(256 days)
No
The summary describes a dental implant system consisting of physical components (fixtures, abutments, screws). While it mentions "digitally designed abutments" and "CAD/CAM zirconia superstructure," this refers to computer-aided design and manufacturing processes, not AI or ML for analysis, diagnosis, or treatment planning. There are no mentions of AI, ML, or related terms in the text.
Yes
This device is a dental implant system used to replace missing teeth and support dental prostheses, directly addressing a health condition (edentulism) and restoring function.
No
The SD Implant System is a dental implant system designed to replace missing teeth and support dental prostheses. It is a restorative and surgical device, not a diagnostic one, as it does not perform any function related to diagnosing a condition or disease.
No
The device description explicitly lists and describes various physical components such as fixtures, abutments, screws, and cylinders, all made of materials like titanium and zirconia. It also details surgical procedures and mechanical testing, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system used for supporting dental restorations in the mouth. This is a surgical and prosthetic device, 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 the components of a dental implant system (fixtures, abutments, screws) and their function in replacing missing teeth and supporting prosthetics. This aligns with a medical device used for treatment and restoration, not for in vitro diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is a dental implant system, which falls under the category of medical devices used for surgical and restorative procedures.
N/A
Intended Use / Indications for Use
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surqical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
SD Implant System consist of below: Fixture - SD Bone Level Fixture Abutment - Cover Screw - Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment - Angled Abutment - Master Fix - Master Fix Screw - Digital Abutment - Temporary Abutment - Multi Abutment - Multi Angled Abutment - Multi Scan Healing Cap - Multi Scan Healing Cap Screw - Multi Master Fix - Multi Master Fix Screw - Multi Ti Cylinder - Multi Digital Cylinder - Multi Temporary Cylinder - Multi Cylinder Screw
SD Implant System is consisted with Fixtures (SD Bone Level Fixture) and Abutments (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment, Master Fix, Digital Abutment, Temporary Abutment, Multi Abutment, Multi Angled Abutment, Multi Scan Healing Cap, Multi Master Fix, Multi Ti Cylinder, Multi Digital Cylinder, Multi Temporary Cylinder)
Fixtures: This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function. An endosseous dental implant is a device made of a material Pure titanium (Conforming to ASTM F67) which will be placed in the alveclar bone to replace the function of missing tooth. The SD Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The subject device abutments are not compatible with 3.8mm diameter implant bodies cleared in K213506 and K230725, nor with 3.2mm diameter implant bodies cleared in K240091.
Abutments: SD Implant System Abutment is compatible with the SD Implant Fixture and Some of the SD Implant System connections are compatible with NB 1 Compatible with SA Implant System, NB Implant System and NB Mini Implant System. (Cleared K213506, K230725, K240091) SD Implant System Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures, Separate sets of abutments are presented for compatibility with each Fixture. Dental Abutments are similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics. The Multi Abutments and Multi Angled Abutments intended to be placed onto osseointegrated dental implants to provide support for prosthetic superstructures at the gingival level. Multi Abutments are available as straight abutments, which have an integrated thread and can be placed directly onto the implant. Multi Angled Abutments are angled abutments, which can be attached to the implant with the corresponding abutment screw. The multi-unit abutments are intended for multi-unit restoration only.
The Cover Screw, Healing Abutment, Scan Healing Abutment, Scan Healing Abutment Screw, Multi Scan Healing Cap and Multi Scan Healing Cap Screw are provided sterile by the manufacturer. All other abutments are provided non-sterile and should be sterilized by the end user before use. The multi-unit abutments included in this system are specifically intended to be used solely for multiunit restorations. The SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are composed of two-piece abutment that is a titanium base at the bottom and zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction. All digitally designed custom abutments for use with SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinderare intended for single-unit or multi-unit restorations.
For the Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations (length above the abutment collar / gingival height) – 4.5 mm; Maximum gingival height - 5.0 mm; Minimum gingival height - 1.5 mm; Angulation - 0° and All zirconia superstructures are for straight abutments only. The Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6AI-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibular and maxillary areas, mandibular central, lateral incisor and maxillary lateral incisor regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility of Ti-6AI-4V Eli (ASTM F136) demonstrated by the reference ARUM DENTISTRY submission, K213506, using the same materials and manufacturing processes as the subject device.
Sterilization validating testing has been performed in accordance with ISO 11137-1 and ISO 11137-2 to verify the sterility assurance level (10°) by selecting and substantiating a 25 kGy dose using method VDmax25. (Referenced from K213506);
End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K213506;
LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016;
Shelf-Life: The tests to validate the Shelf-Life of the device through the proposed Shelf-Life were conducted using the accelerated aging method in accordance to ASTM F1980 and test results validated 5 years Shelf-Life. Also, the following guidance documents were referred to - Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. (referenced from K213506);
Non-Clinical Data: Mechanical performance testing was performed according to ISO 14801. For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing. Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate devices, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible implant designs, or are mitigated by the mechanical performance testing. Non-clinical performance data submitted to demonstrate substantial equivalence included: - Static and fatigue testing according to ISO 14801. - Scanning electron microscopy (SEM) was conducted to demonstrate a clean surface free of any chemical or particle residual from the surface. - Energy dispersive X-ray spectroscopy (EDS) was conducted to demonstrate surface free of contaminants. The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate.
MR Environment Condition: Non-Clinical worst-case MRI review was performed to evaluated the SD Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Terry O. Woods, Jana Delfino, & Sunder Rajan. (2019). Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices. Journal of Testing and Evaluation 49.2, 783-795), based on the entire system including all variations (all compatible implant bodies, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K230725, K232560, K223634, K240091, K240603, K161416, K211090, K231753, K233450, K232268, K190837
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).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ARUM DENTISTRY Co., Ltd. February 24, 2025 Choi Won-Yi Official Correspondent 23, Gukjegwahak 11-ro, Yuseong-gu Daeieon, 34002 REPUBLIC OF KOREA
Re: K241703
Trade/Device Name: SD Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 13, 2024 Received: January 28, 2025
Dear Choi Won-Yi:
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.
