(116 days)
No
The summary describes a traditional dental implant system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The "digitally-designed" aspect refers to CAD/CAM processes for abutment manufacturing, not AI/ML for diagnosis, planning, or other functions.
Yes
The device, a dental implant system, is intended to replace missing teeth and support restorations in edentulous areas, directly addressing a health condition (missing teeth) to improve function and quality of life.
No
Explanation: This device is a dental implant system used for replacing missing teeth, not for diagnosing medical conditions. The provided information describes its physical characteristics, materials, and surgical procedures for implantation and restoration, without any mention of diagnostic capabilities.
No
The device description clearly states it is an endosseous dental implant system made of materials like Pure Titanium and Ti-6Al-4V Eli, which are hardware components. While it mentions digitally-designed abutments and validated milling centers, the core device is a physical implant system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for surgical implantation in the body to support dental restorations. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The description details the materials and components of a dental implant system designed to be placed in bone. This aligns with a surgical implant, not a device used to examine specimens from the body.
- No mention of in vitro testing: There is no mention of the device being used to test samples of blood, tissue, or other bodily fluids outside of the body.
- Anatomical Site: The device is used directly within the mandibles and maxillae (part of the human body), not on samples taken from the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SD TL 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. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed Pre-Milled Abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
An endosseous dental implant is a device made of a material such as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL 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 non-submerged external connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The SD TL Implants are available with a gingival height of 1.5 mm.
The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Pre-Milled cylinders come in engaging and non-engaging types. All designed abutments are sent to an ARUM DENTISTRY validated milling center.
The diameters of Multi Pre-Milled Cylinder are 4.8 mm Square.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles and maxillae
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: Biocompatibility of Ti-6Al-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.
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. 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 TL 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 6, 2024
ARUM DENTISTRY Co., Ltd. Choi Won-Yi Official Correspondent 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 REPUBLIC OF KOREA
Re: K242753
Trade/Device Name: SD TL Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 12, 2024 Received: December 6, 2024
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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 Rule"). 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K242753
Device Name
SD TL Implant System
Indications for Use (Describe)
The SD TL 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. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed Pre-Milled Abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle on top of a smaller, light orange 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, with "DENTISTRY" appearing below "ARUM".
7. 510(K) Summary
Submitter
ARUM DENTISTRY Co., Ltd. Won-Yi Choi 23, Gukjeqwahak 11-ro, Yuseong-qu Daejeon, 34002 Republic of Korea Email: arum ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633
Device Information
- Trade Name: SD TL 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: 01/06/2025
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K222778, Osstem Implant System by Osstem Implant CO., LTD. .
Reference Device
- K153268, NR Line Implant System by Dentium Co., Ltd. .
- K222792, SNUCONE Tissue Level Implant System by SNUCONE Co., Ltd. .
- K223634, Customized Abutment by ARUM DENTISTRY Co., Ltd.
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Image /page/5/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one beige. The words "ARUM DENTISTRY" are in a bold, brown font, with "ARUM" on top and "DENTISTRY" on the bottom.
General Description
SD TL Implant System consist of below:
Fixture
- . SD Tissue Level Fixture
Abutment
- . Multi Pre-Milled Cylinder
Device Description
An endosseous dental implant is a device made of a material such as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL 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 non-submerged external connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The SD TL Implants are available with a gingival height of 1.5 mm.
The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Pre-Milled cylinders come in engaging and non-engaging types. All designed abutments are sent to an ARUM DENTISTRY validated milling center.
The diameters of Multi Pre-Milled Cylinder are 4.8 mm Square.
6
Image /page/6/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM" and "DENTISTRY" on the right. The geometric shape is made up of a red triangle on top of a smaller, light orange triangle. The words "ARUM" and "DENTISTRY" are written in a bold, dark brown font.
Patient-specific abutment design parameters:
Image /page/6/Figure/3 description: The image shows a diagram of a dental implant with labels for gingival height, thickness, post height, angle, and diameter. A table below the diagram lists the minimum and maximum values for each parameter. The post height for a single-unit restoration ranges from 4.0 mm to 13.0 mm, the angle ranges from 0° to 30°, the wall thickness ranges from 0.5 mm to 6.0 mm, the gingival height ranges from 0.5 mm to 4.0 mm, and the diameter ranges from a minimum wall thickness to 13.9 mm.
- Post height for single-unit restoration is defined as the cementable post measured above the gingival collar of the final abutment design
※ When machined at an angle of above 0°
- Post Height for Single-Unit Restoration: 4.25mm -
- Wall Thickness:0.5mm -
- Diameter: 6.25 -
- Gingival Height: 4.0mm -
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Image /page/7/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one beige. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
Indication for Use
The SD TL 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. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed Abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
Materials
The Fixtures are fabricated from Pure Titanium (Conforming to ASTM F67) All Cylinder and Abutment Screws are fabricated from Ti-6AI-4V Eli (Conforming to ASTM F136).
