(105 days)
The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NB Mini Implant System consist of below: Fixture - NB Fixture Mini Abutment - Cover Screw - . Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment Mini - . Angled Abutment Mini - Abutment Screw The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). 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).
This document is a 510(k) summary for the NB Mini Implant System by Arum Dentistry Co., Ltd. It declares that the device is substantially equivalent to existing predicate devices. Consequently, it does not contain a typical acceptance criteria table with reported device performance as would be found in a study demonstrating novel device performance. Instead, it provides a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, here’s an analysis of the "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, this document is a 510(k) summary for substantial equivalence, not a standalone performance study with explicit acceptance criteria. The "acceptance criteria" in this context are implicitly that the subject device's performance is substantially equivalent to legally marketed predicate devices. The "reported device performance" is presented through direct comparison of features and results of non-clinical benchtop tests against these predicate devices.
The table below summarizes the comparative information provided for the NB Fixture Mini (one component of the NB Mini Implant System) against its primary predicate and a reference device. Similar comparative summaries are provided for other components (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment Mini, Angled Abutment Mini, and Abutment Screw), all concluding substantial equivalence.
| Feature | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Subject Device: NB Fixture Mini) | Primary Predicate (IS-III active System, K190849) | Reference Device (Magicore Narrow System, K220079) |
|---|---|---|---|---|
| Intended Use/Indications for use | Must be same or highly similar | Same as predicate | Mandibular/maxillary incisor regions of partially edentulous jaws for prosthetic support; immediate loading. | Mandibular central/lateral incisors and maxillary lateral incisors; immediate loading. |
| Material | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) |
| Anti-Rotational Feature | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| Range of Diameters (Ø) | Comparable range | 3.2, 3.5 | 3.2 | 3.0, 3.5 |
| Range of Lengths (mm) | Comparable range | 8.5, 10, 11.5, 13.0, 15.0 | 8.5, 10, 11.5, 13.0, 15.0 | 11.0, 13.0, 15.0 |
| Surface treatment | SLA or similar proven safe/effective | SLA | SLA | RBM & SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf-life | 5 Years or comparable | 5 Years | 5 Years | 8 Years |
| Principle of Operation | Root-type fixture, replaces functions of missing teeth | Root-type fixture, replaces functions of missing teeth | Root-type fixture, replaces functions of missing teeth | Root-type fixture, replaces functions of missing teeth |
| Dynamic fatigue testing | Performance substantially equivalent to predicate | Found to be substantially equivalent | (Performed on predicate) | (Performed on reference) |
| Bone to Implant Contact (BIC) analysis | Comparable BIC value to predicate | BIC value compared and confirmed substantial equivalence | (Measured for predicate) | (Not specified for reference here) |
| Surface area analysis | Comparable surface area to predicate | Surface area compared and confirmed substantial equivalence | (Measured for predicate) | (Not specified for reference here) |
| Pullout test | Comparable pullout force value to predicate | Pullout force value compared and confirmed substantial equivalence | (Measured for predicate) | (Not specified for reference here) |
2. Sample size used for the test set and the data provenance
The document refers to a variety of non-clinical testing data for various components of the NB Mini Implant System:
- Mechanical performance testing (Fatigue test): "For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing." No specific numerical sample size is provided.
- Bone to Implant Contact (BIC) analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
- Surface area analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
- Pullout test: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
- Biocompatibility: Demonstrated by reference to ARUM DENTISTRY submission K213506.
- Sterilization validation: Performed according to ISO 11137-1 and ISO 11137-2 (method VDmax25 for 25 kGy dose, referenced from K213506), End User Moist Heat Sterilization Test (ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2 and ISO 11138-1, referenced from K213506), and LAL endotoxin testing (AAMI / ANSI ST72:2011/(R)2016).
- Shelf-Life: Accelerated aging method in accordance with ASTM F1980.
The data provenance is not explicitly stated as country of origin, retrospective or prospective, but all tests are non-clinical, meaning they were performed in a lab setting, likely by the manufacturer or a contract lab. The referenced 510(k) submissions (K213506, K190849, K220079, etc.) indicate these are devices marketed in the US, but the company (Arum Dentistry Co., Ltd.) is from the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set
This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies requiring adjudication of human reader interpretations.
