(63 days)
Not Found
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes.
The device is an endosseous dental implant system used to support single or multiple-unit restorations in partially or fully edentulous mandibles and maxillae, directly addressing a medical condition (missing teeth) and restoring function.
No
The provided text describes a dental implant system used to replace missing teeth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an endosseous dental implant made of titanium and includes physical components like fixtures, screws, and abutments, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the NB 1 SA Implant System is an endosseous dental implant placed in the alveolar bone to replace missing teeth. It is a physical device implanted directly into the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens in the intended use or device description.
Therefore, this device falls under the category of an implanted medical device, not an In Vitro Diagnostic.
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, 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 (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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.
Fixture's surface 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 NB I Fixture dimensions are: 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).
The Cover Screw dimensions are: Ø3.6 (D) x 5.3, 6.0, 7.0, 8.0 mm (L).
The Healing Abutment dimensions are: Ø 4.2, 4.7, 5.7, 6.7, 7.7 (D) x 1.0, 2.0, 3.0, 4.0mm (Cuff Height).
The Cemented Abutment dimensions are: Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height).
The Abutment Screw dimensions are: Ø 2.35 (D) x 8.4 mm(L).
Tolerance of dimension shall be within ±1% range.
Fixtures are packaged with cover screw and provided sterile by gamma radiation. Abutments are packaged with abutment screw and provided non-sterilized before use. These devices are intended for single use only.
The Fixtures are fabricated from Pure titanium (Conforming to ASTM F67). Abutment and cover screw are fabricated from Ti-6A1-4V (Conforming to ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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 worst-case MRI review was performed to evaluate the metallic NB 1 SA Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, 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.
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.
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.
Not Found
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arum Dentistry Co., Ltd. Bo-Yeon Lim Assistant Manager 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, 34002 REPUBLIC OF KOREA
Re: K222131
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: August 29, 2022 Received: August 29, 2022
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 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) K222131
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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Image /page/3/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 written in bold, black letters.
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 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: 08/29/2022 9
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K213506, NB 1 SA Implant System manufactured by ARUM DENTISTRY 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 red triangle and a smaller yellow triangle on the left side. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, black letters. "ARUM" is on the top line, and "DENTISTRY" is on the bottom line.
General Description
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.
Fixture's surface 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).
| No. | Device Name | Dimension |
|---|---|---|
| 1 | NB I 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 | Cover Screw | Ø3.6 (D) x 5.3, 6.0, 7.0, 8.0 mm (L) |
| 3 | 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 | Cemented Abutment | 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 dimension ranges of the subject device are below:
Tolerance of dimension shall be within ±1% range.
Fixtures are packaged with cover screw and provided sterile by gamma radiation. Abutments are packaged with abutment screw and provided non-sterilized before use. These devices are intended for single use only.
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, 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.
Materials:
The Fixtures are fabricated from Pure titanium (Conforming to ASTM F67). Abutment and cover screw are fabricated from Ti-6A1-4V (Conforming to ASTM F136).
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Image /page/5/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a smaller yellow triangle on the left side. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, black letters, with "ARUM" on top of "DENTISTRY".
Summaries of Technology Characteristics:
1) NB I Fixture
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | NB 1 SA Implant System | NB 1 SA Implant System |
| Product Name | NB I Fixture | ARUM NB 1 SA Fixture |
| 510(k) Number | NA | K213506 |
| Device classification | Implant, Endosseous, Root-Form | Implant, Endosseous, Root-Form |
| Product Code | DZE | DZE |
| Regulation Number | 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 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. | ||
| Design | Image: Implant Design | Image: Implant Design |
| Material | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
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Image /page/6/Picture/0 description: The image contains a logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is a combination of a red triangle and a yellow triangle. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
| Anti-Rotational
| Feature | Internal Hex | Internal Hex |
|---|---|---|
| Range of Diameters | ||
| (Ø) | 3.8, 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 |
| Gamma Sterilization | Yes | Yes |
Similarities
The NB I Fixture has same fundamental scientific technology, principle of operation, general shape (design), functions, diameter and material to the predicate.
Differences
Only change the product name. Therefore, it doesn't impact product's substantial equivalence.
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Image /page/7/Picture/0 description: The image contains a logo for Arum Dentistry. The logo consists of a red triangle with a smaller yellow triangle at the bottom left. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, black letters. The word "ARUM" is on top of the word "DENTISTRY".
