Customized Abutment

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ARUM DENTISTRY Co., Ltd. Boyeon Lim Official Correspondent 23, Gukjegwahak 11-ro, Yuseong-gu Daeieon, 34002 REPUBLIC OF KOREA May 9, 2024 Re: K234112 Trade/Device Name: Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, DZE Dated: December 27, 2023 Received: April 8, 2024 Dear Boyeon Lim: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ Page 3 For comprehensive regulatory information about mediation-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 Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K234112 Device Name Customized Abutment Indications for Use (Describe) The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw. Patient-Specific Abutment is compatible with following Implant Systems: 1. Zimmer Tapered Screw-Vent® / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7 2. Straumann® Bone Level Tapered Implant / Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4 All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of two triangles on the left side, one red and one yellow. To the right of the triangles is the text "ARUM" in a bold, dark brown font, with the word "DENTISTRY" underneath it in the same font. # 7. 510(K) Summary # Submitter ARUM DENTISTRY Co., Ltd. Boyeon Lim 23, Gukjeqwahak 11-ro, Yuseong-qu Daejeon, 34002 Republic of Korea Email: arum_ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633 #### Device Information - . Trade Name: Customized Abutment - . Common Name: Abutment, Implant, Dental, Endosseous - . Classification Name: Endosseous dental implant abutment - Primary Product Code: NHA - . Panel: Dental - . Regulation Number: 21 CFR 872.3630 - . Device Class: Class II - Date Prepared: 05/09/ 2024 #### Predicate Devices: The subject device is substantially equivalent to the following predicate devices: # Primary Predicate - K223634, Customized Abutment by ARUM DENTISTRY Co., Ltd. . #### Reference Device - . K140878, Straumann® Bone Level Tapered Implant Roxolid SLActive manufactured by Straumann USA, LLC - . K112160, Tapered Screw-Vent® X Implant System manufactured by Zimmer Dental, Incorporated - . K013227, Screw Vent® and Tapered Screw Vent® manufactured by Sulzer Dental Inc. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is made up of a red triangle on top and a smaller yellow triangle on the bottom. The words "ARUM DENTISTRY" are in a bold, sans-serif font. Device Description: Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific abutment are 3.3, 3.7, 4.1, 4.7, 4.8, 6.0 mm and Hex and square connection design. | No. | Proprietary Name | Implant diameter<br>size (mm) | Restorative<br>Platform diameter<br>(mm) | |-----|---------------------------------------|-------------------------------|------------------------------------------| | 1 | Zimmer Tapered Screw-vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | | 2 | Straumann® Bone Level Tapered Implant | 3.3, 4.1, 4.8 | 3.1, 3.7, 4.4 | Customized Abutments are compatible with the implant system listed in the following table: Customized abutments are supplied with an abutment screw and provided non-sterile. Patient-specific abutment design parameters: | Parameter | Min (mm) | 10 Ø Max (mm) | 14 Ø Max (mm) | |---------------------------------------------|------------------------------------|---------------|---------------| | Total Height | 6.0 | 16.0 | 16.0 | | Post Height for Single-<br>Unit Restoration | 4.0 | 13.0 | 13.0 | | Angle | 0° | 30° | 30° | | Wall Thickness | 0.5 | 3.8 | 6.0 | | Diameter | Based on minimum<br>wall thickness | 9.9 | 13.9 | | Gingival Height | 0.5 | 4.0 | 4.0 | * Post height for single-unit restoration is defined as the cementable post measured above the gingival collar of the final abutment design. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a dark brown, bold font. # Indication for Use The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw. Patient-Specific Abutment is compatible with following Implant Systems: - 1. Zimmer Tapered Screw-Vent® / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7 - 2. Straumann® Bone Level Tapered Implant / Implant diameter size (mm): 3.3. 4.1. 4.8 / Restorative Platform diameter (mm): 3.1. 3.7. 4.4 All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture. # Materials: Customized Abutment and Abutment screw are fabricated from Ti-6AI-4V Eli conforming to ASTM F136. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one yellow. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below. The text is in a dark brown color. # Summaries of Technological Characteristics & Substantial Equivalence Discussion | | Subject Device | | | | Primary Predicate | | | | |-------------------------------|--------------------------------------------------------------------|------------------------------------------|------------------|--------------------------|-------------------------------------------------------------------------|------------------------------------------|------------------|------------------| | Manufacturer | ARUM DENTISTRY Co., Ltd. | | | ARUM DENTISTRY Co., Ltd. | | | | | | Trade Name | Customized Abutment | | | Customized Abutment | | | | | | 510(k) Number | NA | | | | K223634 | | | | | Device Classification | Endosseous Dental Implant, Abutment (872.3630) | | | | Endosseous Dental Implant, Abutment (872.3630) | | | | | Product Code | NHA | | | | NHA | | | | | Material | Ti-6AL-4V Eli (ASTM F136) | | | | Ti-6AL-4V Eli (ASTM F136) | | | | | Diameter (mm) | CAD/CAM Patient-Specific Abutment: 3.3, 3.7,<br>4.1, 4.7, 4.8, 6.0 | | | | CAD/CAM Patient-Specific Abutment: 3.8, 4.0,<br>4.5, 5.0, 5.5, 6.0, 6.5 | | | | | | Parameter | Min (mm) | 10 Ø Max<br>(mm) | 14 Ø Max<br>(mm) | Parameter | Min (mm) | 10 Ø Max<br>(mm) | 14 Ø