Scan Abutments and Comfort Caps

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 19, 2019 Dentium Co., Ltd. Byung-sun Kim RA Team Manager 150, Eondong-ro, Giheung-gu Yongin-si, 446-914 REPUBLIC OF KOREA Re: K191634 Trade/Device Name: Scan Abutments and Comfort Caps Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: September 18, 2019 Received: September 20, 2019 Dear Byung-sun Kim: This letter corrects our substantially equivalent letter of November 4, 2019. 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 for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K191634 Device Name Scan Abutments and Comfort Caps | 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) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <svg height="15" width="15"> <rect height="15" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> <path d="M2,2 L13,13 M13,2 L2,13" stroke="black"></path> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg height="15" width="15"> <rect height="15" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | 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 06/10/2019 ## 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 | Byungsun Kim / RA<br>bskim@dentium.com | | Summary Date | 06/10/2019 | ## 2. Device Name | Proprietary name | : | Scan Abutments and Comfort Caps | |------------------------|---|------------------------------------| | 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 for Scan Abutment | | |-------------------------------------|----------------------------------------------| | K172640 | Dentium Implantium® & SuperLine® Prosthetics | | K153268 | NR Line Implant System | Primary Predicate for Comfort Cap K171142 Healing Cap Multi-Unit Titanium {4}------------------------------------------------ Reference Devices | K173374 | TSV BellaTek Encode Healing Abutments | |---------|---------------------------------------| | K172160 | Southern Implants PEEK Abutments | ### 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 expand the Dentium Prosthetics to include the Scan Abutments and Comfort Caps. Scan Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final abutment. Comfort Caps are used provisionally as an accessory to protect the dental abutment before final prosthesis. They have the design feature that enable to transmit position and angulation data of implant when taking a digital impression using an intra-oral scanner. The Scan Abutments and Comfort Caps are prefabricated and made of Ti-6AI-4V ELI (ASTM F136) or PEEK(ASTM F2026). Scan Abutments are compatible with Dentium Implant(k041368 Implantium and k160965 SuperLine or K153268 NR Line) and Comfort Caps are compatible with Dentium Prosthetics(K052957 Implantium and K172640 SuperLine or K153268 NR Line) #### 6. Performance Data Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: · Steam sterilization validation according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10t6. · Biocompatibility of Ti-6Al-4V ELI (ASTM F136) demonstrated by the referenced Dentium submission, K172640, using the same materials and manufacturing processes as the subject device. {5}------------------------------------------------ And cytotoxicity testing of PEEK (ASTM F2026) has been performed according to ISO 10993-5. No clinical data were included in this submission. ### 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 Scan Abutment - Implantium & SuperLine | | Subject device | Primary Predicate | Reference Predicate | | |-----------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Scan Abutment | Dentium Implantium® &<br>SuperLine® Prosthetics<br>(Healing Abutment) | Southern Implants<br>PEEK Abutments | | | Manufacturer | Dentium Co., Ltd. | Dentium Co., Ltd. | Biomet 3i | Southern Implants (Pty)<br>Ltd | | 510(k) Number | New Device | K172640 | K173374 | K172160 | | Indication for<br>use | Dentium Prosthetics are<br>intended for use as an aid<br>in prosthetic<br>rehabilitation. | Dentium Prosthetics are<br>intended for use as an aid<br>in prosthetic<br>rehabilitation. | The TSVTM BellaTek®<br>Encode® Healing<br>Abutments are intended<br>for use as an accessory to<br>endosseous dental<br>implants during<br>endosseous and gingival<br>healing to prepare<br>gingival tissue for<br>acceptance of a final<br>abutment and restoration. | The Southern Implants<br>PEEK Abutments are<br>premanufactured<br>prosthetic components<br>directly connected to<br>endosseous dental<br>implants and are intended<br>for provisional use up to<br>180 days as an aid in<br>prosthetic rehabilitation. | | Materials | Ti-4Al-6V ELI,<br>PEEK | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | PEEK<br>(ASTM F2026) | | Form | Preformed | Preformed | Preformed | Preformed | | Sterilization | Non-sterile | Non-sterile | Sterile | Sterile | | Use | Prescription | Prescription | Prescription | Prescription | | Single Use Only | Yes | Yes | Yes | Yes | #### Comparison of Characteristics #### 510(k) Summary {6}------------------------------------------------ | Design | | | | | |-------------------|------------------|-----------------|-------------------------------------|---------------| | Diameter | 4.09 ~ 6.41mm | 4.04 ~ 9.64 mm | 3.8, 5.0, 5.6, 6.0, 6.8 mm | 6 x 9, 8 x 11 | | Length | 8.4 ~ 14.4 mm | 8.89 ~ 14.51 mm | Gingival Height<br>3.0, 5.0, 7.0 mm | 5.0 ~ 6.0 mm | | Connection type | Internal | Internal | Internal | Internal | | Scanning feature | Machined marking | - | Machined marking | - | | Surface treatment | None | None | None | None | The subject device Scan Abutment is substantially equivalent to the predicate K172640(Healing Abutment) in indication for use, manufacture, function, design and implant/abutment interface. The intended use of the subject device as a healing abutment with scanning feature machined marking to transmit position and angulation data of implant when taking a digital impression using an intra-oral scanner is equivalent to the reference