(107 days)
No
The summary describes a standard dental implant system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is an endosseous dental implant system, directly replacing missing teeth and supporting restorations in the mandibles and maxillae, which constitutes a therapeutic function.
No
The device description indicates it is an implant system used for replacing missing teeth and supporting restorations. It does not mention any function related to diagnosing conditions or diseases.
No
The device description clearly outlines physical components made of titanium, including dental implants and abutments, which are surgically implanted. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NB Implant System is a dental implant system designed to be surgically placed in the jawbone to support dental restorations. It is a physical device used in vivo (within the body).
- Intended Use: The intended use clearly describes a surgical procedure and the support of dental prosthetics, not the analysis of biological samples.
- Device Description: The description details the materials, design, and components of a dental implant and related parts, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The device utilizes intraoral scans/digital impressions, but this is for the purpose of creating a model for prosthetic design and placement, not for diagnostic analysis of the patient's health.
N/A
Intended Use / Indications for Use
The NB Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The NB Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is 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 Scan Healing Abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined marking for identification when taking an abutment level impression or an intraoral scan/digital impression. Identification information is captured in the intraoral scan or model scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoral scan/digital impression
Anatomical Site
mandibles and maxillae, alveolar bone
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)
Biocompatibility: Biocompatibility of TI CP4 (ASTM F67) and Ti-6Al-4V Eli (ASTM F136) demonstrated by the reference ARUM DENTISTRY submission, K213506, using the same materials and manufacturing processes as the subject device.
Sterilization validation: Sterilization validating testing has been performed in accordance with ISO 11137-1 and ISO 11137-2 to verify the sterility assurance level (10°) by selecting and substantiating a 25 kGy dose using method VDmax25. (referenced from K213506); LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016; End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K21350.
Shelf-Life: The tests to validate the Shelf-Life of the device through the proposed Shelf-Life were conducted using the accelerated aging method in accordance to ASTM F1980 and test results validated 5 years Shelf-Life.
Non-Clinical Data: No need to perform any non-clinical testing for the subject device since the subject device and predicate device are substantially equivalent in indications, fundamental technology, material and design. 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.
MR Environment Condition: Non-Clinical worst-case MRI review was performed to evaluated the NB Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Terry O. Woods, Jana Delfino, & Sunder Rajan. (2019). Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices. Journal of Testing and Evaluation 49.2, 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): 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
§ 872.3640 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.
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Image /page/0/Picture/0 description: The image contains 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
ARUN DENTISTRY Co., Ltd. Bo-Yeon Lim Assistant Manager 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 REPUBLIC OF KOREA
Re: K230725
Trade/Device Name: NB Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 7, 2023 Received: April 7, 2023
Dear Bo-Yeon 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
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Indications for Use
510(k) Number (if known) K230725
Device Name NB Implant System
Indications for Use (Describe)
The NB Implant System is indicated for use in partially or fully edentulous mandbles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
| 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/3/Picture/0 description: The image contains a 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" and "DENTISTRY" are stacked on top of each other, with "ARUM" in a larger font than "DENTISTRY".
510(k) Summary
Submitter
ARUM DENTISTRY Co., Ltd. Bo-Yeon Lim 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 Implant System ●
- Common Name: Endosseous Dental Implant
- . Classification Name: Implant, Endosseous, Root-Form
- Primary Product Code: DZE
- . Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- Date Prepared: 06/19/2023
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K213506, NB 1 SA Implant System by ARUM DENTISTRY Co., Ltd. .
Reference Device
- . K173374, TSV BellaTek Encode Healing Abutment by Biomet 3i.
- . K182448, Healing Abutment for AnyRidge Octa 1 Implant System by MegaGen Implant Co., Ltd.
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Image /page/4/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric design on the left and the text "ARUM DENTISTRY" on the right. The geometric design features a red triangle at the top and a smaller, light orange triangle at the bottom left.
The purpose of this submission is to expand the fixtures to include a new external thread design, and prosthetics to include the Scan Healing Abutments. The fixtures and abutments in this system are below:
Fixture
- . NB II Fixture
Abutment
- . Scan Healing Abutment
An endosseous dental implant is a device made of a material such as Pure titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations.
The implant-abutment connection is 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 Scan Healing Abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined marking for identification when taking an abutment level impression or an intraoral scan/digital impression. Identification information is captured in the intraoral scan or model scan.
| No. | Device Name | Dimension |
|---|---|---|
| 1 | NB II Fixture | Ø 4.0 (D) x 7.0, 8.5, 10, 11.5, 13 mm (L) |
| Ø 4.5 (D) x 7.0, 8.5, 10, 11.5, 13 mm (L) | ||
| Ø 5.0 (D) x 7.0, 8.5, 10, 11.5, 13 mm (L) | ||
| Ø 5.5 (D) x 7.0, 8.5, 10, 11.5, 13 mm (L) | ||
| Ø 6.0 (D) x 7.0, 8.5, 10, 11.5, 13 mm (L) | ||
| Ø 6.5 (D) x 7.0, 8.5, 10, 11.5, 13 mm (L) |
The dimension ranges of the subject device are below:
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Image /page/5/Picture/1 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 DENTISTRY" in bold, dark brown letters on the right side. The word "ARUM" is on top of the word "DENTISTRY".
