(118 days)
No
The device description and performance testing focus on the mechanical properties and compatibility of a dental abutment, with no mention of AI or ML.
No
The device provides support for prosthetic restorations and is not described as having any therapeutic function.
No
The device description indicates that the Angled Abutment provides support for prosthetic restorations. This is a structural and supportive function, not a diagnostic one.
No
The device description clearly states it is a physical dental abutment made of Ti-6Al-4V Eli, with specific dimensions and connections, and is provided with a physical abutment screw. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide support for prosthetic restorations such as crown, bridges, or over-dentures" in conjunction with a dental implant. This is a structural and mechanical function within the body.
- Device Description: The device is a physical component (angled abutment and screw) made of a specific material (Ti-6Al-4V Eli) and designed to connect to a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device itself is implanted and provides mechanical support.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a component of a dental restoration.
N/A
Intended Use / Indications for Use
Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown. bridges, or over-dentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506. The dimension ranges of the subject device are Angled Abutment: Ø 4.5, 5.5 (D) x 8 mm (Post Height) x 17° and Abutment Screw (Cleared in K213506): Ø 2.35 (D) x 8.4 mm (L). Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implant
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-44V Eli (ASTM F136) demonstrated by the reference ARUM DENTISTRY submission, K213506, using the same materials and manufacturing processes as the subject device.
The Angled Abutment delivered non-sterile to be end-user sterilized, the recommended sterilization has been validated according to ISO 17655-1 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The predicate devices may be leveraged for the subject devices because of using the same materials, manufacturing methods, and sterilization procedures. The sterilization methods were leveraged from predicated K213506. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices.
Mechanical performance testing was performed according to ISO 14801. For each compatible implant line, worst-case constructs were subjected to static compression and compression fatique 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.
Non-Clinical worst-case MRI review was performed to evaluated the Angled Abutment 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.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2023
Arum Dentistry Co., Ltd. Won-Yi Choi Assistant Manager 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 REPUBLIC OF KOREA
Re: K232560
Trade/Device Name: Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 21, 2023 Received: November 21, 2023
Dear Won-Yi Choi:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
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
510(k) Number (if known)
Device Name Angled Abutment
Indications for Use (Describe)
Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown. bridges, or over-dentures.
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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Image /page/4/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle on top of a smaller, light orange triangle. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, dark brown letters, with "ARUM" on top of "DENTISTRY".
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
Date prepared: December 14, 2023
Device Information
- . Trade Name: Angled Abutment
- Common Name: Endosseous Dental Implant Abutment
- Classification Name: Abutment, Implant, Dental, Endosseous ●
- Primary Product Code: NHA
- Panel: Dental ●
- . Regulation Number: 21 CFR 872.3630
- Device Class: Class II
- . Date Prepared: 11/20/2023
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
K182091, Osstem Abutment System by OSSTEM Implant Co., Ltd.
Reference Device
K213506, NB 1 SA Implant System by ARUM DENTISTRY Co., Ltd. K230725, NB Implant System 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 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.
General Description
Abutment
- . Angled Abutment
The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506.
The dimension ranges of the subject device are below:
| No. | Device Name | Dimension |
|---|---|---|
| 1 | Angled Abutment | $Ø$ 4.5, 5.5 (D) x 8 mm (Post Height) x 17° |
| 2 | Abutment Screw | |
| (Cleared in K213506) | $Ø$ 2.35 (D) x 8.4 mm (L) |
Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.
The Angled Abutment is compatible with the following implant systems.
| Manufacturer | 510(k) No. | Implant system
compatibility | Dimension |
|--------------------------------|------------|---------------------------------|-------------------------------------|
| ARUM
DENTISTRY
Co., Ltd. | K213506 | NB 1 SA Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| ARUM
DENTISTRY
Co., Ltd. | K230725 | NB Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
Indication for Use
Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures.
Materials:
| No. | Component Name | Materials | Surface treatment |
|---|---|---|---|
| 1 | Angled Abutment | Ti-6Al-4V Eli of ASTM F136 | TiN coating |
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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 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.
| | Abutment Screw
(Cleared in K213506) | Ti-6Al-4V Eli of ASTM F136 | Non coating |
|---|----------------------------------------|----------------------------|-------------|
| 2 | | | |
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Image /page/7/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.
Summaries of Technology Characteristics
1) Angled Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Device Name | Angled Abutment | Osstem Abutment System |
| 510(k) Number | N/A | K182091 |
| Intended Use/ | ||
| Indications for use | Angled Abutment is intended for use with a dental | |
| implant to provide support for prosthetic | ||
| restorations such as crown, bridges, or over- | ||
| dentures. | Osstem Abutment System is intended for use | |
| with a dental implant to provide support for | ||
| prosthetic restorations such as crowns, bridges, | ||
| or overdentures. | ||
| Design | Image: Angled Abutment | Image: Osstem Abutment System |
| Material | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) |
| Anti-Rotational | ||
| Feature | Hex, Non-Hex | Hex, Non-Hex |
| Range of | ||
| Diameters (ø) | 4.5, 5.5 | 4.0, 4.5, 5.0, 6.0 |
| Rang of Post | ||
| (mm) | 8 | 8 |
| Angle (°) | 17 | 17 |
| Sterilization | Non-Sterilization | Non-Sterilization |
| Surface | ||
| Treatment | TiN Coating | TiN Coating |
| Substantial | ||
| Equivalent | ||
| Discussion | 1. Similarities | |
| The Angled Abutment has the same intended use for, technological characteristics to the K182091.The | ||
| Angled Abutment have same device characteristics with the reference device predicate such as | ||
| material, anti-rotational feature, range of post, angle, sterilization intended use, functions, general | ||
| shape (Design), structure and applied production method. | ||
| 2. Differences | ||
| Compared to the reference device predicate, the subject device's diameter is different. However, except | ||
| for the diameters, range of lengths (post, angle, intended use, material, functions and general shape | ||
| (Design) are the same. Although the diameters are slightly different but it doesn't impact product's | ||
| safety and effectiveness because the Subject Device is included in the range of reference device | ||
| predicate's diameters. |
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Image /page/8/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is made up of a red triangle on top of a smaller, light orange triangle. The words "ARUM DENTISTRY" are in a bold, dark brown font, with "ARUM" on top of "DENTISTRY".
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Image /page/9/Picture/1 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, brown font.
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
The Angled Abutment delivered non-sterile to be end-user sterilized, the recommended sterilization has been validated according to ISO 17655-1 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The predicate devices may be leveraged for the subject devices because of using the same materials, manufacturing methods, and sterilization procedures. The sterilization methods were leveraged from predicated K213506. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices.
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 fatique 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 Angled Abutment 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
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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 a red triangle on top and a smaller, light orange triangle on the bottom. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
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. Overall, the Technological Characteristics of the Subject device are highly similar to the Predicate devices. The Subject device, the Predicate devices, 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 devices, 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 devices listed above. Overall, the Subject device is substantially equivalent to the Predicate devices.