Who is the manufacturer of Dentium Implantium & SuperLine Prosthetics?

Dentium Co., Ltd. filed the 510(k) submission for Dentium Implantium & SuperLine Prosthetics (K160828).

What is the FDA product code for Dentium Implantium & SuperLine Prosthetics?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Dentium Implantium & SuperLine Prosthetics?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Dentium Implantium & SuperLine Prosthetics?

Implantium Prosthetics (K052957); SimpleLine II Abutment System (K112045).

Who can help prepare an FDA 510(k) submission like Dentium Implantium & SuperLine Prosthetics?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dentium Implantium & SuperLine Prosthetics

K160828 · Dentium Co., Ltd. · NHA · Sep 15, 2016 · Dental

Device Facts

Record ID	K160828
Device Name	Dentium Implantium & SuperLine Prosthetics
Applicant	Dentium Co., Ltd.
Product Code	NHA · Dental
Decision Date	Sep 15, 2016
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Device Story

Dentium Implantium® & SuperLine® Prosthetics are endosseous dental implant abutments used to support prosthetic restorations. The system includes various abutment types: Dual Milling, Dual, Angled (15°/25°), Temporary, Direct-Casting, and Metal Casting. These components connect to Dentium Implantium®/SuperLine® fixtures via a universal conical connection. The device is used by dental clinicians in a clinical setting to facilitate prosthetic rehabilitation. The abutments are supplied non-sterile and require sterilization by the user. By providing a stable interface between the dental implant and the final prosthesis, the device enables the restoration of dental function and aesthetics for the patient.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including biocompatibility (ISO 10993-1: cytotoxicity, systemic toxicity, pyrogenicity, sensitization, intracutaneous reactivity) and mechanical performance (ISO 14801 static compressive and fatigue testing, corrosion testing, and adaptation accuracy). Fatigue testing passed 5,000,000 cycles without fracture, cracks, or severe distortion.

Technological Characteristics

Materials: Pure Titanium Grade 4, Co-Cr-Mo alloy (ASTM F799), Gold alloy, and Polyacetal (POM). Features: Universal conical connection, various hex heights, lengths, and diameters. Some components feature partial TiN coating. Sterilization: User-performed per manual (ISO 17665-1).

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring dental implant-supported restorations.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Implantium Prosthetics (K052957)
SimpleLine II Abutment System (K112045)

Related Devices

K141457 — DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS · Dentium Co., Ltd. · Nov 12, 2014
K172640 — Dentium Implantium & SuperLine Prosthetics · Dentium Co., Ltd. · May 14, 2018
K070228 — IMPLANTIUM PROSTHETICS · Dentium Co., Ltd. · Nov 20, 2007
K221969 — IU Implant System Abutment · Warantec Co., Ltd. · May 12, 2023
K230143 — DESS Dental Smart Solutions · Terrats Medical SL · Apr 13, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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: 4.0~6.5mm Hex Height: 1.15mm | Image: Dual Milling Abutment Dual Milling Abutment Pure Titanium Grade4 Partially TiN coated Total Length: 12.7~14.7mm Diameter: 4.0~6.5mm 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: 9.2~13.7mm Diameter: 4.5~6.5mm Hex Height: 1.15mm | Image: Dual Abutment Dual Abutment Pure Titanium Grade4 Partially TiN coated Total Length: 9.2~13.7mm Diameter: 4.5~6.5mm 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: 4.5~5.5mm 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.