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Image /page/8/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle and a smaller tan triangle on the left side. To the right of the triangles is the text "ARUM" in a bold, dark brown font, with the word "DENTISTRY" underneath it in the same font and color.
Summaries of Technology Characteristics
1) SD Tissue Level Fixture
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Osstem Implant CO., LTD. | SNUCONE Co., LTD. |
| Device Name | SD Tissue Level Fixture | SSIII SA Implant | EF Fixture for SNUCONE Tissue |
| Level Implant System | |||
| 510(k) Number | N/A | K222778 | K222792 |
| Intended Use/ | |||
| Indications for | |||
| use | The SD TL 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. | |||
| Abutments are indicated for screw- | |||
| retained single restorations or | |||
| cement-retained single of multi-unit | |||
| restorations. SD TL Implant | |||
| System is dedicated for two stage | |||
| surgical procedures and for | |||
| immediate loading when there is | |||
| good primary stability and an | |||
| appropriate occlusal load. All | |||
| digitally-designed Pre-Milled | |||
| Abutments are intended to be sent | |||
| to an ARUM DENTISTRY validated | |||
| milling center for manufacture. | The Osstem Implant System is | ||
| indicated for use in partially or fully | |||
| edentulous mandibles and | |||
| maxillae, in support of single or | |||
| multiple-units restorations | |||
| including; cemented retained, | |||
| screw retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment support for | |||
| fixed bridgework. It is intended for | |||
| delayed loading. | |||
| Ultra wide Implant System is | |||
| intended to be used in the molar | |||
| region. | |||
| Products with diameter of less than | |||
| 3.25mm should be used | |||
| exclusively for the lateral incisor in | |||
| the maxilla and a central | |||
| or lateral incisor in the mandible. | SNUCONE Tissue Level 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, or overdenture | |||
| restorations and terminal or | |||
| intermediate Abutment support for | |||
| fixed bridge work. Snucone 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. | |||
| Material | Titanium Grade 4 (ASTM F67) | Titanium Grade 4 (ASTM F67) | Titanium Grade 4 (ASTM F67) |
| Range of | |||
| Diameters (Ø) | |||
| 3.7, 4.2, 4.6, 5.0 | 4.8, 6.0 | 3.7, 3.8, 4.1, 4.3, 4.8, 5.3, 5.5, 5.8 | |
| Range of | |||
| Lengths (mm) | 7.0, 8.5, 10.0, 11.5, 13.0 | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 | 7, 8, 9, 10, 11, 12, 13, 14 |
| Surface | |||
| treatment | SLA | SLA | Acid etching |
| 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. | |||
| Substantial | |||
| Equivalent | |||
| Discussion | Similarities | ||
| The SD Tissue Level Fixture and SSIII SA Implant share similar device characteristics with the Reference Device, | |||
| including indication for use, length, material, functions, structure, and production method. Both devices are | |||
| intended for use in partially or fully edentulous mandibles and maxillae. While the Primary Predicate device has | |||
| diameters of 4.8 and 6.0, the subject device offers diameters of 3.7, 4.2, 4.6, and 5.0. These dimensional | |||
| differences are supported by the Reference Device (K222792), which covers a wider range of sizes, ensuring | |||
| substantial equivalence. | |||
| The abutment intended use is consistent with standard practices and does not introduce new risks. Immediate | |||
| loading is applicable under specific conditions; if these conditions are not met, delayed loading is used, which | |||
| aligns with the Primary Predicate's intended use. The subject device's milling center ensures product quality and | |||
| manufacturing control, without affecting the abutment's material, design, or function. | |||
| In conclusion, the additional details in the subject device do not affect its fundamental operation, intended use, | |||
| or safety. The SD TL Implant System is therefore substantially equivalent to both the Primary Predicate and | |||
| Reference Device. | |||
| Subject Device | Reference Device | Reference Device | |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | Dentium Co., Ltd. |
| Device Name | Multi Pre-Milled Cylinder | Customized Abutment | NR Line Implant System |
| 510(k) No. | N/A | K223634 | K153268 |
| Intended Use/ | |||
| Indications | |||
| for use | The SD TL Implant System is | ||
| indicated for use in partially or fully | |||
| edentulous mandibles and maxillae, | |||
| in support of single or multiple-unit | |||
| including; cemented | |||
| restorations | |||
| retained, | |||
| screw retained, | |||
| or | |||
| restorations, | |||
| overdenture | |||
| and | |||
| terminal or intermediate Abutment | |||
| for fixed bridgework. | |||
| support | |||
| Abutments are indicated for screw- | |||
| retained | |||
| single restorations | |||
| or | |||
| cement-retained single of multi-unit | |||
| restorations. SD TL Implant System | |||
| is dedicated for two stage surgical | |||
| procedures and for immediate | |||
| loading when there is good primary | |||
