INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.

Device Description

INNO SLA Submerged Hybrid Ti-Base System consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment). These two pieces together form the final abutment. Ti-base Abutment System is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The zirconia material is InCoris Zi, cleared under K123664, and the cement is RelyX Unicem 2Automiz, cleared under K100756. Zirconia CAD/CAM abutment or superstructure that composes the final prosthetics is intended to be designed and milled, according to the prosthetic planning and patient clinical situation. It is compatible with the following systems: INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd. The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture. Hybrid S Ti-Base, Hybrid L Ti-Base, Hybrid A Ti-Base.

AI/ML Overview

The provided text is a 510(k) Summary for the INNO SLA Submerged Hybrid Ti-Base System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or extensive non-clinical study that would typically be conducted for a de novo device or a device requiring premarket approval (PMA).

Therefore, the information required to fully answer your request (acceptance criteria, specific study results proving the device meets criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this 510(k) summary.

A 510(k) submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or if there are differences, that these differences do not raise new questions of safety and effectiveness. The "Performance Data (Non-Clinical)" section lists the types of tests performed (sterilization, biocompatibility, fatigue, MR environment review) and states that the "test results support that the subject device is substantially equivalent to the predicate devices." However, it does not provide the actual acceptance criteria or the specific numerical performance results against those criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of pass/fail thresholds for each test. The implicit acceptance criterion for a 510(k) is that the device is "substantially equivalent" to the predicate.
Reported Device Performance: Only general statements are made:
- "Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization." (Result: Implied adequate sterilization)
- "Biocompatibility testing has been performed in accordance with ISO 10993-3, 5, 6, 10, 11, and 23." (Result: Implied biocompatible)
- "Fatigue test in accordance with ISO 14801" (Result: "the result supports that the [subject device is] substantially equivalent to the predicate device in the market.")
- "MR Environment Condition... Non-clinical worst-case MRI review was performed... based on the entire system including all variations... Rationale addressed parameters per the FDA Guidance... including magnetically induced displacement force and torque." (Result: Implied suitable for MR environment, likely "MR Conditional" or "MR Safe" based on the referenced guidance, though not explicitly stated.)

2. Sample sized used for the test set and the data provenance:

Not specified. This document describes non-clinical engineering and materials testing, not a clinical study involving human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This pertains to an AI/ML device where expert review establishes ground truth for image interpretation or diagnosis. This document is about a dental implant abutment system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This applies to expert review of data for AI/ML performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/ML device for diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML diagnostic software.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable in the AI/ML sense. For the engineering tests, the "ground truth" would be established by the specifications of the relevant ISO standards (e.g., ISO 14801 for dental implant fatigue, ISO 10993 for biocompatibility) and comparison to the predicate device's performance (though the specific predicate's performance is not numerated here).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

In summary: The provided 510(k) summary for the INNO SLA Submerged Hybrid Ti-Base System details the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices (URIS Base, Preat Abutment, BioHorizons CAD/CAM Abutments). It does not provide the specific numerical acceptance criteria or quantitative performance results, as is typical for a 510(k) submission which relies heavily on comparison to existing legally marketed devices rather than requiring de novo clinical performance validation against novel acceptance criteria. The questions posed align more with the evaluation of AI/ML or diagnostic software devices, which this dental hardware device is not.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

December 20, 2023

Cowellmedi Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave, STE 160 Irvine. California 92612

Re: K231411

Trade/Device Name: INNO SLA Submerged Hybrid Ti-Base System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 20, 2023 Received: November 21, 2023

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.

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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 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-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 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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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 -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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Indications for Use

510(k) Number (if known) K231411

Device Name

INNO SLA Submerged Hybrid Ti-Base System

Indications for Use (Describe)

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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510(k) Summary (K231411)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: __ Dec 19, 2023___

1. Applicant / Submitter:

Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea Tel. + 82-51-314-2028

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:	INNO SLA Submerged Hybrid Ti-Base System
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Classification:	Class II, 21 CFR 872.3630
Classification Product Code:	NHA

4. Predicate Device:

· Primary Predicate Device: URIS Base (K200817) by TruAbutment Korea Co., Ltd.
· Reference Device: Preat Abutment (K183518) by Preat Corporation
· Reference Device: BioHorizons CAD/CAM Abutments (K151621) by BioHorizons Implant Systems, Inc.

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5. Device Description:

· INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd.
The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture.
· Hybrid S Ti-Base
· Hybrid L Ti-Base
· Hybrid A Ti-Base

6. Indications for Use:

7. Performance Data (Non-Clinical):

The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.

. Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization.
Biocompatibility testing has been performed in accordance with ISO 10993-3, 5, 6, 10, 11, ● and 23.
. Fatigue test in accordance with ISO 14801
MR Environment Condition ●

Non-clinical worst-case MRI review was performed to evaluate the INNO SLA Submerged Hybrid Ti-Base System in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., 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,

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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.

