(144 days)
No
The summary describes a digitally-designed, patient-specific dental abutment that is manufactured by milling. There is no mention of AI or ML being used in the design process, manufacturing, or intended use. The focus is on the material, dimensions, compatibility, and mechanical testing.
No
The device is described as an abutment that supports prosthetic restorations attached to dental implants. Its function is primarily structural and mechanical, not therapeutic in the sense of treating or preventing a disease or condition.
No
The device, "ARUM Dentistry's Customized Abutments," is described as an implant abutment used to support prosthetic restorations. Its function is structural and restorative, not diagnostic. The text focuses on its physical properties, compatibility with implant systems, and mechanical performance, with no mention of any diagnostic capabilities, measurement of biological parameters, or detection of disease.
No
The device is a physical dental abutment made from Ti-6Al-4V Eli, which is a hardware component. While the abutments are digitally designed, the final product is a manufactured physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ARUM Dentistry Customized Abutments are physical components designed to be attached to dental implants within the patient's mouth to support dental prosthetics. They are a structural part of a dental restoration.
- Intended Use: The intended use clearly states they are for "attachment to dental implants in order to provide support for customized prosthetic restorations." This is a mechanical and structural function, not a diagnostic one performed on a sample outside the body.
- Device Description: The description details the material (Ti-6Al-4V Eli), dimensions, and compatibility with implant systems. This aligns with a physical medical device, not a diagnostic test kit or instrument.
The device is a dental prosthetic component, not a tool for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
ARUM Dentistry's Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized 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:
| Implant Platform
compatibility | Restorative Platform
diameter (mm) | Implant Body diameter (mm) |
|:---|:---|:---|
| NB 1 SA Implant
System | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.15, 4.25, 4.5, 5.0 |
All digitally-designed Customized 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)
NHA
Device Description
Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific abutment are 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems:
| Proprietary Name | NB 1 SA Implant System |
|---|---|
| Compatible Implants (K number) | K222131 |
| Implant diameter size | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Implant Interface Connection Type/Size (mm) | Internal Connection type/2.5 |
| Type of Implant-Abutment Connection | Hex/Non-Hex |
Patient-specific abutments are supplied with an abutment screw previous cleared device as K222131 and 7 newly designed screws and provided non-sterile.
Patient-specific abutment design parameters:
| Parameter | Min (mm) | 10 Ø Max (mm) | 14 Ø Max (mm) |
|---|---|---|---|
| Total Height | 6.0 | 16.0 | 16.0 |
| Post Height for Single- | |||
| Unit Restoration | 4.0 | 13.0 | 13.0 |
| Angle | 0° | 30° | 30° |
| Wall Thickness | 0.5 | 3.8 | 6.0 |
| Diameter | Based on minimum | ||
| wall thickness | 9.9 | 13.9 | |
| Gingival Height | 0.5 | 4.0 | 4.0 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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)
MR Environment Condition
Non-clinical worst-case MRI Review was performed to evaluated the metallic. The Customized Abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Non-Clinical Test Data
No need to perform any new additional non-clinical testing for the subject device since the subject device compared to predicate device are substantially equivalent in indications, fundamental technology, material and design. The predicate device may be leveraged for the subject devices because of using the same materials, manufacturing methods, and sterilization procedures. Although the dimensions are slightly different, it doesn't impact product's safety and effectiveness because the predicate device is the worst case based on the product's dimensional comparison analysis provided.
Below tests were performed for primary predicate and leveraged for the subject device:
- . Sterilization validation according to ISO 17665-1. ISO 17665-2, and ISO 14937 referenced in K193425.
- Biocompatibility according to ISO 10993-5 and ANSI/AAMI ST72 referenced with K193425. .
Non-clinical performance data submitted to demonstrate substantial equivalence included:
- . Static and fatigue testing according to ISO 14801. No clinical data is included in this submission.
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate.
Equivalence to Marketed 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 fatigue testing. Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate device, 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.
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.)
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ARUM DENTISTRY Co., Ltd. Boyeon Lim Assistant Manager 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 SOUTH KOREA
Re: K223634
Trade/Device Name: Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 5, 2023 Received: April 5, 2023
Dear Boyeon Lim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
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
2
Indications for Use
Device Name Customized Abutment
Indications for Use (Describe)
ARUM Dentistry's Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cementretained 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:
| Implant Platform
compatibility | Restorative Platform
diameter (mm) | Implant Body diameter (mm) |
|-----------------------------------|---------------------------------------|--------------------------------|
| NB 1 SA Implant
System | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.15, 4.25, 4.5, 5.0 |
All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/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" and "DENTISTRY" are stacked on top of each other and are in a bold, dark brown font.