predicate K173374. The subject device is made of Ti-6A1-4V ELI (ASTM F136) or PEEK (ASTM F2026). Ti-6A1-4V ELI and PEEK are commonly used in endosseous dental implant abutments. The Ti-6AI-4V ELI is identical to the material used for Dentium components cleared previously in K172640 and PEEK is identical to the material cleared previously in K172160. ### 7.2 Scan Abutment - NR Line #### Comparison of Characteristics | | Subject device | Primary Predicate | Reference Predicate | | |-----------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Scan Abutment | NR Line Implant System<br>(Healing Abutment) | TSV BellaTek Encode<br>Healing Abutments | Southern Implants<br>PEEK Abutments | | Manufacturer | Dentium Co., Ltd. | Dentium Co., Ltd. | Biomet 3i | Southern Implants (Pty)<br>Ltd | | 510(k) Number | New Device | K153268 | K173374 | K172160 | | Indication for<br>use | Dentium Prosthetics are<br>intended for use as an aid<br>in prosthetic<br>rehabilitation. | Dentium Prosthetics are<br>intended for use as an aid<br>in prosthetic<br>rehabilitation. | The TSVTM BellaTek®<br>Encode® Healing<br>Abutments are intended<br>for use as an accessory to<br>endosseous dental<br>implants during<br>endosseous and gingival<br>healing to prepare<br>gingival tissue for | The Southern Implants<br>PEEK Abutments are<br>premanufactured<br>prosthetic components<br>directly connected to<br>endosseous dental<br>implants and are intended<br>for provisional use up to<br>180 days as an aid in | {7}------------------------------------------------ | | | acceptance of a final<br>abutment and restoration. | prosthetic rehabilitation. | | |----------------------|------------------------|----------------------------------------------------|-------------------------------------|----------------------| | Materials | Ti-4Al-6V ELI,<br>PEEK | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | PEEK<br>(ASTM F2026) | | Form | Preformed | Preformed | Preformed | Preformed | | Sterilization | Non-sterile | Non-sterile | Sterile | Sterile | | Use | Prescription | Prescription | Prescription | Prescription | | Single Use Only | Yes | Yes | Yes | Yes | | Design | | | | | | Diameter | 4.09 ~ 6.41mm | 3.7 ~ 9.5 mm | 3.8, 5.0, 5.6, 6.0, 6.8 mm | 6 x 9, 8 x 11 | | Length | 9.12 ~ 15.12 mm | 8.6 ~ 12.1 mm | Gingival Height<br>3.0, 5.0, 7.0 mm | 5.0 ~ 6.0 mm | | Connection<br>type | Internal | Internal | Internal | Internal | | Surface<br>treatment | None | None | None | None | The subject device Scan Abutment is substantially equivalent to the predicate K153268 (Healing Abutment) in indication for use, manufacture, function, design and implant/abutment interface. The intended use of the subject device as a healing abutment with scanning feature machined marking to transmit position and angulation data of implant when taking a digital impression using an intra-oral scanner is equivalent to the reference predicate K173374. The subject device is made of Ti-6A1-4V ELI (ASTM F136) or PEEK (ASTM F2026). Ti-6A1-4V ELI and PEEK are commonly used in endosseous dental implant abutments. The Ti-6AI-4V ELI is identical to the material used for Dentium components cleared previously in K153268 and PEEK is identical to the material cleared previously in K172160. ### 6.3 Comfort Cap | | | Comparison of Characteristics | |--|--|-------------------------------| |--|--|-------------------------------| | | Subject device | Primary Predicate | Reference Predicate | |----------------|-------------------------|------------------------------------|-------------------------------------| | Device name | Comfort Cap | Healing Cap Multi-Unit<br>Titanium | Southern Implants<br>PEEK Abutments | | Manufacturer | Dentium Co., Ltd. | Nobel Biocare AB | Southern Implants (Pty) Ltd | | 510(k) Number | New Device | K171142 | K172160 | | Indication for | Dentium Prosthetics are | The Healing Cap Multi-unit | The Southern Implants | 510(k) Summary {8}------------------------------------------------ | use | intended for use as an aid in<br>prosthetic rehabilitation. | Titanium is a<br>premanufactured prosthetic<br>component to be directly<br>connected to the dental<br>abutment during soft tissue<br>healing to protect the<br>internal connection of<br>the abutments and prepare<br>the soft tissue for the<br>prosthetic procedure.<br>Maximum intra-oral use is<br>180-days. | PEEK Abutments are<br>premanufactured<br>prosthetic components<br>directly connected to<br>endosseous dental<br>implants and are intended<br>for provisional use up to 180<br>days as an aid in prosthetic<br>rehabilitation. | |----------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials | Ti-4Al-6V ELI, PEEK | Ti-6Al-4V ELI<br>(ASTM F136) | PEEK<br>(ASTM F2026) | | Form | Preformed | Preformed | Preformed | | Sterilization | Non-sterile | Sterile | Sterile | | Use | Prescription | Prescription | Prescription | | Single Use Only | Yes | Yes | Yes | | Design | | | | | Diameter | 4.5, 5.0, 5.5 mm | 5.0, 6.0, 6.9 mm | 6 x 9, 8 x 11 | | Length | 5.0 mm | 4.1, 5.5 mm | 5.0 ~ 6.0 mm | | Surface<br>treatment | None | None | None | The subject device Comfort Cap is substantially equivalent to the predicate K171142 in indication for use, manufacture, function and design. The intended use of subject and predicate device is to protect the dental abutment before final prosthesis. The subject device is made of Ti-6A1-4V ELI (ASTM F136) or PEEK (ASTM F2026). Ti-6A1-4V ELI and PEEK are commonly used in endosseous dental implant abutments. The Ti-6AI-4V ELI is identical to the material cleared previously in K171142 and PEEK is identical to the material cleared previously in K172160. ### 8. Conclusion The subject device and the primary predicate device have indication for use, have similar technological characteristics, and are made of same materials. The subject device and primary predicate device encompass the equivalent range of physical dimensions, including diameter and length.