Healing Abutments and Cover Screws

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 23, 2020 Dentium Co., Ltd. Byung-Sun Kim RA Team Manager 150, Eondong-ro Giheung-gu Yongin-si 446-914 REPUBLIC OF KOREA Re: K192436 Trade/Device Name: Healing Abutments and Cover Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 21, 2020 Received: January 23, 2020 Dear Byung-Sun Kim: 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 (OS) 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. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192436 Device Name Healing Abutments and Cover Screws | Indications for Use (Describe) | Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation. | |--------------------------------|----------------------------------------------------------------------------------| |--------------------------------|----------------------------------------------------------------------------------| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |--------------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C</label> | | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary #### 1. Company | | Submitter | |----------------|--------------------------------------------------------------------| | Name | Dentium Co., Ltd. | | Address | 150, Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea (16985) | | Phone/Fax | Tel. +82-70-7098-8806, Fax. +82-31-8019-9131 | | Contact person | Byung-sun Kim / RA<br>bskim@dentium.com | | Summary Date | 01/17/2020 | #### 2. Device Name | Proprietary name | : Healing Abutments and Cover Screws | |------------------------|--------------------------------------| | Regulation number | : 21 CFR 872.3630 | | Regulation Description | : Endosseous dental implant abutment | | Product code | : NHA | | Device class | : Class II | | Classification Panel | : Dental Products Panel | | Reviewing Branch | : Dental Devices Branch | ### 3. Predicate Device #### Primary Predicate K052957 Implantium Abutments #### Reference Predicate | K041368 | Implantium | |---------|---------------------------------------------| | K112045 | SimpleLine II Abutment System | | K141457 | Dentium Implantium® and SuperLine® Abutment | | K153268 | NR Line Implant System | {4}------------------------------------------------ Dentium Implantium & SuperLine Prosthetics K172640 #### 4. Indication for use Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation. #### 5. Description The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation. Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant. The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only. #### 6. Performance Data Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: · Gamma radiation sterilization validation according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6. - · Accelerated and real time aging studies according to ASTM F1980 demonstrating a shelf life. · Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Dentium submission, K041368, using the identical materials and manufacturing processes including sterilization as the subject device. {5}------------------------------------------------ ### 7. Technological Characteristics The following comparison table of the technological characteristics of the subject device and the predicate devices outlines and provides the similarities and the substantial equivalency of the subject device and the predicate. #### 7.1 Healing Abutment | | Subject device | Primary<br>Predicate | Reference predicate | | | | |-----------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Device name | Healing<br>Abutments and<br>Cover Screws | Implantium<br>Abutments<br>(Healing<br>Abutment) | Implantium<br>(Healing<br>Abutment) | SimpleLine II<br>Abutment<br>System<br>(Healing<br>Abutment) | NR Line<br>Implant System<br>(Healing<br>Abutment) | Dentium<br>Implantium &<br>SuperLine<br>Prosthetics<br>(Healing<br>Abutment) | | Manufacturer | Dentium Co.,<br>Ltd. | Dentium Co.,<br>Ltd. | Dentium Co.,<br>Ltd. | Dentium Co.,<br>Ltd. | Dentium Co.,<br>Ltd. | Dentium Co.,<br>Ltd. | | 510(k) Number | K192436 | K052957 | K041368 | K112045 | K153268 | K172640 | | Indication for<br>use | Dentium<br>Prosthetics are<br>intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | Implantium<br>Prosthetics is<br>intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | The Dentium<br>Co Ltd<br>Implantium is<br>intended to be<br>surgically<br>placed in the<br>bone of the<br>upper or lower<br>jaw arches to<br>provide support<br>for prosthetic<br>devices, such as<br>artificial<br>teeth, and to<br>restore the<br>patient's<br>chewing<br>function. | The SimpleLine<br>II Abutment<br>system is<br>intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | The NR Line<br>Implants<br>System is<br>indicated for<br>use in surgical<br>and restorative<br>applications for<br>placement in<br>the bone of the<br>upper or lower<br>jaw to provide<br>support for<br>prosthetic<br>devices, such as<br>artificial teeth,<br>in order to<br>restore the<br>patient's<br>chewing<br>function. NR<br>Line Implant<br>System is<br>indicated also<br>for immediate<br>loading when | Dentium<br>Implantium® &<br>SuperLine®<br>Prosthetics are<br>intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | #### Comparison of Characteristics 510(k) Summary {6}------------------------------------------------ | | | | | | | good primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal<br>loading. | | |--------------------|---------------------------------|------------------------------|---------------------------------|------------------------------|------------------------------|---------------------------------------------------------------------------------------------|--| | Materials | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | | | Form | Preformed | Preformed | Preformed | Preformed | Preformed | Preformed | | | Connection<br>type | Internal | Internal | Internal | Internal | Internal | Internal | | | Sterilization | Sterile<br>(Gamma<br>Radiation) | Non-sterile | Sterile<br>(Gamma<br>Radiation) | Non-sterile | Non-sterile | Non-sterile | | | Use | Prescription | Prescription | Prescription | Prescription | Prescription | Prescription | | | Single Use Only | Yes | Yes | Yes | Yes | Yes | Yes | | #### Dimension comparison | | Image | Dimension (mm) | | |-----------------------------|----------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject device<br>(K192436) | Image: implant | Diameter | 4.04 / 4.10 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.54 / 5.64 / 5.75 /<br>6.50 / 6.54 / 6.64 / 6.75 / 7.64 / 8.64 / 9.64 | | | | Length | 8.70 / 10.91 / 10.93 / 11.04 / 11.15 / 12.41 / 12.44 / 12.55 / 12.65 / 12.66 /<br>14.42 / 14.44 / 14.55 / 14.66 | | | Image: implant | Diameter | 4.16 / 4.53 / 5.02 / 5.23 / 6.22 / 6.43 | | | | Length | 10.52 / 10.55 / 12.26 / 12.28 / 14.25 / 14.27 | | | Image: implant | Diameter | 4.80 / 6.50 | | | | Length | 6.15 / 6.30 / 7.15 / 7.30 / 8.15 / 8.30 / 9.15 / 9.30 | | | Image: implant | Diameter | 3.70 / 4.30 / 5.50 / 6.50 / 7.50 / 8.50 / 9.50 | | | | Length | 8.10 / 8.60 / 10.10 / 12.10 | | | Image: implant | Diameter | 4.04 / 4.12 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.45 / 5.64 / 5.75 /<br>6.50 / 6.54 / 6.64 / 6.74 / 7.54 / 7.64 / 8.54 / 8.64 / 9.54 / 9.64 | | | | Length | 8.88 / 8.89 / 8.90 / 10.81 / 10.83 / 10.96 / 11.05 / 11.06 / 11.09 / 12.31 / 12.34 /<br>12.45 / 12.55 / 12.56 / 12.57 / 14.32 / 14.34 / 14.51 / 14.56 | | Predicate device | | | | | K052957 | Image: implant | Diameter | 4.04 / 4.10 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.54 / 5.64 / 5.75 /<br>6.50 / 6.54 / 6.64 / 6.75 / 7.64 / 8.64 / 9.64 | | | | Length | 8.70 / 10.91 / 10.93 / 11.04 / 11.15 / 12.41 / 12.44 / 12.55 / 12.65 / 12.66 /<br>14.42 / 14.44 / 14.55 / 14.66 | 510(k) Summary Page 4 of 8 {7}------------------------------------------------ #### K192436 | K041368 | Image: dental implant | Diameter | 4.16 / 4.53 / 5.02 / 5.23 / 6.22 / 6.43 | |---------|-----------------------|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Length | 10.52 / 10.55 / 12.26 / 12.28 / 14.25 / 14.27 | | K112045 | Image: dental implant | Diameter | 4.80 / 6.50 | | | | Length | 6.15 / 6.30 / 7.15 / 7.30 / 8.15 / 8.30 / 9.15 / 9.30 | | K153268 | Image: dental implant | Diameter | 3.70 / 4.30 / 5.50 / 6.50 / 7.50 / 8.50 / 9.50 | | | | Length | 8.10 / 8.60 / 10.10 / 12.10 | | K172640 | Image: dental implant | Diameter | 4.04 / 4.12 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.45 / 5.64 / 5.75 /<br>6.50 / 6.54 / 6.64 / 6.74 / 7.54 / 7.64 / 8.54 / 8.64 / 9.54 / 9.64 | | | | Length | 8.88 / 8.89 / 8.90 / 10.81 / 10.83 / 10.96 / 11.05 / 11.06 / 11.09 / 12.31 / 12.34<br>12.45 / 12.55 / 12.56 / 12.57 / 14.32 / 14.34 / 14.51 / 14.56 | #### 1) Similarities The subject Healing Abutments have the same characteristics for the followings compared to the primary predicate device. - Indication for use, Material, Connection type, Dimension The subject Healing Abutments have the same dimensions cleared under K052957. K041368. K112045, K153268 and K172640. #### 2) Differences The subject Healing Abutments have the different characteristic for the following compared to the primary predicate device. - Sterilization Method #### 3) Discussion The purpose of this submission is to change the sterilization method of Healing Abutments previously cleared under K052957, K041368, K112045, K153268 