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"
1
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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
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,
Sherrill Lathrop Blitzer
for 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
510(k) Number (if known) K241703
Device Name SD Implant System
Indications for Use (Describe)
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
Submitter
ARUM DENTISTRY Co., Ltd. Won-Yi Choi 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 Republic of Korea Email: arum_ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633
Device Information
- Trade Name: SD Implant System ●
- Common Name: Implant, Endosseous, Root-Form
- Classification Name: Endosseous Dental Implant .
- Primary Product Code: DZE ●
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3640 ●
- Device Class: Class II ●
- Date Prepared: 02/24/2025 .
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K213506, NB 1 SA Implant System by Arumdentistry Co., Ltd.
Reference Device
- . K230725, NB Implant System by Arumdentistry Co., Ltd.
- K232560, Angled Abutment by Arumdentistry Co., Ltd. .
- K223634, Customized Abutment by Arumdentistry Co., Ltd.
- K240091, NB Mini Implant System, by Arumdentistry Co., Ltd. ●
- . K240603, Ti-Base & Master Fix by Arumdentistry Co., Ltd.
- K161416, Multi-unit Abutment Plus by Nobel Biocare AB ●
- . K211090, ZENEX Implant System by Izenimplant Co., Ltd.
- K231753, Oneday Implant Abutment by Oneday Biotech Co., Ltd. ●
- K233450, MegaGen Dental Implant Abutment Scan Healing Abutment; Temporary . Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment;
5
Multi-unit Abutment; Multi-unit Angled Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw by MegaGen Implant Co., Ltd.
- K232268, STERI-OSS Implant System by Zeros Co., Ltd. .
- K190837, Internal Hex Implant System by EBI Inc. .
7.1. Device Description
7.1.1. General Description
SD Implant System consist of below:
Fixture
- . SD Bone Level Fixture
Abutment
- . Cover Screw
- Healing Abutment
- . Scan Healing Abutment
- . Scan Healing Abutment Screw
- . Cemented Abutment
- Angled Abutment
- . Master Fix
- . Master Fix Screw
- . Digital Abutment
- Temporary Abutment
- Multi Abutment
- . Multi Angled Abutment
- Abutment Screw
- Multi Scan Healing Cap
- . Multi Scan Healing Cap Screw
- . Multi Master Fix
- Multi Master Fix Screw
- . Multi Ti Cylinder
- . Multi Digital Cylinder
- . Multi Temporary Cylinder
- . Multi Cylinder Screw
SD Implant System is consisted with Fixtures (SD Bone Level Fixture) and Abutments (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment, Master Fix, Digital Abutment, Temporary Abutment, Multi Abutment, Multi Angled Abutment,
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Multi Scan Healing Cap, Multi Master Fix, Multi Ti Cylinder, Multi Digital Cylinder, Multi Temporary Cylinder)
Device Description
1) Fixtures
This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function.
An endosseous dental implant is a device made of a material Pure titanium (Conforming to ASTM F67) which will be placed in the alveclar bone to replace the function of missing tooth. The SD Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
The subject device abutments are not compatible with 3.8mm diameter implant bodies cleared in K213506 and K230725, nor with 3.2mm diameter implant bodies cleared in K240091.
2) Abutments
SD Implant System Abutment is compatible with the SD Implant Fixture and Some of the SD Implant System connections are compatible with NB 1 Compatible with SA Implant System, NB Implant System and NB Mini Implant System. (Cleared K213506, K230725, K240091)
SD Implant System Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures, Separate sets of abutments are presented for compatibility with each Fixture. Dental Abutments are similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
The Multi Abutments and Multi Angled Abutments intended to be placed onto osseointegrated dental implants to provide support for prosthetic superstructures at the gingival level. Multi Abutments are available as straight abutments, which have an integrated thread and can be placed directly onto the implant. Multi Angled Abutments are angled abutments, which can be attached to the implant with the corresponding abutment screw. The multi-unit abutments are intended for multi-unit restoration only.
Below are the abutment's features:
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| No. | Device Name | Uses | Surface treatment |
|---|---|---|---|
| 1 | Cover Screw | The Cover Screw is Intended to be temporarily | |
| connected to an endosseous dental implant to | |||
| protect the implant connection interface during | |||
| bone healing. | N/A | ||
| 2 | Healing Abutment | The Healing Abutment is designed to aid in | |
| soft tissue contouring during the healing | |||
| period after implant placement, creating an | |||
| emergence profile for the final prosthesis. | N/A | ||
| 3 | Scan Healing | ||
| Abutment | The Scan Healing Abutments are designed to | ||
| aid in soft tissue contouring during the healing | |||
| period after implant placement, creating an | |||
| emergence profile for the final prosthesis. | |||
| They have the added design feature of | |||
| machined marking for identification when | |||
| taking an abutment level impression or an | |||
| intraoral scan/digital impression. Identification | |||
| and orientation information is captured in the | |||
| intraoral scan or model scan. | N/A | ||
| 4 | Scan Healing | ||
| Abutment Screw | The Scan Healing Abutment Screw is used for | ||
| connect fixture and Scan Healing abutment. | N/A | ||
| 5 | Cemented | ||
| Abutment | The Cemented Abutment is used as a support | ||
| of prosthesis to restore the patient's chewing | |||
| function. | N/A | ||
| 6 | Angled Abutment | The Angled Abutment is used as a support of | |
| prosthesis to restore the patient's chewing | |||
| function. | N/A | ||
| 7 | Master Fix | The Master Fix is used as a support of | |
| prosthesis to restore the patient's chewing | |||
| function. | N/A | ||
| 8 | Master Fix Screw | The Master Fix Screw is used for connect | |
| fixture and Master Fix. | N/A | ||
| 9 | Digital Abutment | The Digital Abutment is used as a support of | |
| prosthesis to restore the patient's chewing | |||
| function. | N/A | ||
| 10 | Temporary | ||
| Abutment | The Temporary Abutment is used as a support | ||
| for provisional prosthesis to restore the | |||
| patient's chewing function. The Temporary | |||
| Abutment is not to exceed 180 days | N/A | ||