| stability and an appropriate occlusal | |||
| load. All digitally-designed Pre-Milled | |||
| Abutments are intended to be sent to | |||
| an ARUM DENTISTRY validated | |||
| milling center for manufacture. | ARUM | ||
| Dentistry's | |||
| Customized | |||
| Abutments | |||
| intended | |||
| are | |||
| for | |||
| attachment to dental implants in | |||
| provide | |||
| support | |||
| order | |||
| to | |||
| for | |||
| customized prosthetic restorations. | |||
| Customized Abutments are indicated | |||
| for screw-retained single restorations | |||
| or cement-retained single or multi- | |||
| unit restorations. The Customized | |||
| Abutment will be attached to a dental | |||
| implant using the included ARUM | |||
| Dentistry prosthetic screw. | |||
| Customized | |||
| Abutments | |||
| are | |||
| compatible with the implant systems | |||
| listed in the Compatibility Table: | |||
| lmplant | |||
| Restorativ | |||
| Implant | |||
| e Platform | |||
| Platform | |||
| Body | |||
| compatibili | |||
| diameter | |||
| diameter | |||
| (mm) | |||
| (mm) | |||
| tv | |||
| 3.8, 4.0, | |||
| NB 1 SA | |||
| 3.8, 4.0, | |||
| 4.5, 5.0, | |||
| 4.15, 4.25, | |||
| Implant | |||
| 5.5, 6.0, 6.5 | |||
| 4.5, 5.0 | |||
| System | |||
| digitally-designed | |||
| Customized | |||
| All | |||
| Abutments are intended to be sent to | |||
| an ARUM Dentistry-validated milling | |||
| center for manufacture. | The NR Line Implant System is | ||
| indicated for use in surgical and | |||
| restorative | |||
| applications | |||
| for | |||
| placement in the bone of the upper | |||
| or lower jaw to provide support for | |||
| prosthetic devices, such as artificial | |||
| teeth, in order to restore the patient's | |||
| chewing function. NR Line Implant | |||
| System is indicated also for | |||
| immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. | |||
| Sterilization | Steam Sterilization by user | ||
| (Provided Non-Sterile) | Steam Sterilization by user | ||
| (Provided Non-Sterile) | Steam Sterilization by user | ||
| (Provided Non-Sterile) | |||
| Type of | |||
| Retention | Screw-retained or cement retained | Screw-retained or cement retained | Screw-retained or cement retained |
| Diameter | |||
| (mm) | CAD/CAM Patient-Specific | ||
| Abutment: 4.2, 4.35, 4.6, 4.75, 5.0, | |||
| 5.15, 6.2 | CAD/CAM Patient-Specific | ||
| Abutment: 3.8, 4.0, 4.5, 5.0, 5.5, | |||
| 6.0, 6.5 | 3.7, 4.3, 5.5, 6.5 | ||
| 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) | |||
| Connection | |||
| type | Square | Internal Hex | Square |
| Surface | |||
| Treatment | Machined | Machined | Machined |
| Substantial | |||
| Equivalent | |||
| Discussion | 1. Similarities | ||
| The Multi Pre-Milled Cylinder is substantially equivalent in designs, dimensions, material, indications, abutment seat, | |||
| screw seat, anatomical site, and technological characteristics with the identified primary predicate device. The | |||
| patient-specific abutment is similar in fundamental scientific technology to the predicate. The Indications for Use of | |||
| the subject and primary predicate device are identical. |
- Differences
The differences between the subject device and reference device are the connection type. To support the square
connection, K153268 was added as reference device. Although, connection type is slightly different but it doesn't
impact product's safety and effectiveness. Therefore, this difference doesn't impact substantial equivalence. | | |
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Image /page/9/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one light orange. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
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Image /page/10/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one beige. The words "ARUM DENTISTRY" are in a bold, sans-serif font, with "ARUM" on top and "DENTISTRY" on the bottom.
2) Multi Pre-Milled Cylinder
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Image /page/11/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of two triangles, one red and one light orange, placed next to each other. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, dark brown letters, with "ARUM" on top of "DENTISTRY".
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Image /page/12/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of two triangles, one red and one light orange, on the left side of the text. The text "ARUM" is on the top line, and "DENTISTRY" is on the bottom line, with both lines in a bold, dark brown font.
Performance Data
Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
Biocompatibility of Ti-6Al-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.
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Image /page/13/Picture/0 description: The image contains a logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one light yellow. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
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 TL 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 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.