(87 days)
The Luna Dental 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. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.
The Luna Dental Implant System is a device of pure titanium (ASTM F67) and titanium alloy (ASTM F1136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. This 510k is intended to add the new models of the following abutments to the Luna Dental Implant System: Healing Abutment I, Duo Abutment, Duo Plus Abutment, Temporary Abutment.
The document provided does not contain information about the performance of an AI/ML powered device, but rather pertains to the 510(k) clearance of the Luna Dental Implant System, which is a traditional medical device (dental implants and their components).
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML powered device from this document. The document describes the mechanical and material characteristics of dental implants and their substantial equivalence to previously cleared predicate devices, not AI/ML model performance.
To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML powered medical device.
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Shinhung MST Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. , STE 160 Irvine. California 92612
Re: K223395
Trade/Device Name: Luna Dental Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 1, 2022 Received: November 8, 2022
Dear Priscilla Chung:
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223395
Device Name Luna Dental Implant System
Indications for Use (Describe)
The Luna Dental 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. The Luna Dental Implant System is intended for delayed loading is possible when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K223395)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 2/2/2023
1. Submitter
SHINHUNG MST CO., LTD. 110-2, Donghwagondan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea, 26365
Tel: +82-33-730-1901
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Trade Name: Luna Dental Implant System ●
- Common Name: Dental Implant System ●
- Classification Name: Endosseous Dental Implant ●
- Product Code: NHA
- . Classification regulation: 21CFR 872.3640
4. Predicate Device:
- · Primary predicate device: LUNA DENTAL IMPLANT SYSTEM by SHINHUNG MST CO., LTD (K123155)
- · Reference predicate device: LUNA DENTAL IMPLANT SYSTEM by SHINHUNG MST CO., LTD (K160106) ET/SS IMPLANT SYSTEM by OSSTEM IMPLANT CO.,LTD (K120847) Temporary Snap Abutment by Nobel Biocare AB (K161435)
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5. Description:
The Luna Dental Implant System is a device of pure titanium (ASTM F67) and titanium alloy (ASTM F1136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. This 510k is intended to add the new models of the following abutments to the Luna Dental Implant System.
- Healing Abutment I
- י Duo Abutment
- I Duo Plus Abutment
- I Temporary Abutment
6. Indication for use:
The Luna Dental 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. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.
7. Basis for Substantial Equivalence
Comparison Chart
| Device Name | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. |
| Device Name | Healing Abutment | Healing Abutment | Healing Abutment |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design |
| 510(k)Number | K223395 | K123155 | K120847 |
| Indications forUse | The Luna Dental Implantsystem is intended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas artificial teeth, and torestore the patient's | The Luna Dental ImplantSystem is intended to besurgically placed in the boneof the upper or lower jawarches to provide supportfor prosthetic devices, suchas artificial teeth, and torestore the patient' schewing function. | The ET/SS ImplantSystem is indicated foruse in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenture |
- · Healing Abutment
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| chewing function. TheLuna Dental ImplantSystem is intended fordelayed loading andimmediate loading ispossible when goodprimary stability isachieved and withappropriate occlusalloading. | restorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. Theabutment is intended foruse with a dental implantfixture to provide supportfor prosthetic restorationssuch as crowns, bridges, | ||
|---|---|---|---|
| or overdenture. | |||
| Diameter(mm) | 4.0 ~ 5.3 | 4.5 ~ 7.0 | 4.0 ~ 8.0 |
| Post Height(mm) | 2.0 ~ 10.0 | 2.0~7.0 | 3.0 ~ 9.0 |
| Material | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) | Titanium Alloy Ti-6Al-4V(ASTM F136) |
| Sterilization | Radiation Sterilization | Radiation Sterilization | Radiation Sterilization |
| S.E | The subject device has the same intended use, design, and technologicalcharacteristics as the primary predicate device (K123155, K160106). The diameter ofthe new model is smaller than the primary predicate device. We identified a referencedevice which has the diameter size (4mm). The post height is slightly higher than thereference device, however, this minor difference does not raise a question insubstantial equivalence since the user can select an appropriate height modelaccording to each patient need. |
| Device Name | Subject Device | Primary Predicate Device |
|---|---|---|
| Manufacturer | SHINHUNG MST CO., LTD. | SHINHUNG MST CO., LTD. |
| Device Name | Duo Abutment | Duo Abutment |
| Design | Image: Duo Abutment | Image: Duo Abutment |
| 510(k) Number | K223395 | K123155 |
| Indications forUse | The Luna Dental Implant system isintended to be surgically placed in thebone of the upper or lower jaw arches toprovide support for prosthetic devices,such as artificial teeth, and to restore thepatient's chewing function. The LunaDental Implant System is intended fordelayed loading and immediate loadingis possible when good primary stabilityis achieved and with appropriate occlusalloading. | The Luna Dental Implant System isintended to be surgically placed in thebone of the upper or lower jaw arches toprovide support for prosthetic devices,such as artificial teeth, and to restore thepatient's chewing function. |
| Diameter (mm) | 4.6 ~ 5.1 | 4.6 ~ 6.1 |