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
This section is not applicable. The device is an endosseous dental implant system, not an AI or software-based diagnostic tool that would typically be evaluated with MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the device is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical performance tests:
- Mechanical fatigue: The "ground truth" or reference for evaluating performance is the established mechanical properties and fatigue resistance standards (e.g., ISO 14801), and the performance of the predicate devices.
- Biocompatibility: Demonstrated via material testing and reference to previous submissions, ensuring the material meets established safety standards for biological interaction.
- Sterilization: Ground truth is defined by sterility assurance levels (e.g., SAL of 10^-6) and adherence to recognized standards (ISO 11137, ANSI/AAMI ST79).
- Shelf-Life: Ground truth is established by test methods (ASTM F1980) that predict long-term stability and integrity.
- BIC, Surface Area, Pullout: These are physical measurements compared against predicate device performance, implying the predicate's performance serves as the reference for "substantially equivalent" ground truth.
8. The sample size for the training set
This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set and corresponding ground truth.
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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arum Dentistry Co., Ltd. Won-Yi Choi Official Correspondent 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 REPUBLIC OF KOREA
April 26, 2024
Re: K240091
Trade/Device Name: NB Mini Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 12, 2024 Received: April 23, 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 (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.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Submission Number (if known)
K240091
Device Name
NB Mini Implant System
Indications for Use (Describe)
The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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 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, bold font, while the text "DENTISTRY" is in a smaller, bold font and is located below the word "ARUM".
7. 510(K) Summary
Submitter
ARUM DENTISTRY Co., Ltd. Won-Yi Choi 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 Republic of Korea Email: arum ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633
Device Information
- Trade Name: NB Mini Implant System
- Common Name: Implant, Endosseous, Root-Form .
- . Classification Name: Endosseous Dental Implant
- . Primary Product Code: DZE
- . Secondary Product Code: NHA
- . Panel: Dental
- . Requlation Number: 21 CFR 872.3640
- Device Class: Class II
- Date Prepared: 04/26/2024 ●
Predicate Devices
The subject device is substantially equivalent to the following predicate and reference devices:
Primary Predicate
- K190849, IS-III active System by Neobiotech Co., Ltd.
Reference Device
- K220079, Magicore Narrow System by InnoBioSurg Co., Ltd.
- K161604, Osstem Implant System by Osstem Implant Co., Ltd. .
- K173374, TSV™ BellaTek® Encode® Healing Abutments by Biomet 3i .
- . K213506. NB 1 SA Implant System by ARUM DENTISTRY Co., Ltd.
- . K182091, Osstem Abutment System by Osstem Implant Co., Ltd.
- K222131, NB 1 SA Implant System by ARUM DENTISTRY Co., Ltd. .
- K230725, NB Implant System by ARUM DENTISTRY Co., Ltd. .
- K232560, Angled Abutment by ARUM DENTISTRY Co., Ltd.
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Image /page/5/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side, with the words "ARUM" and "DENTISTRY" in bold, dark brown letters on the right side. The word "ARUM" is above the word "DENTISTRY".
General Description
The NB Mini Implant System consist of below:
Fixture
- NB Fixture Mini
Abutment
- Cover Screw
- . Healing Abutment
- Scan Healing Abutment
- Scan Healing Abutment Screw
- Cemented Abutment Mini
- . Angled Abutment Mini
- Abutment Screw
The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations.
The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). 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 dimension ranges of the subject device are below:
| No. | Device Name | Dimension |
|---|---|---|
| 1 | NB Fixture Mini | Ø 3.2, 3.5 (D) x 8.5, 10, 11.5, and 13 mm (L) |
| No. | Device Name | Dimension |
| 1 | Cover Screw | Ø2.8 (D) x 5.1, 5.8, 6.8, 7.8 mm (L) |
| 2 | Healing Abutment | Ø4.2, 4.7, 5.7, 6.7, 7.7 (D) x 1.0, 2.0, 3.0, 4.0 mm (CuffHeight) |
| 3 | Scan Healing Abutment | Ø4.2, 4.7 (D) x 1.4, 3.4, 5.4, 7.4, 9.4 mm (Cuff Height) |
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Image /page/6/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of a geometric shape on the left, with a red triangle above a smaller, light orange triangle. To the right of the geometric shape is the text "ARUM" in a bold, dark brown font, with "DENTISTRY" in the same font directly below it. The overall design is clean and modern.