| 11 | Multi Abutment | The Multi Abutment is a straight type, it is | |
| connected with fixture and it support | |||
| prosthesis which restores tooth function. | N/A | ||
| 12 | Multi Angled | ||
| Abutment | The Multi Angled Abutment is an angled type, | ||
| it is connected with fixture and it support | |||
| prosthesis which restores tooth function. | N/A | ||
| 13 | Abutment Screw | The Abutment Screw is used for connect | |
| fixture and abutment. | N/A | ||
| 14 | Multi Scan | ||
| Healing Cap | The Multi Scan Healing Cap has the added | ||
| feature of machined marking for easy | |||
| identification when taking an abutment-level | |||
| impression or an intraoral scan/digital | |||
| impression from the healing abutment. | |||
| Identification and orientation information is | |||
| captured in the intraoral scan or model scan. | N/A | ||
| 15 | Multi Scan | ||
| Healing Cap | |||
| Screw | The Multi Scan Healing Cap Screw is used for | ||
| connecting Abutment and Multi Scan Healing | |||
| cap. | N/A | ||
| 16 | Multi Master Fix | The Multi Master Fix is used for connecting | |
| with Multi Abutment, Multi Angled Abutment to | |||
| provide support for provisional restoration and | |||
| used for fabricating the single and multiple | |||
| abutments. | N/A | ||
| 17 | Multi Master Fix | ||
| Screw | The Multi Master Fix Screw is used for | ||
| connecting Abutment and Multi Master Fix | |||
| Screw | N/A | ||
| 18 | Multi Ti Cylinder | The Ti Cylinder is used in conjunction with | |
| Multi Abutment, Multi Angled Abutment to | |||
| provide support for provisional restoration and | |||
| used for fabrication the single and multiple | |||
| abutments. | N/A | ||
| 19 | Multi Digital | ||
| Cylinder | The Digital Cylinder is used in conjunction with | ||
| Multi Abutment, Multi Angled Abutment to | |||
| provide support for provisional restoration and | |||
| used for fabrication the single and multiple | |||
| abutments. | N/A | ||
| 20 | Multi Temporary | ||
| Cylinder | The Multi Temporary Cylinder is used in | ||
| conjunction with Multi Abutment, Multi Angled | |||
| Abutment to provide support for provisional | |||
| restoration and used for fabricating the single | |||
| and multiple abutments. The Multi Temporary | |||
| Cylinder is not to exceed 180 days | N/A | ||
| 21 | Multi Cylinder | ||
| Screw | The Multi Cylinder Screw is used for | ||
| connecting Multi Abutment and Multi Angled | |||
| Abutment to Multi Cylinder | N/A |
8
The Cover Screw, Healing Abutment, Scan Healing Abutment, Scan Healing Abutment Screw, Multi Scan Healing Cap and Multi Scan Healing Cap Screw are provided sterile by the manufacturer. All other abutments are provided non-sterile and should be sterilized by the end user before use. The multi-unit abutments included in this system are specifically intended to be used solely for multiunit restorations. The SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are composed of two-piece abutment that is a titanium base at the bottom and zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle
9
or divergence correction. All digitally designed custom abutments for use with SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinderare intended for single-unit or multi-unit restorations.
For the Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder the design parameters for the CAD/CAM zirconia superstructure are:
Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations (length above the abutment collar / gingival height) – 4.5 mm; Maximum gingival height - 5.0 mm; Minimum gingival height - 1.5 mm; Angulation - 0° and All zirconia superstructures are for straight abutments only.
The Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder are used as part of a twopiece abutment, where the base is premanufactured from titanium alloy (Ti-6AI-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
Raw material Zirconia Block
K190112, Non-Sterile Zirconia Block by FINE ADVANCED COMPOUND Co., Ltd.
Dental Cement
K193260, U-Cem Premium & MAZIC Cem by Vericom Co., Ltd.
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Image /page/10/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle on the upper left and a yellow triangle on the lower left. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, dark brown letters.
The SD Implant System is intended for single use only. The Abutments are made of Ti-6AI-4V Eli (Conforming to ASTM F136) The SD Implant System connections compatible with NB 1 SA Implant System, NB Implant System and NB Mini Implant System
The dimension ranges of the subject device are below:
| No. | Device Name | Dimension |
|---|---|---|
| 1 | SD Bone Level Fixture | Ø3.3, 3.7 (D) x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L) |
| 2 | Cover Screw | Ø4.2, 4.6, 5.0 (D) x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L) |
| 3 | Healing Abutment | Ø3.0, 3.75 (D) x 5.4, 5.8, 6.4, 6.8 mm (L) |
| 4 | Scan Healing Abutment | Ø4.2, 4.7, 5.7, 6.7 (D) x 1.5, 3.0, 4.5, 5.5 mm (G/H) |
| 5 | Scan Healing Abutment | |
| Screw | Ø4.7, 5.7, 6.7 (D) x 1.5, 3.0, 4.5, 5.5 mm (G/H) | |
| 6 | Cemented Abutment | Ø2.49 (D) x 9.8 ~ 14.7 mm (Length) |
| 7 | Angled Abutment | Ø4.0, 4.5, 5.5, 6.5 (D) x 5.5 mm (Post Height) x 1.5, 2.5, 3.5, 4.5, 5.5 (G/H) |
| 8 | Master Fix | Ø4.0, 4.5, 5.5 (D) x 8.0mm (Post Height) x 2.0, 4.0 mm (G/H) x 17° (angle) |
| 9 | Master Fix Screw | Ø 4.0, 4.5, 5.5 (D) x 4.0mm (Post Height) x 1.5, 2.5, 3.5, 4.5, 5.5mm (G/H) |
| 10 | Digital Abutment | Ø2.2, 2.25 (D) x 10.4, 10.75, 11.4, 11.75, 12.4, 12.75, 13.4, 13.75 14.4, 14.75 mm (Length) |
| 11 | Temporary Abutment | Ø4.0, 4.5, 5.5 (D) x 4.0mm (Post Height) x 1.5, 2.5, 3.5mm (G/H) |
| 12 | Multi Abutment | Ø3.7, 4.0 (D) x 7.0mm (Post Height) x 1.0, 3.0mm (G/H)) |
| 13 | Multi Angled Abutment | Ø4.8 (D) x 2.0mm (Post Height) x 1.5, 2.5, 3.5, 4.5 mm (G/H) |
| 14 | Abutment Screw | Ø4.8 (D) x 2.5, 3.5, 4.5 mm (G/H) x 17, 30° (angle) |
| 15 | Multi Scan Healing Cap | Ø2.0, 2.2, 2.3, 2.35 (D) x 6.4, 6.7, 6.8, 8.0, 8.5, 9.2 mm (L) |
| 16 | Multi Scan Healing Cap | |
| Screw | Ø5.5 (D) x 4.78, 6.28 mm (Length) | |
| 17 | Multi Master Fix | Ø2.49 (D) x 4.8, 6.3 mm (Length) |
| 18 | Multi Master Fix Screw | Ø5.5 (D) x 1.5, 2.5, 3.5 (G/H) |
| 19 | Multi Ti Cylinder | Ø2.25 (D) x 5.5, 6.5, 7.5 (Length) |
| 20 | Multi Digital Cylinder | Ø5.5 (D) x 5.5 mm (Post Height) x 1.5 mm (G/H) |
| 21 | Multi Temporary Cylinder | Ø5.5 (D) x 4.0, 6.0 (Post Height) x 1.5 mm (G/H) |
| 22 | Multi Cylinder Screw | Ø5.5 (D) x 7.0 mm (Post Height) X 1 mm (G/H) |
| Ø2.1 (D) x 4.5 mm (Length) |
Tolerance of dimension shall be within ± 1% range.
