(353 days)
No
The summary describes a physical dental implant and its components, with performance studies focused on mechanical properties, biocompatibility, and MRI compatibility. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The Stella device is intended to restore the patient's chewing capabilities by supporting prosthetic devices, which alleviates a medical condition (loss of teeth and chewing function).
No
The device is a dental implant, which is a surgically placed device providing support for prosthetic devices, not a device used to identify or determine the presence of a disease, injury, or other condition.
No
The device description clearly states it is a "dental implant fixture" made of titanium and includes various physical abutments. The performance studies focus on material properties, mechanical testing, and biocompatibility, all indicative of a physical medical device, not software.
Based on the provided information, the Stella device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Stella is a surgically placed device in the jawbone to support prosthetic devices and restore chewing capabilities. This is a therapeutic and structural function within the body.
- Device Description: The description confirms it's a dental implant fixture made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Stella device is used in vivo (inside the body) as a structural support.
N/A
Intended Use / Indications 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.
Product codes
DZE, NHA
Device 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 pickling to roughen the surface.
The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jawbone
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)
- Fatigue test was performed in accordance with ISO 14801.
- SLA Surface treatment (K123155 and K160106)
- Biocompatibility (K123155)
- Shelf Life (K123155)
- Sterilization (K123155)
- Gamma radiation method
- Moist Heat Method
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
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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3
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 Fixture | |
| Luna Dental Implant | |||
| System | |||
| 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 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 | ET/SS Implant System is | ||
| indicated for use in | |||
| partially or fully | |||
| edentulous mandibles and | |||
| maxillae, in support of | |||
| single or multiple-unit | |||
| restorations including; | |||
| cemented retained, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. The | |||
| abutment is intended for | |||
| use with a dental implant | |||
| fixture to provide support | |||
| for prosthetic restorations | |||
| such as crowns, bridges, or | 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. | |||
| partial denture. | overdenture. | ||
| Structure | - Tissue level fixture |
-
Self tapping
-
Internal Octagonal
connection -
Taper body shape | - Tissue level fixture
-
Self tapping
-
Internal Octagonal
connection -
Straight / Taper body
shape | - Bone level fixture -
Self tapping
-
Internal Hexagonal
connection -
Taper body shape |
| Platform
Diameter
(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 size
configurations are not
included.
· 4.8mm platform diameter
x 3.7mm body diameter x
7.0mm length.
· 4.8mm platform diameter
x 5.2mm body diameter x
all length.
· 6.0mm platform diameter
x 3.7 mm body diameter x
all length.
· 6.0mm platform diameter
x 4.2 mm body diameter x
all length. | 6.0, 7.0, 8.5, 10.0, 11.5,
13.0
*The following size
configurations are not
included.
· 4.8mm platform diameter
x 3.5mm body diameter x
7.0mm length.
· 4.8mm platform diameter
x all body diameter x
6.0mm length.
· 4.8mm platform diameter
x 5.0mm body diameter x
all length.
· 4.8mm platform diameter
x 6.0mm body diameter x
all length.
· 4.8mm platform diameter
x 7.0mm body diameter x
all length.
· 6.0mm platform diameter
x 3.5mm body diameter x
all length.
· 6.0mm platform diameter
x 4.0mm body diameter x
all length.
· 6.0mm platform diameter
x 4.5mm body diameter x
6.0mm length. | 7.0, 8.5, 10.0, 11.5, 13.0,
15.0
*The following size
configurations are not
included.
· 3.7mm body diameter x
7.0mm length.
· 5.7mm body diameter x
15.0mm length.
· 6.0mm body diameter x
15.0mm length.
· 7.0mm body diameter x
15.0mm 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
5
6
| 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 size | |||
| configurations are not | |||
| included. | |||
| . 6.0mm diameter x 2.0mm | |||
| Gingiva height. | 2.0, 3.0, 4.0, 5.0, 6.0 | ||
| *The following size | |||
| configurations are not | |||
| included. | |||
| . 6.0mm diameter x 6.0mm | |||
| Gingiva height. | |||
| Material | Pure Titanium Gr 4 | Titanium Alloy Ti-6Al-4V | Pure Titanium Gr 4 |
7
| (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 permanent | ||
| superstructure. This product has the same purpose as the predicate device and has a | |||
| size within the product size range of Osstem. Unlike Osstem's, the raw material was | |||
| manufactured with Pure Titanium Grade 4 (ASTM F67), and was manufactured with | |||
| the 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 for | ||
| cement retained crown and bridge restorations. This product has the same purpose as | |||
| the predicate device and has a size within the product size range of Osstem. The raw | |||
| material is the same as the predicate device. In addition, it is manufactured through the | |||
| same manufacturing process as our Luna Dental Implant System. Our previously | |||
| approved product, Luna Dental Implant System (K123155), uses the same raw | |||
| materials as the applied product, but only a part of it is coated with TiN. However, the | |||
| whole is not coated with TiN, and it 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 | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO., | ||
| LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO., | |
| LTD. | |||
| Device Name | Duo Abutment | ComOcta Abutment | Duo Abutment |
8
| 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 cement | ||
| retained crown and bridge restorations. This product has the same purpose as the | |||
| predicate device and has a size within the product size range of Osstem. The raw | |||
| material is the same as the predicate device. In addition, it is manufactured through the | |||
| same manufacturing process as our Luna Dental Implant System. Our previously | |||
| approved product, Luna Dental Implant System (K123155), uses the same raw | |||
| materials as the applied product, but only a part of it is coated with TiN. However, the | |||
| whole is not coated with TiN, and it 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 | Contour Abutment | ComOcta Milling | ||
| Abutment | 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 the | |||
| product 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 as | ||||
| our Luna Dental Implant System. Our previously approved product, Luna Dental | ||||
| Implant System (K123155), uses the same raw materials as the applied product, but | ||||
| only 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 Angled | ||
| Abutment | 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 the | |||
| product 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 as | ||||
| our Luna Dental Implant System. Our previously approved product, Luna Dental | ||||
| Implant System (K123155), uses the same raw materials as the applied product, but | ||||
| only a part of it is coated with TiN. However, the whole is not coated with TiN, and it | ||||
| 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 | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST CO., | ||
| LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO., | |
| LTD. | |||
| Device Name | Temporary Abutment | ComOcta Temporary | |
| Abutment | 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 size | |||
| configurations are not | |||
| included. | |||
| • 4.1mm diameter x all | |||
| gingiva height x 12.5mm | |||
| length. | |||
| • 4.1mm diameter x all | |||
| gingiva height x 14.5mm | |||
| length. | |||
| • 4.6mm diameter x all | |||
| gingiva height x 12.6mm | |||
| length. | |||
| • 4.6mm diameter x all | |||
| gingiva height x 14.6mm | |||
| length. | |||
| 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 the | ||
| product 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 as | |||
| our Luna Dental Implant System. Our previously approved product, Luna Dental | |||
| Implant System (K123155), uses the same raw materials as the applied product, but | |||
| only a part of it is coated with TiN. However, the whole is not coated with TiN, and it | |||
| 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. |
▪ 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 the | ||
| product 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 as | |||
| our Luna Dental Implant System. This product is sterilized 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. | |
| Device Name | Closing Screw | Cover Screw |
12
| 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 the | ||
| product 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 as | |||
| our Luna Dental Implant System. This product is sterilized 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 | 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 the | ||
| product 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 as | |||
| our Luna Dental Implant System. This product is sterilized by the user by the method | |||
| described 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
13
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.