| Ø4.7, 5.7, 6.7, 7.7 (D) x 1.3, 3.3, 5.3, 7.3, 9.3 mm (Cuff Height) | ||
|---|---|---|
| 4 | Scan Healing Abutment Screw | Ø2.49 (D) x 9.7, 11.4, 11.7, 13.4, 13.7, 15.4, 15.7, 17.4, 17.7, 19.4 mm (L) |
| 5 | Cemented Abutment Mini | Ø4.0, 4.5 (D) x 5.0, 7.0 mm (Post Height) x 1.0, 2.0, 3.0, 4.0, 5.0(Cuff Height) |
| 6 | Angled Abutment Mini | Ø4.0, 4.5 (D) x 8 mm (Post Height) x 2, 4mm (Cuff Height) |
| 7 | Abutment Screw | Ø2.2 (D) x 10.8 mm (L) |
Below are the abutment's features:
| No. | Device Name | Uses | Surface treatment |
|---|---|---|---|
| 1 | Cover Screw | The Cover Screw is Intended to betemporarily connected to an endosseousdental implant to protect the implantconnection interface during bone healing. | No surfacetreatment |
| 2 | Healing Abutment | The Healing Abutment is designed to aid insoft tissue contouring during the healingperiod after implant placement, creating anemergence profile for the final prosthesis. | No surfacetreatment |
| 3 | Scan HealingAbutment | The Scan Healing Abutment has the addedfeature of machined markings for easyidentification when taking an abutment-levelimpression or an intraoral scan/digitalimpression from the healing abutment.Identification and orientation information iscaptured in the intraoral scan or model scan. | No surfacetreatment |
| 4 | Scan HealingAbutment Screw | The Scan Healing Abutment Screw is usedfor connect fixture and Scan Healingabutment. | No surfacetreatment |
| 5 | CementedAbutment Mini | The Cemented Abutment Mini is used as asupport of prosthesis to restore the patient'schewing function. | TiN Coating |
| 6 | Angled AbutmentMini | The Angled Abutment Mini is used as asupport of prosthesis to restore the patient'schewing function. | TiN Coating |
| 7 | Abutment Screw | The Abutment Screw is used for connectfixture and abutment. | No surfacetreatment |
The Cover Screw, Healing Abutment and Scan Healing Abutment is provided Sterile from manufacturer. Other abutments should be sterilized before use by end user sterilization. These devices are intended for single use only.
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Image /page/7/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle on top of a yellow triangle, with the text "ARUM" in bold, dark brown letters to the right of the triangles. Below "ARUM" is the word "DENTISTRY" in the same font and color, but slightly smaller.
K240091
Indication for Use
The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Materials
The Fixtures are fabricated from Ti-6AI-4V Eli (Conforming to ASTM F136).
All Abutments and 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 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 left. The words "ARUM DENTISTRY" are in a bold, dark brown font, with "ARUM" on top and "DENTISTRY" on the bottom.
Summaries of Technology Characteristics
1) NB Fixture Mini
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | Neobiotech Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | NB Mini Implant System | IS-III active System | Magicore Narrow System |
| 510(k) Number | K240091 | K190849 | K220079 |
| Intended Use/Indications for use | The NB Mini Implant System isindicated for use in surgical andrestorative applications forplacement in the mandibularcentral, lateral incisor andmaxillary lateral incisor regionsof partially edentulous jawswhere the horizontal space islimited by the adjacent teethand roots, to provide support forprosthetic devices, such asartificial teeth, in order torestore the patient's chewingfunction. The NB Mini ImplantSystem is indicated also forimmediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. | The IS-III active System_S-narrow Type is indicated for usein surgical and restorativeapplications for placement in themandibular central, lateral incisorand maxillary lateral incisorregions of partially edentulousjaws where the horizontal spaceis limited by the adjacent teethand roots, to provide support forprosthetic devices, such asartificial teeth, in order to restorethe patient's chewing function.The IS-III active System_S-narrow Type is indicated also forimmediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. | The The Magicore NarrowSystem(3.0, 3.5mm) may be used as anartificial root structure for singletooth replacement of mandibularcentral and lateral incisors andmaxillary lateral incisors. Theimplants may be restoredimmediately 1) with a temporaryprosthesis that is not infunctional occlusion, 2) whensplinted together as an artificialroot structure for multiple toothreplacement of mandibularincisors, or 3) for denturestabilization using multipleimplants in the anterior mandibleand maxilla. The implants maybe placed in immediate functionwhen good primary stability hasbeen achieved and withappropriate occlusal loading. |
