(353 days)
The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then pickling to roughen the surface. The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.
The provided text describes the regulatory clearance for the "Stella" dental implant system. It does not contain information about acceptance criteria or a study demonstrating the device meets performance criteria in the context of AI/ML or diagnostic applications. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a novel AI/ML algorithm.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies for an AI/ML device is not present in the provided document.
However, I can extract the non-clinical testing performed to support the substantial equivalence claim for the Stella dental implant system.
Here's the relevant information that is available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the context of an AI/ML device's diagnostic performance. The document only lists types of non-clinical tests performed for physical characteristics of the dental implant system, and states that the "Stella" has "similar fatigue testing results to the predicate devices in the market" without providing specific acceptance criteria or quantitative results for these comparisons.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable to this document. The document describes a medical device (dental implant), not a diagnostic algorithm.
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 to this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable to this document.
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:
Not applicable to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable to this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable to this document. The "ground truth" for a physical device like a dental implant would be engineering specifications and material properties, validated through physical testing, not expert consensus on images or pathology.
8. The sample size for the training set:
Not applicable to this document, as it does not describe an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable to this document.
Summary of Non-Clinical Testing (as described in the document for the physical device Stella, not an AI/ML component):
The document highlights the following non-clinical tests performed to support substantial equivalence of the Stella dental implant system:
| Test Type | Basis for Performance Claim |
|---|---|
| Fatigue Test | Performed in accordance with ISO 14801. The document states "similar fatigue testing results to the predicate devices in the market" and that "it was confirmed that there was no strength problem through the fatigue test on the fixture diameter 3.7mm." (No specific acceptance criteria or quantitative results are provided in this summary, but the test was done.) |
| SLA Surface Treatment | Evaluated under previous 510(k)s (K123155 and K160106) for SHINHUNG MST CO., LTD.'s Luna Dental Implant System. The subject device "Stella" is stated to be made of the same material and goes through the same manufacturing processes, implying similar surface characteristics to already cleared devices. |
| Biocompatibility | Evaluated under a previous 510(k) (K123155) for SHINHUNG MST CO., LTD.'s Luna Dental Implant System. The "Stella" is stated to be made of the same material (Pure Titanium Gr 4, ASTM F67) and process, with the safety of raw materials (including TiN coating where applicable) being demonstrated through the previously approved Luna system. |
| Shelf Life | Evaluated under a previous 510(k) (K123155). |
| Sterilization | Evaluated under a previous 510(k) (K123155) for both Gamma radiation and Moist Heat Methods. The Stella implant fixture and cover screw are radiation sterile. Abutments and other components are user sterile. |
| Packaging | Evaluated under a previous 510(k) (K123155). |
| Endotoxin/LAL Testing | Will be conducted on every batch of the subject device. (This is an ongoing quality control measure, not a pre-market test result presented here). |
| MRI Review | A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (e.g., Woods et al., 2019). Titanium Grade 4 was assessed according to ASTM F2052 (magnetic induced displacement force), ASTM F2213 (magnetic induced torque), ASTM F2182 (RF induction heating), and ASTM F2119 (image artifact). This addresses parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." |
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
SHINHUNG MST CO., LTD.
% Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. Suite 160 Irvine, California 92612
Re: K221752
Trade/Device Name: Stella Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 28, 2023 Received: March 6, 2023
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) K221752
Device Name Stella
Indications for Use (Describe)
The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.
The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (K221752)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 6/02/2023
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 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: Stella
- Common Name: Dental Implant System ●
- Classification Name: Endosseous Dental Implant
- Product Code: DZE, NHA ●
- . Classification regulation: 21CFR 872.3640
4. Predicate Device:
SSII/III SA Fixture by OSSTEM Implant Co., Ltd. (K120847) Luna Dental Implant System by SHINHUNG MST CO., LTD. (K123155 / K160106)
5. Description:
Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then
{4}------------------------------------------------
pickling to roughen the surface.