| Gingiva Height(mm) | 1.0 ~ 5.0 | 1.0 ~ 5.0 |
| Post Height(mm) | 7.0 | 4.0 ~ 7.0 |
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| Material | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) |
|---|---|---|
| Sterilization | User Sterilization | User Sterilization |
| S.E. | The subject device has the same intended use, design, and technologicalcharacteristics as the primary predicate device (K123155). The modification is only foradding a few more size options within the same range. |
| Device Name | Subject Device | Primary PredicateDevice | Reference Device |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. |
| Device Name | Duo Plus Abutment | Transfer Abutment | Duo Abutment |
| Design | Image: Duo Plus Abutment | Image: Transfer Abutment | Image: Duo Abutment |
| Indications forUse | The Luna Dental Implantsystem is intended to besurgically placed in thebone of the upper or lowerjaw arches to providesupport for prostheticdevices, such as artificialteeth, and to restore thepatient's chewingfunction. The Luna DentalImplant System isintended for delayedloading and immediateloading is possible whengood primary stability isachieved and withappropriate occlusalloading. | The ET/SS ImplantSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. Theabutment is intended foruse with a dental implantfixture to provide supportfor prosthetic restorationssuch as crowns, bridges, oroverdenture. | The Luna Dental ImplantSystem is intended to besurgically placed in thebone of the upper or lowerjaw arches to providesupport for prostheticdevices, such as artificialteeth, and to restore thepatient' s chewingfunction. |
| 510(k) Number | K223395 | K120847 | K123155 |
| Diameter (mm) | 4.1 ~ 6.1 | 4.0 ~ 7.0 | 4.6 ~ 6.1 |
| Gingiva Height(mm) | 1.0 ~ 5.0 | 1.0 ~ 5.0 | 1.0 ~ 5.0 |
| Material | Pure Titanium Gr 4(ASTM F67) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Pure Titanium Gr 4(ASTM F67) |
| Sterilization | User Sterilization | User Sterilization | User Sterilization |
| S.E. | The subject device has the same intended use, design, and technologicalcharacteristics as the primary predicate device (K120847). The only difference wouldbe area of TiN coating, but this difference does not raise a question in substantialequivalence. | ||
| Device Name | Subject Device | Primary Predicate Device | Reference Device |
| Manufacturer | SHINHUNG MST CO.,LTD. | SHINHUNG MST CO.,LTD. | Nobel Biocare AB |
| Device Name | Temporary Abutment | Temporary Abutment | Temporary Snap Abutment |
| Design | Image: Temporary Abutment | Image: Temporary Abutment | Image: Temporary Snap Abutment |
| 510(k)Number | K223395 | K123155 | K161435 |
| Indications forUse | The Luna Dental Implantsystem is intended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas artificial teeth, and torestore the patient'schewing function. TheLuna Dental ImplantSystem is intended fordelayed loading andimmediate loading ispossible when goodprimary stability isachieved and withappropriate occlusalloading. | The Luna Dental ImplantSystem is intended to besurgically placed in thebone of the upper or lowerjaw arches to providesupport for prostheticdevices, such as artificialteeth, and to restore thepatient's chewing function. | The Temporary SnapAbutment is intended to beused to fabricate andsupport provisionalrestorations that aid increatingan esthetic emergencethrough the gingiva duringthe healing period andprior to final restoration.The Temporary SnapAbutment can be used forcement retained or screw-retained provisionalrestorations. Theabutments can be used forsingle-unit and multi-unitrestorations. Use of theTemporary Snap Abutmentis not to exceed onehundred and eighty(180) days. |
| Diameter(mm) | 4.6~5.1 | 4.1 ~ 4.6 | 4.0 ~ 6.0 |
| GingivaHeight (mm) | 2.0 ~ 3.0 | 1.0 ~ 3.0 | 1.5 ~ 3.0 |
| Material | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) | Titanium vanadium alloy(ASTM F136) |
| Sterilization | User sterile | User sterile | User sterile |
| S.E | The subject device has the same intended use, design, and technological characteristicsas the primary predicate device (K123155). The only difference is that the diameter ofthe new models is outside of the range. We identified a reference device which coverthe diameter range of the subject device. |
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Substantial Equivalence Discussion
The Luna Dental Implant System (Healing Abutment, Duo Abutment, Duo Plus Abutment, and Temporary Abutment) are substantially equivalent to its predicate device (K123155) in terms of indications for use, raw material, and design. The wording of the indications for use statement is slightly different but that does not affect the intended use.
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The difference is in size range. We have identified a reference device that encompass the size range of the subiect device. Based on the information submitted here in we conclude that the subject device is substantially equivalent to the predicate devices.
8. Non-Clinical Testing
Risk analysis and validation activities were performed according to the ISO 14971 and the result support that the predicate device does not raise a new question in safety and performance.
A non-clinical worst-case MRI review was conducted to evaluate the Luna Implant System device in an MRI environment using scientific evidence 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). Titanium Grade 4 and Titanium alloy (Ti-6Al-4V, ELI) were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) by T. O. Woods et al. Based on that rationale, we have addressed parameters per FDA guidance " Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetic induced displacement force and torque.
The following test items were previously submitted and reviewed under K123155.
- . Sterilization - Radiation and Moist Heat
- . Shelf life for sterile devices
- Biocompatibility ●
9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics.
Based on the similarities, we conclude that the Luna Dental Implant System is substantially equivalent to the 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.)