(455 days)
The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.
The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.
This 510(k) clearance letter details the regulatory approval for the ISO Abutment, an endosseous dental implant abutment. It establishes its substantial equivalence to a predicate device based on similar indications for use, technological characteristics, materials, design, and sterilization methods.
However, the provided document does not contain information related to software, artificial intelligence (AI), diagnostic accuracy studies, or clinical performance data typically associated with acceptance criteria tables, sample sizes for medical imaging datasets, expert adjudication, or MRMC studies. The device itself is a physical dental implant component, not an AI-powered diagnostic tool.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (as these would be mechanical and biocompatibility tests, not diagnostic accuracy metrics)
- Sample sizes used for the test set and data provenance (not applicable for this type of device)
- Number of experts used to establish ground truth and qualifications (not applicable)
- Adjudication method (not applicable)
- MRMC comparative effectiveness study (not applicable)
- Standalone (algorithm-only) performance (not applicable)
- Type of ground truth used (e.g., pathology, outcomes data - not applicable for this device beyond engineering/material testing)
- Sample size for the training set (not applicable)
- How the ground truth for the training set was established (not applicable)
The "Non-clinical Tests" section (Page 13) describes the types of studies performed for a physical device, which include:
- Sterilization validation testing (ISO 17665-1 & 2)
- Biocompatibility tests (ISO 10993-5, -10, -11, -3, -33) including:
- Cytotoxicity
- Oral mucosa irritation
- Skin sensitization
- Acute systemic toxicity
- Subchronic systemic toxicity
- Bacterial reverse mutation
- Reverse engineering analysis of OEM implant body, abutment, and fixation screw (for compatibility verification)
- TiN coating tests (F1044, F1147, F1160)
- Non-clinical worst-case MRI review (using scientific evidence and published literature) to assess magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).
These tests establish the physical, mechanical, and biological safety and compatibility of the dental abutment, rather than the diagnostic performance of an AI system.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
SEUM Medi Co., Ltd.
℅ Priscilla Chung
Regulatory Affairs Consultant
LK Consulting Group USA, Inc
18881 Von Karman Ave. STE 160
Irvine, California 92612
Re: K241183
Trade/Device Name: ISO Abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: June 19, 2025
Received: June 27, 2025
July 28, 2025
Dear Priscilla Chung:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K241183 - Priscilla Chung Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K241183 - Priscilla Chung Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K241183
Device Name
ISO Abutment
Indications for Use (Describe)
The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.
| ISO Abutment | Fixture Description | Body Diameter | Manufacturer | 510(k) Number |
|---|---|---|---|---|
| SMSOT351 ~ SMSOT356SMSOT351H ~ SMSOT356H | Osstem_TSIII_SA Implant | Ø 3.75, 3.77 | Osstem Implant Co., Ltd. | K121995 |
| SMSOT401 ~ SMSOT406SMSOT401H ~ SMSOT406H | Ø 4.2, 4.25, 4.63, 4.65, 5.05, 5.08 | |||
| SMSAA401 ~ SMSAA406SMSAA401H ~ SMSAA406H | Medimecca Chaorum_PSF Model Series_NP | Ø 3.75 | Medimecca Co.,Ltd. | K160536 |