The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.
6. Indication for use:
The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
7. Basis for Substantial Equivalence
Comparison Chart
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd.SHINHUNG MST CO.,LTD. | |
| Device Name | Stella | SSII/III SA FixtureLuna Dental ImplantSystem | |
| Design | Image: Stella Implant | Image: SSII/III SA Fixture | Image: Luna Dental Implant System |
| 510(k) Number | K221752 | K120847 | K123155 / K160106 |
| Intended use | The Stella is intended to besurgically placed in theupper or lower jawbone toprovide support forprosthetic devices, such asartificial teeth, restoringthe patient's chewingcapabilities. The Stella isintended for delayedloading and immediateloading is possible whengood primary stability isachieved and withappropriate occlusalloading.The Stella Abutment isintended to be connectedto the dental implant toretain the overdenture or | ET/SS Implant System isindicated for use inpartially 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, or | 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. |
| partial denture. | overdenture. | ||
| Structure | - Tissue level fixture- Self tapping- Internal Octagonalconnection- Taper body shape | - Tissue level fixture- Self tapping- Internal Octagonalconnection- Straight / Taper bodyshape | - Bone level fixture- Self tapping- Internal Hexagonalconnection- Taper body shape |
| PlatformDiameter(D) (mm) | 4.8, 6.0 | 4.8, 6.0 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0,7.0 |
| Body Diameter(D) (mm) | 3.7, 4.2, 4.7, 5.2 | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.7, 4.2, 4.7, 5.2, 5.7, 6.0,7.0 |
| Length (mm) | 7.0, 8.5, 10.0, 11.5, 13.0,15.0*The following sizeconfigurations are notincluded.· 4.8mm platform diameterx 3.7mm body diameter x7.0mm length.· 4.8mm platform diameterx 5.2mm body diameter xall length.· 6.0mm platform diameterx 3.7 mm body diameter xall length.· 6.0mm platform diameterx 4.2 mm body diameter xall length. | 6.0, 7.0, 8.5, 10.0, 11.5,13.0*The following sizeconfigurations are notincluded.· 4.8mm platform diameterx 3.5mm body diameter x7.0mm length.· 4.8mm platform diameterx all body diameter x6.0mm length.· 4.8mm platform diameterx 5.0mm body diameter xall length.· 4.8mm platform diameterx 6.0mm body diameter xall length.· 4.8mm platform diameterx 7.0mm body diameter xall length.· 6.0mm platform diameterx 3.5mm body diameter xall length.· 6.0mm platform diameterx 4.0mm body diameter xall length.· 6.0mm platform diameterx 4.5mm body diameter x6.0mm length. | 7.0, 8.5, 10.0, 11.5, 13.0,15.0*The following sizeconfigurations are notincluded.· 3.7mm body diameter x7.0mm length.· 5.7mm body diameter x15.0mm length.· 6.0mm body diameter x15.0mm length.· 7.0mm body diameter x15.0mm length. |
| Material | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) |
| Surface | S.L.A. | S.L.A. | S.L.A. |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
- Dental fixture
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| This product has the same intended use as the predicate device, and its main purpose is to restore the masticatory function by implanting it in the toothless areas of the upper and lower jaws. It is a non-submerged fixture identical to Osstem's SSII/III SA Fixture (K120847), and there is a groove for self-tapping at the end of the body. The diameter of the platform is the same as that of the Osstem. The diameter of the body is similar to that of the Osstem, and the safety of the 3.7mm diameter has been proven in the Luna Dental Implant System. In addition, it was confirmed that there was no strength problem through the fatigue test on the fixture diameter 3.7mm. The length of the product is within the range of the length of the Osstem product. The connection to the abutment is also made of an internal octagonal structure. The raw material was made of Pure Titanium Grade 4 (ASTM F67) in the same way as the predicate device, and the surface treatment was SA-treated. It is manufactured through the same raw materials and manufacturing process as our previously licensed Luna Dental Implant Systems (K123155 / K160106). Sterilization is also provided through gamma sterilization. | |
|---|---|