Fixtures are provided sterile by gamma radiation.
| No. | Device Name | Dimension |
|---|---|---|
| 1 | Scan Healing Abutment | Ø4.7, 5.7, 6.7, 7.7 (D) x 1.3, 3.3, 5.3, 7.3, 9.3 mm (Cuff) |
| 2 | Scan Healing Abutment | |
| Screw | Ø2.49 (D) x 9.7, 11.7, 13.7, 15.7, 17.7 mm (L) |
Scan Healing Abutment is provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.
Indication for Use
The NB Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Materials:
The Fixtures are fabricated from Pure Titanium (Conforming to ASTM F67). Abutment and Abutment Screw are fabricated from Ti-6AI-4V Eli (Conforming to ASTM F136).
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Image /page/6/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of two triangles, one red and one light orange, on the left side of the text "ARUM" and "DENTISTRY". The text is in a bold, dark brown font. The logo is simple and modern, and the colors are eye-catching.
Summaries of Technology Characteristics
1) NB II Fixture
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | NB Implant System | NB 1 SA Implant System |
| 510(k) Number | N/A | K213506 |
| Intended Use/ | ||
| Indications for use | The NB Implant System is indicated for use in | |
| partially or fully edentulous mandibles and | ||
| maxillae, in support of single or multiple-unit | ||
| restorations including; cemented retained, screw | ||
| retained, or overdenture restorations, and terminal | ||
| or intermediate Abutment support for fixed | ||
| bridgework. NB Implant System is dedicated for | ||
| two stage surgical procedures and for immediate | ||
| loading when there is good primary stability and | ||
| an appropriate occlusal load. Also, implants with | ||
| diameters larger than 5mm are indicated for molar | ||
| regions. | The NB 1 SA Implant System is indicated for use | |
| in partially or fully edentulous mandibles and | ||
| maxillae, in support of single or multiple-unit | ||
| restorations including; cemented retained, screw | ||
| retained, or overdenture restorations, and terminal | ||
| or intermediate Abutment support for fixed | ||
| bridgework. NB 1 SA Implant System is dedicated | ||
| for two stage surgical procedures and for | ||
| immediate loading when there is good primary | ||
| stability and an appropriate occlusal load. Also, | ||
| implants with diameters larger than 5mm are | ||
| indicated for molar regions. | ||
| Material | Pure Titanium (ASTM F67) | Pure Titanium (ASTM F67) |
| Anti-Rotational Feature | Internal Hex | Internal Hex |
| Range of Diameters (Ø) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Range of Lengths (mm) | 7.0, 8.5, 10, 11.5, 13.0 | 7.0, 8.5, 10, 11.5, 13.0 |
| Surface treatment | SLA | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of Operation | This product is a root-type fixture which is inserted | |
| in the alveolar bone. It replaces the functions of | ||
| the missing teeth as a dental implant fixture. | This product is a root-type fixture which is inserted | |
| in the alveolar bone. It replaces the functions of | ||
| the missing teeth as a dental implant fixture. |
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Image /page/7/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of two triangles on the left side, one red and one beige. To the right of the triangles is the text "ARUM" in bold, followed by "DENTISTRY" in bold on the line below. The text is in a dark brown color.
| Substantial Equivalent
Discussion | 1. Similarities
The NB II Fixture have same device characteristics with the Primary predicate such as diameters,
length, intended use, material, functions, general shape (Design), structure and applied production
method. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Differences
Compared to the Primary predicate, the subject device's cutting-edge is longer than the Primary
predicate. However, except for the cutting-edge, the diameters, length, intended use, material, functions
and general shape (Design) are the same. This function of the cutting-edge is self-tapping by creating a
screw path. Therefore, this difference doesn't impact substantial equivalence. |
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Image /page/8/Picture/0 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side, followed by the words "ARUM" and "DENTISTRY" in bold, black letters on the right side. The word "ARUM" is on top of the word "DENTISTRY".
