(93 days)
The Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally-designed Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
The Ti-Base & Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment.
Device Components:
- Abutment
- Ti-Base
- Master Fix
- Abutment Screw
The Ti-Base and Master Fix are provided non-sterilized. Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
The provided document is a 510(k) premarket notification for the "Ti-Base & Master Fix" dental implant abutments. It includes a summary of technology characteristics and performance data but does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert opinions, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device (DESS Dental Smart Solutions, K191986) primarily through material composition, intended use, and mechanical testing that mitigates minor design differences.
Therefore, many of the requested details cannot be extracted from this document.
However, based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum fracture strength, fatigue life thresholds) or report specific numerical performance outcomes against such criteria for the "Ti-Base & Master Fix" directly.
- It references mechanical performance testing as a method to mitigate differences in design and ensure safety and effectiveness, implying that such tests were conducted and their results were deemed acceptable, but the actual data/criteria are not provided in this summary.
- It also mentions biocompatibility testing according to ISO 10993-5 and ISO 10993-12, and moist heat sterilization validation according to ISO 17665 -1 and ISO 17665-2. These standards implicitly contain acceptance criteria, but the specific results or criteria are not detailed in this submission summary.
Table of Acceptance Criteria and Reported Device Performance (Based only on what's implicitly mentioned as having been met)
| Acceptance Criteria Category | Acceptance Criteria (Implicit from referenced standards/statements) | Reported Device Performance (Implicit from overall submission) |
|---|---|---|
| Mechanical Performance | Meets performance requirements to ensure safety and effectiveness despite design differences (e.g., fracture strength, fatigue resistance). | Testing was conducted, and differences were mitigated, implying acceptable performance. No specific values or thresholds provided. |
| Biocompatibility | Complies with ISO 10993-5 (cytotoxicity) and ISO 10993-12 (sample preparation). | Testing was performed according to these standards, implying compliance. |
| Sterilization | Validated for moist heat sterilization per ISO 17665-1 and ISO 17665-2. | Validation was performed, implying a sterile product post-processing by the end-user. |
| MRI Safety | Evaluation performed for magnetically induced displacement force and torque, per FDA guidance. | Review performed using scientific rationale and published literature, implying acceptable safety in MR environment. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide details on sample sizes for mechanical performance testing, biocompatibility, or sterilization validation.
- No information on the country of origin of the data or whether the studies were retrospective or prospective can be extracted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided. The submission is for a medical device (dental implant abutment), and the performance data primarily relates to physical and material properties, not diagnostic imaging or clinical interpretation requiring expert ground truth establishment in that typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. This typically applies to clinical or imaging studies where expert consensus is formed, which is not the type of study described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable and not provided. This is a medical device (dental implant abutment) submission, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For physical device testing, ground truth would typically refer to established engineering standards, material properties, and validated test methods (e.g., ISO standards for mechanical testing, biocompatibility).
8. The sample size for the training set
- Not applicable and not provided. There is no machine learning or AI component described that would require a training set.
9. How the ground truth for the training set was established
- Not applicable and not provided.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ARUM DENTISTRY Co., Ltd. Won-Yi Choi Official Correspondent 23, Gukjegwahak 11-ro, Yuseong-gu Daeieon, 34002 REPUBLIC OF KOREA
June 5, 2024
Re: K240603
Trade/Device Name: Ti-Base & Master Fix Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 4, 2024 Received: March 4, 2024
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.
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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 (OS) 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.
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3
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
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Indications for Use
510(k) Number (if known) K240603
Device Name
Ti-Base & Master Fix
Indications for Use (Describe)
The Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally-designed Ti-Base and Master Fix 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 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 yellow triangle on the bottom left. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
K240603
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: Ti-Base & Master Fix
- . Common Name: Endosseous Dental Implant Abutment
- . Classification Name: Abutment, Implant, Dental, Endosseous
- Product Code: NHA ●
- . Panel: Dental
- . Regulation Number: 21 CFR 872.3630
- . Device Class: Class II
- Date Prepared: 06/04/2024 ●
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K191986, DESS Dental Smart Solutions by Terrats Medical SL
Reference Device
- K190112, Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione HT, Trione C, . Trione HT+) by Fine Advanced Compound Co., Ltd
- K193260, U-Cem Premium & MAZIC Cem by Vericom Co., Ltd. .
