(156 days)
No
The summary describes a dental implant system composed of physical components and materials, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a dental implant system used to replace missing teeth, which is a restorative rather than therapeutic function.
No
Explanation: The device description and intended use clearly indicate that this is an implant system designed to replace missing teeth, not for diagnosing conditions. It is comprised of physical components like fixtures, screws, and abutments that are surgically placed.
No
The device description clearly states it is composed of physical components like fixtures, screws, and abutments made of materials like TI CP4, which are implanted into the body. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for supporting dental restorations in the jawbone. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a dental implant system made of titanium, designed to be placed in the alveolar bone. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the NB 1 SA Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE, NHA
Device Description
The NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth.
The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.
The dimensions of the subject device are as following:
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | ARUM NB 1 SA Fixture | Ø 3.8 (D) x 8.5, 10, 11.5, and 13 mm (L) Ø 4.0, 4.5, 5.0 (D) x 7.0, 8.5, 10, 11.5, and 13 mm (L) Ø 5.5, 6.0, 6.5 (D) x 7.0, 8.5, 10, 11.5, and 13 mm (L) |
| 2 | ARUM NB Cover Screw | Ø 3.6 (D) x 5.3, 6, 7, 8 mm (L) |
| 3 | ARUM NB Healing Abutment | Ø 4.2, 4.7, 5.7, 6.7, 7.7 (D) x 1.0, 2.0, 3.0, 4.0mm(Cuff Height) |
| 4 | ARUM Cemented Abutment_Hex | Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height) |
| ARUM Cemented Abutment_Non Hex | Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height) | |
| 5 | Abutment Screw | Ø 2.35 (D) x 8.4 mm(L) |
Tolerance of dimension shall be within ± 1% range.
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| ARUM NB Cover Screw | 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 | Non | Screw Retained |
| ARUM NB Healing Abutment | Used to formation appropriate gingival shape during the soft tissue healing period combined with implant | Non | Screw Retained |
| ARUM Cemented Abutment | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | TiN Coating | Internal Hex, Non-hex |
| Abutment Screw | Abutment Screw is used to connect an abutment to the fixture. | Non | Screw Retained |
ARUM NB 1 SA Fixture and ARUM NB Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.
ARUM NB 1 SA Fixture is enclosed with ARUM NB Cover Screw in a packing. ARUM Cemented abutment is enclosed with Abutment Screw in a packing.
Materials:
- The fixtures are fabricated from Pure titanium of ASTM F67
- ARUM Cemented abutment, abutment screw, Healing Abutment, and cover screw are fabricated from . Ti-6Al-4V of ASTM F136
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibles and maxillae (partially or fully edentulous). Anterior or posterior site of maxillary or mandibular jawbone. Molar regions.
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)
Non-Clinical Test Data:
Below tests were performed on subject device:
- Gamma Sterilization Validation Test on Fixtures according to ISO 11137-1.2.3
- Shelf-Life Test on Fixtures according to ASTM F1980
- Biocompatibility testing on fixtures according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006
- Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
- LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016
Below tests were performed for predicate device, K193425 and leveraged for the subject device:
- 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 K193425
- Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-. 1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K193425
Key results: The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided.
For devices delivered sterile (ARUM NB 1 SA Fixture and Cover Screw) - a sterility assurance level (SAL) of 106 have been validated in accordance with ISO 11137-1:2006.
Shelf Life Testing was performed in accordance with ASTM F1980. The shelf life for devices provided sterile is 5 years.
For all other subject devices delivered non-sterilized, the recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
Biocompatibility Testing was performed according to ISO 10993-1:2009 and to the FDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", Document issued on: June 16, 2016", for each of the subject devices.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Arumdentistry Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K213506
Trade/Device Name: NB 1 SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 4, 2022 Received: March 7, 2022
Dear April Lee:
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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name NB 1 SA Implant System
Indications for Use (Describe)
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, 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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary
Submitter
Arumdentistry Co., Ltd. Hyang Mi Lee 1-dong, 44, Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea Email: arum ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633
Official Correspondent
Withus Group Inc. April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: NB 1 SA 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: 04/06/2022
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K181138, IS-III active System by Neobiotech Co., Ltd.
