ISO Abutment
Device Facts
| Record ID | K241183 |
|---|---|
| Device Name | ISO Abutment |
| Applicant | Seum Medi Co., Ltd. |
| Product Code | NHA · Dental |
| Decision Date | Jul 28, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Intended 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.
Device Story
ISO Abutment is a dental implant abutment placed into endosseous dental implants to support prosthetic restorations (overdentures or partial dentures). Device is manufactured from Titanium grade Ti-6Al-4V ELI; features TiN coating on the head part. It is compatible with various third-party implant fixtures. Used in dental clinics by dental professionals. Output is a mechanical interface for prosthetic attachment, facilitating denture retention. Benefits include restoration of dental function for patients with missing teeth. Device is provided sterile via autoclave.
Clinical Evidence
Bench testing only. Includes sterilization validation (ISO 17665-1 & 2), biocompatibility (ISO 10993-5, -10, -11, -3), TiN coating tests (ASTM F1044, F1147, F1160), and non-clinical MRI safety assessment based on literature and ASTM standards (F2052, F2213, F2182, F2119). Reverse engineering analysis performed to verify compatibility with OEM implant bodies.
Technological Characteristics
Material: Titanium grade Ti-6Al-4V ELI (ASTM F-136). Surface: TiN coating on head. Sterilization: Autoclave. Form factor: Dental abutment with varying gingival heights (1-6mm), post height (1.5mm), and angulation (0°).
Indications for Use
Indicated for patients requiring overdentures or partial dentures retained by endosseous implants in the mandible or maxilla.
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- Kerator (K112787)
Reference Devices
Related Devices
- K221969 — IU Implant System Abutment · Warantec Co., Ltd. · May 12, 2023
- K142115 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT · Prismatik Dentalcraft, Inc. · Nov 13, 2014
- K151375 — Inclusive Titanium Abutments compatible with: Hiossen HG Implant System · Prismatik Dentalcraft, Inc. · Oct 7, 2015
- K142118 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE · Prismatik Dentalcraft, Inc. · Nov 25, 2014
- K100993 — INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS · Prismatik Dentalcraft, Inc. · Dec 28, 2010
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
SEUM Medi Co., Ltd.
% Priscilla Chung
Regulatory Affairs Consultant
LK Consulting Group USA, Inc
18881 Von Karman Ave. STE 160
Irvine, California 92612
July 28, 2025
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
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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.
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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
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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 ~ SMSOT356
SMSOT351H ~ SMSOT356H | Osstem_TSIII_SA Implant | Ø 3.75, 3.77 | Osstem Implant Co., Ltd. | K121995 |
| SMSOT401 ~ SMSOT406
SMSOT401H ~ SMSOT406H | | Ø 4.2, 4.25, 4.63, 4.65, 5.05, 5.08 | | |
| SMSAA401 ~ SMSAA406
SMSAA401H ~ SMSAA406H | Medimecca Chaorum_PSF Model Series_NP | Ø 3.75 | Medimecca Co.,Ltd. | K160536 |
| SMSAS401 ~ SMSAS406
SMSAS401H ~ SMSAS406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 |
| SMSZP351 ~ SMSZP356
SMSZP351H ~ SMSZP356H | Biohorizons_Tapered Internal Implant, Mountless, RBT_3.8 | Ø3.8 | BioHorizons Implant Systems, Inc. | K071638 |
| SMSNA301 ~ SMSNA306
SMSNA301H ~ SMSNA306H | Surgikor Fixation_NP | Ø3.0 | Surgikor LLC | K182615 |
| SMSNA351 ~ SMSNA356
