(387 days)
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No
The summary describes a physical dental implant system made of titanium and titanium alloy, with no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML.
Yes
The device is intended to restore the patient's chewing function and provide support for prosthetic devices, which are therapeutic actions to treat a condition (missing teeth/impaired chewing).
No
The device is a dental implant system intended to provide support for prosthetic devices and restore chewing function, not to identify or diagnose a condition.
No
The device description explicitly states it is made of pure titanium and titanium alloy and consists of physical components like fixtures, abutments, and screws, which are surgically implanted. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Luna Dental Implant System is "surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices... and to restore the patient's chewing function." This describes a device that is implanted directly into the body for a structural and functional purpose.
- Device Description: The description details the physical components (fixture, abutment, screws) and materials (titanium) of the implant system. It also mentions surgical placement and support for prosthetic devices.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
- Biocompatibility and Performance Testing: The described testing focuses on the device's interaction with biological tissues (biocompatibility) and its mechanical performance (static compressive, fatigue, torque, etc.). These are typical tests for implantable medical devices, not IVDs.
In summary, the Luna Dental Implant System is a surgically implanted medical device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications 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
Product codes
DZE, NHA
Device Description
The Luna Dental Implant System is a device of pure titanium(ASTM F67) and titanium alloy(ASTM F136) 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. The fixture's surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System fixture and healing abutment are supplied with gamma sterilization.
Fixtures consisted of mount type and mount free type. Abutments consisted of simple abutment, hex and non-hex duo abutment, hex and non-hex angled abutment (15° & 25°), hex and non-hex contour abutment, hex and non-hex temporary abutment screw abutment with titanium cylinder, ball abutment with socket assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone of the upper or lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Biocompatibility testing on the proposed Luna Dental Implant System has been completed. Requirements for biological evaluation of the proposed device were based on the ISO7405(2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
-ISO Cytotoxicity
-ISO Pyrogenicity
-ISO Intracutaneous reactivity
-ISO Systemic toxicity
-ISO Sensitization
-ISO Implantation
The proposed -ISO Sensitization was evaluated using the following performance bench testing to confirm the performance characteristics:
-ISO Static compressive
-Torque Force
-Rotational shear strength
-ISO Fatigue
-Adaptation Accuracy
-Loosening torque
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Luna Dental Implant System met the established specifications necessary for consistent performance according to its intended use.
Luna Dental Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Submitted by :
Oct /31/2013
Sunbyung, Lee / Manager / Quality assurance team SHINHUNG MST Co., Ltd 1642-8, Donghwa-Ri, Munmak-Eup, Wonju-Si, Gangwon-Do, 220-878, South Korea Phone : +82-33-730-1900 Fax : +82-33-730-1919
2. Device Name :
| Trade Name | : | Luna Dental Implant System |
|---|---|---|
| Common Names | : | Endosseous Dental Implant |
| Classification Name | : | Implant, Endosseous, Root-Form |
3. Predicate Device :
3.1 Dentium Implantium (K041368) Manufactured by Dentium Co., Ltd 3.2 Implantium Prosthetics(K052957) Manufactured by Dentium Co., Ltd
OCT 3 1 2013
4. Device Description :
The Luna Dental Implant System is a device of pure titanium(ASTM F67) and titanium alloy(ASTM F136) 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. The fixture's surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System fixture and healing abutment are supplied with gamma sterilization.
Fixtures consisted of mount type and mount free type. Abutments consisted of simple abutment, hex and non-hex duo abutment, hex and non-hex angled abutment (15° & 25°), hex and non-hex contour abutment, hex and non-hex temporary abutment screw abutment with titanium cylinder, ball abutment with socket
1
assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm
5. Intended 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
6. Substantial Equivalence :
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINHUNG MST Co., Ltd | Dentium Co., Ltd | Dentium Co., Ltd |
| 510(k) Number | New | K041368 | K052957 |
| Materials | Titanium, Titanium Alloy | Titanium, Titanium Alloy | Titanium, Titanium alloy, Gold alloy |
| Form | Implant, Endosseous, Root- | ||
| Form | Implant, Endosseous, Root- | ||
| Form | Abutment, Dental, | ||
| Endosseous, implants | |||
| Indications 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 Dentium Co., Ltd | ||
| Implantium 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 | Intended for use as an aid in | ||
| prosthetic rehabilitation. | |||
| Use | Prescription | Prescription | Prescription |
| Sterilization | It is supplied sterile(Gamma | ||
| radiation) | It is supplied sterile(Gamma | ||
| radiation) | It is supplied Non-sterile |
The comparison between Luna Dental Implant System and other predicated devices is claimed to be substantially equivalence in terms of indication for use, materials, product form, technology, and performance specifications.
The difference between Luna Dental Implant System and predicate devices are the product shape and slight mechanical and physical characteristics. However, the slight differences do not affect to the application of the device. Therefore, we state that Luna Dental Implant System is substantially equivalent to the predicate devices
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SHINHUNG MST
7. Performance Testing
Biocompatibility testing on the proposed Luna Dental Implant System has been completed. Requirements for biological evaluation of the proposed device were based on the ISO7405(2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed
| -ISO Cytotoxicity | -ISO Systemic toxicity |
|---|---|
| -ISO Pyrogenicity | -ISO Sensitization |
| -ISO Intracutaneous reactivity | -ISO Implantation |
The proposed -ISO Sensitization was evaluated using the following performance bench testing to confirm the performance characteristics:
| -ISO Static compressive | -ISO Fatigue |
|---|---|
| -Torque Force | -Adaptation Accuracy |
| -Rotational shear strength | -Loosening torque |
8. Review
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Luna Dental Implant System met the established specifications necessary for consistent performance according to its intended use.
Luna Dental Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
9. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification SHINHUNG MST Co., Ltd concludes that the Luna Dental Implant System is substantially equivalent to the predicate devices as described herein.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines extending from its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2013
SHINHUNG MST Company, Limited Sunbyung Lee Team Leader 1642-8, Donghwa-Ri, Munmak-Eup Wonju-Si. Gangwon-Do 220-878 REPUBLIC OF KOREA
Re: K123155
Trade/Device Name: Luna Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: August 26, 2013 Received: August 30, 2013
Dear Mr. Lee:
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. 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.
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 (reporting of medical
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Page 2 - Mr. Lee
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MarySTBuner-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for use Statement
K123155 510(k) Number ( If known ) :
Device Name : Luna Dental Implant System
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
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/12 description: The image shows a signature and some text. The signature appears to be "Susan Runner, DDS, MA". Above the signature, the text reads "Mary S. Runner - SVA 2013.10.31 12:30:37 -04'00'". The text seems to indicate a date and time.
Indication for use statement