Reference Device
- . K150060, J2A Dental Implant System manufactured by KJ Meditech Co., Ltd.
- K172100, URIS Implant System by Truabutment Inc. ●
- K193425, Pre-Milled Blank by Arumdentistry Co., Ltd.
Indication for Use:
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.
4
Device Description:
The NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth.
The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | ARUM NB 1 SA Fixture | Ø 3.8 (D) x 8.5, 10, 11.5, and 13 mm (L) |
| Ø 4.0, 4.5, 5.0 (D) x 7.0, 8.5, 10, 11.5, and 13 mm (L) | ||
| Ø 5.5, 6.0, 6.5 (D) x 7.0, 8.5, 10, 11.5, and 13 mm (L) | ||
| 2 | ARUM NB Cover Screw | Ø 3.6 (D) x 5.3, 6, 7, 8 mm (L) |
| 3 | ARUM NB Healing Abutment | Ø 4.2, 4.7, 5.7, 6.7, 7.7 (D) x 1.0, 2.0, 3.0, 4.0mm(Cuff |
| Height) | ||
| 4 | ARUM Cemented Abutment_Hex | Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height) |
| ARUM Cemented Abutment_Non Hex | Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height) | |
| 5 | Abutment Screw | Ø 2.35 (D) x 8.4 mm(L) |
The dimensions of the subject device are as following:
Tolerance of dimension shall be within ± 1% range.
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| ARUM NB Cover | |||
| Screw | 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 | Non | Screw | |
| Retained | |||
| ARUM NB Healing | |||
| Abutment | Used to formation appropriate gingival shape | ||
| during the soft tissue healing period combined | |||
| with implant | Non | Screw | |
| Retained | |||
| ARUM Cemented | |||
| Abutment | The Abutment is connected with fixture and it | ||
| supports prosthesis which restores tooth function. | TiN Coating | Internal | |
| Hex, Non- | |||
| hex | |||
| Abutment Screw | Abutment Screw is used to connect an abutment | ||
| to the fixture. | Non | Screw | |
| Retained |
ARUM NB 1 SA Fixture and ARUM NB Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.
ARUM NB 1 SA Fixture is enclosed with ARUM NB Cover Screw in a packing. ARUM Cemented abutment is enclosed with Abutment Screw in a packing.
5
Materials:
- The fixtures are fabricated from Pure titanium of ASTM F67 ●
- ARUM Cemented abutment, abutment screw, Healing Abutment, and cover screw are fabricated from . Ti-6Al-4V of ASTM F136
Summaries of Technological Characteristics & Substantial Equivalence Discussion
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | ARUMDENTISTRY Co., Ltd. | Neobiotech Co., Ltd | KJ Meditech Co., Ltd. |
| Device Name | NB 1 SA Implant System | IS-III active System | J2A Dental Implant System |
| 510(k) Number | K213506 | K181138 | K150060 |
| Device | |||
| Classification | Implant, Endosseous, | ||
| Root-Form | Implant, Endosseous, | ||
| Root-Form | Implant, Endosseous, | ||
| Root-Form | |||
| Product Code | DZE | DZE | DZE |
| Regulation | |||
| Number | 872.3640 | 872.3640 | 872.3640 |
| Indications for | |||
| Use | 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. | The IS-III active 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. | |||
| IS-III active 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 J2A Dental 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. | |||
| The J2A Dental Implant | |||
| System is for single and two | |||
| stage surgical procedures. The | |||
| system is intended for delayed | |||
| loading. | |||
| Material | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 | Ti-6Al-4V ELI of ASTM |
| F136 | |||
| Design | Image: Design of NB 1 SA Implant System | Image: Design of IS-III active System | Image: Design of J2A Dental Implant System |
| Anti-Rotational | |||
| Feature | Internal Hex | Internal Hex | Internal Hex |
| Diameters( $\varnothing$ ) | 3.8/4.0/4.5/5.0/5.5/6.0/6.5 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 | 3.75/4.0/4.3/4.5/5.0/5.5/6.0 |
| Lengths(mm) | 7.0/ 8.5/ 10/ 11.5/ 13.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | 7.0/8.5/10.0/11.5/13.0/15.0 |
| Surface | |||
| Treatment | SLA | SLA | RBM |
| Sterilization | Gamma 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. | 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. | |||
