SIMDA Abutments

K252320 · Simda Co., Ltd. · NHA · Dec 18, 2025 · Dental

Device Facts

• Record ID: K252320
• Device Name: SIMDA Abutments
• Applicant: Simda Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Dec 18, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Story

SIMDA Abutments are endosseous dental implant abutments used to support prosthetic restorations. The system includes Pre-Milled Blanks, Ti-Base abutments, Multi-unit Abutments, and Multi-unit Bases. Pre-Milled Blanks are patient-specific components designed by clinicians or labs and manufactured at a SIMDA-validated milling center. Ti-Base abutments support CAD/CAM-designed zirconia superstructures. Multi-unit components provide support for prosthetic restorations. The device interfaces directly with specific compatible endosseous dental implants. Clinicians use these components to restore chewing function and aesthetics in edentulous patients. The device is provided non-sterile and requires sterilization after assembly/cementation. The system benefits patients by providing a stable, customized connection between the dental implant and the final prosthetic restoration.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including fatigue testing (ISO 14801:2016), steam sterilization validation (ISO 17665-1/2, ANSI/AAMI ST79), and biocompatibility testing (ISO 10993-1/5/10). Dimensional analysis and reverse engineering confirmed compatibility with OEM implant platforms.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI, ASTM F136) and Zirconia (ZrO2). Components: Pre-Milled Blanks, Ti-Base, Multi-unit Abutments/Bases. Connectivity: Mechanical interface to specific dental implants. Sterilization: Non-sterile; requires steam sterilization. Design: Patient-specific CAD/CAM workflow via validated milling centers.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple tooth prosthetic support in the maxilla or mandible via dental implants.

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

• SIMDA Abutment (K223663)

Reference Devices

• OsseoSpeed Profile EV (K130999)
• OsseoSpeed Plus (K120414)
• Astra Tech Fixture OsseoSpeed, Astra Tech Fixture MicroMacro (K024111)
• Astra Tech Implant System (K101732)
• BioHorizons Laser-Lok 3.0 Implant System (K093321)
• BioHorizons Tapered Internal Implant System (K143022)
• BioHorizons Tapered Internal Implant System (K071638)
• CP4 Osseotite Certain Dental Implants (K130949)
• Straumann BLX Implant System (K173961)
• Straumann BLX Line Extension (K181703)
• Straumann BLX Ø3.5 mm Implants (K191256)
• URIS OMNI Narrow System & Prosthetic (K200817)
• INCORIS ZI (K123664)
• MALTA (K100756)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 18, 2025

SIMDA Co.,ltd.
Cha Young Woo
Regulatory Affairs Manager
233, Hakgam dea-ro, Sasang-gu
Busan, 46986
REPUBLIC OF KOREA

Re: K252320
Trade/Device Name: SIMDA Abutments
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: November 18, 2025
Received: November 18, 2025

Dear Cha Young Woo:

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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K252320 - Cha Young Woo
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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K252320 - Cha Young Woo
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 ([e-mail]) or phone [phone] 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)
K252320

Device Name

SIMDA Abutments

Indications for Use (Describe)
SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Pre-Milled Blank, Patient-specific abutment

| Compatible System | Implant Body Diameter(mm) | Implant Platform |
| --- | --- | --- |
| Astra OsseoSpeed® EV (K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 |
| Astra Tech Implant System (K101732)
Astra Tech OsseoSpeed
Astra Tech Fixture MicroMacro (New indication) (K024111) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) |
| BioHorizons Laser-Lok 3.0 Implant System (K093321)
BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 |
| Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |

Ti-Base abutment

| Compatible System | Implant Body Diameter(mm) | Implant Platform |
| --- | --- | --- |
| BioHorizons Laser-Lok 3.0 Implant System (K093321) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 |
| BioHorizons Tapered Internal Implant System (K143022, K071638) | | |
| Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |

Multi-unit abutment

| Compatible System | Implant Body Diameter(mm) | Implant Platform |
| --- | --- | --- |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |

Multi-unit Abutment is only compatible with Straumann BLX Implant System.