| Material | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) | Ti-6Al-4V Eli (ASTM F136) |
| Anti-Rotational Feature | Internal Hex | Internal Hex | Internal Hex |
| Range of Diameters (Ø) | 3.2, 3.5 | 3.2 | 3.0, 3.5 |
| Range of Lengths (mm) | 8.5, 10, 11.5, 13.0, 15.0 | 8.5, 10, 11.5, 13.0, 15.0 | 11.0, 13.0, 15.0 |
| Surface treatment | SLA | SLA | RBM & SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years | 8 Years |
| Principle of Operation | This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture. | This product is a root-type fixturewhich is inserted in the alveolarbone. It replaces the functions ofthe missing teeth as a dentalimplant fixture. | This product is a root-type fixturewhich is inserted in the alveolarbone. It replaces the functions ofthe missing teeth as a dentalimplant fixture. |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe NB Fixture Mini has similar device characteristics with the Primary predicate such as Indications foruse, functions, material, surface treatment (SLA), fixture diameter, surgical technique, sterilizationmethod and shelf list, structure and applied production method.2. DifferencesThe difference between the subject device and primary predicate are device design and the longestimplantable length of Ø3.5. To support the Ø3.5 X13mm long length, K220079 was added as referencedevice. A surface area comparison and dynamic fatigue testing show that the subject device has |
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Image /page/9/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.
substantially equivalent performance compared to the predicate and reference devices.
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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 light orange. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Cover Screw | NB 1 SA Implant System | Magicore Narrow System |
| 510(k) No. | K240091 | K222131 | K220079 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Range of Diameters (Ø) | 2.8 | 3.6 | 2.75 |
| Range of Length (mm) | 5.1, 5.8, 6.8, 7.8 | 5.3, 6.0, 7.0, 8.0 | 5.2 |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Surface Treatment | Non-Anodizing | Non-Anodizing | Anodizing |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe subject device is similar in intended use, fundamental scientific technology, principle of operation,design, technology, functions, and materials with the identified primary predicate.2. DifferencesThe difference between the subject and primary predicate is the dimension. There are slightly differentdimensions. This dimensional difference doesn't affect device safety and effectiveness. |
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Image /page/11/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.
3) Healing Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | Osstem Implant Co., Ltd |
| Device Name | Healing Abutment | NB 1 SA Implant System | Osstem Implant System |
| 510(k) No. | K240091 | K222131 | K161604 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Range of Diameters (ø) | 4.2, 4.7, 5.7, 6.7, 7.7 | 4.2, 4.7, 5.7, 6.7, 7.7 | 3.8, 4.1, 5.0, 5.6, 6.0, 6.8, 7.5 |
| Range of Cuff (ø) | 1.0, 2.0, 3.0, 4.0 | 1.0, 2.0, 3.0, 4.0 | 3.0, 4.0, 6.0, 8.0 |
| Sterilization | Gamma Sterilization | Non-Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years | |
| Surface Treatment | Non-Anodizing | Non-Anodizing | Anodizing |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe Healing Abutment has same indication for use, principle of operation, functions, diameter andmaterial to the predicate K222131.The intended use of the subject device as a healing abutment is designed to aid in soft tissue contouringduring the healing period after implant placement, creating emergence profile for the final prosthesis isequivalent to the reference predicate K161604.2. DifferencesThere are slightly different Sterilization, To support sterilization, K161604 were added. Therefore, thissterilization method difference doesn't affect device safety and effectiveness. |
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Image /page/12/Picture/0 description: The image contains the logo for Arum Dentistry. The logo features a red triangle and a smaller tan triangle on the left side. To the right of the triangles, the word "ARUM" is written in a bold, dark brown font, with the word "DENTISTRY" written in the same font directly below it.
