The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

Device Description

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw tvpe. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Dual Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

AI/ML Overview

The provided text describes the regulatory clearance of the S-Plant Dental Implant System and its components (Fixture, Dual Abutment, Healing Abutment, Abutment Screw, Cover Screw) by demonstrating substantial equivalence to predicate and reference devices. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing and comparison with existing, legally marketed devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the FDA's "substantial equivalence" framework, meaning the device must perform as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness. The reported device performance is demonstrated by comparing its design, materials, intended use, and technological characteristics to the predicate and reference devices, and by non-clinical testing that meets established industry standards.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Substantial Equivalence and Standards)	Reported Device Performance
Intended Use	The device's intended use should be substantially equivalent to that of predicate devices, aiming for functional and aesthetic rehabilitation through prosthetic attachment in the upper and lower jaw arches to restore chewing function.	Fixture: "The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function." This is directly compared to and found to be substantially equivalent to the predicate device (DIO UF HSA Internal Sub-merged Implant System, K122519) and reference device (DIO UF(II) Narrow Implant System, K161987).Abutments (Dual, Healing): "Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." "Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration." These are found to be substantially equivalent to their respective reference devices.Cover Screw: "Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete." This is found to be substantially equivalent to its reference device.Abutment Screw: "Abutment Screw is used to connect an abutment to the fixture." This is found to be substantially equivalent to its reference device.
Materials	Device materials should be biocompatible and consistent with established standards for dental implants and their components (e.g., CP Ti Grade 4, Ti-6Al-4V ELI alloy).	Fixture: "commercial pure titanium, grade 4 (ASTM F67)". Compared to predicate/reference devices also using CP Ti Grade 4 (ASTM F67).Abutment (Dual/Healing), Abutment Screw, Cover Screw: "Ti-6AL-4V ELI alloy (ASTM F136)". Compared to reference devices also using Titanium Alloy (Ti-6Al-4V, ASTM F136) or Pure Titanium Grade 4 (ASTM F67) for healing abutment. Demonstrated biocompatibility through ISO 7405, ISO 10993-1, -3, -5, -6, -10, -11, -12 testing.
Design and Dimensions	The device's design (e.g., screw type, tapered conical hex connection, surface treatment) and range of dimensions should be comparable to predicate devices. Minor variations should not raise new safety or effectiveness concerns.	Fixture: "Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint." "S.L.A (Sand blasted large grit acid etched) treated surface." Dimensions are provided in a detailed table and compared to predicate/reference devices; "The S-Plant Dental Implant System also includes diameters (3.4mm and 3.6mm) that are not covered by the predicate device, but they fall within the range between the diameter of the reference device (K161987) and the diameter of the predicate device." Found substantially equivalent.Abutments, Screws, Cover Screw: Designs are shown via images (text states "Image: Subject Device Design") and dimensions are provided/compared in tables, demonstrating substantial equivalence. For Abutment Screw, explicit mention that "Although the diameter and length of the screws differ slightly, the gap range is minimal, measuring less than 1-1.5mm. Consequently, this variance does not give rise to any concerns about the safety and effectiveness..."Surface modification confirmed via EDS and SEM evaluations.
Sterilization	The device should be sterilized according to validated methods and have an appropriate shelf life.	Fixture: "supplied sterile (gamma radiation)." Sterilization validation included gamma radiation and gravity displacement moist heat, per ISO 11137-1, ISO 11137-2, ANSI/AAMI ST79. Shelf life of 8 years determined through accelerated aging studies, longer than predicate's 5 years, but not raising new safety concerns. Abutments are supplied non-sterile and autoclaved by the end user (as expected for these components).
Biocompatibility	The device must be biocompatible, demonstrating no unacceptable levels of toxicity, irritation, sensitization, or local effects after implantation.	Tested per ISO 7405, ISO 10993-1, ISO 10993-3 (genotoxicity, carcinogenicity, reproductive toxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (local effects after implantation), ISO 10993-10 (irritation and skin sensitization), ISO 10993-11 (systemic toxicity), and ISO 10993-12 (sample preparation). All tests "met the criteria set by industry standards".
MRI Safety	The device should be safe for use in magnetic resonance (MR) environments, with appropriate labeling.	"Non-clinical worst-case MRI review was performed... using scientific rationale and published literature... based on the entire system... to include all variations... and material compositions." Rationale addressed parameters per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. Implies that the device meets "MR Conditional" criteria.
Manufacturing Controls	The device manufacturer must adhere to Quality System (QS) regulations (21 CFR Part 820), including design controls and change management. (Implicit, as this is a general requirement for all devices).	The FDA letter mentions that the device is "subject to... the Quality System (QS) regulation (21 CFR Part 820), which includes... design controls; nonconforming product; and corrective and preventive action." This is an ongoing regulatory requirement for the manufacturer.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The information provided does not describe a clinical study with a test set of patient data. Instead, it details non-clinical testing (bench testing, biocompatibility testing, sterilization validation, shelf-life determination, and MRI safety assessment) and a comparative analysis of the device's characteristics against predicate and reference devices.

