sample of devices) and comparing the design specifications and materials to a predicate device.
- Fatigue Testing: "Fatigue Testing under the worst-case scenario according to ISO 14801:2016." The standard dictates sample sizes.
- End User Sterilization Validation: Performed on the "subject Healing Abutment Mini with the greatest surface area" to be representative. Standards dictate sample sizes.
- Data Provenance: The document does not specify the country of origin for the testing data. Test results are generally from controlled laboratory environments using product samples. Most data is "leveraged" from previous 510(k) clearances (K192294 and K161987) for similar devices, suggesting a retrospective use of existing data to support the current claim of equivalence.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable in the context of this 510(k) summary for a traditional medical device. Ground truth for device performance is established through adherence to recognized international standards (e.g., ISO, ASTM) for material properties and mechanical testing, and through comparison to a device already cleared by the FDA (the predicate). There is no "expert panel" establishing a clinical ground truth for a diagnostic output as there would be for an AI/ML imaging device.
4. Adjudication Method for the Test Set:
- Not applicable. There is no "adjudication" of results in the sense of reconciling differing expert opinions, as this is not an AI/ML diagnostic device with human readers. Testing results are objective measurements against pre-defined engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-powered ones, to assess the impact of the AI on human reader performance. This document is for a physical medical implant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone evaluation was not done. This concept applies to AI/ML algorithms that might provide a diagnostic output without human intervention. This document is for a physical medical implant.
7. The type of ground truth used:
- The "ground truth" for the Oneday Mini Implant System is based on:
- Adherence to recognized international standards: e.g., ISO 14801:2016 for fatigue, ISO 11137 for sterilization, ISO 10993 for biocompatibility, etc.
- Demonstrated equivalence to a legally marketed predicate device: The predicate device (UF(II) Narrow Implant System, K161987) has already been determined to be safe and effective by the FDA. The substantial equivalence argument posits that since the new device is fundamentally similar and meets performance parameters, it is also safe and effective.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Oneday Biotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K222946
Trade/Device Name: Oneday Mini Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 24, 2023 Received: July 25, 2023
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222946
Device Name Oneday Mini Implant System
Indications for Use (Describe)
The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
-
The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
-
Immediate placement in extraction situations with a partially or completely healed alveolar ridge.
-
It is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| 人 上一篇: | 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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{3}------------------------------------------------
510(K) Summary
Submitter
Oneday Biotech Co., Ltd. Jae Hyun Song 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 Mini Implant System
- Common Name: Dental Implant System
- Classification Name: Endosseous dental implant
- Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- Date Prepared: 08/14/2023
Predicate Devices:
Primary Predicate
-
K161987, UF(II) Narrow Implant System by DIO Corporation .
Reference devices -
K192294, I Do by I Do Biotech Co., Ltd. .
Indication for Use:
The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- -The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- -Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading. -
Device Description:
The Oneday Mini Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is two stage endosseous screw type implant with internal hexagonal connection.
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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This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures.
The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.
The dimensions of fixture Mini are as following:
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | Fixture Mini | $\text{\O}3.0, 3.3 (D) X 8.5, 10, 11.5, 13, and 15mm$ |
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
| No. | Device Name | Dimension Ranges | Angulation |
|---|---|---|---|
| 1 | Cover Screw Mini | Ø2.7 (D) x 4.7mm (L)Ø3.55 (D) x 6.8mm (L) | 0° |
| 2 | Cemented Abutment Mini | Ø4.0(D) X 8.4, 9.4, 10.4, 11.4mm (L)Ø4.0(D) X 9.9, 10.9, 11.9, 12.9, 13.9mm (L) | 0° |
| 3 | Solid Abutment Mini | Ø4.0(D) X 13.3, 14.3, 16.3mm (L) | 0° |
| 4 | Angled Abutment Mini | Ø4.0 (D) X 10.67, 12.67mm (L) | 15° |
| 5 | Healing Abutment Mini | Ø4.2, 4.7(D) X 8.3, 9.3, 11.3mm (L) | 0° |
| 6 | Abutment Screw Mini | Ø1.85 (D) X 7.6mm (L) | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| Cover Screw Mini | It is used for protecting inner hole and connectingpart with exposed upper part of structure during thehealing period after inserting dental implant fixture | N/A | ScrewRetained |
| Cemented Abutment Mini | The Abutment is connected with fixture and itsupports prosthesis which restores tooth function. | N/A | Internal Hex |
| Solid Abutment Mini | The Abutment is connected with fixture and itsupports prosthesis which restores tooth function | N/A | |
| Angled Abutment Mini | N/A | ||
| Healing Abutment Mini | The healing Abutment is used for protecting innerhole of fixture and adjusting the appropriate heightduring the healing period | N/A | ScrewRetained |
| Abutment Screw Mini | Connection body to connect abutment tofixture | N/A | ScrewRetained |
Tolerance of dimension for Abutments shall be within ± 1% range. All abutments are provided non-sterilized.