All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services [phone]

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FORM FDA 3881 (6/20)
Page 2 of 2

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SIMDA

K252320

# 510(k) Summary

## Applicant

Name: SIMDA Co., Ltd.
Address: 233, Hakgam dea-ro, Sasang-gu, Busan, South Korea
Phone: [phone]
Contact: Young Woo, Cha
Email: Email: [e-mail]
Date Prepared: 12/17/2025

## Subject Device

Trade Name: SIMDA Abutment
Common Name: Endosseous dental implant abutment
Classification Name: Abutment, Implant, Dental, Endosseous
Product Code: NHA
Panel: Dental
Regulation Number: 21 CFR 872.3630
Device Class: Class II

| Primary | 510(k) | Manufacturer(s) |
| --- | --- | --- |
| SIMDA Abutment | K223663 | SIMDA Co., Ltd. |
| Reference | 510(k) | Manufacturer(s) |
| --- | --- | --- |
| OsseoSpeed Profile EV | K130999 | Dentsply Implants Manufacturing GmbH |
| OsseoSpeed Plus | K120414 | Astra Tech AB |
| Astra Tech Fixture OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) | K024111 | Astra Tech, Inc. |
| Astra Tech Implant System | K101732 | Astra Tech AB |
| BioHorizons Laser-Lok 3.0 Implant System | K093321 | BioHorizons Implant Systems, Inc. |
| BioHorizons Tapered Internal Implants | K143022 | BioHorizons Implant Systems, Inc. |
| BioHorizons Tapered Internal Implant System | K071638 | BioHorizons Implant Systems, Inc. |
| CP4 Osseotite Certain Dental Implants | K130949 | Biomet 3i |
| Straumann BLX Implant System | K173961 | Institut Straumann AG |
| Straumann BLX Line Extension – Implants, SRAs and Anatomic Abutments | K181703 | Institut Straumann AG |
| Straumann BLX Ø3.5 mm Implants | K191256 | Institut Straumann AG |
| URIS OMNI Narrow System & Prosthetic | K200817 | Truabutment, Inc. |
| INCORIS ZI | K123664 | Sirona Dental Systems GmbH |
| MALTA | K100756 | 3M Espe AG Dental Products |

Rev.06_12/17/2025

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SIMDA

K252320

Device Description

SIMDA Abutment is intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank, Ti-Base, Multi-unit Abutment, Multi-unit Base. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant.

## Pre-milled Blank Design

This device is a patient-specific abutment composed of titanium alloy (Ti-6Al-4V ELI, ASTM F136) which is designed by a clinician or lab, and milled at a SIMDA validated milling center.

Pre-Milled Blank Design Limitation for Patient-specific abutment:

| Design parameter (Patient-specific abutment) | Subject System Design Limit |
| --- | --- |
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5mm |
| Minimum and Maximum diameter at abutment/implant interface | Ø4.0~Ø8.0 |
| Minimum and Maximum length of abutment | 6~12mm |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) | 4~8mm |
| Minimum wall thickness at abutment/implant interface | 0.32 (Astra EV)
0.32 (Astra TX)
0.39 (BioHorizons)
0.4 (Biomet 3i)
0.42 (Straumann BLX) |
| Minimum and Maximum abutment angle | 0~15° (Astra EV and Astra TX)
0~25° (BioHorizons, Biomet 3i, and Straumann BLX) |

Pre-Milled Blank Design Limitation for Patient-specific abutment:

Astra OsseoSpeed EV, Astra Tech OsseoSpeed TX is minimum and maximum abutment angle 0~15°

## Ti-Base Abutment

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured titanium component that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.

## Raw material blanks

- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.

## Cement

- RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.

