(107 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the NB Implant System, based on the provided text. It's important to note that this document is a 510(k) summary for a dental implant system, which primarily relies on substantial equivalence to predicate devices and existing testing, rather than a de novo AI/software device that would have explicit AI performance acceptance criteria.
Therefore, the "acceptance criteria" here are related to demonstrating substantial equivalence for a medical device (dental implant), focusing on material safety, sterilization, and mechanical characteristics, rather than specific performance metrics for an AI algorithm. The study described is primarily non-clinical testing to support this equivalence.
Device Name: NB Implant System
Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)
Product Code: DZE, NHA
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a physical dental implant system, the "acceptance criteria" are focused on demonstrating a device that is as safe and effective as a legally marketed predicate. Performance is demonstrated through non-clinical testing and comparison to predicates.
| Acceptance Criteria Category | Specific Criteria (from text, implied or explicit) | Reported Device Performance / Justification |
|---|---|---|
| Biocompatibility | TI CP4 (ASTM F67) and Ti-6Al-4V Eli (ASTM F136) materials are biocompatible. | Demonstrated by reference to previous ARUM DENTISTRY submission (K213506) using the same materials and manufacturing processes. |
| Sterilization Efficacy | Achieve sterility assurance level (SAL) of 10⁻⁶ for gamma-sterilized components (fixtures). | Sterilization validating testing performed according to ISO 11137-1 and ISO 11137-2, substantiating a 25 kGy dose using method VDmax25 (referenced from K213506). |
| Endotoxin Content | Acceptable levels of Bacterial Endotoxin Units (EU) for sterile components. | LAL endotoxin testing performed according to AAMI / ANSI ST72:2011/(R)2016 (referenced from K213506). |
| End-User Sterilization (Abutments) | Non-sterile abutments can be effectively sterilized by end-users. | 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 | Device maintains safety and effectiveness for its proposed shelf-life. | Accelerated aging method in accordance with ASTM F1980 used; test results validated 5 years Shelf-Life. |
| Mechanical Equivalence (Fixture Design) | New external thread design does not negatively impact safety/effectiveness compared to predicate, despite dimensional difference (longer cutting-edge). | Stated that "this function of the cutting-edge is self-tapping by creating a screw path. Therefore, this difference doesn't impact substantial equivalence." Implies mechanical testing or analysis showed no worse performance, but specific data not provided in summary. "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." However, it then states: "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." This suggests a comparative analysis was done to deem the predicate the "worst case" for certain mechanical properties. |
| Mechanical Equivalence (Abutment Dimensions) | Slightly different abutment dimensions (cuff ranges) do not affect safety/effectiveness. | Stated that "this dimensional difference doesn't affect device safety and effectiveness. To support cuffs, K182448 were added." (This implies the range expansion is covered by reference to another device). |
| MRI Safety | Devices are safe for use in an MRI environment. | Non-Clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA guidance (e.g., Terry O. Woods et al., 2019 publication). |
| Functional Equivalence | NB Implant System Fixture (new thread) and Scan Healing Abutment (new scanning feature) function comparably to predicate devices for their intended use. | Fixture design is "substantially equivalent... such as diameters, length, intended use, material, functions, general shape (Design), structure and applied production method" to primary predicate (K213506). Scan Healing Abutment has "same indication for use, principle of operation, functions, diameter and material to the predicate K213506," and its scanning feature is "equivalent to the reference predicate K173374." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the non-clinical tests (biocompatibility, sterilization, shelf-life, MRI). It refers to the tests being performed "in accordance with" relevant ISO and ASTM standards, which would dictate minimum sample sizes for each specific test type.
- Data Provenance: All data referenced appears to be from non-clinical (laboratory/bench) testing. The document heavily relies on previously submitted data (K213506, K173374, K182448) from ARUM DENTISTRY Co., Ltd. and other manufacturers. The company's address is in Daejeon, Republic of Korea, suggesting the testing was likely conducted in Korea or by contract labs following international standards. The data is retrospective in the sense that it relies on previously generated and accepted data for predicate devices and earlier versions/components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for a physical medical device (dental implant), not an AI/software device that requires expert-established ground truth for a test set of images or clinical data. The ground truth for device safety and performance relies on physical measurements, material properties, and established laboratory testing protocols (e.g., ISO, ASTM standards).
4. Adjudication Method for the Test Set
Not applicable. No human adjudication of results is described, as the studies are non-clinical tests (e.g., sterilization reports, material testing).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic devices, not for physical dental implants.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant system, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established through:
- Standardized Non-Clinical Testing: Adherence to established international standards (ISO, ASTM) for biocompatibility, sterilization, shelf-life, and material properties.
- Predicate Device Data: The safety and effectiveness of previously cleared, substantially equivalent predicate devices.
- Scientific Rationale/Literature: For MRI safety, peer-reviewed literature and scientific rationale are cited.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
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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.
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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 AbutmentScrew | 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 inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple-unitrestorations including; cemented retained, screwretained, or overdenture restorations, and terminalor intermediate Abutment support for fixedbridgework. NB Implant System is dedicated fortwo stage surgical procedures and for immediateloading when there is good primary stability andan appropriate occlusal load. Also, implants withdiameters larger than 5mm are indicated for molarregions. | The NB 1 SA Implant System is indicated for usein partially or fully edentulous mandibles andmaxillae, in support of single or multiple-unitrestorations including; cemented retained, screwretained, or overdenture restorations, and terminalor intermediate Abutment support for fixedbridgework. NB 1 SA Implant System is dedicatedfor two stage surgical procedures and forimmediate loading when there is good primarystability and an appropriate occlusal load. Also,implants with diameters larger than 5mm areindicated 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 insertedin the alveolar bone. It replaces the functions ofthe missing teeth as a dental implant fixture. | This product is a root-type fixture which is insertedin the alveolar bone. It replaces the functions ofthe 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 EquivalentDiscussion | 1. SimilaritiesThe 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 productionmethod. |
|---|---|
| 2. DifferencesCompared to the Primary predicate, the subject device's cutting-edge is longer than the Primarypredicate. However, except for the cutting-edge, the diameters, length, intended use, material, functionsand general shape (Design) are the same. This function of the cutting-edge is self-tapping by creating ascrew 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 DENTISTRYCo., Ltd. | ARUM DENTISTRYCo., Ltd. | Biomet 3i | MegaGen ImplantCo., Ltd. |
| Device Name | Scan Healing Abutment | Healing Abutment | TSV BellaTek EncodeHealing Abutments | Healing Abutment forAnyRidge Octa 1Implant 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 protectinginner hole andconnecting part withexposed upper part ofstructure during thehealing period afterinserting dental implantfixture. When insertingthe Abutment, Coverscrew is removed. | it is used for protectinginner hole andconnecting part withexposed upper part ofstructure during thehealing period afterinserting dental implantfixture. When insertingthe Abutment, Coverscrew is removed. | The TSVTM BellaTek®Encode® HealingAbutments areintended for use as anaccessory toendosseous dentalimplants duringendosseous andgingival healing toprepare gingival tissuefor acceptance of afinal abutment andrestoration. | The AnyRidge Octa 1Implant System isintended to besurgically placed in themaxillary or mandibulararches for the purposeof providing prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction in the followingsituations and with theclinical protocols: -Delayed loading. -Immediate loadingwhen 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 EquivalentDiscussion | 1. SimilaritiesThe Scan Healing Abutment has same indication for use, principle of operation, functions, diameterand material to the predicate K213506.The intended use of the subject device as a 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. DifferencesThere are slightly different dimensions. To support cuffs, K182448 were added. Therefore, thisdimensional 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.
§ 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.