SD Implant System
Device Facts
| Record ID | K241703 |
|---|---|
| Device Name | SD Implant System |
| Applicant | Arum Dentistry Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Feb 24, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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 surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
Device Story
SD Implant System comprises endosseous dental implants (fixtures) and various abutments; used to replace missing teeth and support prosthetic restorations (crowns, bridges, overdentures). Fixtures are placed into alveolar bone; abutments connect to fixtures via internal hex and morse taper bevel. Some abutments are two-piece, consisting of a titanium base (Ti-6Al-4V Eli) and a CAD/CAM zirconia superstructure milled at a validated center. Scan healing abutments/caps feature machined markings for digital impression capture via intraoral scanners. System used by dental professionals in clinical settings. Output is a stable foundation for dental prosthetics; benefits include restored masticatory function and improved aesthetics. Device is for single use; some components provided sterile, others require end-user sterilization.
Clinical Evidence
Bench testing only. Mechanical performance evaluated via static compression and fatigue testing per ISO 14801. Biocompatibility leveraged from predicate K213506. Sterilization validated per ISO 11137 (gamma) and ANSI/AAMI ST79 (end-user). Surface cleanliness verified via SEM and EDS.
Technological Characteristics
Fixtures: Pure Titanium (ASTM F67), SLA surface. Abutments: Ti-6Al-4V Eli (ASTM F136). Connection: Internal hex and morse taper. CAD/CAM components: Zirconia superstructures (K190112). Sterilization: Gamma or end-user steam. Connectivity: Compatible with digital impression systems via scan-specific abutments.
Indications for Use
Indicated for partially or fully edentulous mandibular and maxillary areas in adults requiring single or multiple unit restorations (cemented, overdenture, or fixed bridgework). Suitable for two-stage surgical procedures and immediate loading given sufficient primary stability and occlusal load. Specific diameters (>5mm) for molar regions; smaller diameters (3.3mm, 3.7mm) for mandibular/maxillary incisor regions.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- NB 1 SA Implant System (K213506)
Reference Devices
- NB Implant System (K230725)
- Angled Abutment (K232560)
- Customized Abutment (K223634)
- NB Mini Implant System (K240091)
- Ti-Base & Master Fix (K240603)
- Multi-unit Abutment Plus (K161416)
- ZENEX Implant System (K211090)
- Oneday Implant Abutment (K231753)
- MegaGen Dental Implant Abutment (K233450)
- STERI-OSS Implant System (K232268)
- Internal Hex Implant System (K190837)
- Non-Sterile Zirconia Block (K190112)
- U-Cem Premium & MAZIC Cem (K193260)
Related Devices
- K242753 — SD TL Implant System · Arum Dentistry Co., Ltd. · Jan 6, 2025
- K240570 — IPD Dental Implant Abutments · Implant Protesis Dental 2004, S.L. · Jun 7, 2024
- K251471 — IPD Dental Implant Abutments · Implant Protesis Dental 2004, S.L. · Aug 20, 2025
- K200867 — Implantswiss Dental Implant System and Implantswiss Dental Abutment System · Novodent SA · Apr 28, 2020
- K190637 — Fit & Brilliant Dental Implant System · F&B Technology Co., Ltd. · Jun 19, 2020
Submission Summary (Full Text)
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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"
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(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.
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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
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## 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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## 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;
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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<br>connected to an endosseous dental implant to<br>protect the implant connection interface during<br>bone healing. | N/A |
| 2 | Healing Abutment | The Healing Abutment is designed to aid in<br>soft tissue contouring during the healing<br>period after implant placement, creating an<br>emergence profile for the final prosthesis. | N/A |
| 3 | Scan Healing<br>Abutment | The Scan Healing Abutments are designed to<br>aid in soft tissue contouring during the healing<br>period after implant placement, creating an<br>emergence profile for the final prosthesis.<br>They have the added design feature of<br>machined marking for identification when<br>taking an abutment level impression or an<br>intraoral scan/digital impression. Identification<br>and orientation information is captured in the<br>intraoral scan or model scan. | N/A |
| 4 | Scan Healing<br>Abutment Screw | The Scan Healing Abutment Screw is used for<br>connect fixture and Scan Healing abutment. | N/A |
| 5 | Cemented<br>Abutment | The Cemented Abutment is used as a support<br>of prosthesis to restore the patient's chewing<br>function. | N/A |
| 6 | Angled Abutment | The Angled Abutment is used as a support of<br>prosthesis to restore the patient's chewing<br>function. | N/A |
| 7 | Master Fix | The Master Fix is used as a support of<br>prosthesis to restore the patient's chewing<br>function. | N/A |