Rev.06_12/17/2025

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SIMDA

K252320

Design Limitation for Zirconia superstructure:



| Design Parameter | Limit (Min.~Max.) |
| --- | --- |
| Minimum and Maximum abutment angle | 0~15 |
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5.0 |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) | 4.0~6.0 |
| Minimum and Maximum diameter at abutment/implant interface | 5.0~8.0 |
| Minimum wall thickness at abutment/implant interface | 0.33 |

## Multi-unit Abutment and Base

Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The Multi-unit Abutment has a post height less than 4mm and are always combined with Multi-unit Base, increasing the post height to a minimum of 4.5mm.

Rev.06_12/17/2025

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SIMDA

# K252320

## Indication for Use

SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

### Pre-Milled Blank, Patient-specific abutment

| Compatible System | Implant Body Diameter(mm) | Implant Platform |
| --- | --- | --- |
| Astra OsseoSpeed EV (K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 |
| Astra Tech Implant System (K101732)
Astra Tech Fixture OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) |
| BioHorizons Laser-Lok 3.0 Implant System (K093321)
BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 |
| Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |

### Ti-Base

| Compatible System | Implant Body Diameter(mm) | Implant Platform |
| --- | --- | --- |
| BioHorizons Laser-Lok 3.0 Implant System (K093321)
BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 |
| Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |

### Multi-unit abutment

| Compatible System | Implant Body Diameter(mm) | Implant Platform |
| --- | --- | --- |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |

Multi-unit Abutment is only compatible with Straumann BLX Implant System.

All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.

Rev.06_12/17/2025

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SIMDA

# K252320

## Primary Predicate / Reference devices:

The subject device is substantially equivalent to the following primary predicate and reference devices:

- Primary Predicate
- SIMDA Abutment (K223663)

- Reference devices
- OsseoSpeed Profile EV (K130999) by Dentsply Implants Manufacturing GmbH
- OsseoSpeed Plus (K120414) by Astra Tech AB
- Astra Tech Fixture OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111) by Astra Tech, Inc.
- Astra Tech Implant System (K101732) by Astra Tech AB.
- BioHorizons Laser-Lok 3.0 Implant System (K093321) by Biohorizons Implant Systems, Inc.
- Biohorizons Tapered Internal Implant System (K143022) by Biohorizons Implant Systems, Inc.
- Biohorizons Tapered Internal Implant System (K071638) by Biohorizons Implant Systems, Inc.
- CP4 Osseotite Certain Dental Implants (K130949) by Biomet 3i
- Straumann BLX Implant System (K173961) by Institut Straumann AG
- Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments (K181703) by Institut Straumann AG
- Straumann BLX Ø3.5 Mm Implants (K191256) by Institut Straumann AG
- URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Inc.
- INCORIS ZI (K123664) by Sirona Dental Systems GmbH
- MALTA (K100756) by 3M Espe AG Dental Products

## Comparison between Primary predicates

### Pre-Milled Blank

| Feature | Proposed Device SIMDA Abutment | Primary predicate SIMDA Abutment | SE discussion |
| --- | --- | --- | --- |
| Applicant | SIMDA Co., Ltd. | SIMDA Co., Ltd. | = |
| Part Name | Pre-Milled Blank | Pre-Milled Blank | = |
| 510(K) No. | - | K223663 | = |
| Classification Name | Endosseous Dental Implant Abutments (872.3630) | Endosseous Dental Implant Abutments (872.3630) | Identical |
| Product Code | NHA | NHA | Identical |
| Screw and Abutment Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Identical |
| Indications For Use | SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | The subject device is substantially equivalent in indications and design principles to the primary predicate device listed above. Provided tables are comparing |