and K172640. These Healing Abutments which have been provided non-sterile will be sterilized by gamma radiation. In terms of sterilization method there is difference between the subject device and primary predicate device. However, the reference device K041368 is sterilized via gamma radiation as the subject device. And the sterilization method of subject device was validated according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6 In conclusion, the subject device is substantially equivalent to the predicate device because it is verified that the difference does not affect substantial equivalence. {8}------------------------------------------------ #### 7.2 Cover Screw #### Comparison of Characteristics | | Primary<br>Subject device<br>Predicate | | Reference predicate | | | |-----------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Device name | Cover Screw | Implantium<br>(Cover Screw) | SimpleLine II<br>Abutment System<br>(Cover Screw) | NR Line Implant<br>System<br>(Cover Screw) | Dentium<br>Implantium® and<br>SuperLine®<br>Abutments<br>(Cover Screw) | | Manufacturer | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | | 510(k) Number | K192436 | K052957 | K112045 | K153268 | K141457 | | Indication for<br>use | Dentium<br>Prosthetics are<br>intended for use as<br>an aid in<br>prosthetic<br>rehabilitation. | Implantium<br>Prosthetics is<br>intended for use as<br>an aid in<br>prosthetic<br>rehabilitation. | The SimpleLine II<br>Abutment system<br>is intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | The NR Line<br>Implants System<br>is indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement in the<br>bone of the<br>upper or lower jaw<br>to provide support<br>for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's<br>chewing function.<br>NR Line Implant<br>System is<br>indicated also for<br>immediate loading<br>when good<br>primary stability is<br>achieved and with<br>appropriate<br>occlusal loading. | Dentium<br>Prosthetics are<br>intended for use as<br>an aid in<br>prosthetic<br>rehabilitation. | | Materials | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | | Form | Preformed | Preformed | Preformed | Preformed | Preformed | | Sterilization | Sterile<br>(Gamma<br>Radiation) | Non-sterile | Non-sterile | Non-sterile | Non-sterile | | Use | Prescription | Prescription | Prescription | Prescription | Prescription | | Single Use Only | Yes | Yes | Yes | Yes | Yes | 510(k) Summary {9}------------------------------------------------ #### Dimension comparison | | Image | Dimension (mm) | | |-----------------------------|-----------------------|----------------|--------------------| | Subject device<br>(K192436) | Image: dental implant | Diameter | 3.18 / 3.37 / 4.12 | | | | Length | 6.36 / 6.88 / 8.92 | | | Image: dental implant | Diameter | 3.10 / 3.50 | | | | Length | 4.70 / 5.70 | | | Image: dental implant | Diameter | 3.50 / 4.30 | | | | Length | 5.40 / 5.75 | | | Image: dental implant | Diameter | 3.55 | | | | Length | 6.35 | | Predicate device | | | | | K052957 | Image: dental implant | Diameter | 3.18 / 3.37 / 4.12 | | | | Length | 6.36 / 6.88 / 8.92 | | K112045 | Image: dental implant | Diameter | 3.10 / 3.50 | | | | Length | 4.70 / 5.70 | | K153268 | Image: dental implant | Diameter | 3.50 / 4.30 | | | | Length | 5.40 / 5.75 | | K141457 | Image: dental implant | Diameter | 3.55 | | | | Length | 6.35 | #### 1) Similarities The subject Cover Screws have the same characteristics for the followings compared to the primary predicate device. - Indication for use, Material, Dimension The subject Cover Screws have the same dimensions cleared under K052957, K112045, K153268 and K141457. #### 2) Differences The subject Cover Screws have the different characteristic for the following compared to the primary predicate device. - Sterilization Method {10}------------------------------------------------ #### 3) Discussion The purpose of this submission is to change the sterilization method of Cover Screws previously cleared under K052957, K112045, K153268 and K141457. These Cover Screws which have been provided non-sterile will be sterilized by gamma radiation. In terms of sterilization method there is difference between the subject device and primary predicate device. However the sterilization method of subject device was validated according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6. In conclusion, the subject device is substantially equivalent to the predicate device because it is verified that the difference does not affect substantial equivalence. #### 8. Conclusion Based on the information provided, the subject device is substantially equivalent to the predicate devices.