| 8 | Master Fix Screw | The Master Fix Screw is used for connect<br>fixture and Master Fix. | N/A |
| 9 | Digital Abutment | The Digital Abutment is used as a support of<br>prosthesis to restore the patient's chewing<br>function. | N/A |
| 10 | Temporary<br>Abutment | The Temporary Abutment is used as a support<br>for provisional prosthesis to restore the<br>patient's chewing function. The Temporary<br>Abutment is not to exceed 180 days | N/A |
| 11 | Multi Abutment | The Multi Abutment is a straight type, it is<br>connected with fixture and it support<br>prosthesis which restores tooth function. | N/A |
| 12 | Multi Angled<br>Abutment | The Multi Angled Abutment is an angled type,<br>it is connected with fixture and it support<br>prosthesis which restores tooth function. | N/A |
| 13 | Abutment Screw | The Abutment Screw is used for connect<br>fixture and abutment. | N/A |
| 14 | Multi Scan<br>Healing Cap | The Multi Scan Healing Cap has the added<br>feature of machined marking for easy<br>identification when taking an abutment-level<br>impression or an intraoral scan/digital<br>impression from the healing abutment.<br>Identification and orientation information is<br>captured in the intraoral scan or model scan. | N/A |
| 15 | Multi Scan<br>Healing Cap<br>Screw | The Multi Scan Healing Cap Screw is used for<br>connecting Abutment and Multi Scan Healing<br>cap. | N/A |
| 16 | Multi Master Fix | The Multi Master Fix is used for connecting<br>with Multi Abutment, Multi Angled Abutment to<br>provide support for provisional restoration and<br>used for fabricating the single and multiple<br>abutments. | N/A |
| 17 | Multi Master Fix<br>Screw | The Multi Master Fix Screw is used for<br>connecting Abutment and Multi Master Fix<br>Screw | N/A |
| 18 | Multi Ti Cylinder | The Ti Cylinder is used in conjunction with<br>Multi Abutment, Multi Angled Abutment to<br>provide support for provisional restoration and<br>used for fabrication the single and multiple<br>abutments. | N/A |
| 19 | Multi Digital<br>Cylinder | The Digital Cylinder is used in conjunction with<br>Multi Abutment, Multi Angled Abutment to<br>provide support for provisional restoration and<br>used for fabrication the single and multiple<br>abutments. | N/A |
| 20 | Multi Temporary<br>Cylinder | The Multi Temporary Cylinder is used in<br>conjunction with Multi Abutment, Multi Angled<br>Abutment to provide support for provisional<br>restoration and used for fabricating the single<br>and multiple abutments. The Multi Temporary<br>Cylinder is not to exceed 180 days | N/A |
| 21 | Multi Cylinder<br>Screw | The Multi Cylinder Screw is used for<br>connecting Multi Abutment and Multi Angled<br>Abutment to Multi Cylinder | N/A |
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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
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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<br>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<br>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<br>Compatibility | Dimension |
|--------------------------------|------------|---------------------------------|--------------------------------|
| ARUM<br>DENTISTRY<br>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/<br>Indications for<br>use | The SD Implant System is<br>indicated for use in partially<br>or fully edentulous<br>mandibular and maxillary<br>areas, in support of single or<br>multiple unit restorations<br>including; cemented<br>retained, screw retained, or<br>overdenture restorations,<br>and final or temporary<br>abutment support for fixed<br>bridgework. SD Implant<br>System is dedicated for two<br>stage surgical procedures<br>and for immediate loading<br>when there is good primary<br>stability and an appropriate<br>occlusal load. Also, implants<br>with diameters larger than | The NB 1 SA Implant System<br>is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-<br>unit restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate Abutment<br>support for fixed bridgework.<br>NB 1 SA Implant System is<br>dedicated for two stage<br>surgical procedures and for<br>immediate loading when<br>there is good primary stability<br>and an appropriate occlusal<br>load. Also, implants with<br>diameters larger than 5mm | The NB Mini Implant System<br>is indicated for use in<br>surgical and restorative<br>applications for placement in<br>the mandibular central,<br>lateral incisor and maxillary<br>lateral incisor regions ot<br>partially edentulous jaws<br>where the horizontal space is<br>limited by the adjacent teeth<br>and roots, to provide support<br>for prosthetic devices, such<br>as artificial teeth, in order to<br>restore the patient's chewing<br>function. The NB Mini<br>Implant System is indicated<br>also for immediate loading<br>when good primary stability | The Internal Hex Implant<br>System is intended for<br>placement in the maxillary<br>and/or mandibular arches to<br>support crowns, bridges, or<br>overdentures in edentulous<br>or partially edentulous<br>patients. For implant bodies<br>Ø4.1 and greater, the<br>Internal Hex Implant System<br>is intended for immediate<br>loading when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading. Implant bodies with<br>a diameter less than Ø4.1<br>are intended for immediate<br>loading when using a<br>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 | |…