The SD Implant System is compatible with the SD Bone Level Fixtures and NB Implant Systems. (as the below table).
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Image /page/11/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 of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, sans-serif font.
| Manufacturer | 510(k) No. | Implant system
Compatibility | Dimension |
|--------------------------------|------------|---------------------------------|--------------------------------|
| ARUM
DENTISTRY
Co., Ltd. | K213506 | NB 1 SA Implant System | Ø 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| | K230725 | NB Implant System | Ø 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| | K240091 | NB Mini Implant System | Ø 3.5 |
Indication for Use
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surqical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
Materials
The Fixtures are fabricated from Pure Titanium (Conforming to ASTM F67) All Abutments and Abutment Screws are fabricated from Ti-6Al-4V Eli (Conforming to ASTM F136). Raw material Zirconia Block K190112, Non-Sterile Zirconia Block by FINE ADVANCED COMPOUND Co., Ltd.
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Image /page/12/Picture/0 description: The image contains a 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 bold, dark brown font, with "ARUM" on top of "DENTISTRY".
7.2.1. Summaries of Technology Characteristics
1) SD Bone Level Fixture
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | EBI Inc. |
| Device Name | SD Implant System | NB 1 SA Implant System | NB Mini Implant System | Internal Hex Implant System |
| 510(k) Number | N/A | K213506 | K240091 | K190837 |
| Intended Use/ | ||||
| Indications for | ||||
| use | The SD Implant System is | |||
| indicated for use in partially | ||||
| or fully edentulous | ||||
| mandibular and maxillary | ||||
| areas, in support of single or | ||||
| multiple unit restorations | ||||
| including; cemented | ||||
| retained, screw retained, or | ||||
| overdenture restorations, | ||||
| and final or temporary | ||||
| abutment support for fixed | ||||
| bridgework. SD Implant | ||||
| System is dedicated for two | ||||
| stage surgical procedures | ||||
| and for immediate loading | ||||
| when there is good primary | ||||
| stability and an appropriate | ||||
| occlusal load. Also, implants | ||||
| with diameters larger than | The NB 1 SA Implant System | |||
| is indicated for use in | ||||
| partially or fully edentulous | ||||
| mandibles and maxillae, in | ||||
| support of single or multiple- | ||||
| unit restorations including; | ||||
| cemented retained, screw | ||||
| retained, or overdenture | ||||
| restorations, and terminal or | ||||
| intermediate Abutment | ||||
| support for fixed bridgework. | ||||
| NB 1 SA Implant System is | ||||
| dedicated for two stage | ||||
| surgical procedures and for | ||||
| immediate loading when | ||||
| there is good primary stability | ||||
| and an appropriate occlusal | ||||
| load. Also, implants with | ||||
| diameters larger than 5mm | The NB Mini Implant System | |||
| is indicated for use in | ||||
| surgical and restorative | ||||
| applications for placement in | ||||
| the mandibular central, | ||||
| lateral incisor and maxillary | ||||
| lateral incisor regions ot | ||||
| partially edentulous jaws | ||||
| where the horizontal space is | ||||
| limited by the adjacent teeth | ||||
| and roots, to provide support | ||||
| for prosthetic devices, such | ||||
| as artificial teeth, in order to | ||||
| restore the patient's chewing | ||||
| function. The NB Mini | ||||
| Implant System is indicated | ||||
| also for immediate loading | ||||
| when good primary stability | The Internal Hex Implant | |||
| System is intended for | ||||
| placement in the maxillary | ||||
| and/or mandibular arches to | ||||
| support crowns, bridges, or | ||||
| overdentures in edentulous | ||||
| or partially edentulous | ||||
| patients. For implant bodies | ||||
| Ø4.1 and greater, the | ||||
| Internal Hex Implant System | ||||
| is intended for immediate | ||||
| loading when good primary | ||||
| stability is achieved and | ||||
| with appropriate occlusal | ||||
| loading. Implant bodies with | ||||
| a diameter less than Ø4.1 | ||||
| are intended for immediate | ||||
| loading when using a | ||||
| minimum of 4 | ||||
| 5mm are indicated for molar | are indicated for molar | is achieved and with | implants with length >8mm. | |
| regions. The multi-unit | regions. | appropriate occlusal loading. | ||
| abutments are designed for | ||||
| use in multi-unit restorations. | ||||
| They should be used in | ||||
| cases where multiple | ||||
| implants are placed to | ||||
| support a prosthetic dental | ||||
| restoration not suitable for | ||||
| single-unit restorations. All | ||||
| digitally designed abutments | ||||
| for use with Customized | ||||
| Abutment are intended to be | ||||
| manufactured at an ARUM | ||||
| DENTISTRY validated | ||||
| milling center. Smaller | ||||
| diameter implant bodies (i.e., | ||||
| 3.3mm and 3.7mm) are | ||||
| indicated for use in surgical | ||||
| and restorative applications | ||||
| for placement in the | ||||
| mandibular central, lateral | ||||
| incisor and maxillary lateral | ||||
| incisor regions. | ||||
| Material | Pure Titanium (ASTM F67) | Pure Titanium (ASTM F67) | Ti-6Al-4V Eli (ASTM F136) | Pure Titanium (ASTM F67) |
| Anti-Rotational | ||||
| Feature | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| Range of | ||||
| Diameters (Ø) | 3.3, 3.7, 4.2, 4.6, 5.0 | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.2, 3.5 | 3.25 - 5.5 |
| Range of | ||||
| Lengths (mm) | 7.0, 8.5, 10.0, 11.5, 13.0 | 7.0, 8.5, 10, 11.5, 13.0 | 8.5, 10.0, 11.5, 13.0 | 7 - 18 |
| Surface | ||||
| treatment | SLA | SLA | SLA | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of | ||||
| Operation | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. It replaces | ||||
| the functions of the missing | ||||
| teeth as a dental implant | ||||
| fixture. | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. It replaces | ||||
| the functions of the missing | ||||
| teeth as a dental implant | ||||
| fixture. | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. It replaces | ||||
| the functions of the missing | ||||
| teeth as a dental implant | ||||
| fixture. | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. It replaces | ||||
| the functions of the missing | ||||
| teeth as a dental implant | ||||
| fixture. | ||||
| Substantial | ||||
| Equivalent | ||||
| Discussion | 1. Similarities | |||
| The SD Bone Level Fixture have similar device characteristics with the Primary predicate such as diameters, length, intended | ||||
| use, material, functions, general shape (Design), sterilization, structure and applied production method. |
- Differences
The SD Bone Level Fixture's diameter and is slightly different. However, except for the diameter, the length, intended use,
material, functions and general shape (Design) are the same. The diameter dimension is range of the reference device
encompasses the size of the subject device. Therefore, this difference doesn't impact substantial equivalence. | | | |
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Image /page/13/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, dark brown font.