SMSNA351H ~ SMSNA356H | Surgikor Fixation_RP | Ø3.5, 3.9 | | |
| SMSNA431 ~ SMSNA436
SMSNA431H ~ SMSNA436H | Surgikor Fixation_WP | Ø4.3, 5.0 | | |
| SMSMAR401 ~ SMSMAR406
SMSMAR401H ~ 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 ~ SMSDQ306
SMSDQ301H ~ SMSDQ306H | Dentis_s-Clean One-Q-SL_Narrow | Ø3.0, 3.3 | DENTIS CO., LTD. | K161244 |
| SMEBM331 ~ SMEBM336
SMEBM331H ~ | Osstem_USIII_SA | Ø3.75 | Osstem Implant Co., Ltd. | K161103 |
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| SMEBM336H | | | | |
| --- | --- | --- | --- | --- |
| SMEBM401 ~ SMEBM406 SMEBM401H ~ SMEBM406H | | Ø4.23, 4.27, 4.65 | | |
| MEBM501 ~ SMEBM506 SMEBM501H ~ SMEBM506H | | Ø5.05, 5.1 | | |
| SMETW501 ~ SMETW506 SMETW501H ~ SMETW506H | | Ø5.05, 5.1, 5.13 | | |
| SMSTC331 ~ SMSTC336 SMSTC331H ~ SMSTC336H | 3I Osseotite Certain Dental Implant_3.4 | Ø 3.25 | Implant Innovation, INC. | K063341 |
| SMSTC401 ~ SMSTC406 SMSTC401H ~ SMSTC406H | 3I Osseotite Certain Dental Implant_4.1 | Ø 4.0 | | |
| SMITT401 ~ SMITT406 SMITT401H ~ SMITT406H | Neobiotech IT III_Active | Ø4.0 | Neobiotech Co., Ltd. | K181137 |
| SMITB331 ~ SMITB336 SMITB331H ~ SMITB336H | Straumann Bone Level_NC | Ø3.3 | STRAUMANN USA, LLC | K150938 |
| SMITB401 ~ SMITB406 SMITB401H ~ 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)
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FORM FDA 3881 (6/20)
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# 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-6Al-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 |
| --- | --- | --- | --- | --- |
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| SMSOT351 ~ SMSOT356
SMSOT351H ~ SMSOT356H | Osstem_TSIII_SA Implant | Ø 3.75, 3.77 | Osstem Implant Co., Ltd. | K121995 |
| --- | --- | --- | --- | --- |
| SMSOT401 ~ SMSOT406
SMSOT401H ~ SMSOT406H | | Ø 4.2, 4.25, 4.63, 4.65, 5.05, 5.08, , | | |
| SMSAA401 ~ SMSAA406
SMSAA401H ~ SMSAA406H | Medimecca Chaorum_PSF Model Series_NP | Ø 3.75 | Medimecca Co.,Ltd. | K160536 |
| SMSAS401 ~ SMSAS406
SMSAS401H ~ SMSAS406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 |
| SMSZP351 ~ SMSZP356
SMSZP351H ~ SMSZP356H | Biohorizons_Tapered Internal Implant, Mountless, RBT_3.8 | Ø3.8 | BioHorizons Implant Systems, Inc. | K071638 |
| SMSNA301 ~ SMSNA306
SMSNA301H ~ SMSNA306H | Surgikor Fixation_NP | Ø3.0 | Surgikor LLC | K182615 |
| SMSNA351 ~ SMSNA356
SMSNA351H ~ SMSNA356H | Surgikor Fixation_RP | Ø3.5, 3.9 | | |
| SMSNA431 ~ SMSNA436
SMSNA431H ~ SMSNA436H | Surgikor Fixation_WP | Ø4.3, 5.0 | | |
| SMSMAR401 ~ SMSMAR406
SMSMAR401H ~ 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 ~ SMSDQ306
SMSDQ301H ~ SMSDQ306H | Dentis_s-Clean One-Q-SL_Narrow | Ø3.0, 3.3 | DENTIS CO., LTD. | K161244 |
| SMEBM331 ~ SMEBM336
SMEBM331H ~ SMEBM336H | Osstem_USIII_SA | Ø3.75 | Osstem Implant Co., Ltd. | K161103 |
| SMEBM401 ~ SMEBM406
SMEBM401H ~ SMEBM406H | | Ø4.23, 4.27, 4.65 | | |
| SMEBM501 ~ SMEBM506
SMEBM501H ~ SMEBM506H | | Ø5.05, 5.1 | | |
| SMETW501 ~ SMETW506
SMETW501H ~ SMETW506H | | Ø5.05, 5.1, 5.13 | | |
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| SMSTC331 ~
SMSTC336
SMSTC331H ~
SMSTC336H | 3I Osseotite Certain
Dental Implant_3.4 | Ø 3.25 | Implant Innovation,
INC. | K063341 |
| --- | --- | --- | --- | --- |
| SMSTC401 ~
SMSTC406
SMSTC401H ~
SMSTC406H | 3I Osseotite Certain
Dental Implant _4.1 | Ø 4.0 | | |
| SMITT401 ~
SMITT406
SMITT401H ~
SMITT406H | Neobiotech IT
III_Active | Ø4.0 | Neobiotech Co.,
Ltd. | K181137 |
| SMITB331 ~
SMITB336
SMITB331H ~
SMITB336H | Straumann Bone
Level_NC | Ø3.3 | STRAUMANN
USA, LLC | K150938 |
| SMITB401 ~
SMITB406
SMITB401H ~
