(174 days)
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No
The document describes standard dental implant prosthetics and their materials and performance testing, with no mention of AI or ML.
No.
The device description and intended use state that it serves as "an aid in prosthetic rehabilitation," which are components for dental prosthetics and not directly involved in treating a disease or condition.
No
The device is described as an aid in prosthetic rehabilitation, consisting of various abutments used for dental prosthetics. It does not perform any diagnostic function.
No
The device description explicitly states that the device consists of physical components made of materials like Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, and Polyacetal (POM). It also mentions sterilization and performance bench testing on these physical components. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation." This describes a device used in a clinical setting to support dental prosthetics, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details components like abutments made of titanium and alloys, which are used to connect dental implants to prosthetics. This aligns with a surgical or restorative device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The performance studies focus on mechanical properties, biocompatibility, and structural integrity, which are typical for implantable or surgically placed devices.
Therefore, the Dentium Implantium® & SuperLine® Prosthetics are classified as a medical device used in dental procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.
They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.
The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.
Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,
Gold Alloy and Polyacetal (POM): Direct Casting Abutment.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing on the proposed Dentium Implantium® / SuperLine® Prosthetics has been completed. Requirements for biological evaluation of the purposed device were based on ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are nontoxic 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
The proposed Dentium Implantium® / SuperLine® Prosthetics were evaluated using the following performance bench testing to confirm the performance characteristics:
-ISO Static compressive
-Corrosion Testing
-ISO Fatigue
-Adaptation Accuracy
Static Compressive mean and Fatique Limit were evaluated according to ISO 14801. Fracture or cracks or severe distortion of any parts were not detected at the fatigue limit and passed 5,000,000 cycles.
Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.
Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.
In addition, sterilization validation information and recommended sterilization method based on ISO 17665-1 is provided in the Information for Use.
The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles embedded within its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
Dentium Co., Ltd. Sangpil Yoon Regulatory 150. Eondong-ro. Giheung-gu Gyeonggi-do 443-270 KOREA
Re: K160828
Trade/Device Name: Dentium Implantium® & SuperLine® Prosthetics Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 5, 2016 Received: August 9, 2016
Dear Sangpil Yoon:
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.
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 (reporting of medical 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 Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Dentium Co. Ltd. Implantium® & SuperLine® Prosthetics Abbreviated 510(k)
Indications for Use
K160828 510(k) Number:
Device Name: Dentium Implantium® & SuperLine® Prostehtics
Indications for Use:
Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Prescription Use 区 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use □ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
COMPANY CONFIDENTIAL Indications for Use Statement Section 4 - Page 2
3
Dentium Co. Ltd. Implantium® / SuperLine® Prosthetics Abbreviated 510(k)
510(k) Summary
1. Company
| Submitter | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 150, Eondong-ro, Giheung-gu, Youngin-si, Gyeonggi-do, 446- |
| 914, Korea | |
| Phone / Fax | +82 31 207 2200 / +82 31 207 3883 |
| Contact person | Sangpil Yoon |
| spyoon@dentium.com |
2. Device Name
| Trade / Proprietary name: | Dentum Implantium® / SuperLine®
Prosthetics |
|---------------------------|------------------------------------------------|
| Common name: | Prosthetic Device |
| Classification name: | Abutment, Implant, Dental, Endosseous |
| Regulation number: | 872.3630 |
| Class: | II |
| Panel: | Dental |
| Product code: | NHA |
3. Predicate Device
K052957 - Implantium Prosthetics K112045 - SimpleLine II Abutment System
4
4. Description
Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.
They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.
The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.
Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,
Gold Alloy and Polyacetal (POM): Direct Casting Abutment.
5. Indication for Use
Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.
6. Substantial Equivalence
-
Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment
-
. Angled abutments are only available at 15 degree and 25 degree angles.
-
. All other abutments are cast straight. (0 degrees)
| | Implantium® / SuperLine®
Prosthetics
(Subject Device) | Implantium Prosthetics
(Primary Predicate) | Similarities /
Differences
of Devices |
|---------------------------------------|-------------------------------------------------------------|-----------------------------------------------|---------------------------------------------|
| Company
Name | Dentium Co., Ltd. | Dentium Co., Ltd. | Same |
| 510(k)
Number | New Device | K052957 | - |
| Classification
and Product
Code | Class II; 872.3630; NHA | Class II; 872.3630; NHA | Same |
5
Dentium® / SuperLine® Prosthetics® Prostheticss
Implantium® / SuperLine® Prostheticss
Abbreviated 510(k) Abbreviated 510(k)
| Indications
for use | Dentium Implantium®/
SuperLine® Prosthetics is | Implantium® SuperLine®
Prosthetics is intended for | Same |
|------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------|------|
| intended for use as an aid
in prosthetic rehabilitation | use as an aid in prosthetic
rehabilitation | | |
6
Dentium Co. Ltd. lmplantium® / SuperLine® Prosthetics Abbreviated 510(k)
| Shape
Material
Coating
Dimension | Image: Dual Milling Abutment
Dual Milling Abutment
Pure Titanium Grade4
Non-coated
Total Length: 14.7mm
Diameter: 4.06.5mm14.7mm
Hex Height: 1.15mm | Image: Dual Milling Abutment
Dual Milling Abutment
Pure Titanium Grade4
Partially TiN coated Total
Length: 12.7
Diameter: 4.06.5mm13.7mm
Hex Height: 0.93mm | New devices
are designed to
add various
Hex Height
options.
Detailed SE
discussions
mentioned as
belows. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Dual Abutment
Dual Abutment
Pure Titanium Grade4
Non-coated
Total Length: 9.2
Diameter: 4.56.5mm Hex13.7mm
Height: 1.15mm | Image: Dual Abutment
Dual Abutment
Pure Titanium Grade4
Partially TiN coated Total
Length: 9.2
Diameter: 4.56.5mm5.5mm
Hex Height: 0.93mm | New devices
are designed to
add various
Hex Height
options.