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Image /page/14/Picture/0 description: The image contains a logo for "Arum Dentistry". The logo consists of a geometric shape on the left, with a red triangle above a smaller, light orange triangle. To the right of the geometric shape, the words "ARUM" and "DENTISTRY" are written in a bold, dark brown font, with "DENTISTRY" appearing below "ARUM". The overall design is clean and professional, likely representing a dental practice.
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Image /page/15/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a smaller tan triangle on the left side of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are stacked on top of each other in a bold, sans-serif font.
2) Cover Screw
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | NB Mini Implant System |
| 510(k) Number | N/A | K240091 |
| Range of Diameters (ø) | 3.0, 3.75 | 2.8 |
| Range of Lengths (mm) | 5.4, 5.8, 6.4, 7.8 | 5.1, 5.8, 6.8, 7.8 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, | ||
| technology, functions, sterilization and materials with the identified reference device. |
-
Differences
The difference between the subject and reference device is the dimension. There are slightly different dimensions.
This dimensional difference doesn't affect device safety and effectiveness; therefore, it is substantial equivalent. | |
| | Subject Device | Reference Device |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | NB 1 SA Implant System |
| 510(k) No. | N/A | K240091 |
| Range of Diameters (Ø) | 4.2, 4.7, 5.7, 6.7 | 4.2, 4.7, 5.7, 6.7, 7.7 |
| Range of Cuff (mm) | 1.5, 3.0, 4.5, 5.5 | 1.0, 2.0, 3.0, 4.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years |
| Surface Treatment | Machined | Machined |
| Substantial Equivalent
Discussion | 1. Similarities
The Healing Abutment has same indication for use, principle of operation, functions, diameter, material and
sterilization to the reference device K240091.
The intended use of the subject device as a healing abutment is designed to aid in soft tissue contouring during the
healing period after implant placement, creating emergence profile for the final prosthesis is equivalent to the reference
device K240091. -
Differences
The difference between the subject and reference device is the dimension. The size range of the reference device
encompasses the size of the subject device. This dimensional difference doesn't affect device safety and
effectiveness; therefore, it is substantial equivalent | |
| | Subject Device | Reference Device |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | NB Mini Implant System |
| 510(k) No. | N/A | K240091 |
| Range of Diameters (Ø) | 4.7, 5.7, 6.7 | 4.2 ~ 7.7 |
| Range of Cuff (mm) | 1.5, 3.0, 4.5, 5.5 | 1.3 ~ 9.4 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Scanning feature | Machined marking | Machined marking |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years |
| Substantial Equivalent
Discussion | 1. Similarities
The Scan Healing Abutment has same indication for use, principle of operation, functions, diameter material and
sterilization to the reference device, K240091.
The intended use of the subject device as a scan healing abutment with scanning feature to transmit position and
angulation data of implant when taking a digital impression using an intra-oral scanner is equivalent to the reference
device, K240091. -
Differences
The difference between the subject and reference device is the dimension. The size range of the reference device
encompasses the size of the subject device. This dimensional difference doesn't affect device safety and
effectiveness; therefore, it is substantial equivalent. | |
| | Subject Device | Reference Device |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | NB Mini Implant System |
| 510(k) No. | N/A | K240091 |
| Range of Diameters (Ø) | 2.49 | 2.49 |
| Length (mm) | 9.8 ~ 14.7 | 9.7 ~ 19.4 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Scanning feature | Machined marking | Machined marking |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years |
| Substantial Equivalent
Discussion | 1. Similarities
The Scan Healing Abutment Screw has same indication for use, principle of operation, functions, diameter material
and sterilization to the reference device, K240091.