SMITB406H | Straumann
Bone Level_RC | Ø4.1 | | |
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# 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 | Kerator Model No. | Fixture Description | Manufacturer |
| SMSOT351~SMSOT356 | Osstem_TSIII_SA Implant | Ø 3.75, 3.77 | Osstem Implant Co., Ltd. | K121995 | B331 - B337 | Branemark 3.3 Type | NOBELPHARMA USA, INC. |
| SMSOT351H~SMSOT356H | B401 - B407 | Branemark 4.0 Type |
| SMSOT401~SMSOT406 | B501 - B507 | Branemark 5.0 Type |
| SMSOT401H~SMSOT406H | Ø 4.2, 4.25, 4.63, 4.65, 5.05, 5.08 | AS351 - AS357 | Astra3.5 Type | ASTRA TECH AB |
| AS401 - AS407 | Astra 4.0 Type |
| G400 - G406 | Nobel Biocare USA, Inc. |
| SRS350 - SRS356 | Replace 3.5 Type |
| SRS450 - SRS457 | Replace 4.3 Type | BICON, INC. |
| SMSAA401~SMSAA406 | Medimecca Chaorum_PSF Model Series_NP | Ø 3.75 | Medimecca Co.,Ltd. | K160536 | SRS500 - SRS506 | Replace 5.0 Type |
| BC201 - BC207 | Bicon 2.0(well) Type | BICON, INC. |
| SMSAA401H~SMSAA406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 | BC301 - BC307 | Bicon 3.0(well) Type |
| PA350 - PA356 | Paragon 3.5 Type | CORE-VENT BIO-ENGINEERING, INC. |
| SMSAA401H~SMSAA406H | Dentium_Superline | Ø 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | Dentium Co., Ltd. | K160965 | PA450 - PA456 | Paragon 4.5 Type |
| T401 - T407 | ITI 4.0 Type | INSTITUT STRAUMANN AG |
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| | SMSZP351 ~ SMSZP356
SMSZP351H ~ SMSZP356H | Biohorizons_Tapered Internal Implant, Mountless, RBT_3.8 | Ø3.8 | BioHorizons Implant Systems, Inc. | K071638 | |
| --- | --- | --- | --- | --- | --- | --- |
| | SMSNA301 ~ SMSNA306
SMSNA301H ~ SMSNA306H | Surgikor Fixation_NP | Ø3.0 | Surgikor LLC | K182615 | |
| | SMSNA351 ~ SMSNA356
SMSNA351H ~ SMSNA356H | Surgikor Fixation_RP | Ø3.5, 3.9 | | | |
| | SMSNA431 ~ SMSNA436
SMSNA431H ~ SMSNA436H | Surgikor Fixation_WP | Ø4.3, 5.0 | | | |
| | SMSMAR401 ~ SMSMAR406
SMSMAR401H ~ 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 ~ SMSDQ306
SMSDQ301H ~ SMSDQ306H | Dentis_s-Clean One-Q-SL_Narrow | Ø3.0, 3.3 | DENTIS CO., LTD. | K161244 | |
| | SMEBM331 ~ SMEBM336
SMEBM331H ~ SMEBM336H | Osstem_USIII_SA | Ø3.75 | Osstem Implant Co., Ltd. | K161103 | |
| | SMEBM401 ~ SMEBM406
SMEBM401H ~ SMEBM406H | | Ø4.23, 4.27, 4.65 | | | |
| | MEBM501 ~ SMEBM506
SMEBM501H ~ SMEBM506H | | Ø5.05, 5.1 | | | |
| | SMETW501 ~ SMETW506 | | Ø5.05, 5.1, 5.13 | | | |
Page 5 / 8
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| | SMETW501H~SMETW506H | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | SMSTC331~SMSTC336SMSTC331H~SMSTC336H | 3I Osseotite CertainDental Implant_3.4 | Ø 3.25 | ImplantInnovation,INC. | K063341 | |
| | SMSTC401~SMSTC406SMSTC401H~SMSTC406H | 3I Osseotite CertainDental Implant_4.1 | Ø 4.0 | | | |
| | SMITT401~SMITT406SMITT401H~SMITT406H | NeobiotechIT III_Active | Ø4.0 | NeobiotechCo., Ltd. | K181137 | |
| | SMITB331~SMITB336SMITB331H~SMITB336H | StraumannBone Level_NC | Ø3.3 | STRAUMANN USA, LLC | K150938 | |
| | SMITB401~SMITB406SMITB401H~SMITB406H | StraumannBone Level_RC | Ø4.1 | | | |
| | | | | | | |
| 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 | Post Height | Angulation | | Gingival Height | Post Height |
| | 1-6mm | 1.5mm | 0 | | 0-8mm | 1.48mm |
| Surface Treatment | TiN Coating only for the head part of the abutment | | | | | TiN Coating only for the head part of the abutment |
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| 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.
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# 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.