Rev.06_12/17/2025

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SIMDA

K252320

| Feature | Proposed Device SIMDA Abutment | | | Primary predicate SIMDA Abutment | | | SE discussion |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | It is compatible with the following systems:Pre-Milled Blank, Patient-specific abutment | | | It is compatible with the following systems: | | | the Indications for Use Statements and the technological characteristics of The subject device, the primary predicate device. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent in intended use to the primary predicate device. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Slight differences in the language of the subject device and primary predicate is Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. The minor differences between the subject device and the primary predicate device are related to the compatible OEM implant lines and the implant platform diameter. |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| | Astra OsseoSpeed EV (K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | Ostma TS (K121995) | 3.5, 3.75 | Max | |
| | Astra Tech Implant System (K101732) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) | Straumann Bone Level (only the BoneA49 implants from K140878) | 3.5 | NC | |
| | Straumann BLX Implant (K130949) | | | | 4.1, 4.8 | RC | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | | | |
| | Ti-Base | | | | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | | | | |
| | BioHorizons Laser-Lok 3.0 Implant System (K093321) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | | | | |
| | BioHorizons Tapered Internal Implant System (K143022, K071638) | | | | | | |
| | Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | | | | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | | | |
| | Multi-unit abutment | | | | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | | | | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | | | |
| | Multi-unit Abutment is only compatible with Straumann BLX Implant System. | | | | | | |

Rev.06_12/17/2025

{11}

SIMDA

K252320

| Feature | Proposed Device
SIMDA Abutment | Primary predicate
SIMDA Abutment | SE discussion |
| --- | --- | --- | --- |
| | All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | | |
| Design Limits for patient-specific abutment (Min. ~ Max.) | Maximum Angulation : 0~25°
* Astra OsseoSpeed EV,
Astra Tech OsseoSpeed TX : 0~15°
Maximum Cuff Height : 0.5~5mm
Minimum Diameter : Ø 4.0~ Ø 8.0mm
Minimum Thickness : 0.32 (Astra EV)
0.32 (Astra TX), 0.39 (BioHorizons)
0.4 (Biomet 3i), 0.42 (Straumann BLX)
Minimum Post Height : 4~6mm | Maximum Angulation : 0~25°
Maximum Cuff Height : 0.5~5mm
Minimum Diameter : Ø 4.0~ Ø 8.0mm
Minimum Thickness : 0.4mm
Minimum Post Height : 4~6mm | The minor difference between the two products in the design parameters are as follow.
The minimum thickness of the primary predicate device is 0.4, while the subject device can be designed up to 0.32~0.71. |
| Surface Treatment | None | None | - |
| Sterile | Non-sterile | Non-sterile | - |

Rev.06_12/17/2025

{12}

SIMDA

# K252320

- Ti Base

| Feature | Proposed Device SIMDA Abutment | | Primary predicate SIMDA Abutment | | SE discussion |
| --- | --- | --- | --- | --- | --- |
| Applicant | SIMDA Co., Ltd. | | SIMDA Co., Ltd. | | = |
| Part Name | Ti-Base | | Ti-Base | | = |
| 510(K) No. | - | | K223663 | | = |
| Classification Name | Endosseous Dental Implant Abutments (872.3630) | | Endosseous Dental Implant Abutments (872.3630) | | Identical |
| Product Code | NHA | | NHA | | Identical |
| Material | Ti-6Al-4V ELI (ASTM F136) Zirconia Oxide | | Ti-6Al-4V ELI (ASTM F136) Zirconia Oxide | | Identical |
| Indications For Use | SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
It is compatible with the following systems:
Pre-Milled Blank, Patient-specific abutment | | SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
It is compatible with the following systems: | | The subject device is substantially equivalent in indications and design principles to the primary predicate device listed above. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent in intended use to the primary predicate device. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Slight differences in the language of the subject device and primary predicate is Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. The minor differences between the subject device and the primary predicate device are related to the compatible OEM implant lines and the implant platform diameter. |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | Compatible System | |
| | Astra OsseoSpeed EV (K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | Ostena TS (K121995) | |
| | Astra Tech Implant System (K101732)
Astra Tech Fixture OsseoSpeed Astra Tech Fixture MicroMacro (New indication) (K024111) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) | Strasmann Bone Level (only the Rewold® implants from K140878) | |
| | BioHorizons Laser-Lok 3.0 Implant System (K093321)
BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | |
| | Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | |

Rev.06_12/17/2025

{13}

SIMDA

K252320

| Feature | Proposed Device SIMDA Abutment | | | Primary predicate SIMDA Abutment | SE discussion |
| --- | --- | --- | --- | --- | --- |
| | Ti-Base | | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | | |
| | BioHorizons Laser-Lok 3.0 Implant System (K093321) BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | | |
| | Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | |
| | Multi-unit abutment | | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | |
| Multi-unit Abutment is only compatible with Straumann BLX Implant System. All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | | | | | |
| Titanium base | Angulation | | 0 | 0 | Idential |
| | Gingival collar | | 3.8, 3.9, 4.0, 4.2, 4.3, 4.5, 5.2, 5.5, 5.8, 6.2 | 3.8, 4.0, 4.5 | The minor difference between the two products in the gingival collar are as follow. The gingival collar of predicate device is 3.8, 3.9, 4.0, 4.2, 4.3, 4.5, 5.0, 5.2, 5.4, 5.8, 6.0, while the subject device is 3.8, 4.0, 4.5. |
| | Post height | | 3.5, 5.5 | 3.5, 5.5 | Idential |
| | Thickness | | 0.18~1.11 | 0.16~0.87 | Idential |
| Design Limits for Zirconia top-half (Min. ~ Max.) | - Post Angle (°): 0~15 - Cuff Height (mm): 0.5~5.0 -Post Length (mm): 4.0~6.0 -Diameter (Ø, mm): 5.0~8.0 -Thickness (mm): 0.33 | | | - Post Angle (°): 0~15 - Cuff Height (mm): 0.5~5.0 -Post Length (mm): 4.0~6.0 -Diameter (Ø, mm): 5.0~8.0 -Thickness (mm): 0.4 | Idential |
| Prothesis Attachment | Cement-retained, Screw-retained | | | Cement-retained, Screw-retained | Identical |
| Surface Treatment | None | | | None | - |
| Sterile | Non-sterile | | | Non-sterile | Identical |

Rev.06_12/17/2025

{14}

SIMDA

# K252320

- Multi-unit Abutment

| Feature | Proposed Device
SIMDA Abutment | | | Primary predicate
URIS OMNI Narrow System & Prosthetic |
| --- | --- | --- | --- | --- |
| Applicant | SIMDA Co., Ltd. | | | TruAbutment Inc. |
| Part Name | Multi-unit Abutment | | | Multi-unit Straight Abutment |
| 510(K) No. | - | | | K200817 |
| Classification Name | Endosseous Dental Implant Abutments
(872.3630) | | | Endosseous Dental Implant Abutments
(872.3630) |
| Product Code | NHA | | | NHA |
| Material | Ti-6Al-4V ELI
(ASTM F136) | | | Ti-6Al-4V ELI
(ASTM F136) |
| Indications For Use | SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Pre-Milled Blank, Patient-specific abutment | | | Multi-Unit Straight Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit cement retained restorations. |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| | Astra OsseoSpeed EV
(K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | |
| | Astra Tech Implant System
(K101732)
Astra Tech Fixture OsseoSpeed
Astra Tech Fixture MicroMacro
(New indication)
(K024111) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) | |
| | BioHorizons Laser-Lok 3.0 Implant System
(K093321)
BioHorizons Tapered Internal Implant System
(K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | |
| | Biomet 3i Certain®
(K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | |
| | Strasmann BLX Implant
(K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | |

Rev.06_12/17/2025

{15}

SIMDA

K252320

| Feature | Proposed Device
SIMDA Abutment | | | Primary predicate
URIS OMNI Narrow System & Prosthetic |
| --- | --- | --- | --- | --- |
| | Ti-Base | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| | BioHorizons Laser-Lok 3.0 Implant System (K093321)
BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | |
| | Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | |
| | Multi-unit abutment | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | |
| Multi-unit Abutment is only compatible with Straumann BLX Implant System.
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | | | | |
| Diameters | 4.6/4.8mm | | | 5.0mm |
| Lengths | G/H : 3.0mm | | | G/H : 1.0/2.0/3.0/4.0/5.0/6.0mm |
| Surface Treatment | None | | | None |
| Sterile | Non-sterile | | | Non-sterile |
| SE | The subject device and predicate devices (K200817) have the same intended use, have similar technological characteristic, and are made of similar materials. The subject device and predicate devices have similar physical dimensions, including diameter. Therefore, the subject device is substantially equivalent to the currently cleared devices. The cuff height of the primary predicate device is 1.0mm~6.0mm, while the subject device is less than 4.0mm and are always combined with Multi-unit Base, increasing the post height to a minimum of 4.5mm. | | | |