The intended use of the subject device as a scan healing abutment screw is used for connect fixture and Scan
Healing Abutment. -
Differences
The difference between the subject and reference device is the dimension. The size range of the reference device
encompasses the size of the subject device. This dimensional difference doesn't affect device safety and
effectiveness; therefore, it is substantial equivalent. | |
| | Subject Device | Reference Device |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | NB 1 SA Implant System |
| 510(k) No. | N/A | K213506 |
| Diameters (Ø) | 4.0, 4.5, 5.5, 6.5 | 4.5, 5.5, 6.5 |
| Post Height (mm) | 5.5 | 5.0, 5.5, 7.0 |
| Range of Cuff (mm) | 1.5, 2.5, 3.5, 4.5, 5.5 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | TiN Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent
Discussion | 1. Similarities
The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, technology, functions, dimensions, and materials with the identified reference device, K213506. -
Differences
The difference between the subject and reference device is the dimensions of the device. There are slightly different dimensions. However, the size range of the reference device encompasses the size of the subject device. It does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | |
| | Subject Device | Reference Device |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | Angled Abutment |
| 510(k) No. | N/A | K232560 |
| Diameters (Ø) | 4.0, 4.5, 5.5 | 4.0, 4.5, 5.0, 6.0 |
| Post Height (mm) | 8.0 | 8.0 |
| Range of Cuff (mm) | 2.0, 4.0 | 2.0, 4.0 |
| Angulation (°) | 17 | 17 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | TiN Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent
Discussion | 1. Similarities
The Angled Abutment has same design, function and indication for use statement and is made with same material
as Ti-6Al-4V Eli conforming to ASTM F136 is generally used for cemented-retained restoration compared to that of
the reference device, K232560. -
Differences
Surface treatment between the proposed and predicated Angled Abutment is different. But proposed Angled
Abutment and predicated Angled Abutment have common in design, function, indications for use, material, etc.
therefore, the proposed Angled Abutment is substantially equivalent to the reference device, K232560 | |
| | Subject Device | Reference Device |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | Ti-Base & Master Fix |
| 510(k) No. | N/A | K240603 |
| Implant Body Diameter (Ø) | 3.3 ~ 6.2 | 3.35 |
| Diameter (Ø) | 4.5, 5.5 | 3.5, 4.0, 5.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent
Discussion | 1. Similarities
The Master Fix have same design, function and indication for use statement and is made with same material as Ti-
6Al-4V Eli conforming to ASTM F136 is generally used for cemented-retained restoration compared to that of the
reference device, K240603. -
Differences
The minor difference with the reference device K240603 is slightly different dimension. These minor differences do
not impact safety and effectiveness because these differences are related to the compatible implant design and are
mitigated by the mechanical performing testing. | |
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Image /page/16/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo features a geometric design on the left, consisting of a red triangle above a smaller, light orange triangle. To the right of the geometric design, the words "ARUM" and "DENTISTRY" are stacked on top of each other in a bold, dark brown font. The word "ARUM" is larger than the word "DENTISTRY".
3) Healing Abutment
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Image /page/17/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 is the text "ARUM DENTISTRY" in a dark brown font.
4) Scan Healing Abutment
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Image /page/18/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 is the text "ARUM" in a bold, brown font, with the word "DENTISTRY" in a smaller, bold, brown font below it.
5) Scan Healing Abutment Screw
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Image /page/19/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of a geometric shape on the left, resembling two triangles, one red and one light orange. To the right of the geometric shape is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below. The text is in a dark brown color.
6) Cemented Abutment
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Image /page/20/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 two triangles, one red and one light orange. The word "ARUM" is on top of the word "DENTISTRY", and both words are in a bold, dark brown font.
7) Angled Abutment
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Image /page/21/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of a geometric shape on the left and the text "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one beige. The text "ARUM" is on top of the text "DENTISTRY", and both are in a bold, dark brown font.
8) Master Fix
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Image /page/22/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 tan. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
9) Digital Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Zeros Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | STERI-OSS Implant System | NB 1 SA Implant System |
| 510(k) No. | N/A | K232268 | K213506 |
| Diameters (Ø) | 4.0, 4.5, 5.5 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 4.5, 5.5, 6.5 |
| Post Height (mm) | 4.0, 6.0 | 4.0, 5.5, 7.0 | 5.0, 5.5, 7.0 |
| Range of Cuff | |||
| (mm) | 1.5, 2.5, 3.5 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| Material | Ti-6Al-4V Eli | ||
| (Conforming to ASTM F136) | Ti-6Al-4V Eli | ||
| (Conforming to ASTM F136) | Ti-6Al-4V Eli | ||
| (Conforming to ASTM F136) | |||
| Surface Treatment | Machined | Machined | TiN Coating |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Substantial | |||
| Equivalent | |||
| Discussion | 1. Similarities | ||
| The Digital Abutment have similar function and indication for use statement and is made with same material as Ti-6Al-4V Eli conforming to ASTM F136 is generally used for cemented-retained restoration compared to that of the reference device, K213506. |
- Differences
The difference between the subject and reference device is the dimensions of the device. And added K232268 reference device, to support surface treatment. However, it does not affect device's fundamental functions and safety. Digital Abutment and reference device are same indications for use; therefore, it is substantial equivalent. | | |
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Image /page/23/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 yellow. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, sans-serif font, with "ARUM" on top of "DENTISTRY".
10) Temporary Abutment
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | MegaGen Implant Co., Ltd. |
| Device Name | SD Implant System | Temporary Abutment |
| 510(k) No. | N/A | K233450 |
| Diameters (Ø) | 3.7, 4.0 | 3.5, 4.0, 4.5, 4.75 |
| Post Height (mm) | 7.0 | 8.0 |
| Range of Cuff (mm) | 1.0, 3.0 | 1.8, 2.0, 2.2, 2.8, 3.0, 3.2, 3.8, 4.0, 4.2,4.8, 5.0, 5.2 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | TiN Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Temporary Abutment have same design, function and indication for use statement and is made with same material | ||
| as Ti-6AI-4V Eli conforming to ASTM F136 is generally used for cemented-retained restoration compared to that of the | ||
| reference device, K233450. |
- Differences
The difference between the subject and reference device is the dimensions of the device. However, it does not affect
device's fundamental functions and safety. Temporary Abutment and reference device are same indications for use;
therefore, it is substantial equivalent. | |
24
Image /page/24/Picture/0 description: The image contains a logo for "Arum Dentistry". The logo consists of a geometric shape on the left and the text "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one light orange. The text "ARUM" is on top of the text "DENTISTRY", and both are in a bold, sans-serif font.