510(K) Summary
Submitter
ARUM DENTISTRY Co., Ltd. Lee Jeong Hyun 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: April 28, 2023
Device Information
- Trade Name: Customized Abutment
- . Common Name: Abutment, Implant, Dental, Endosseous
- Classification Name: Endosseous dental implant abutment
- . Primary Product Code: NHA
- Panel: Dental ●
- Regulation Number: 21 CFR 872.3630
- . Device Class: Class II
Predicate Device Information
The devices within this submission are substantially equivalent in indications, intended use and
design principles to the following primary predicate and reference devices:
Primary Predicate
| 510(k) | Device Name | Company Name |
|---|---|---|
| K193425 | Pre-Milled Blank | ARUM DENTISTRY Co., Ltd. |
Reference Device
| 510(k) | Device Name | Company Name |
|---|---|---|
| K222131 | NB 1 SA Implant System | ARUM DENTISTRY Co., Ltd. |
4
Image /page/4/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, sans-serif font.
Device Description:
Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific abutment are 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems:
| Proprietary Name | NB 1 SA Implant System |
|---|---|
| Compatible Implants (K number) | K222131 |
| Implant diameter size | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Implant Interface Connection Type/Size (mm) | Internal Connection type/2.5 |
| Type of Implant-Abutment Connection | Hex/Non-Hex |
Patient-specific abutments are supplied with an abutment screw previous cleared device as K222131 and 7 newly designed screws and provided non-sterile.
| Parameter | Min (mm) | 10 Ø Max (mm) | 14 Ø Max (mm) |
|---|---|---|---|
| Total Height | 6.0 | 16.0 | 16.0 |
| Post Height for Single- | |||
| Unit Restoration | 4.0 | 13.0 | 13.0 |
| Angle | 0° | 30° | 30° |
| Wall Thickness | 0.5 | 3.8 | 6.0 |
| Diameter | Based on minimum | ||
| wall thickness | 9.9 | 13.9 | |
| Gingival Height | 0.5 | 4.0 | 4.0 |
Patient-specific abutment design parameters:
Indication for Use
ARUM Dentistry's Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized 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:
5
Image /page/5/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of two triangles, one red and one light orange, stacked on top of each other. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
| Implant Platform
compatibility | Restorative Platform diameter
(mm) | Implant Body diameter (mm) |
|-----------------------------------|---------------------------------------|--------------------------------|
| NB 1 SA Implant
System | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.15, 4.25, 4.5, 5.0 |
All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistryvalidated milling center for manufacture.
Materials:
Customized Abutment and Abutment screw are fabricated from Ti-6Al-4V Eli conforming to ASTM F136.
6
Image /page/6/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a smaller yellow triangle on the left side of the text "ARUM" and "DENTISTRY" stacked on top of each other. The text is in a dark brown color.
Summaries of Technological Characteristics & Substantial Equivalence Discussion
| Subject Device | Primary Predicate | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | ||||||||||||||||||
| Trade Name | Customized Abutment | Pre-Milled Blanks | ||||||||||||||||||
| 510(k) Number | NA | K193425 | ||||||||||||||||||
| Device Classification | Endosseous Dental Implant, Abutment (872.3630) | Endosseous Dental Implant, Abutment (872.3630) | ||||||||||||||||||
| Product Code | NHA | NHA | ||||||||||||||||||
| Material | Ti-6AL-4V Eli (ASTM F136) | Ti-6AL-4V Eli (ASTM F136) | ||||||||||||||||||
| Diameter (mm) | CAD/CAM Patient-Specific Abutment: 3.6, 4.0, 4.5, | |||||||||||||||||||
| 5.0, 5.5, 6.0, 6.5 | CAD/CAM Patient-Specific Abutment: 5.8/6.8 | |||||||||||||||||||
| Sterile | Steam Sterilization by user (Provided Non-Sterile) | Steam Sterilization by user (Provided Non-Sterile) | ||||||||||||||||||
| Type of Retention | Screw-retained or cement retained | Screw-retained or cement retained | ||||||||||||||||||
| Anatomical Site | Oral Cavity | Oral Cavity | ||||||||||||||||||
| Constructions | Machined | Machined | ||||||||||||||||||
| Indications For Use | ARUM Dentistry's Customized Abutments are intended for | |||||||||||||||||||
| attachment to dental implants in order to provide support | ||||||||||||||||||||
| for customized prosthetic restorations. Customized | ||||||||||||||||||||
| Abutments are indicated for screw-retained single | ||||||||||||||||||||
| restorations or cement-retained single or multi-unit | ||||||||||||||||||||
| restorations. The Customized 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: | ||||||||||||||||||||
| Implant Platform | ||||||||||||||||||||
| compatibility Restorative Platform | ||||||||||||||||||||
| diameter (mm) Implant Body | ||||||||||||||||||||
| diameter (mm) NB 1 SA Implant | ||||||||||||||||||||
| System 3.8, 4.0, 4.5, 5.0, 5.5, | ||||||||||||||||||||
| 6.0, 6.5 3.8, 4.0, 4.15, 4.25, | ||||||||||||||||||||
| 4.5, 5.0 | ARUM DENTISTRY's Pre-Milled Blank abutments are | |||||||||||||||||||