| Similarities | The NB 1 SA Implant System has same device characteristics with the Primary predicate device, | ||
| IS-III active System(K181138) such as intended use, material, functions, surface treatment, | |||
| general shape (Design), structure, anti-rotational feature, principle operation and applied | |||
| production method. | |||
| Differences | The differences between the subject device and the primary predicate device are the product | ||
| design and dimensional range. The design difference doesn't affect product's fundamental | |||
| function. To support the dimensional differences such as fixture with Ø4.0 X 7.0mm, we selected | |||
| K 150060 as the reference device, which covers the subject device's dimensional range. | |||
| Therefore, it is substantially equivalent. |
1) ARUM NB 1 SA Fixture
6
2) ARUM NB Cover Screw
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | ARUMDENTISTRY Co., Ltd. | Neobiotech Co., Ltd |
| Device Name | NB 1 SA Implant System | IS-III active System |
| 510(k) Number | K213506 | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Implant design 1 | Image: Implant design 2 |
| Diameters(Ø) | 3.6 | 3.45/3.6 |
| Lengths(mm) | 5.3, 6, 7, 8 mm (L) | 5.85/6.85/7.45/ |
| 6.4/7.4/8.0/ | ||
| Surface Treatment | Non-Anodizing | Anodizing/ Non-Anodizing, |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of Operation | 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. |
| Similarities | The subject device has same intended use, material, functions, principle of operation, shelf life and similar design and dimensions. | |
| Differences | There are slightly different designs and dimension. These differences do not affect product's fundamental function; therefore, it is substantial equivalent. |
7
| Subject Device | Primary Predicate | Reference Device | ||
|---|---|---|---|---|
| Company | ARUMDENTISTRY Co., | |||
| Ltd. | Neobiotech Co., Ltd | TruAbutment Korea Co., | ||
| Ltd. | ||||
| Device Name | NB 1 SA Implant System | IS-III active System | URIS OMNI System | |
| 510(k) Number | K213506 | K181138 | K172100 | |
| Material | Ti-6Al-4V ELI of ASTM | |||
| F136 | Ti-6Al-4V ELI of ASTM | |||
| F136 | Ti-6Al-4V ELI (ASTM | |||
| F136) | ||||
| Design | Image: design | Image: design | Image: design | |
| Diameters (Ø) | 4.2/4.7/5.7/6.7/7.7 | 4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0 | 4.0/4.5/5.5/6.5/7.5mm | |
| Cuff height (mm) | 1.0,2.0, 3.0, 4.0mm | 2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8 | ||
| /6.3/6.8/7.8/ | 1.0mm~5.0mm | |||
| Surface | ||||
| Treatment | N/A | N/A | Anodizing (Yellow, Green) | |
| Sterilization | Non-sterile | Gamma Sterilization | Non-sterile | |
| Principle of | ||||
| Operation | This product is healing | |||
| Abutment to formation | ||||
| appropriate gingival shape | ||||
| during the soft tissue healing | ||||
| period combined with | ||||
| implant. This product should | ||||
| be removed when the | ||||
| superstructure is set up. | This product is healing | |||
| Abutment to formation | ||||
| appropriate gingival shape | ||||
| during the soft tissue healing | ||||
| period combined with | ||||
| implant. This product should | ||||
| be removed when the | ||||
| superstructure is set up. | This product is healing | |||
| Abutment to formation | ||||
| appropriate gingival shape | ||||
| during the soft tissue healing | ||||
| period combined with | ||||
| implant. This product should | ||||
| be removed when the | ||||
| superstructure is set up. | ||||
| Similarities | The subject device has same intended use, material, functions, principle of operation, and | |||
| similar design and dimensions. | ||||
| Differences | The differences between the subject device and the primary predicate device are the | |||
| sterilization, dimensions and design. To support the difference of the sterilization, K172100 | ||||
| was added and the differences of design and dimensions do not affect product's fundamental | ||||
| function, therefore, it is substantially equivalent. |