11) Multi Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Nobel Biocare AB |
| Device Name | SD Implant System | Multi-unit Abutment Plus |
| 510(k) No. | N/A | K161416 |
| Diameters (Ø) | 4.8 | 4.8 |
| Range of Cuff (mm) | 1.5, 2.5, 3.5, 4.5 | 1.5, 2.5, 3.5, 4.5 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The multi abutment and primary predicate are made of the same material and have similar design. The size range of | ||
| the primary predicate encompasses the size of the subject device. | ||
| They have same design, function and indication for use statement and is made with same material as Ti-6AI-4V Eli | ||
| conforming to ASTM F136 compared to that of the primary predicate, K161416. |
- Differences
The difference between subject device and primary predicate is design. These differences do not impact the product's
fundamental functions and safety. Therefore, The Multi Abutment and Primary predicate are substantially equivalent. | |
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Image /page/25/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, light orange triangle on the bottom left. The words "ARUM DENTISTRY" are in a bold, sans-serif font, with "ARUM" on top and "DENTISTRY" on the bottom.
12) Multi Angled Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Nobel Biocare AB |
| Device Name | SD Implant System | Multi-unit Abutment Plus |
| 510(k) No. | N/A | K161416 |
| Diameters (Ø) | 4.8 | 4.8 |
| Range of Cuff (mm) | 2.5, 3.5, 4.5 | 2.5, 3.5, 4.5 |
| Angulation (°) | 17, 30 | 17, 30 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Abutment and primary predicate are made of the same material and have similar design. The size range of | ||
| the primary predicate encompasses the size of the subject device. | ||
| They have same design, function and indication for use statement and is made with same material as Ti-6AI-4V Eli | ||
| conforming to ASTM F136 compared to that of the primary predicate, K161416. |
- Differences
The difference between subject device and primary predicate is design. These differences do not impact the product's
fundamental functions and safety. Therefore, The Multi Abutment and Primary predicate are substantially equivalent. | |
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Image /page/26/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 yellow. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, dark brown letters, with "DENTISTRY" appearing below "ARUM".
13) SD Abutment Screw
| Subject Device | Reference Device | Subject Device | Reference Device | Reference Device | ||
|---|---|---|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | MegaGen Implant Co., Ltd. |
| Device Name | SD Implant System | NB 1 SA Implant System | Device Name | SD Implant System | NB Mini Implant System | Healing Cap |
| 510(k) No. | N/A | K213506 | 510(k) No. | N/A | K240091 | K233450 |
| Diameters (Ø) | 2.0, 2.2, 2.3, 2.35 | 2.35 | Range of | |||
| Diameters (Ø) | 5.5 | 4.2 ~ 7.7 | 4.9, 5.0, 5.5, 6.0, 6.1, 6.5, 6.8 | |||
| Length (mm) | 6.4, 6.7, 6.8, 8.0, 8.5, 9.2 | 8.4 | Length (mm) | 4.78, 6.28 | 6.6 ~ 15.2 | 4.2 ~ 8.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) | Material | Ti-6AI-4V Eli (Conforming to ASTM | ||
| F136) | Ti-6Al-4V Eli (Conforming to ASTM | |||||
| F136) | Ti-6Al-4V Eli (Conforming to ASTM | |||||
| F136) | ||||||
| Surface Treatment | Machined | Machined | Scanning feature | Machined | Machined | Machined, Anodizing |
| Sterilization | End User Sterilization | End User Sterilization | Sterilization | Gamma Sterilization | Gamma Sterilization | Non-sterile |
| Substantial Equivalent | ||||||
| Discussion | 1. Similarities | |||||
| The Abutment Screw and Reference Device are made of same material and have similar design. | ||||||
| They have same design, function and indication for use statement and is made with same material as Ti-6Al-4V Eli | ||||||
| conforming to ASTM F136 compared to that of the reference device, K213506. |
- Differences
The difference between subject device and reference device is dimension. These differences do not impact the
product's fundamental functions and safety. Therefore, The Abutment Screw and Reference Device are substantially
equivalent. | | Shelf life | 5 Years | 5 Years | - |
| Substantial
Equivalent
Discussion | 1. Similarities
The Multi Scan Healing Cap has same indication for use, principle of operation, functions, diameter material and sterliization
to the reference device, K240091 and K233450.
The intended use of the subject device as a Scan Healing Abutment Cap with scanning feature to transmit position and
angulation data of implant when taking a digital impression using an intra-oral scanner is equivalent to the reference device,
K240091. - Differences
The difference between the subject and reference device is the dimension. There are slightly different dimensions. This
dimensional difference doesn't affect device safety and effectiveness; therefore, it is substantial equivalent. The Multi Scan
Healing Cap is connected to the multi abutment and The Scan Healing Abutment is connected to the Implant. | | | | | |
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Image /page/27/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 two triangles, one red and one beige. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
14) Multi Scan Healing Cap
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Image /page/28/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 dark brown font, with "ARUM" on top of "DENTISTRY".
15) Multi Scan Healing Cap Screw
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | NB Mini Implant System |
| 510(k) No. | N/A | K240091 |
| Range of Diameters (ø) | 2.49 | 2.49 |
| Length (mm) | 4.8, 6.3 | 9.7, 11.4, 11.7, 13.4, 13.7, 15.4, 15.7, 17.4, 17.7, 19.4 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Scanning feature | Machined | Machined |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Scan Healing Abutment Screw has same indication for use, principle of operation, functions, diameter | ||
| material and sterilization to the reference device, K240091. | ||
| The intended use of the subject device as a Scan Healing abutment Screw with scanning feature to transmit position | ||
| and angulation data of implant when taking a digital impression using an intra-oral scanner is equivalent to the | ||
| reference device, K240091. |
- Differences
The difference between the subject and reference device is the dimension. There are slightly different dimensions.
This dimensional difference doesn't affect device safety and effectiveness; therefore, it is substantial equivalent. | |
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Image /page/29/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of two triangles on the left side of the image. The top triangle is red, and the bottom triangle is a light tan color. To the right of the triangles is the text "ARUM" in bold, black letters, with the word "DENTISTRY" underneath it in the same style.
16) Multi Master Fix
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | SD Implant System | Ti-Base & Master Fix |
| 510(k) No. | N/A | K240603 |
| Diameters (Ø) | 5.5 | 3.35 |
| Length (mm) | 5.5, 6.7, 7.5 | 3.5, 4.0, 5.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Master Fix and reference device are made of the same material and have similar design. | ||
| They have same design, function and indication for use statement and is made with same material as Ti-6Al-4V Eli | ||
| conforming to ASTM F136 compared to that of the primary predicate, K240603. |
- Differences
The difference between subject device and primary predicate is dimension and design. These differences do not
impact the product's fundamental functions and safety. Therefore, The Multi Master Fix and reference device are
substantially equivalent. | |
30
Image /page/30/Picture/0 description: The image contains a 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 bold, black font.