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8. Substantial Equivalence

Comparison Chart

	Subject Device	Primary Predicate Device	Reference Device
510(K) No.	K231411	K200817	K183518	K151621
Applicant	Cowellmedi Co., Ltd.	TruAbutment Korea Co., Ltd.	Preat Corporation	BioHorizons Implant Systems, Inc.
Trade Name	INNO SLA Submerged Hybrid Ti-Base System	URIS Base	Preat Abutment	BioHorizons CAD/CAM Abutments
ClassificationName	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)
Product Code	NHA	NHA	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)Zirconia Oxide	Ti-6Al-4V ELI (ASTM F136)Zirconia Oxide	Ti-6Al-4V ELI (ASTM F136)Zirconia Oxide	Ti-6Al-4V (ASTM F136);additionally, Y-TZP Ceramic forTitanium Base Abutment
IndicationsFor Use/Intended Use	INNO SLA Submerged Hybrid Ti-Base System is intended for use inconjunction with the fixture inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit cementretained restorations. All digitallydesigned zirconia superstructuresfor use with the INNO SLASubmerged Hybrid Ti-Base Systemare intended to be sent to aCowellmedi validated millingcenter for manufacture.	URIS OMNI Narrow System isindicated for use in the treatmentof missing maxillary lateralincisors or the mandibular centraland lateral incisors, in support ofsingle or multiple-unit restorationsincluding: cemented retained,screw retained,or overdenture restorations, andfinal or temporary abutmentsupport for fixed bridgework. It isintended for delayed loading.The URIS OMNI Prostheticabutments are intended for usewith URIS OMNI dental implantsto provide support for prostheticrestorations such as crowns,bridges, or over-dentures.All digitally designed abutmentsand/or coping for use with URISOMNI Prosthetic abutments are	Preat Abutments are intended to be used in conjunction with endosseous dental implants inthe maxillary or mandibular arch to provide support for single-unit or multi-unit prostheticrestorations.All digitally designed custom abutments for use with Titanium Base or Titanium Blank areto be sent to a Preat validated milling center for manufacture.Compatible Implant SystemsCompatible Implant SystemImplant Body Diameter (mm)Implant Platform Diameter (mm)3i OSSEOTITE Certain3.254.05.06.04.14.35.06.0Astra Tech OsteoSpeed™3.03.5,4.04.5,5.03.03.5/4.04.5/5.0BioHorizons Tapered Internal3.03.54.03.03.54.5HIOSSEN ET III3.54.0, 4.5, 5.0, 6.0, 7.0MiniRegularImplant Direct Legacy3.23.7,4.24.7,5.25.7,7.03.03.55.05.7MegaGen AmyRidge3.5, 4.0, 4.5, 5.0, 5.53.5Neoss3.5, 4.0, 4.5, 5.0, 5.53.5NobelActive3.54.3, 5.0NPRFNobel Replace™3.54.0,4.3,5.05.06.0NPWP5.06.0Straumann Bone Level3.34.1,4.8NCRNStraumann Tissue Level3.3, 4.1, 4.84.8,6.5NCWNZimmer Screw-Vent/Tapered Screw-Vent3.3,3.7,4.14.76.03.54.75.7		All digitally designed abutmentsand/or copings for use withBioHorizons CAD/CAM Abutmentsare intended to be sent to aBioHorizons-validated millingcenter for manufacture.BioHorizons abutments designedusing CAD/CAM techniques mustfulfill the BioHorizons allowablerange of design parameters.

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	Subject Device	Primary Predicate Device	Reference Device
		intended to be sent to aTruAbutment-validated millingcenter for manufacture.
ProsthesisAttachment	Cement-retained, Screw-retained	Cement-retained, Screw-retained	Cement-retained, Screw-retained
Restoration	Single-unit, Multi-unit	Single-unit, Multi-unit	Single-unit, Multi-unit
Abutment/ImplantPlatformDiameter(mm)	3.5~6 mm	Narrow 2.6Regular 3.3	3.0~6.5mm
Design Limits(Min.~Max.)	Maximum Angulation 20°Maximum Cuff Height 5.0mmMinimum Gingival Height, 0.5mmMinimum Diameter Ø 5.0mmMinimum Thickness 0.4mmMinimum Post Height 4.0mm	Maximum Angulation 15°Maximum Cuff Height 5mmMinimum Diameter Ø 5.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm	Maximum Angle 30°Minimum Thickness 0.5 mmMinimum Post Height for single-unit restoration 4.0 mmMaximum Gingival Height 1.5 mmto 2.65 mm (varies by implant line).
Abutment/ImplantInterface	Internal Connection	Internal Connection	Internal Connection
Sterile	Non-sterile	Non-sterile	Non-sterile

Substantial Equivalence Discussion

The subject device (NNO SLA Submerged Hybrid Ti-Base System) is substantially equivalent to the primary predicate device (URIS Base, K200817). The subject device and the predicate device have and similar technological characteristics. The wording of the indications for use statement between the subject and the predicate devices is slightly different, however, the fundamental intended use is the same and has no difference. They are made of Ti-6A1-4V ELI, and have similar interface connections, and use similar material for restoration. Both dentical design parameters except for angle. We identified reference devices which cover the size of the angle range of the subject device. We also perform faigue testing, and the result supports that the substantially equivalent to the predicate device in the market.

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Conclusion: 9.

Based on the testing results, Cowellmedi Co., Ltd. concludes that the INNO SLA Submerged Hybrid Ti-Base System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.)