(311 days)
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
The IU Implant System Abutment is a dental implant superstructure made of titanium alloy. It is an abutment used to support or maintain the restoration after the implantation of the fixture in the oral cavity. The abutments are provided non-sterile and should be sterilized before use.
This document is a 510(k) summary for the IU Implant System Abutment, a dental implant superstructure. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain the specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or effect size for AI assistance. The document focuses on showing the device's substantial equivalence to existing predicate devices based on design, materials, and non-clinical testing.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria are implicitly related to demonstrating substantial equivalence to predicate devices through comparisons of material, design, intended use, and non-clinical testing results (fatigue, biocompatibility, sterilization, MRI safety).
- Reported Device Performance: Performance is reported in terms of meeting specific standards and showing substantial equivalence in non-clinical tests, rather than clinical performance metrics.
| Acceptance Criteria (Implied from Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10^-6 | Validated according to ISO 17665-1 and ISO 17665-2 |
| Biocompatibility of Ti-6A1-4V ELI (ASTM F136) | Demonstrated by referenced Warantec submission K172345 (same materials/manufacturing) |
| Fatigue Resistance (worst case) | Conducted according to ISO 14801:2016 and FDA Special Controls Guidance Document |
| Magnetic Resonance (MR) Environment Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing displacement force and torque. |
| Substantial Equivalence to Predicate Devices | Demonstrated through comparison of intended use, design, material, surface treatment, connection, and dimensions. Minor differences (surface treatment, angulation, dimensional range) do not affect fundamental function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for performance metrics. The "tests" mentioned are non-clinical (sterilization, biocompatibility, fatigue, MRI review). These typically involve a specific number of samples for mechanical or material testing, but not a "test set" from patients or images.
- Data Provenance: The submission is from Warantec Co., Ltd. in the Republic of Korea. The testing itself (e.g., ISO standards) does not specify "data provenance" in the way clinical studies would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This information is relevant for clinical studies or studies using expert readers for image interpretation, which were not conducted for this submission ("No clinical data were included in this submission.").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical or expert-read studies, which were not performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This is a dental implant abutment, not an AI-powered diagnostic device. The submission explicitly states, "No clinical data were included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests:
- Sterilization: Ground truth is defined by the objective measurement of sterility (SAL) and adherence to ISO standards.
- Biocompatibility: Ground truth is established by chemical composition and biological response testing, adhering to material standards (ASTM F136) and prior submissions.
- Fatigue: Ground truth is based on physical endurance under simulated physiological loads according to ISO standards.
- MRI Safety: Ground truth is based on existing scientific literature and physics principles related to magnetic forces and materials.
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Warantec Co., Ltd, Younggwang Choi RA Team Manager 411~412, 474, Dunchon-dearo, Jungwon-gu Seongnam-si, Gyeonggi-do 13229 REPUBLIC OF KOREA
Re: K221969
Trade/Device Name: IU Implant System Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 14, 2023 Received: April 14, 2023
Dear Younggwang Choi:
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.
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221969
Device Name IU Implant System Abutment
Indications for Use (Describe)
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "WARANTEC" in a sans-serif font. The color of the text is a light teal. The letters are all capitalized and evenly spaced. The overall impression is clean and modern.
510(k) Summary – K221969
May 10, 2023
1. Submitter
| Submitter | |
|---|---|
| Name | WARANTEC Co., Ltd. |
| Address | 411-412, 474, Dunchon-daero, Jungwon-gu, Seongnam-si,Gyeonggi-do, 13229, Rep. of Korea |
| Phone/Fax | +82-2-3675-5851/+82-2-3675-5853 |
| Contact person | Younggwang Choi / RAygchoi@oneplant.co.kr |
| Summary Date | May 10, 2023 |
2. Device information
| a) | Trade Name : | IU Implant System Abutment |
|---|---|---|
| b) | Common Name : | Endosseous Dental Implant Abutment |
| c) | Classification Name : | Endosseous Dental Implant Abutment |
| d) | Product Code : | NHA |
| e) | Regulation Number : | 872.3630 |
| f) | Class of device : | Class II |
| g) | Panel : | Dental |
3. Predicate devices
- Primary Predicate Device: a)
IU Implant System / Warantec Co., Ltd. / K172345
Reference Device: b)
ONEPLANT Dental Implant System / Warantec Co., Ltd. / K081748 Implantium® / SuperLine® Prosthetics / Dentium Co., Ltd. / K160828
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4. Device description
The IU Implant System Abutment is a dental implant superstructure made of titanium alloy. It is an abutment used to support or maintain the restoration after the implantation of the fixture in the oral cavity.