Detailed SE
discussions
mentioned as
belows. |
| | Image: Angled Abutment
Angled Abutment
Pure Titanium Grade4
Non-coated
Total Length: 15.31mm
Diameter: 4.5
Hex Height: 1.15mm | Image: Angled Abutment
Angled Abutment
Pure Titanium Grade4
Partially TiN coated
Total Length: 13.3mm
Diameter: 4.5~5.5mm
Hex Height: 0.93mm | New devices
are designed to
add various
Total Length &
Hex Height
options.
Detailed SE
discussions
mentioned as
belows. |
| | Image: Temporary Abutment
Temporary Abutment
Pure Titanium Grade4
Non-coated
Total Length: 13.7mm
Diameter: 4.5mm
Hex Height: 1.15mm | Image: Temporary Abutment
Temporary Abutment
Pure Titanium Grade4
Non-coated
Total Length: 13.7mm
Diameter: 4.5mm
Hex Height: 0.93mm | New devices
are designed to
add various
Hex Height
options.
Detailed SE
discussions
mentioned as
belows. |
- Metal Casting Abutment, Direct Casting Abutment
| | Implantium® / SuperLine®
Prosthetics
(Subject Device) | SimpleLine II Abutment
System
(Primary Predicate) | Similarities /
Differences
of Devices |
|------------------|-------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------|
| Company
Name | Dentium Co., Ltd. | Dentium Co., Ltd. | Same |
| 510(k)
Number | New Device | K112045 | - |
7
Dentium Co. Ltd. Implantium® / SuperLine® Prosthetics Abbreviated 510(k)
| Classification
and Product
| Code | Class II; 872.3630; NHA | Class II; 872.3630; NHA | Same |
|---|---|---|---|
| Indications | |||
| for use | Dentium Implantium®/ | ||
| SuperLine® Prosthetics is | |||
| intended for use as an aid | |||
| in prosthetic rehabilitation | SimpleLine II Abutment | ||
| system is intended for use | |||
| as an aid in prosthetic | |||
| rehabilitation. | Same | ||
| Shape | |||
| Material | |||
| Coating | |||
| Dimension | Metal Casting Abutment | ||
| Image: Metal Casting Abutment | |||
| Co-Cr-Mo | |||
| Non-coated | |||
| Total Length:18.7mm | |||
| Diameter: 4.30mm | |||
| Hex Height: 1.15mm |
Direct Casting Abutment
Image: Direct Casting Abutment
Gold alloy
Non-coated
Total Length:19.2
Diameter: 4.50
Hex Height: 1.15mm | Metal Casting Abutment
Image: Metal Casting Abutment
Co-Cr-Mo
Non-coated
Total Length:19.2
Diameter: 4.50
Hex Height: 0.93mm
Direct Casting Abutment
Image: Direct Casting Abutment
Gold alloy
Non-coated
Total Length:18.95 to 19.1
Diameter: 4.50
Hex Height: 0.93mm | New devices
are designed to
add various
Total Length &
Diameter &
Hex Height
options.
Detailed SE
discussions
mentioned as
belows. |
Raw material, mechanical and physical properties, shape, and intended use are similar to the predicated devices. The differences between the Implantium® / SuperLine® Prosthetics and predicate devices are the slight mechanical and physical characteristics. However, the slight differences do not affect the application of the device. Therefore, we state that Implantium® / SuperLine® Prosthetics are substantial equivalent with the predicate devices.
7. Identification of the Risk
Risk analysis was performed according to Guidance for Industry and FDA staff - Class II Special Controls Guidance Document:Root-form Endosseous Dental Implants and Endosseous Dental Abutments issued on May 12, 2004 and ISO 14971:2007, "Medical devices - Application of risk management to medical devices". All risks identified have been mitigated based on performance testing results and any residual risk is within acceptable levels.
8
Dentium Co. Ltd. Implantium® / SuperLine® Prosthetics Abbreviated 510(k)
8. Device Characteristics
Dentium Implantium® / SuperLine® Prosthetics are supplied in many different shapes and sizes to meet the patient specific needs of our customers. All abutments are made with Dentium's universal conical connection so that they securely mate with any Dentium Implantium® / SuperLine® Fixture(cleared under 510(k) # 041368).
9. Performance Testing
Biocompatibility testing on the proposed Dentium Implantium® / SuperLine® Prosthetics has been completed. Requirements for biological evaluation of the purposed device were based on ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are nontoxic 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 |
The proposed Dentium Implantium® / SuperLine® Prosthetics were evaluated using the following performance bench testing to confirm the performance characteristics:
| -ISO Static compressive | -ISO Fatigue |
|---|---|
| -Corrosion Testing | -Adaptation Accuracy |
Static Compressive mean and Fatique Limit were evaluated according to ISO 14801. Fracture or cracks or severe distortion of any parts were not detected at the fatigue limit and passed 5,000,000 cycles.
10. Non-clinical Testing
Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.
COMPANY CONFIDENTIAL
9
Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.
In addition, sterilization validation information and recommended sterilization method based on ISO 17665-1 is provided in the Information for Use.
The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
11. Review
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Dentium Implantium® / SuperLine® Prosthetics met the established specifications necessary for consistent performance according to its intended use.
Dentium Implantium® / SuperLine® Prosthetics have been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices complying with the applicable International and US regulations.
12. Conclusions
All of the data, consistent with the recommendations in the FDA guidance document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments, demonstrate that Dentium Implantium & SuperLine Prosthetics are substantially equivalent to the predicate device.