| S.E. |
▪ Abutment
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. |
| Device Name | Healing Abutment | Healing Abutment | Healing Abutment |
| Design | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment |
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 4.8, 6.0 | 4.8, 6.0 | 4.0, 4.5, 5.0, 6.0 |
| Gingiva Height(mm) | 2.0, 3.0, 4.0 | 2.0, 3.0, 4.0, 5.0*The following sizeconfigurations are notincluded.. 6.0mm diameter x 2.0mmGingiva height. | 2.0, 3.0, 4.0, 5.0, 6.0*The following sizeconfigurations are notincluded.. 6.0mm diameter x 6.0mmGingiva height. |
| Material | Pure Titanium Gr 4 | Titanium Alloy Ti-6Al-4V | Pure Titanium Gr 4 |
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| (ASTM F67) | (ASTM F136) | (ASTM F67) | |
|---|---|---|---|
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| S.E. | Healing Abutment is a product that is used temporarily before installing a permanentsuperstructure. This product has the same purpose as the predicate device and has asize within the product size range of Osstem. Unlike Osstem's, the raw material wasmanufactured with Pure Titanium Grade 4 (ASTM F67), and was manufactured withthe same material as our previously approved product, Luna Dental Implant System(K123155). It is gamma-sterilized and provided to the user. |
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. |
| Device Name | Simple Abutment | Solid Abutment | Simple Abutment |
| Design | Image: Simple Abutment | Image: Solid Abutment | Image: Simple Abutment |
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 4.8, 6.0 | 4.8, 6.0 | 4.1, 4.6, 5.1, 6.1 |
| Post Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Material | Titanium Alloy Ti-6Al-4V(ASTM F136) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Titanium Alloy Ti-6Al-4V(ASTM F136) |
| Sterilization | User sterile | User sterile | User sterile |
| S.E. | Simple abutments can be used in both anterior and posterior areas of the mouth forcement retained crown and bridge restorations. This product has the same purpose asthe predicate device and has a size within the product size range of Osstem. The rawmaterial is the same as the predicate device. In addition, it is manufactured through thesame manufacturing process as our Luna Dental Implant System. Our previouslyapproved product, Luna Dental Implant System (K123155), uses the same rawmaterials as the applied product, but only a part of it is coated with TiN. However, thewhole is not coated with TiN, and it can be seen that the portion with TiN coating isthe worst case in terms of biocompatibility. Thus, the safety of the raw material isdemonstrated. This product is sterilized by the user by the method described in theuser manual. |
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. |
| Device Name | Duo Abutment | ComOcta Abutment | Duo Abutment |
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| Design | Image: Abutment design | Image: Abutment design | Image: Abutment design |
|---|---|---|---|
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 4.8, 6.0 | 4.8, 6.0 | 4.6, 5.1, 6.1 |
| Post Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Material | Pure Titanium Gr 4(ASTM F67) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Pure Titanium Gr 4(ASTM F67) |
| Sterilization | User sterile | User sterile | User sterile |
| S.E. | Duo abutment can be used in both anterior and posterior areas of the mouth for cementretained crown and bridge restorations. This product has the same purpose as thepredicate device and has a size within the product size range of Osstem. The rawmaterial is the same as the predicate device. In addition, it is manufactured through thesame manufacturing process as our Luna Dental Implant System. Our previouslyapproved product, Luna Dental Implant System (K123155), uses the same rawmaterials as the applied product, but only a part of it is coated with TiN. However, thewhole is not coated with TiN, and it can be seen that the portion with TiN coating isthe worst case in terms of biocompatibility. Thus, the safety of the raw material isdemonstrated. This product is sterilized by the user by the method described in theuser manual. |
| Device Name | Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. | |