- . 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 shows a logo for "Arum Dentistry". The logo consists of a geometric shape on the left and the text "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one light orange. The text "ARUM" is in a larger font than "DENTISTRY", and both are in a dark brown color.
General Description
Device Components
-
- Abutment
- Ti-Base
- Master Fix
- Abutment Screw
The Ti-Base and Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment.
| No. | Device Name | Dimension |
|---|---|---|
| 1 | Ti-Base | Ø3.35 (D) x 4.0 mm (Post Height) |
| 2 | Master Fix | Ø4.5, 5.5, 6.5 (D) x 3.5, 4.0, 5.0, mm (Post Height) |
| 3 | Abutment Screw(Cleared in K213506) | Ø 2.35 (D) x 8.4 mm(L) |
| 4 | Master Fix Screw | Ø2.25 (D) x 10.3, 11.3, 11.8, 12.3, 12.8, 13.3, 13.8, 14.3,14.8, 15.3, 15.8mm (L) |
The dimension ranges of the subject device are below:
Below are the abutment's features:
| Name | Uses | Surface |
|---|---|---|
| Ti-Base | The Ti-Base is used as a support of prosthesis torestore the patient's chewing function. | N/A |
| Master Fix | The Master Fix is used as a support of prosthesis torestore the patient's chewing function. | N/A |
| Abutment Screw(Cleared in K213506) | The Abutment Screw is used for connect fixture andabutment. | N/A |
| Master Fix Screw | The Master Fix Screw is used for connect fixture andabutment. | N/A |
Ti-Base, Master Fix, Abutment Screw and Master Fix Screw are provided non-sterilized.
Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared
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ARUM
DENTISTRY
K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension.
The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
For the Ti-Base the design parameters for the CAD/CAM zirconia superstructure are:
Minimum wall thickness - 0.5 mm;
Minimum post height* for single-unit restorations - 4.5 mm;
Maximum gingival height - 5.0 mm;
Minimum gingival height - 0.5 mm;
Angulation - 0°
and All zirconia superstructures are for straight abutments only.
*Post Height is measured above the gingival height of the final patient-matched design
For the Master Fix, the design parameters for the CAD/CAM zirconia superstructure are:
Minimum wall thickness - 0.5 mm;
Minimum post height* for single-unit restorations - 4.0 mm;
Maximum qinqival height - 5.0 mm:
Minimum gingival height - 0.5 mm;
Angulation - 0°
and All zirconia superstructures are for straight abutments only.
*Post Height is measured above the gingival height of the final patient-matched design
The Ti-Base and Master Fix is compatible with the following implant systems.
| Manufacturer | 510(k) No. | Implant SystemCompatibility | Dimension |
|---|---|---|---|
| ARUMDENTISTRYCo., Ltd. | K213506 | NB 1 SA Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| ARUMDENTISTRYCo., Ltd. | K230725 | NB Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
The titanium bases are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
Raw material Zirconia Block
K190112, Non-Sterile Zirconia Block by FINE ADVANCED COMPOUND Co., Ltd.
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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.
Dental Cement
K193260, U-Cem Premium & MAZIC Cem by Vericom Co., Ltd.
Zirconia structure Details
| Specification | Zirconia Block |
|---|---|
| Trade name | Non-Sterile Zirconia Block |
| Common name | Dental zirconia blanks/blocks |
| Manufacturer | FINE ADVANCED COMPOUND Co., Ltd |
| 510(k) No. | K190112 |
| Product code | EIH |
| Regulatory class | Class II |
| Intended use | Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT,Trione C, Trione HT+) are indicated for the production of artificial teeth infixed or removable dentures, or for jacket crowns, facings, and veneers. |
Indication for Use
Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in
the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally-designed Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
Materials
Pre-Manufactured titanium components of Abutment Screws are fabricated from Ti-6Al-4V Eli (Conforming to ASTM F136).