Materials:
- Fixtures are fabricated from Pure titanium of ASTM F67 ●
- . Cover Screw, Cemented Abutment, Solid Abutment, Angled Abutment, Healing Abutment, and Abutment Screw are fabricated from Ti-6Al-4V of ASTM F136
{5}------------------------------------------------
Summaries of Technological Characteristics & Substantial Equivalence Discussion
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | NA | K161987 |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation |
| Trade Name | Oneday Mini Implant System | UF(II) Narrow Implant System |
| Design | Image: Oneday Mini Implant System | Image: UF(II) Narrow Implant System |
| Indications for Use | The Oneday Mini Implant System isintended for two-stage surgical proceduresin the following situations and with thefollowing clinical protocols:- The intended use for the 3.0mm,3.3mm diameter Oneday Mini Implantis limited to the replacement ofmaxillary lateral incisors andmandibular incisors.- Immediate placement in extractionsites and in situations with a partiallyor completely healed alveolar ridge.- It is intended for delayed loading. | The UF(II) Narrow Implant System isintended for two-stage surgical proceduresin the following situations and with thefollowing clinical protocols:- The intended use for the 3.0mm,3.3mm diameter UF)II) Narrow Implantis limited to the replacement ofmaxillary lateral incisors andmandibular incisors.- Immediate placement in extraction sitesand in situations with a partially orcompletely healed alveolar ridge.- It is intended for delayed loading. |
| Diameter(mm) | 3.0/3.3 | 3.0/3.3 |
| Length(mm) | 8.5/10/11.5/13/15 | 8.5/10/11.5/13/15 |
| Surface Treatment | SLA | SLA |
| Material | Titanium Gr4 (ASTM F67) | Titanium Gr4 (ASTM F67) |
| Sterilization | Gamma Irradiation | Gamma Irradiation |
| Comparison | The Subject Device and primary predicate have same characteristics such as indicationsfor Use, design, diameter, length, surface treatment, material, abutment connection, andsterilization method.The difference between two devices is only fixture design. This difference doesn't impactproduct's fundamental technologies; therefore, subject device and predicate device aresubstantially equivalent. |
Oneday Mini Implant Fixture
{6}------------------------------------------------
Cover Screw Mini
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | NA | K161987 |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation |
| Trade Name | Oneday Mini Implant System | UF(II) Narrow Implant System |
| Model | Cover Screw Mini | Cover Screw |
| Design | Image: Subject Device Design | Image: Primary Predicate Design |
| Diameter(mm) | 2.7/3.55 | 2.7/2.794 |
| Length(mm) | 4.7/6.8 | 4.7/5.7/6.3/7.3 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have the same characteristics such asindications for Use, design, material, and sterilization method.The difference between two devices is design and dimensions. These differences donot impact the product's fundamental technologies; therefore, subject device andpredicate device are substantially equivalent. |
Cemented Abutment Mini
| Subject Device | Primary Predicate | |||
|---|---|---|---|---|
| K number | NA | K161987 | ||
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation | ||
| Trade Name | Oneday Mini Implant System | UF(II) Narrow Implant System | ||
| Model | Cemented Abutment Mini | Cemented Abutment | ||
| Hex | Non-Hex | Hex | Non-Hex | |
| Design | Image: Hex Design | Image: Non-Hex Design | Image: Hex Design | Image: Non-Hex Design |
| Diameter(mm) | 4 | 4/4.5 | ||
| Length(mm) | 8.4/9.4/10.4/11.4/9.9/10.9/11.9/12.9/13.9 | 8.4/9.4/10.4/11.4/9.9/10.9/11.9/12.9/13.9 | ||
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | ||
| Sterilization | End User Sterilization | End User Sterilization | ||
| Comparison | The Subject Device and primary predicate have same characteristics such as indicationsfor Use, design, material, and sterilization method.The difference between two devices is design. This difference does not impactproduct's fundamental technologies; therefore, subject device and predicate device aresubstantially equivalent. |
{7}------------------------------------------------
Solid Abutment Mini
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | NA | K161987 |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation |
| Trade Name | Oneday Mini Implant System | UF(II) Narrow Implant System |
| Model | Solid Abutment Mini | Solid Abutment |
| Design | Image: Solid Abutment Mini | Image: Solid Abutment |
| Diameter(mm) | 4.0 | 4.0/4.5 |