| Device Name | Contour Abutment | ComOcta MillingAbutment | Contour Abutment | |
| Design | Image: Contour Abutment | Image: ComOcta Milling Abutment | Image: Contour Abutment | |
| 510(k) Number | K221752 | K120847 | K123155 | |
| Diameter (mm) | 5.5, 6.7 | 4.8, 6.0 | 4.1, 5.6 | |
| Gingiva Height(mm) | 2.0, 4.0 | 2.0 | 1.5, 3.0 | |
| Material | Pure Titanium Gr 4(ASTM F67) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Pure Titanium Gr 4(ASTM F67) | |
| Sterilization | User sterile | User sterile | User sterile | |
| S.E. | This product has the same purpose as the predicate device and has a size within theproduct size range of Osstem. The raw material is the same as the predicate device(K123155). In addition, it is manufactured through the same manufacturing process asour Luna Dental Implant System. Our previously approved product, Luna DentalImplant System (K123155), uses the same raw materials as the applied product, butonly a part of it is coated with TiN. However, the whole is not coated with TiN, and it |
{9}------------------------------------------------
can be seen that the portion with TiN coating is the worst case in terms of biocompatibility. Thus, the safety of the raw material is demonstrated. This product is sterilized by the user by the method described in the user manual.
| Device Name | Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. | |
| Device Name | Angled Abutment | ComOcta AngledAbutment | Angled Abutment | |
| Design | Image: angled abutment | Image: angled abutment | Image: angled abutment | |
| 510(k) Number | K221752 | K120847 | K123155 / K160106 | |
| Angle (°) | 15, 20 | 15, 20 | 15, 25 | |
| Diameter(mm) | 3.7, 4.8 | 4.8, 6.0 | 4.6, 5.6 | |
| Material | Pure Titanium Gr 4(ASTM F67) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Pure Titanium Gr 4(ASTM F67) | |
| Sterilization | User sterile | User sterile | User sterile | |
| S.E. | This product has the same purpose as the predicate device and has a size within theproduct size range of Osstem. The raw material is the same as the predicate device(K123155). In addition, it is manufactured through the same manufacturing process asour Luna Dental Implant System. Our previously approved product, Luna DentalImplant System (K123155), uses the same raw materials as the applied product, butonly a part of it is coated with TiN. However, the whole is not coated with TiN, and itcan be seen that the portion with TiN coating is the worst case in terms ofbiocompatibility. Thus, the safety of the raw material is demonstrated. This product issterilized by the user by the method described in the user manual. |
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. |
| Device Name | Temporary Abutment | ComOcta TemporaryAbutment | Temporary Abutment |
| Design | Image: Subject Device Design | Image: Predicate Device Design | Image: SHINHUNG MST CO., LTD. Design |
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 5.3, 6.5 | 4.8, 6.0 | 4.1, 4.6 |
{10}------------------------------------------------
| Gingiva Height(mm) | 1.0 | 0, 2.0 | 1.0, 3.0 |
|---|---|---|---|
| Length (mm) | 12.25, 13.55 | 10.0, 12.0 | 12.5, 12.6, 14.5, 14.6*The following sizeconfigurations are notincluded.• 4.1mm diameter x allgingiva height x 12.5mmlength.• 4.1mm diameter x allgingiva height x 14.5mmlength.• 4.6mm diameter x allgingiva height x 12.6mmlength.• 4.6mm diameter x allgingiva height x 14.6mmlength. |
| Material | Pure Titanium Gr 4(ASTM F67) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Pure Titanium Gr 4(ASTM F67) |
| Sterilization | User sterile | User sterile | User sterile |
| S.E. | This product has the same purpose as the predicate device and has a size within theproduct size range of Osstem. The raw material is the same as the predicate device(K123155). In addition, it is manufactured through the same manufacturing process asour Luna Dental Implant System. Our previously approved product, Luna DentalImplant System (K123155), uses the same raw materials as the applied product, butonly a part of it is coated with TiN. However, the whole is not coated with TiN, and itcan be seen that the portion with TiN coating is the worst case in terms ofbiocompatibility. Thus, the safety of the raw material is demonstrated. This product issterilized by the user by the method described in the user manual. |
