(330 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on material properties, sterilization, and mechanical testing.
Yes
The device, an implant system designed to replace missing teeth, is inherently therapeutic as it addresses and treats a medical condition (tooth loss) by restoring function and structure.
No
The device description clearly states it is an implant system used to replace missing teeth, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly states it is a "two stage endosseous screw type implant with internal hexagonal connection" and consists of physical components like "fixture, cover screw, and various abutments" made of "Pure Titanium". This indicates a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "two-stage surgical procedures" to replace missing teeth. This is a surgical intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical implant system (fixture, cover screw, abutments) made of titanium, designed to be surgically placed in the jawbone. This is consistent with a medical device for implantation, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and biological properties of the implant (fatigue, sterilization, shelf-life, biocompatibility, MRI compatibility), which are relevant to a surgical implant, not an IVD.
Therefore, the Oneday Mini Implant System is a medical device intended for surgical use, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 situations with a partially or completely healed alveolar ridge.
-
It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors and mandibular incisors
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)
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 , and USP 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.
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
§ 872.3640 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.
0
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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
4
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 connecting | ||
| part with exposed upper part of structure during the | |||
| healing period after inserting dental implant fixture | N/A | Screw | |
| Retained | |||
| Cemented Abutment Mini | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function. | N/A | Internal Hex | |
| Solid Abutment Mini | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function | N/A | ||
| Angled Abutment Mini | N/A | ||
| Healing Abutment Mini | 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 Mini | Connection body to connect abutment to | ||
| fixture | N/A | Screw | |
| Retained |
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 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. | The UF(II) Narrow 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 UF)II) Narrow 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. |
| 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 indications
for Use, design, diameter, length, surface treatment, material, abutment connection, and
sterilization method.
The difference between two devices is only fixture design. This difference doesn't impact
product's fundamental technologies; therefore, subject device and predicate device are
substantially 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 as | |
| indications for Use, design, material, and sterilization method. | ||
| The difference between two devices is design and dimensions. These differences do | ||
| not impact the product's fundamental technologies; therefore, subject device and | ||
| predicate 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 indications | |||
| for Use, design, material, and sterilization method. | ||||
| The difference between two devices is design. This difference does not impact | ||||
| product's fundamental technologies; therefore, subject device and predicate device are | ||||
| substantially 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 as | |
| indications for Use, design, material, and sterilization method. | ||
| The difference between two devices is design. This difference does not impact | ||
| product's fundamental technologies; therefore, subject device and predicate device | ||
| are 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 as | ||
| indications for Use, design, material, angulation, and sterilization method. | |||
| The difference between two devices is design. This difference does not impact | |||
| product's fundamental technologies; therefore, subject device and predicate device | |||
| are 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 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. |
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 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. |
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 , and USP 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.