4) Scan Healing Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. | Biomet 3i |
| Device Name | Scan Healing Abutment | NB Implant System | TSV™ BellaTek® Encode®Healing Abutments |
| 510(k) No. | K240091 | K230725 | K173374 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Range of Diameters ( $∅$ ) | 4.2 ~ 7.7 | 4.2 ~ 7.7 | 3.8 ~ 6.8 |
| Range of Cuff ( $∅$ ) | 1.3 ~ 9.4 | 1.3 ~ 9.4 | 3.0, 5.0, 7.0 |
| Scanning feature | Machined marking | Machined marking | Machined marking |
| Surface Treatment | Non-Anodizing | Non-Anodizing | Anodizing |
| Sterilization | Gamma Sterilization | Non-Sterilization | Gamma Sterilization |
| Shelf life | 5 Years | 5 Years | |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe Scan Healing Abutment has same indication for use, principle of operation, functions, diameter andmaterial to the predicate K230725.The intended use of the subject device as a scan healing abutment with scanning feature to transmitposition and angulation data of implant when taking a digital impression using an intra-oral scanner isequivalent to the reference predicate K173374.2. DifferencesThe difference between the subject and primary device is the sterilization method. To supportsterilization method, K173374 were added. Therefore, this sterilization method difference doesn't affectdevice safety and effectiveness. |
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Image /page/13/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 beige. The text "ARUM" is in a larger font than the text "DENTISTRY".
5) Cemented Abutment Mini
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | Cemented Abutment Mini | NB 1 SA Implant System |
| 510(k) No. | K240091 | K213506 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Diameters (Ø) | 4.0, 4.5 | 4.5, 5.5, 6.5 |
| Post Height (mm) | 5.0, 7.0 | 5.0, 5.5, 7.0 |
| Cuff Height (mm) | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| Surface Treatment | TiN Coating | TiN Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe subject device is similar in intended use, fundamental scientific technology, principle of operation,design, technology, functions, dimensions, and materials with the identified reference device.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/14/Picture/0 description: The image contains 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, the words "ARUM" and "DENTISTRY" are written in a bold, dark brown font, with "ARUM" on top of "DENTISTRY".
6) Angled Abutment Mini
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | Angled Abutment Mini | Angled Abutment |
| 510(k) No. | K240091 | K232560 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Diameters (Ø) | 4.0, 4.5 | 4.5, .5.5 |
| Post Height (mm) | 8 | 8 |
| Cuff Height (mm) | 2, 4 | 2, 4 |
| Angulation (°) | 17 | 17 |
| Surface Treatment | TiN Coating | TiN Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial EquivalentDiscussion | 1. SimilaritiesThe Angled Abutment Mini has same design, function, surface treatment, indication for use statementand is made with same material as Ti-6Al-4V Eli conforming to ASTM F136. The Angled AbutmentMini is generally used for cemented-retained restoration compared to that of the predicate AngledAbutment (K232560). | |
| 2. DifferencesAngled Abutment Mini and predicate Angled Abutment have common in design, function, indicationsfor use, material, surface treatment.The 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 | ||
| Subject Device | Reference Device | |
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | NB Mini Implant System | NB 1 SA Implant System |
| 510(k) No. | K240091 | 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/15/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left, resembling an abstract letter "A" formed by two triangles, one red and one light orange. To the right of the shape is the text "ARUM" in bold, followed by "DENTISTRY" in a smaller font size, both in a dark brown color.
7) Abutment Screw
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Image /page/16/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 peach-colored. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, brown letters, with "DENTISTRY" appearing below "ARUM".
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
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 Moist Heat Sterilization Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2 and ISO 11138-1. (Referenced from 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);
Benchtop Performance Testing
- Fatigue test
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. The dynamic fatigue testing showed that the subject devices have performance that is substantially equivalent to the predicate.
- Bone to Implant Contact (BIC) analysis
BIC analysis is conducted with NB Fixture Mini containing implants of diameters less than 3.25mm. We compared the BIC value and confirmed the substantial equivalence status with the predicate device; IS-III active System, Neobiotech Co., Ltd. K190849.
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Image /page/17/Picture/0 description: The image contains a logo for "ARUM DENTISTRY". The logo consists of two parts: 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, with "ARUM" on top and "DENTISTRY" below.
- Surface area analysis
Surface area analysis is conducted with NB Fixture Mini containing implants of diameters less than 3.25mm. We compared the surface area and confirmed the substantial equivalence status with the predicate device; IS-III active System, Neobiotech Co., Ltd. K190849.
- Pullout test
Pullout force test was conducted with NB Fixture Mini containing implants of diameters less than 3.25mm. We compared the pullout force value and confirmed the substantial equivalence status with the predicate device; IS-III active System, Neobiotech Co., Ltd. K190849.
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 Indications for Use statements are highly similar, differing only in the list of compatible implant system 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.
§ 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.