▪ Screw
| Device Name | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | SHINHUNG MST CO.,LTD. |
| Device Name | Cover Screw | Cover Screw |
| Design | Image: Cover Screw | Image: Cover Screw |
| 510(k) Number | K221752 | K120847 |
| Material | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) |
| Length (mm) | 7.3 | 6.45 |
| Diameter (mm) | 6.15 | 4.8, 6.0 |
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| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
|---|---|---|---|
| S.E. | This product has the same purpose as the predicate device and has a size within theproduct size range of Osstem. The raw material is the same as the predicate device(K123155). In addition, it is manufactured through the same manufacturing process asour Luna Dental Implant System. This product is sterilized by the user by the methoddescribed in the user manual. |
| Device Name | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. |
| Device Name | Closing Screw | Cover Screw |
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| Design | Image: Dental Implant | Image: Dental Implant | Image: Dental Implant |
|---|---|---|---|
| 510(k) Number | New device | K120847 | K123155 |
| Material | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) | Pure Titanium Gr 4(ASTM F67) |
| Length (mm) | 5.5 | 6.45 | 5.3, 5.95 |
| Diameter (mm) | 5.0 | 4.8, 6.0 | 2.84, 3.37 |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| S.E. | This product has the same purpose as the predicate device and has a size within theproduct size range of Osstem. The raw material is the same as the predicate device(K123155). In addition, it is manufactured through the same manufacturing process asour Luna Dental Implant System. This product is sterilized by the user by the methoddescribed in the user manual. |
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO.,LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,LTD. |
| Device Name | Abutment Screw | Ti Screw | |
| Design | Image: Abutment Screw | Image: Ti Screw | Image: SHINHUNG MST CO., LTD. |
| 510(k) Number | K221752 | K120847 | K123155 |
| Material | Titanium Alloy Ti-6Al-4V(ASTM F136) | Titanium Alloy Ti-6Al-4V(ASTM F136) | Titanium Alloy Ti-6Al-4V(ASTM F136) |
| Length (mm) | 8.0 | 6.75 | 8.35, 8.7, 10.0 |
| Diameter (mm) | 2.5 | 2.5 | 2.17, 2.32 |
| Sterilization | User sterile | User sterile | User sterile |
| S.E. | This product has the same purpose as the predicate device and has a size within theproduct size range of Osstem. The raw material is the same as the predicate device(K123155). In addition, it is manufactured through the same manufacturing process asour Luna Dental Implant System. This product is sterilized by the user by the methoddescribed in the user manual. |
8. Non-Clinical Testing
- Fatigue test was performed in accordance with ISO 14801.
- . The following tests were evaluated under the 510k mentioned below. These predicate devices are made by our company and the subject device is made of the same material
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and goes through the same manufacturing processes.
- i. SLA Surface treatment (K123155 and K160106)
- ii. Biocompatibility (K123155)
- iii. Shelf Life (K123155)
- iv. Sterilization (K123155)
-
- Gamma radiation method
-
- Moist Heat Method
-
- v. Packaging (K123155)
- . Endotoxin/LAL testing will be conducted on every batch of the subject device.
- A non-clinical worst-case MRI review was conducted to evaluate the Stella 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 was 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.
9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics.
Overall, the Stella has the following similarities to the predicate device:
- have the same intended use.
- use the same operating principle, ●
- incorporate similar design, ●
- . incorporate the same material and the sterilization method
- similar fatigue testing results to the predicate devices in the market. .
Based on the similarities, we conclude that the Stella is substantially equivalent to the predicate devices.
§ 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.