| SMSAS401 ~ SMSAS406SMSAS401H ~ SMSAS406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 |
| SMSZP351 ~ SMSZP356SMSZP351H ~ SMSZP356H | Biohorizons_Tapered Internal Implant, Mountless, RBT_3.8 | Ø3.8 | BioHorizons Implant Systems, Inc. | K071638 |
| SMSNA301 ~ SMSNA306SMSNA301H ~ SMSNA306H | Surgikor Fixation_NP | Ø3.0 | Surgikor LLC | K182615 |
| SMSNA351 ~ SMSNA356SMSNA351H ~ SMSNA356H | Surgikor Fixation_RP | Ø3.5, 3.9 | ||
| SMSNA431 ~ SMSNA436SMSNA431H ~ SMSNA436H | Surgikor Fixation_WP | Ø4.3, 5.0 | ||
| SMSMAR401 ~ SMSMAR406SMSMAR401H ~ SMSMAR406H | Megagen_Xpeed AnyRidge Internal Fixture | Ø4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 | Megagen Implant Co., Ltd. | K140091 |
| SMSDQ301 ~ SMSDQ306SMSDQ301H ~ SMSDQ306H | Dentis_s-Clean OneQ-SL_Narrow | Ø3.0, 3.3 | DENTIS CO., LTD. | K161244 |
| SMEBM331 ~ SMEBM336SMEBM331H ~ | Osstem_USIII_SA | Ø3.75 | Osstem Implant Co., Ltd. | K161103 |
Page 5
| SMEBM336H | ||||
|---|---|---|---|---|
| SMEBM401 ~ SMEBM406SMEBM401H ~ SMEBM406H | Ø4.23, 4.27, 4.65 | |||
| MEBM501 ~ SMEBM506SMEBM501H ~ SMEBM506H | Ø5.05, 5.1 | |||
| SMETW501 ~ SMETW506SMETW501H ~ SMETW506H | Ø5.05, 5.1, 5.13 | |||
| SMSTC331 ~ SMSTC336SMSTC331H ~ SMSTC336H | 3I Osseotite Certain Dental Implant_3.4 | Ø 3.25 | Implant Innovation, INC. | K063341 |
| SMSTC401 ~ SMSTC406SMSTC401H ~ SMSTC406H | 3I Osseotite Certain Dental Implant _4.1 | Ø 4.0 | ||
| SMITT401 ~ SMITT406SMITT401H ~ SMITT406H | Neobiotech IT III_Active | Ø4.0 | Neobiotech Co., Ltd. | K181137 |
| SMITB331 ~ SMITB336SMITB331H ~ SMITB336H | Straumann Bone Level_NC | Ø3.3 | STRAUMANN USA, LLC | K150938 |
| SMITB401 ~ SMITB406SMITB401H ~ SMITB406H | Straumann Bone Level_RC | Ø4.1 |
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) Page 2 of 2
Page 6
510(k) Summary
(K241183)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: July 28, 2025
1. 510k Submitter:
SEUM Medi Co., Ltd.
2F, 95, Baekbeom-ro, Namdong-gu, Incheon, Republic of Korea, 21540
Tel: +82-32-321-7306
2. Device:
Trade name: ISO Abutment
Common name: Dental implant abutment
Classification name: Endosseous dental implant abutment, 21CFR 872.3630
Product code: NHA
3. Predicate Devices:
Primary predicate device -
Kerator, K112787 (Product Code: NHA, 21CFR 872.3630) by KJ Meditech Co., Ltd.
Reference devices -
K121995, K160536, K160965, K071638, K182615, K140091, K161244, K161103, K063341, K181137, K150938
4. Description:
The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.
5. Indication for use:
The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.
| ISO Abutment | Fixture Description | Body Diameter | Manufacturer | 510(k) Number |
|---|
Page 1 / 8
Page 7
| SMSOT351 ~ SMSOT356SMSOT351H ~ SMSOT356H | Osstem_TSIII_SA Implant | Ø 3.75, 3.77 | Osstem Implant Co., Ltd. | K121995 |
|---|---|---|---|---|
| SMSOT401 ~ SMSOT406SMSOT401H ~ SMSOT406H | Ø 4.2, 4.25, 4.63, 4.65, 5.05, 5.08 | |||
| SMSAA401 ~ SMSAA406SMSAA401H ~ SMSAA406H | Medimecca Chaorum_PSF Model Series_NP | Ø 3.75 | Medimecca Co.,Ltd. | K160536 |
| SMSAS401 ~ SMSAS406SMSAS401H ~ SMSAS406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 |
| SMSZP351 ~ SMSZP356SMSZP351H ~ SMSZP356H | Biohorizons_Tapered Internal Implant, Mountless, RBT_3.8 | Ø3.8 | BioHorizons Implant Systems, Inc. | K071638 |
| SMSNA301 ~ SMSNA306SMSNA301H ~ SMSNA306H | Surgikor Fixation_NP | Ø3.0 | Surgikor LLC | K182615 |
| SMSNA351 ~ SMSNA356SMSNA351H ~ SMSNA356H | Surgikor Fixation_RP | Ø3.5, 3.9 | ||