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Image /page/8/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of a red triangle and a smaller, light orange triangle on the left side. To the right of the triangles, the word "ARUM" is written in bold, dark brown letters, with the word "DENTISTRY" written in the same font and color directly below it.
Summaries of Technology Characteristics
1) Ti-Base
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Terrats Medical SL |
| Device Name | Ti-Base & Master Fix | DESS Dental Smart Solutions |
| 510(k) No. | N/A | K191986 |
| Intended Use/Indications foruse | Ti-Base & Master Fix are intended to be used inconjunction with endosseous dental implants in themaxillary or mandibular arch to provide support forprosthetic restorations.All digitally-designed Ti-Base and Master Fix areintended to be sent to an ARUM DENTISTRYvalidated milling center for manufacture. | DESS Dental Smart Solutions abutments areintended to be used in conjunction with endosseousdental implants in the maxillary or mandibular arch toprovide support for prosthetic restorations.All digitally designed custom abutments for use withTi Base abutments or Pre-milled (Blank) abutmentsare to be sent to a Terrats Medical validated millingcenter for manufacture. |
| Diameter (⌀) | 3.35 | 4.5 - 6.5 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| SuperstructureMaterial | Zirconia (Y-TZP)Non-Sterile Zirconia Block, cleared in K190112 | Zirconia (Y-TZP)(Not stated in 510(k) Summary) |
| Cement Material | CementU-Cem Premium & MAZIC Cem, cleared in K193260 | Multilink Hybrid Abutment Cement(Ivoclar Vivadent AG, Cleared in K130436) |
| Sterilization | End User Sterilization | End User Sterilization |
| DesignParameter | Minimum wall thickness – 0.5 mm;Minimum post height for single-unit restorations – 4.5mm;Maximum gingival height – 5.0 mmMinimum gingival height – 0.5 mmAngulation - 0° | Minimum wall thickness - 0.4 mmMinimum post height - 4.2 mmMaximum gingival height - 6.0 mm |
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Image /page/9/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.
Г
| 1. SimilaritiesThe Ti-Base has the same intended use for, technological characteristics to the K191986. The Ti-Base havesame device characteristics with the Primary Predicate such as material, sterilization, intended use, functions,structure. | |
|---|---|
| SubstantialEquivalentDiscussion | 2. DifferencesThe minor differences with the primary predicated K191986 are slightly different dimension and insignificantshapes. However, the subject diameters are in the range of diameters of primary predicate and this dimensionaldifference doesn't affect device safety and effectiveness. The shape is only for the manufacture's propertiessuch as design and compatible to their own dental implant design. These minor differences do not impact safetyand effectiveness because these differences are related to the compatible implant design and are mitigated bythe mechanical performing testing. |
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Image /page/10/Picture/0 description: The image contains the logo for Arum Dentistry. The logo features a geometric design on the left, consisting of a red triangle above a smaller, light orange triangle. To the right of the geometric design is the text "ARUM" in a bold, dark brown font, with the word "DENTISTRY" directly below it in the same font and color. The overall design is clean and modern, conveying a sense of professionalism.