3) ARUM NB Healing Abutment
8
| Subject Device | Primary Predicate Device | ||||
|---|---|---|---|---|---|
| Company | ARUMDENTISTRY Co., Ltd. | Neobiotech Co., Ltd | |||
| Device Name | NB 1 SA Implant System | IS-III active System | |||
| 510(k) Number | K213506 | K181138 | |||
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | |||
| Design | Image: dental implant | Image: dental implant | Image: dental implant | Image: dental implant | Image: dental implant |
| Hex | Non-Hex | Hex | Non-Hex | SCRP | |
| Diameters (Ø) | 4.5 / 5.5 / 6.5 | 4.5/5.2/5.7/6.5 | |||
| Post height | |||||
| (mm) | 5.0/ 5.5 / 7.0 | 4.0/4.5/5.5/7.0/8.0 | |||
| Surface | |||||
| Treatment | TiN-Coating | TiN-Coating | |||
| Principle of | |||||
| Operation | It is indicated for screw-retained single | ||||
| tooth or cement retained single tooth and | |||||
| bridge restorations. | It is indicated for screw-retained single tooth or cement | ||||
| retained single tooth and bridge restorations. | |||||
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface | ||||
| treatment, and general shape (design) as the primary predicate. | |||||
| Differences | The design of the devices is slightly different, but it doesn't affect device's fundamental functions; | ||||
| therefore, it is substantial equivalent. |
4) ARUM Cemented Abutment
5) Abutment Screw
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| Company | ARUMDENTISTRY Co., Ltd. | Neobiotech Co., Ltd | |
| Device Name | NB 1 SA Implant System | IS-III active System | |
| 510(k) Number | K213506 | K181138 | |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | |
| Design | Image: Screw | Image: Two screws | |
| Diameters (Ø) | 2.35 | 2.3 | |
| Length (mm) | 8.4 | 8.8/8.3 | |
| Surface Treatment | N/A | N/A | |
| Principle of Operation | This product is a screw for connected | ||
| with Abutment and fixture. | This product is a screw for connected with | ||
| Abutment and fixture. | |||
| Similarities | The subject and primary predicate have same indications for use, functions, materials, | ||
| surface treatment, general shape (design) and diameters. | |||
| Differences | The design of the devices is slightly different, but it doesn't affect device's fundamental | ||
| functions; therefore, it is substantial equivalent. |
9
Non-Clinical Test Data
Below tests were performed on subject device:
- . Gamma Sterilization Validation Test on Fixtures according to ISO 11137-1.2.3
- . Shelf-Life Test on Fixtures according to ASTM F1980
- . Biocompatibility testing on fixtures according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006
- . Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
- . LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016
Below tests were performed for predicate device, K193425 and leveraged for the subject device:
- 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 K193425
- Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-. 1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K193425
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided.
For devices delivered sterile (ARUM NB 1 SA Fixture and Cover Screw) - a sterility assurance level (SAL) of 106 have been validated in accordance with ISO 11137-1:2006. Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Shelf Life Testing was performed in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 5 years. The devices will not be marketed as non-pyrogenic.
For all other subject devices delivered non-sterilized, the recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case construct was tested, and results demonstrated equivalence to the predicate device.
Biocompatibility Testing was performed according to ISO 10993-1:2009. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", Document issued on: June 16, 2016", for each of the subject devices.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
10
Conclusion
The documentation submitted in this premarket notification demonstrates the NB 1 SA Implant System is substantially equivalent to the primary predicate and reference devices.