| intended for attachment to dental implants in order to | ||||||||||||||||||||
| provide support for customized prosthetic restorations. | ||||||||||||||||||||
| Pre-Milled Blank abutments are indicated for screw- | ||||||||||||||||||||
| retained single restorations or cement-retained single or | ||||||||||||||||||||
| multi-unit restorations. The customized Pre-Milled Blank | ||||||||||||||||||||
| abutment will be attached to a dental implant using the | ||||||||||||||||||||
| included ARUM DENTISTRY prosthetic screw. | ||||||||||||||||||||
| ARUM DENTISTRY's Pre-Milled Blanks are compatible | ||||||||||||||||||||
| with the implant systems listed in the Compatibility Table: | ||||||||||||||||||||
| ARUM Pre-Milled Blanks Implant | ||||||||||||||||||||
| Platform | ||||||||||||||||||||
| compatibility Restorative | ||||||||||||||||||||
| Platform | ||||||||||||||||||||
| diameter (mm) Implant | ||||||||||||||||||||
| Body | ||||||||||||||||||||
| diameter (mm) Abutment | ||||||||||||||||||||
| Screw Ø10 mm Ø14 mm |
7
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 beige. The words "ARUM DENTISTRY" are stacked on top of each other in a bold, sans-serif font.
| All digitally-designed Customized Abutments are intended
to be sent to an ARUM Dentistry-validated milling center
for manufacture. | | CIHE03
7 | CIHE038 | NobelActive
NP | 3.5 | 3.5 | CSTO001 |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|---------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| | | CIHE03
9 | CIHE040 | NobelActive
RP | 3.9 | 4.3/5.0 | CSTO002 |
| | | CIHE13
5 | CIHE136 | NobelActive
WP | 5.1 | 5.5 | |
| | | | | | All digitally-designed Pre-Milled Blank abutments are
intended to be sent to an ARUM DENTISTRY validated
milling center for manufacture. | | |
| Abutment
Design
Parameters | Minimum wall thickness: 0.5 mm | | | | | | |
| | Minimum post height: 4 mm | | | | | | |
| | Maximum post height: 13 mm | | | | | | |
| | Maximum angulation: 30 ° | | | | | | |
| | Maximum diameter: 13.9 mm | | | | | | |
| | Minimum gingival height: 0.5 mm | | | | | | |
| | Maximum gingival height: 4 mm | | | | | | |
| Substantial
Equivalence
Comparison | Except for the device name, reference/model numbers, the list of specific compatible platforms the Subject
and Predicate devices have identical manufacturers, manufacturing processes, and Indications for Use.
These differences do not change the intended use of the Subject and Predicate devices to provide support
for single or multi-unit prosthetic restorations. Minor differences in abutment interface geometry due to
compatible implant systems or restorative interface diameters do not introduce new risk nor change the
intended use of the device to provide support for single and multi-unit prosthetic restorations. Overall, the
Technological Characteristics, mode of operation and materials of the Subject device are substantially
equivalent to that of the Predicate device. | | | | | | |
8
Image /page/8/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of a geometric shape on the left and the text "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one light orange. The text "ARUM DENTISTRY" is in a bold, sans-serif font.
MR Environment Condition
Non-clinical worst-case MRI Review was performed to evaluated the metallic. The Customized Abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Non-Clinical Test Data
No need to perform any new additional non-clinical testing for the subject device since the subject device compared to predicate device are substantially equivalent in indications, fundamental technology, material and design. The predicate device may be leveraged for the subject devices because of using the same materials, manufacturing methods, and sterilization procedures. Although the dimensions are slightly different, it doesn't impact product's safety and effectiveness because the predicate device is the worst case based on the product's dimensional comparison analysis provided.
Below tests were performed for primary predicate and leveraged for the subject device:
- . Sterilization validation according to ISO 17665-1. ISO 17665-2, and ISO 14937 referenced in K193425.
- Biocompatibility according to ISO 10993-5 and ANSI/AAMI ST72 referenced with K193425. .
Non-clinical performance data submitted to demonstrate substantial equivalence included:
- . Static and fatigue testing according to ISO 14801. No clinical data is included in this submission.
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate.
Equivalence to Marketed 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 fatigue testing. Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence
9
Image /page/9/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one light orange. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in a bold, dark brown font, with "DENTISTRY" appearing below "ARUM".
because these differences are related to the compatible implant designs, or are mitigated by the mechanical performance testing.
Conclusion
The Customized Abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, the Customized Abutment and its predicates are substantially equivalent.