- Master Fix
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Terrats Medical SL |
| Device Name | Ti-Base & Master Fix | DESS Dental Smart Solutions |
| 510(k) No. | N/A | K191986 |
| Intended Use/Indications foruse | Ti-Base & Master Fix are intended to be used inconjunction with endosseous dental implants in themaxillary or mandibular arch to provide support forprosthetic restorations.All digitally designed abutments for use with Ti-Baseand Master Fix are intended to be manufactured at anARUM DENTISTRY validated milling center. | DESS Dental Smart Solutions abutments areintended to be used in conjunction with endosseousdental implants in the maxillary or mandibular arch toprovide support for prosthetic restorations.All digitally designed custom abutments for use withTi Base abutments or Pre-milled (Blank) abutmentsare to be sent to a Terrats Medical validated millingcenter for manufacture. |
| Diameter (ø) | 4.5, 5.5, 6.5 | 4.5 - 6.5 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| SuperstructureMaterial | Zirconia (Y-TZP)Non-Sterile Zirconia Block, cleared in K190112 | Zirconia (Y-TZP)(Not stated in 510(k) Summary) |
| Cement Material | CementU-Cem Premium & MAZIC Cem, cleared in K193260 | Multilink Hybrid Abutment Cement(Ivoclar Vivadent AG, Cleared in K130436) |
| Sterilization | End User Sterilization | End User Sterilization |
| DesignParameter | Minimum wall thickness - 0.5 mm;Minimum post height for single-unit restorations - 4.5 mm;Maximum gingival height – 5.0 mmMinimum gingival height - 0.5 mmAngulation - 0° | Minimum wall thickness – 0.4 mmMinimum post height - 4.2 mmMaximum gingival height - 6.0 mm |
| SubstantialEquivalentDiscussion | 1. SimilaritiesThe Master Fix has the same intended use for, technological characteristics to the K191986. The Master Fixhave same device characteristics with the Primary Predicate such as material, sterilization, intended use,functions, structure. | |
| 2. DifferencesThe predicate device has a notch for anti-rotation, but the subject device features an enhanced anti-rotation design with two flat surfaces to prevent rotation between the zirconia superstructure and theabutment, allowing for precise positioning and orientation of the superstructure.The subject device features a slot in the post design, providing a larger area for improved cement adhesion,with differences in shape and design compared to the predicate device. These differences have been validatedthrough mechanical performance testing and do not affect safety or effectiveness. Therefore, the designchanges aim to improve the stability and retention of the prosthesis. |
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Image /page/11/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.
Г
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Image /page/12/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the text "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one light orange. The text "ARUM" is above the text "DENTISTRY", and both are in a dark brown color.
3) Abutment Screw
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | Ti-Base & Master Fix | NB 1 SA Implant System |
| 510(k) No. | N/A | K213506 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Range of Diameters (ø) | 2.2 | 2.35 |
| Length (mm) | 10.8 | 8.4 |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe Abutment Screw has same indication for use, principle of operation, functions, and material to thepredicate K213506.2. DifferencesThe difference between the subject and reference device is the dimensions of the device. However, itdoes not affect device's fundamental functions and safety; therefore, it is substantial equivalent. |
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Image /page/13/Picture/0 description: The image shows 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.
4) Master Fix Screw
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | Ti-Base & Master Fix | NB 1 SA Implant System |
| 510(k) No. | N/A | K213506 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Range of Diameters (ø) | 2.25 | 2.35 |
| Length (mm) | 10.3, 11.3, 11.8, 12.3, 12.8, 13.3, 13.8, 14.3,14.8, 15.3, 15.8 | 8.4 |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe Abutment Screw has same indication for use, principle of operation, functions, to secure a dentalabutment to a dental implant in the upper or lower jaw, and material to the predicate K213506.2. DifferencesThe screw's design features a larger head to increase retention in screw-retained prostheses. Theextended head fills the abutment's empty space, enhancing stability and preventing screw fractures.Additionally, the design facilitates easier access for the screw driver.However, it does not affect device's fundamental functions and safety; therefore, it is substantialequivalent. |
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Image /page/14/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below.
Performance Data
Non-clinical data submitted to demonstrate substantial equivalence include: biocompatibility testing according to ISO 10993-5 and ISO 10993-12 and moist heat sterilization validation according to ISO 17665 -1 and ISO 17665-2.
No clinical data were included in this submission.
MR Environment Condition
Non-Clinical worst-case MRI review was performed to evaluated the NB Mini 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 Subject device and the Primary predicate device have the same intended use, have the same technological characteristics, and are made of the same materials. The Subject device and the Primary predicate device encompass the same range of physical dimensions and are to be sterilized using the same methods. Although there is slightly difference design of the anti-rotation feature, this difference is the same purpose. This minor difference do not impact safety and effectiveness because this difference are related to increase the adhesion of cement to the prosthesis. The data included in this premarket notification demonstrate substantial equivalence to the primary predicate device listed above. Therefore, the subject device and primary predicate device are substantial equivalence.
§ 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.)