17) Multi Ti Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Oneday Biotech Co., Ltd. |
| Device Name | SD Implant System | Oneday Implant Abutment |
| 510(k) No. | N/A | K231753 |
| Diameters (Ø) | 5.5 | 4.8 |
| Length (mm) | 7.0 | 7.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti 6Al 4V ELI (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Ti Cylinder and reference device are made of the same material and have similar design. | ||
| They have same function and indication for use statement and is made with same material as Ti-6Al-4V Eli conforming | ||
| to ASTM F136 compared to that of the reference device, K231753. |
- Differences
The difference between subject device and reference device is dimension. These differences do not impact the
product's fundamental functions and safety. Therefore, The Multi Abutment and reference device are substantially
equivalent. | |
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Image /page/31/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 two triangles, one red and one light orange. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
18) Multi Digital Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Oneday Biotech Co., Ltd. |
| Device Name | SD Implant System | Oneday Implant Abutment |
| 510(k) No. | N/A | K231753 |
| Diameters (Ø) | 5.5 | 4.8 |
| Length (mm) | 5.5, 7.5 | 7.0 |
| Material | Ti 6Al 4V ELI (Conforming to ASTM F136) | Ti 6AI 4V ELI (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Digital Cylinder and reference device are made of the same material and have similar design. | ||
| They have same function and indication for use statement and is made with same material as Ti-6Al-4V Eli conforming | ||
| to ASTM F136 compared to that of the primary predicate, K231753. |
- Differences
The difference between subject device and reference device are dimension and surface treatment. These differences
do not impact the product's fundamental functions and safety. Therefore, The Multi Abutment and Primary predicate
are substantially equivalent. | |
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Image /page/32/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 is the text "ARUM" in a bold, brown font, with the word "DENTISTRY" in a smaller, bold, brown font below it.
19) Multi Temporary Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | MegaGen Implant Co., Ltd. |
| Device Name | SD Implant System | Temporary Cylinder |
| 510(k) No. | N/A | K233450 |
| Range of Diameters (ø) | 5.5 | 4.8, 4.9, 5.7 |
| Post Height (mm) | 7.0 | 8.5 |
| Range of Cuff (mm) | 1.0 | 3.0 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Temporary Cylinder has same indication for use, principle of operation, functions, material and | ||
| sterilization to the reference device, K233450. |
- Differences
The difference between the subject and reference device is the dimension. There are slightly different dimensions.
This dimensional difference doesn't affect device safety and effectiveness; therefore, it is substantial equivalent. | |
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Image /page/33/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. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, sans-serif font.
20) Multi Cylinder Screw
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | MegaGen Implant Co., Ltd. |
| Device Name | SD Implant System | Cylinder Screw |
| 510(k) No. | N/A | K233450 |
| Range of Diameters (Ø) | 2.1 | 2.1 |
| Length (mm) | 4.5 | 4.2 ~ 4.65 |
| Material | Ti-6Al-4V Eli (Conforming to ASTM F136) | Ti-6Al-4V Eli (Conforming to ASTM F136) |
| Surface Treatment | Machined | Machined |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalent | ||
| Discussion | 1. Similarities | |
| The Multi Cylinder Screw has same indication for use, principle of operation, functions, material and sterilization to the reference device, K233450. |
- Differences
The difference between the subject and reference device is the dimension. The size range of the reference device encompasses the size of the subject device. This dimensional difference doesn't affect device safety and effectiveness; therefore, it is substantial equivalent. | |
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Image /page/34/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 two triangles, one red and one light orange. The words "ARUM DENTISTRY" are in a bold, sans-serif font, with "ARUM" on top and "DENTISTRY" on the bottom.
Performance Data
Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
Biocompatibility of Ti-6AI-4V Eli (ASTM F136) demonstrated by the reference ARUM DENTISTRY submission, K213506, using the same materials and manufacturing processes as the subject device.
Sterilization validation
Sterilization validating testing has been performed in accordance with ISO 11137-1 and ISO 11137-2 to verify the sterility assurance level (10°) by selecting and substantiating a 25 kGy dose using method VDmax25. (Referenced from K213506);
End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K213506;
LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016;
Shelf-Life
The tests to validate the Shelf-Life of the device through the proposed Shelf-Life were conducted using the accelerated aging method in accordance to ASTM F1980 and test results validated 5 years Shelf-Life. Also, the following guidance documents were referred to
- . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. (referenced from K213506);
Non-Clinical Data
Mechanical performance testing was performed according to ISO 14801. For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing. Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate devices, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible implant designs, or are mitigated by the mechanical performance testing.
Non-clinical performance data submitted to demonstrate substantial equivalence included:
- . Static and fatigue testing according to ISO 14801.
- . Scanning electron microscopy (SEM) was conducted to demonstrate a clean surface free of any chemical or particle residual from the surface.
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Image /page/35/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 two triangles, one red and one yellow. The words "ARUM DENTISTRY" are in a bold, sans-serif font, with "ARUM" on top and "DENTISTRY" on the bottom.
- Energy dispersive X-ray spectroscopy (EDS) was conducted to demonstrate surface free of contaminants.
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate.
MR Environment Condition
Non-Clinical worst-case MRI review was performed to evaluated the SD Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Terry O. Woods, Jana Delfino, & Sunder Rajan. (2019). Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices. Journal of Testing and Evaluation 49.2, 783-795), based on the entire system including all variations (all compatible implant bodies, 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.
Conclusion
The Indications for Use statements are highly similar, differing only in the list of compatible implant system systems. Overall, the Technological Characteristics of the Subject device are highly similar to the Predicate device. The Subject device, the Predicate device, and the Reference devices have the same intended use, have similar technological characteristics, and are made of the same materials. The Subject device, the Predicate, and Reference devices encompass the same range of physical dimensions, and are to be sterilized using similar methods. The data included in this premarket notification demonstrate substantial equivalence to the Predicate device listed above. Overall, the Subject device is substantially equivalent to the Predicate device.