| SMSNA431 ~ SMSNA436SMSNA431H ~ SMSNA436H | Surgikor Fixation_WP | Ø4.3, 5.0 | ||
| SMSMAR401 ~ SMSMAR406SMSMAR401H ~ SMSMAR406H | Megagen_Xpeed AnyRidge Internal Fixture | Ø4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 | Megagen Implant Co., Ltd. | K140091 |
| SMSDQ301 ~ SMSDQ306SMSDQ301H ~ SMSDQ306H | Dentis_s-Clean OneQ-SL_Narrow | Ø3.0, 3.3 | DENTIS CO., LTD. | K161244 |
| SMEBM331 ~ SMEBM336SMEBM331H ~ SMEBM336H | Osstem_USIII_SA | Ø3.75 | Osstem Implant Co., Ltd. | K161103 |
| SMEBM401 ~ SMEBM406SMEBM401H ~ SMEBM406H | Ø4.23, 4.27, 4.65 | |||
| SMEBM501 ~ SMEBM506SMEBM501H ~ SMEBM506H | Ø5.05, 5.1 | |||
| SMETW501 ~ SMETW506SMETW501H ~ SMETW506H | Ø5.05, 5.1, 5.13 |
Page 2 / 8
Page 8
| SMSTC331 ~ SMSTC336SMSTC331H ~ SMSTC336H | 3I Osseotite Certain Dental Implant_3.4 | Ø 3.25 | Implant Innovation, INC. | K063341 |
|---|---|---|---|---|
| SMSTC401 ~ SMSTC406SMSTC401H ~ SMSTC406H | 3I Osseotite Certain Dental Implant _4.1 | Ø 4.0 | ||
| SMITT401 ~ SMITT406SMITT401H ~ SMITT406H | Neobiotech IT III_Active | Ø4.0 | Neobiotech Co., Ltd. | K181137 |
| SMITB331 ~ SMITB336SMITB331H ~ SMITB336H | Straumann Bone Level_NC | Ø3.3 | STRAUMANN USA, LLC | K150938 |
| SMITB401 ~ SMITB406SMITB401H ~ SMITB406H | Straumann Bone Level_RC | Ø4.1 |
Page 3 / 8
Page 9
6. Substantial Equivalence:
Comparison Chart
| Subject Device | Predicate Device | |
|---|---|---|
| 510k Number | K241183 | K112787 |
| Device Name | ISO Abutment | Kerator |
| Manufacturer | Zeros Co., Ltd. | KJ Meditech Co., Ltd. |
| Product Code | NHA | NHA |
| Indications for Use | The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures. | The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures. |
| ISO Abutment | Fixture Description | Body Diameter | Manufacturer | 510(k) Number |
|---|---|---|---|---|
| SMSOT351 ~ SMSOT356SMSOT351H ~ SMSOT356H | Osstem_TSIII_SA Implant | Ø 3.75, 3.77 | Osstem Implant Co., Ltd. | K121995 |
| SMSOT401 ~ SMSOT406SMSOT401H ~ SMSOT406H | Ø 4.2, 4.25, 4.63, 4.65, 5.05, 5.08 | |||
| SMSAA401 ~ SMSAA406SMSAA401H ~ SMSAA406H | Medimecca Chaorum_PSF Model Series_NP | Ø 3.75 | Medimecca Co.,Ltd. | K160536 |
| SMSAS401 ~ SMSAS406SMSAS401H ~ SMSAS406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 |
Page 4 / 8
Page 10
| SMSZP351 ~ SMSZP356SMSZP351H ~ SMSZP356H | Biohorizons_Tapered Internal Implant, Mountless, RBT_3.8 | Ø3.8 | BioHorizons Implant Systems, Inc. | K071638 |
|---|---|---|---|---|
| SMSNA301 ~ SMSNA306SMSNA301H ~ SMSNA306H | Surgikor Fixation_NP | Ø3.0 | Surgikor LLC | K182615 |
| SMSNA351 ~ SMSNA356SMSNA351H ~ SMSNA356H | Surgikor Fixation_RP | Ø3.5, 3.9 | ||
| SMSNA431 ~ SMSNA436SMSNA431H ~ SMSNA436H | Surgikor Fixation_WP | Ø4.3, 5.0 | ||
| SMSMAR401 ~ SMSMAR406SMSMAR401H ~ SMSMAR406H | Megagen_Xpeed AnyRidge Internal Fixture | Ø4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 | Megagen Implant Co., Ltd. | K140091 |
| SMSDQ301 ~ SMSDQ306SMSDQ301H ~ SMSDQ306H | Dentis_s-Clean One-Q-SL_Narrow | Ø3.0, 3.3 | DENTIS CO., LTD. | K161244 |
| SMEBM331 ~ SMEBM336SMEBM331H ~ SMEBM336H | Osstem_USIII_SA | Ø3.75 | Osstem Implant Co., Ltd. | K161103 |
| SMEBM401 ~ SMEBM406SMEBM401H ~ SMEBM406H | Ø4.23, 4.27, 4.65 | |||
| SMEBM501 ~ SMEBM506SMEBM501H ~ SMEBM506H | Ø5.05, 5.1 | |||
| SMETW501 ~ SMETW506SMETW501H ~ SMETW506H | Ø5.05, 5.1, 5.13 |
Page 5 / 8
Page 11
| SMSTC331 ~ SMSTC336SMSTC331H ~ SMSTC336H | 3I Osseotite Certain Dental Implant_3.4 | Ø 3.25 | Implant Innovation, INC. | K063341 |
|---|---|---|---|---|
| SMSTC401 ~ SMSTC406SMSTC401H ~ SMSTC406H | 3I Osseotite Certain Dental Implant _4.1 | Ø 4.0 | ||
