(311 days)
No
The summary describes a standard dental abutment made of titanium alloy and focuses on mechanical and biocompatibility testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is a dental abutment intended for prosthetic rehabilitation, meaning it aids in supporting or maintaining a dental restoration after an implant, which is a supportive rather than a therapeutic function.
No
Explanation: The device is a dental abutment intended to aid in prosthetic rehabilitation, not to diagnose a medical condition.
No
The device description explicitly states it is a "dental implant superstructure made of titanium alloy," indicating it is a physical hardware device, not software. The performance studies also focus on hardware-related testing like sterilization, biocompatibility, fatigue, and MRI compatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a "dental implant superstructure made of titanium alloy" used to "support or maintain the restoration after the implantation of the fixture in the oral cavity." This further reinforces its role as an implanted medical device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic or monitoring information
The information provided clearly describes a dental prosthetic component, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
Product codes
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
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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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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 / RA |
| ygchoi@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 System | |
| Abutment | |
| (Subject device) | The Warantec dental abutment is intended to be used with the root-form |
| endosseous dental implant to aid in prosthetic rehabilitation. | |
| IU Implant System | |
| (Primary Predicate | |
| Device: K172345) | The IU Implant System 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, and to restore the patient's chewing function. | |
| ONEPLANT Dental | |
| Implant System | |
| (References Predicate | |
| Device: K081748) | ONEPLANT is designed for use in dental implant Surgery. These are intended |
| for use in partially or fully edentulous mandibles and maxillae to support for | |
| single or multiple-unit restorations such as cemented retained, screw retained, or | |
| over denture restorations and terminal or intermediate abutment support for fixed | |
| bridework. | |
| Implantium® / | |
| SuperLine® | |
| Prosthetics | |
| (References Predicate | |
| Device: K160828) | Implantium® SuperLine® Prosthetics is intended for use as an aid in prosthetic |
| rehabilitation |
5
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 and | |||
| Product 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 and | ||
| general shape (design). | |||
| Differences | The differences between the subject device and the reference predicate device are the surface | ||
| treatment, 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 as | |||
| diameter and length and the angle difference of the abutment, including the dimensions and | |||
| angle 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.