2) Cover Screw
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | NB 1 SA Implant System | NB 1 SA Implant System |
| Product Name | Cover Screw | ARUM NB Cover Screw |
| 510(k) No. | N/A | K213506 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Implant Screw | Image: Implant Screw |
| Range of Diameters | ||
| (Ø) | 3.6 | 3.6 |
| Range of Lengths | ||
| (mm) | 5.3, 6.0, 7.0, 8.0 | 5.3, 6.0, 7.0, 8.0 |
| Surface treatment | Non-Anodizing | Non-Anodizing |
| Gamma Sterilization | Yes | Yes |
Similarities
The Cover Screw has same findamental scientific technology, principle of operation, general shape (design), functions, diameter and material to the predicate.
Differences
Only change the product name. Therefore, it doesn't impact product's substantial equivalence.
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Image /page/8/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a geometric shape on the left, with a red triangle on top and a smaller yellow triangle below it. To the right of the geometric shape, the words "ARUM" and "DENTISTRY" are written in bold, black letters, with "ARUM" on top of "DENTISTRY".
3) Healing Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | NB 1 SA Implant System | NB 1 SA Implant System |
| Product Name | Healing Abutment | ARUM NB Healing Abutment |
| 510(k) No. | N/A | K213506 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Design of Subject Device | Image: Design of Primary Predicate |
| Range of Diameters | ||
| (Ø) | 4.2, 4.7, 5.7, 6.7, 7.7 | 4.2, 4.7, 5.7, 6.7, 7.7 |
| Range of Lengths | ||
| (mm) | 5.3, 6.0, 7.0, 8.0 | 5.3, 6.0, 7.0, 8.0 |
| Range of Cuff (Ø) | 1.0, 2.0, 3.0, 4.0 | 1.0, 2.0, 3.0, 4.0 |
| Gamma Sterilization | Yes | Yes |
| Surface Treatment | N/A | N/A |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Healing Abutment has same fundamental scientific technology, principle of operation, general shape (design), functions, diameter and material to the predicate.
Differences
Compared to the Primary predicate, the subject devices have screw hole and changed the product name. However, except for the screw hole, the diameter, length, intended use, material, functions and general shape (Design) are the same. Therefore, this difference doesn't impact substantial equivalence.
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Image /page/9/Picture/0 description: The image contains the logo for Arum Dentistry. The logo consists of a red triangle and a yellow triangle on the left side of the image. To the right of the triangles, the words "ARUM" and "DENTISTRY" are written in bold, black letters.
4) Cemented Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | ARUM DENTISTRY Co., Ltd. | ARUM DENTISTRY Co., Ltd. |
| Device Name | NB 1 SA Implant System | NB 1 SA Implant System |
| Product Name | Cemented Abutment | ARUM Cemented Abutment |
| 510(k) No. | N/A | K213506 |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Two abutments, one with a white base and one with a silver base. | Image: Two abutments, one with a white base and one with a silver base. |
| Range of Diameters | ||
| (mm) | 4.5, 5.5, 6.5 | 4.5, 5.5, 6.5 |
| Range of Lengths | ||
| (mm) | 5.3, 6.0, 7.0, 8.0 | 5.3, 6.0, 7.0, 8.0 |
| Range of Post (mm) | 5.0, 5.5, 7.0 | 5.0, 5.5, 7.0 |
| Gamma Sterilization | Yes | Yes |
| Surface Treatment | N/A | N/A |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Cemented Abutment has same fundamental scientific technology, principle of operation, general shape (design), functions, diameter and material to the predicate.
Differences
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Image /page/10/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 written in bold, black letters, with "ARUM" on top of "DENTISTRY".
Compared to the Primary predicate, only change the product name and code. Therefore, it doesn't impact product's substantial equivalence.
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Image /page/11/Picture/1 description: The image shows the logo for Arum Dentistry. The logo consists of a geometric shape on the left and the words "ARUM DENTISTRY" on the right. The geometric shape is made up of two triangles, one red and one yellow. The words "ARUM DENTISTRY" are in a bold, sans-serif font.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic. NB 1 SA Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, 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.
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.
Conclusion
The comparison between the target device and the predicate device shows that general information, including dimensions, fundamental designs and material information are identical. Therefore, the subject device is substantially equivalent to the predicate device.