Rev.06_12/17/2025

{16}

SIMDA

# K252320

- Multi-unit Base

| Feature | Proposed Device
SIMDA Abutment | | | Primary predicate
URIS OMNI Narrow System & Prosthetic |
| --- | --- | --- | --- | --- |
| Applicant | SIMDA Co., Ltd. | | | TruAbutment Inc. |
| Part Name | Multi-unit Base | | | Multi-unit Base |
| 510(K) No. | - | | | K200817 |
| Classification Name | Endosseous Dental Implant Abutments
(872.3630) | | | Endosseous Dental Implant Abutments
(872.3630) |
| Product Code | NHA | | | NHA |
| Material | Ti-6Al-4V ELI
(ASTM F136) | | | Ti-6Al-4V ELI
(ASTM F136) |
| Indications For Use | SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Pre-Milled Blank, Patient-specific abutment | | | Multi-unit Base is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| | Astra OsseoSpeed EV
(K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | |
| | Astra Tech Implant System
(K101732)
Astra Tech Fixture OsseoSpeed
Astra Tech Fixture MicroMacro
(New indication)
(K024111) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) | |
| | BioHorizons Laser-Lok 3.0 Implant System
(K093321)
BioHorizons Tapered Internal Implant System
(K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | |
| | Biomet 3i Certain®
(K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | |
| | Strasmann BLX Implant
(K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | |

Rev.06_12/17/2025

{17}

SIMDA

K252320

| Feature | Proposed Device
SIMDA Abutment | | | Primary predicate
URIS OMNI Narrow System & Prosthetic |
| --- | --- | --- | --- | --- |
| | Ti-Base | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| | BioHorizons Laser-Lok 3.0 Implant System (K093321)
BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 | |
| | Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 | |
| | Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | |
| | Multi-unit abutment | | | |
| | Compatible System | Implant Body Diameter(mm) | Implant Platform | |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB | | |
| Multi-unit Abutment is only compatible with Straumann BLX Implant System.
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture. | | | | |
| Diameters | 4.8/5.0/5.1mm | | | 5.0mm |
| Lengths | 4.85/5.0/7.5/12.5mm | | | 4.35/7.35mm |
| Surface Treatment | None | | | None |
| Sterile | Non-sterile | | | Non-sterile |
| SE | The subject device and predicate devices (K200817) have the same intended use, have similar technological characteristic, and are made of similar materials. The subject device and predicate devices have similar physical dimensions, including diameter. Therefore, the subject device is substantially equivalent to the currently cleared devices. | | | |

Rev.06_12/17/2025

{18}

SIMDA

K252320

# Summary of Technological Characteristics

The subject device and the primary predicate have the same intended use, similar technological characteristics, and are made of the same materials. The subject device and the primary predicate encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the primary predicate listed above.

# MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic SIMDA abutment 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 bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

# Non-clinical Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

- Fatigue Test according to ISO 14801:2016
- End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the primary predicate. The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the primary predicate.

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario through fatigue testing.

Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant body, the OEM implant abutment, and the OEM abutment screw. The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with reference devices.

Clinical testing was not necessary to establish substantial equivalency of the device.

Rev.06_12/17/2025

{19}

SIMDA

K252320

## Conclusion

SIMDA Abutments constitute a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its primary predicate. Therefore, SIMDA Abutment and its predicate are substantially equivalent.

Rev.06_12/17/2025