Max<br>(mm) | | | Total Height | 6.0 | 16.0 | 16.0 | Total Height | 6.0 | 16.0 | 16.0 | | | Post Height for<br>Single-Unit<br>Restoration | 4.0 | 13.0 | 13.0 | Post Height for<br>Single-Unit<br>Restoration | 4.0 | 13.0 | 13.0 | | Abutment Design<br>Parameters | Angle | 0° | 30° | 30° | Angle | 0° | 30° | 30° | | | Wall Thickness | 0.5 | 3.8 | 6.0 | Wall Thickness | 0.5 | 3.8 | 6.0 | | | Diameter | Based on<br>minimum<br>wall<br>thickness | 9.9 | 13.9 | Diameter | Based on<br>minimum<br>wall<br>thickness | 9.9 | 13.9 | | | Gingival<br>Height | 0.5 | 4.0 | 4.0 | Gingival<br>Height | 0.5 | 4.0 | 4.0 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM" and "DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one yellow, that are arranged to form a larger triangle. The words "ARUM" and "DENTISTRY" are written in a bold, sans-serif font, with "ARUM" on top and "DENTISTRY" on the bottom. | Sterile | Steam Sterilization by user (Provided Non-Sterile) | | | | Steam Sterilization by user (Provided Non-Sterile) | | | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|----------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------|--------------------------------| | Type of Retention | Screw-retained or cement retained | | | | Screw-retained or cement retained | | | | | Anatomical Site | Oral Cavity | | | | Oral Cavity | | | | | Constructions | Machined | | | | Machined | | | | | Indications For Use | The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. | | | | The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. | | | | | | No. | Proprietary Name | Implant diameter size (mm) | Restorative Platform diameter (mm) | No. | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) | | | 1 | Zimmer Tapered Screw-vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | 1 | NB I Implant System | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.15, 4.25, 4.5, 5.0 | | | All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. | | | | All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture. | | | | | | 2 | Straumann® Bone Level Tapered Implant | 3.3, 4.1, 4.8 | 3.1, 3.7, 4.4 | | | | | | Substantial<br>Equivalence<br>Comparison | The subject patient-specific abutment is substantially equivalent in designs, dimensions, material, indications, abutment seat, screw seat, anatomical site, connection, abutment design parameters and technological characteristics with the identified primary predicate device. The patient-specific abutment is similar in fundamental scientific technology to the predicate. The Indications for Use of the subject and | | | | | | | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one light orange. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below. | primary predicate device are identical other than the compatible implant systems. The difference is | |-----------------------------------------------------------------------------------------------------------| | mitigated by fatigue testing, reverse engineering, and the identification of reference devices for | | compatible implant bodies. Both the predicate and subject devices are intended to be milled into patient- | | specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any | | differences in technical characteristics are accompanied by information that demonstrated the device is | | substantially equivalent to the predicate. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is made up of a red triangle on top of a smaller, light orange triangle. The words "ARUM DENTISTRY" are in a bold, dark brown font, with "ARUM" on top and "DENTISTRY" below. ### MR Environment Condition Non-clinical worst-case MRI Review was performed to evaluated the metallic. The Customized Abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. #### Biocompatibility Biocompatibility of Ti-6Al-4V Eli (ASTM F136) demonstrated by the reference ARUM DENTISTRY submission, K223634, using the same materials and manufacturing processes as the subject device. #### Sterilization validation The Customized Abutment delivered non-sterile to be end-user sterilized, the recommended sterilization has been validated according to ISO 17655-1 and to applicable recommendations in the FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The predicate devices may be leveraged for the subject devices because of using the same materials, manufacturing methods, and sterilization procedures. The sterilization methods were leveraged from predicated K223634. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. #### Non-Clinical Test Data Non-clinical performance data submitted to demonstrate substantial equivalence included: Biocompatibility testing of the K223634 predicate device to ISO 10993-5 and ANSI/AAMI ST72 in support of the Subject device; reverse engineering of the OEM implant bodies, OEM abutments and OEM abutment screws to confirm compatibility; and static and fatigue testing according to ISO 14801. No clinical data is included in this submission. # Conclusion Slight differences in the compatible implant system abutments available in the Subject and Predicate device systems does not change the intended use of the devices to provide support for single or multi-unit prosthetic restorations. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, sans-serif font. K234112 The slight differences in the Technological Characteristics of the Subject and Predicate devices do not change the intended use of the devices to provide support for single or multiunit prosthetic restorations or introduce new risk or concerns of safety and effectiveness. Differences in Subject device abutment design parameters were validated with respect to intended use through Performance testing. Overall, the Customized Abutment is substantially equivalent to the Predicate device.