| Length(mm) | 13.3/14.3/16.3 | 13.3/14.3/16.3 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| 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. This difference does not impactproduct's fundamental technologies; therefore, subject device and predicate deviceare substantially equivalent. |
Angled Abutment Mini
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| K number | NA | K161987 | |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation | |
| Trade Name | Oneday Mini Implant System | UF(II) Narrow Implant System | |
| Model | Angled Abutment Mini | Angled Abutment | |
| Design | Image: Angled Abutment Mini | Image: Angled Abutment | |
| Diameter(mm) | 4.0 | 4.0 | |
| Lengths (mm) | 10.67, 12.67 | 10.67, 12.67 | |
| Angle(°) | 15 ° | 15 ° | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Comparison | The Subject Device and primary predicate have same characteristics such asindications for Use, design, material, angulation, and sterilization method.The difference between two devices is design. This difference does not impactproduct's fundamental technologies; therefore, subject device and predicate deviceare substantially equivalent. |
{8}------------------------------------------------
Healing Abutment Mini
| Healing Abutment Mini | ||
|---|---|---|
| Subject Device | Primary Predicatea | |
| K number | NA | K161987 |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation |
| Trade Name | MINI Healing abutment | UF(II) Narrow Implant System |
| Model | Healing Abutment Mini | Healing Abutment |
| Design | Image: Healing Abutment Mini Subject Device Design | Image: Healing Abutment Primary Predicatea Design |
| Diameter(mm) | 4.2/4.7 | 4.0/4.5/4.6/5.5/5.6/6.5/6.6/7.5/7.6/8.0/8.2/9.0/9.2 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and primary predicate have same characteristics such as indicationsfor Use, design, material, and sterilization method.The difference between two devices is design and dimensions. These differences do notimpact product's fundamental technologies; therefore, subject device and predicatedevice are substantially equivalent. |
Abutment Screw Mini
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| K number | NA | K182194 | |
| Manufacturer | Oneday Biotech Co., Ltd. | DIO Corporation | |
| Trade Name | MINI Abutment screw | UV Active Implant System | |
| Model | Abutment Screw Mini | Abutment Screw | |
| Design | Image: Abutment screw mini | Image: Abutment screw | |
| Diameter(mm) | 1.85 | 2.2 | |
| Length(mm) | 7.6 | 6.0 | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| 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. |
{9}------------------------------------------------
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 subject healing abutment according to ● ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
Below tests were performed for predicate devices and leveraged for the subject device:
- Gamma Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3 referenced in ● K192294
- Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K192294
- Biocompatibility testing on fixtures 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 referenced in K192294
- Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP <161>, and USP <85> referenced in K192294
- . Biocompatibility testing on Abutments made with Ti-6AI-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 surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. To compare surface modification between the subject and predicate devices, K192294, surface roughness, surface composition analysis, and SEM imaging were provided and it demonstrate the substantial equivalence.
The Sterilization validation test and shelf life test for fixtures were performed for predicate device, K 192294 and leveraged for the subject device because the material, sterilization method, packaging methods, and manufacturing process of the both products are exactly same.
The End User Sterilization such as Autoclave Validation was performed on the subject Healing Abutment Mini with the greatest surface area to be representative of all the proposed abutments.
The Biocompatibility Test was conducted on the predicate device 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 non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., 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 to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The 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.
{10}------------------------------------------------
Conclusion
Oneday Mini Implant System 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 Mini Implant System and its predicates are substantially equivalent.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.