The abutments are provided non-sterile and should be sterilized before use.
5. Indication for use
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
6. Substantial equivalence comparison
The IU Implant System is similar designs and dimensions, and has the same material, intended use, surface treatment and technological characteristics as the identified primary predicate device (K172345) and reference devices (K081748 / K160828). When compared with predicate device, no new questions of substantial equivalence have been raised for the IU Implant System Abutment.
| Device Name | Indication for use |
|---|---|
| IU Implant SystemAbutment(Subject device) | The Warantec dental abutment is intended to be used with the root-formendosseous dental implant to aid in prosthetic rehabilitation. |
| IU Implant System(Primary PredicateDevice: K172345) | The IU Implant System is intended to be surgically placed in the bone of theupper or lower jaw arches to provide support for prosthetic devices, such asartificial teeth, and to restore the patient's chewing function. |
| ONEPLANT DentalImplant System(References PredicateDevice: K081748) | ONEPLANT is designed for use in dental implant Surgery. These are intendedfor use in partially or fully edentulous mandibles and maxillae to support forsingle or multiple-unit restorations such as cemented retained, screw retained, orover denture restorations and terminal or intermediate abutment support for fixedbridework. |
| Implantium® /SuperLine®Prosthetics(References PredicateDevice: K160828) | Implantium® SuperLine® Prosthetics is intended for use as an aid in prostheticrehabilitation |
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The subject device (IU system abutment) has substantially the equivalent in indications and design principles as the predicate and reference devices listed above.
All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and prosthetic rehabilitation of the edentulous maxilla and mandible.
The differences between the target device IFUS(Indications for Use Statements) and the predicate and reference device are related to the specific device names, design feature, compatible implant lines.
None of these differences impact substantial equivalence. because all IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
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WaRantec
Device comparison
- Angled Abutment
| - Angled Abutment | |||
|---|---|---|---|
| IU Implant System Abutment(Subject Device) | ONEPLANT Dental Implant System(References Predicate) | Dentium Implantium® &SuperLine® Prosthetics(References Predicate) | |
| Company Name | Warantec Co., Ltd. | Warantec Co., Ltd. | DENTIUM Co., Ltd. |
| 510(k) Number | New Device | K081748 | K160828 |
| Classification andProduct Code | Class II; 872.3630; NHA | ||
| Design | Image: Abutment 1 | Image: Abutment 2 | Image: Abutment 3 |
| Material | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI(ASTM F136) | Pure Titanium Grade4(ASTM F67) |
| Surface Treatment | None | None | None |
| Connection | Internal Hex Connection | Internal Hex Connection | Internal Hex Connection |
| Angulation | 15°, 17° | 20° | 15°, 25° |
| Diameter | 4.0~5.0mm | 5.0mm | 4.5~5.5mm |
| Post height | 6, 8mm | 6, 8mm | 7mm |
| Gingival Height | 2~6mm | 2~5mm | 1.5mm, 2.5mm, 3.5mm |
| Restoration type | Single & Multi | Single & Multi | Single & Multi |
| Similarities | The subject and reference devices have same intended use, functions, materials andgeneral shape (design). | ||
| Differences | The differences between the subject device and the reference predicate device are the surfacetreatment, angulation, and dimensional range.These minor differences don't affect product's fundamental function.K160828 was selected as the reference device to support the difference in dimensions such asdiameter and length and the angle difference of the abutment, including the dimensions andangle range of the subject device.Therefore, the subject device and the reference devices are substantially equivalent. |
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7. Non-clinical testing data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
• Steam sterilization validation according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10-6.
• Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Warantec submission. K172345, using the same materials and manufacturing processes as the subject device.
• Fatigue testing was conducted on the worst case according to ISO 14801:2016 and the FDA Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Abutment.
· Non-clinical worst-case MRI review was performed to evaluate the metallic IU System Abutment 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 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.
No clinical data were included in this submission.
8. Conclusion
The subject device has the similar technological characteristics to the predicate device, main material, indication for use and design.
Based on the information provided for this premarket notification of Warantec Co., Ltd. conclude that IU System Abutment are substantially equivalent to predicate devices.
§ 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.)