2) Scan Healing Abutment
| Subject Device | Primary Predicate | Reference Device | ||
|---|---|---|---|---|
| Manufacturer | ARUM DENTISTRY | |||
| Co., Ltd. | ARUM DENTISTRY | |||
| Co., Ltd. | Biomet 3i | MegaGen Implant | ||
| Co., Ltd. | ||||
| Device Name | Scan Healing Abutment | Healing Abutment | TSV BellaTek Encode | |
| Healing Abutments | Healing Abutment for | |||
| AnyRidge Octa 1 | ||||
| Implant System | ||||
| 510(k) No. | N/A | K213506 | K173374 | K182448 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Intended use | It is used for protecting | |||
| inner hole and | ||||
| connecting part with | ||||
| exposed upper part of | ||||
| structure during the | ||||
| healing period after | ||||
| inserting dental implant | ||||
| fixture. When inserting | ||||
| the Abutment, Cover | ||||
| screw is removed. | it is used for protecting | |||
| inner hole and | ||||
| connecting part with | ||||
| exposed upper part of | ||||
| structure during the | ||||
| healing period after | ||||
| inserting dental implant | ||||
| fixture. When inserting | ||||
| the Abutment, Cover | ||||
| screw is removed. | The TSVTM BellaTek® | |||
| Encode® Healing | ||||
| Abutments are | ||||
| intended for use as an | ||||
| accessory to | ||||
| endosseous dental | ||||
| implants during | ||||
| endosseous and | ||||
| gingival healing to | ||||
| prepare gingival tissue | ||||
| for acceptance of a | ||||
| final abutment and | ||||
| restoration. | The AnyRidge Octa 1 | |||
| Implant System is | ||||
| intended to be | ||||
| surgically placed in the | ||||
| maxillary or mandibular | ||||
| arches for the purpose | ||||
| of providing prosthetic | ||||
| support for dental | ||||
| restorations (Crown, | ||||
| bridges, and | ||||
| overdentures) in | ||||
| partially or fully | ||||
| edentulous individuals. | ||||
| It is used to restore a | ||||
| patient's chewing | ||||
| function in the following | ||||
| situations and with the | ||||
| clinical protocols: - | ||||
| Delayed loading. - | ||||
| Immediate loading | ||||
| when good primary | ||||
| stability is achieved and | ||||
| with appropriate | ||||
| occlusal loading. Larger | ||||
| implants are dedicated | ||||
| for the molar region. | ||||
| Range of Diameters (Ø) | 4.2 ~ 7.7 | 4.2 ~ 7.7 | 3.8 ~ 6.8 | 3.2 ~ 7.2 |
| Range of Cuff (Ø) | 1.3 ~ 9.4 | 1.0 ~ 4.0 | 3.0, 5.0, 7.0 | 2.5 ~ 9.5 |
| Sterilization | Non-Sterilization | Non-Sterilization | Gamma Sterilization | Gamma Sterilization |
| Scanning feature | Machined marking | - | Machined marking | - |
| Surface Treatment | Non-Anodizing | Anodizing, Non-Anodizing | Anodizing | Anodizing |
| Substantial Equivalent | ||||
| Discussion | 1. Similarities | |||
| The Scan Healing Abutment has same indication for use, principle of operation, functions, diameter | ||||
| and material to the predicate K213506. | ||||
| The intended use of the subject device as a healing abutment with scanning feature to transmit | ||||
| position and angulation data of implant when taking a digital impression using an intra-oral scanner is | ||||
| equivalent to the reference predicate K173374. |
- Differences
There are slightly different dimensions. To support cuffs, K182448 were added. Therefore, this
dimensional difference doesn't affect device safety and effectiveness. | | | |
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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 tan triangle on the left side of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are stacked on top of each other in a bold, sans-serif font.
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Image /page/10/Picture/1 description: The image shows the logo for Arum Dentistry. The logo consists of a red triangle and a tan triangle on the left side of the image. To the right of the triangles is the text "ARUM" in a bold, dark brown font, with the word "DENTISTRY" underneath it in the same font.
Performance Data
Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
Biocompatibility of TI CP4 (ASTM F67) and Ti-6Al-4V Eli (ASTM F136) demonstrated by the reference ARUM DENTISTRY submission, K213506, using the same materials and manufacturing processes as the subject device.
Sterilization validation
Sterilization validating testing has been performed in accordance with ISO 11137-1 and ISO 11137-2 to verify the sterility assurance level (10°) by selecting and substantiating a 25 kGy dose using method VDmax25. (referenced from K213506);
LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016;
End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K21350;
Shelf-Life
The tests to validate the Shelf-Life of the device through the proposed Shelf-Life were conducted using the accelerated aging method in accordance to ASTM F1980 and test results validated 5 years Shelf-Life. Also, the following guidance documents were referred to
- . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. (referenced from K213506);
Non-Clinical Data
No need to perform any non-clinical testing for the subject device since the subject device and predicate device are substantially equivalent in indications, fundamental technology, material and design.
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.
MR Environment Condition
Non-Clinical worst-case MRI review was performed to evaluated the NB 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
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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, brown font.
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.