| SMITT401 ~ SMITT406SMITT401H ~ SMITT406H | Neobiotech IT III_Active | Ø4.0 | Neobiotech Co., Ltd. | K181137 |
| SMITB331 ~ SMITB336SMITB331H ~ SMITB336H | Straumann Bone Level_NC | Ø3.3 | STRAUMANN USA, LLC | K150938 |
| SMITB401 ~ SMITB406SMITB401H ~ SMITB406H | Straumann Bone Level_RC | Ø4.1 |
| Subject Device | Predicate Device | |
|---|---|---|
| Performance Characteristics | The ISO Abutment is an abutment which is placed into dental implant to provide support for a prosthetic restoration. | The Kerator is an abutment which is placed into dental implant to provide support for a prosthetic restoration. |
| Material | Titanium 6Al 4V ELI Alloy ASTM F136 | Titanium 6Al 4V ELI Alloy ASTM F136 |
| Gingival Height (mm)Post Height (mm)Angulation (°) | Gingival Height: 1-6mmPost Height: 1.5mmAngulation: 0 | Gingival Height: 0-8mmPost Height: 1.48mmAngulation: 0 |
| Surface Treatment | TiN Coating only for the head part of the abutment | TiN Coating only for the head part of the abutment |
Page 6 / 8
Page 12
| Recommended Sterilization Method | Autoclave | Autoclave |
|---|
Substantial Equivalence Discussion
The subject device and the predicate device have the same indications and fundamental scientific technology. The subject and predicate device have similar design and employ the same materials, surface treatment, and sterilization method. When compared with predicate devices, no new question of safety or effectiveness has been raised for the subject device. The major difference is that the subject device can be used with more 3rd party manufacturer implants. We have performed reverse engineering analysis and the cross-section validation to verify compatibility, and the results support that the substantial equivalence to the predicate device.
Page 7 / 8
Page 13
7. Non-clinical Tests
- Sterilization validating testing has been performed in accordance with ISO 17665-1 & 2.
- Biocompatibility test including cytotoxicity test per ISO 10993-5, oral mucosa irritation per ISO 10993-10, skin sensitization per ISO 10993-10, acute systemic toxicity per ISO 10993-11, sub chronic systemic toxicity per 10993-11, bacterial reverse mutation per 10993-3 and ISO 10993-33
- Reverse engineering analysis was conducted on the OEM implant body, OEM abutment, and OEM fixation screw.
- TiN coating tests in accordance with F1044, F1147, and F1160
- A non-clinical worst-case MRI review was conducted to evaluate the Luna Implant System device in an MRI environment using scientific evidence 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). Titanium Grade 4 and Titanium alloy (Ti-6Al-4V, ELI) were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) by T. O. Woods et al. Based on that rationale, we have addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetic induced displacement force and torque.
8. Conclusions:
The subject devices and the predicate device have the same intended use and have similar technological characteristics. The substantial equivalence of the different dimensions between the subject device and predicate device is supported by the reference device.
Overall, the ISO Abutment has the following similarities to the predicate device:
- have the same intended use,
- use the same operating principle,
- incorporate similar design,
- incorporate the same material and the sterilization method
Based on the similarities, we conclude that the ISO Abutment is substantially equivalent to the predicate devices.
Page 8 / 8
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)