Sample Size for Test Set: Not applicable in the context of patient data. The "test set" refers to samples of the device components used for various laboratory tests (e.g., material samples for biocompatibility, sterility test units, accelerated aging samples, MRI phantom testing). The specific number of samples for each non-clinical test is not detailed in this summary but would be found in the full submission.
Data Provenance: The studies are non-clinical (laboratory/bench testing) and therefore do not involve patient data from specific countries or have a retrospective/prospective nature in the typical clinical sense. The tests were conducted by the manufacturer (IDIS Co., Ltd. in Republic of Korea) or their designated testing facilities to demonstrate compliance with international standards (ISO, ASTM, ANSI/AAMI) as required for FDA clearance.

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

Not applicable. This is not a study involving expert readers interpreting medical images or clinical outcomes. Ground truth for non-clinical tests is established by adhering to defined scientific methodologies and international standards for material science, biomechanics, and biocompatibility.

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

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for ground truth establishment.

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

Not applicable. This submission does not involve an AI-enabled device or MRMC studies.

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

Not applicable. This submission does not pertain to an algorithm or AI device.

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

The "ground truth" for the substantial equivalence determination and non-clinical testing is based on:

Established Industry Standards and Regulations: ISO 7405, ISO 10993 standards (biocompatibility), ISO 11137-1/2, ANSI/AAMI ST79 (sterilization), ASTM F1980 (shelf life), ASTM F67, ASTM F136 (materials), and FDA guidance documents (e.g., "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
Predicate and Reference Device Specifications: The detailed characteristics (materials, dimensions, surface treatment, intended use) of the legally marketed predicate and reference devices serve as the benchmark for comparison to claim substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable, as no training set is described.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2023

IDIS Co., Ltd. % Joyce Kwon CEO Provision Consulting Group, Inc. 13925 City Center Dr., Suite 200 Chino Hills, California 91709

Re: K231429

Trade/Device Name: S-Plant Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 13, 2023 Received: November 14, 2023

Dear Joyce Kwon:

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,

Sherrill Lathrop Blitzer

for Andrew 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) K231429

Device Name S-Plant Dental Implant 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

510(k) Submitter

Aiden Lee IDIS Co, Ltd. #1314~ #1319, 122, Jomaru-ro, 385 beon gil, Bucheon-si, Gyeunggi-do, 14556, Republic of Korea

Official Correspondent / Contact Person

Joyce Kwon, CEO/Principal Consultant Provision Consulting Group, Inc. 13925 City Center Dr. Suite 200 Chino Hills, CA 91709 +1-909-493-3276 joyce@provisionfda.com

Date Prepared: 12/18/2023

Device Information

Trade Name: S-Plant Dental Implant System
Common Name: Endosseous Dental Implant
Classification Name: Endosseous dental implant
Regulation Number: 21 CFR 872.3640
Device Class: Class II
Primary Product Code: DZE
Secondary Product Code: NHA ●

Predicate Devices

Fixture:

DIO UF HSA Internal Sub-merged Implant System (K122519) ●

Reference Device

Fixture

DIO UF(II) Narrow Implant System (K161987) .

Abutment:

Angled Abutment- Osstem Implant Angled Abutment (K182091) ●
Dual Abutment- Osstem Implant Dual Abutment (K182091) ●
Healing Abutment- Hiossen Healing Abutment (K203360)

Accessories:

Cover Screw- Dentium Implantium SuperLine Abutments Cover Screw (K141457) ●
Abutment Screw- Osstem Implant Abutment Screw (K182091) ●

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Prior Submission Information

N/A

Indications for Use

Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

Device Description

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The dimensions of subject devices are as following:

No.	Device Name	Dimensions
1.	S-Plant Fixture	Ø 3.4 x 8.5, 10.0, 11.5, 13.0, 15.0 mm (L)Ø 3.6 x 8.5, 10.0, 11.5, 13.0, 15.0 mm (L)Ø 3.8 x 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 mm (L)Ø 4.2 x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L)Ø 4.7 x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L)Ø 5.2 x 7.0, 8.5, 10.0, 11.5 mm (L)Ø 6.0 x 7.0, 8.5, 10.0, 11.5 mm (L)Ø 7.0 x 7.0, 8.5 mm (L)
2.	Dual Abutment	D(Ø) G/H Post 4 1,2,3,4,5 5.5,7 4.5 1,2,3,4,5 5.5,7 4.5 1,2,3,4,5 5.5,7 5 1,2,3,4,5 4,5.5,7 6 1,2,3,4,5 4,5.5,7 7 1,2,3,4,5 5.5
3.	Healing Abutment	Ø 4.0 x 3.0, 4.0, 5.0, 6.0, 7.0 mm (L)Ø 4.5 x 3.0, 4.0, 5.0, 6.0, 7.0 mm (L)Ø 5.0 x 3.0, 4.0, 5.0, 6.0, 7.0 mm (L)Ø 6.0 x 3.0, 4.0, 5.0, 6.0, 7.0 mm (L)Ø 7.0 x 3.0, 4.0, 5.0, 6.0, 7.0 mm (L)
4.	Abutment Screw	Ø 2.25 x 10.2 mm (L)Ø 2.5 x 9.0 mm (L)
5.	Cover Screw	Ø 3.60 x 6.5 mm (L)

Substantial Equivalent Comparison Chart with Primary Predicate Device and Reference Device for Fixture

	Subject Device	Primary Predicate Device	Reference Device
Product Name	S-Plant Implant SystemFixture	DIO UF HSA InternalSub-merged Implant System	DIO UF(II) NarrowImplant System
510(k)Number	K231429	K122519	K161987
Manufacturer	IDIS	DIO Corporation	DIO Corporation
ClassificationRegulation	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640
PrimaryProduct Code	DZE	DZE	DZE
Intended Use	Functional and estheticrehabilitation of theedentulous mandible ormaxilla	Functional and estheticrehabilitation of theedentulous mandible ormaxilla	Functional andestheticrehabilitation of theedentulousmandible or maxilla
Indications	The S-Plant Dental ImplantSystem is indicated for surgicalplacement in the upper andlower jaw arches, to provide aroot form means for single ormultiple units' prostheticattachment to restore a patient'schewing function. The smallerS-Plant Dental Implants (Ø3.4,3.6, 3.8, 4.2, 4.7, 5.2 mm) canbe placed with a conventionaltwo stage surgical process withan option for transmucosalhealing or they can be placed ina single stage surgical processfor immediate loading whengood primary stability isachieved with appropriateocclusal loading. The largerS-Plant Dental Implants(Ø6.0, 7.0 mm) can be placedwith a conventional two stagesurgical process with an optionfor transmucosal healing and areindicated for the molar regionwith delayed loading. Dualabutments are intended for usewith a dental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures.Healing abutments are used tomake a natural soft tissue shapebefore setting up prosthetics andremoving cover screw afterosseointegration. Cover Screwsare used to protect the internalportion of the implant,preventing soft tissue growthinto the implant, facilitatingprovisional restorations whennecessary, and enabling thetransition to final restorationcomponents onceosseointegration is complete.	The DIO UF HSA InternalSub-Merged Implant Systemsindicated for surgicalplacement in the upper andlower jaw arches, to provide aroot form means for single ormultiple units' prostheticattachment to restore apatient's chewing function.The smaller The DIO UFHSA Internal Sub-Merged(03.8~ Ø5.5) implants can beplaced with a conventionaltwo stage surgical processwith an option fortransmucosal healing or theycan be placed in a single stagesurgical process forimmediate loading when goodprimary stability is achievedwith appropriate occlusalloading. The larger (Ø6.0 ~Ø7.0) implants can be placedwith a conventional two stagesurgical process with anoption for transmucosalhealing and are indicated forthe molar region with delayedloading.	The UF(II) NarrowImplant System isintended for two-stage surgicalprocedures in thefollowing situationsand with thefollowing clinicalprotocols:- The intended usefor the 3.0mm,3.3mm diameterUF(II) NarrowImplant is limitedto the replacementof maxillary lateralincisors andmandibularincisors.- Immediateplacement inextraction sites andin situations with apartially orcompletely healedalveolar ridge.- It is intended fordelayed loading.
ProstheticInterfaceConnection	Tapered conical hex	Tapered conical hex	Tapered conicalhex
FixtureDiameter andLength	Diameters 3.4 mm; 3.6 mmEach in lengths of 8.5, 10.0,11.5, 13.0, 15.0 mmDiameter 3.8 mmIn lengths of 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mmDiameters 4.2 mm; 4.7 mm;Each in lengths of 7.0, 8.5,10.0, 11.5, 13.0 mmDiameter 5.2 mm; 6.0 mm;Each in lengths of 7.0, 8.5,10.0, 11.5 mmDiameter 7.0 mmin lengths of 7.0, 8.5 mm	Fixture Diameter:3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0Fixture Length:7.0, 8.5, 10, 11.5, 13.0, 15.0,16.0	Fixture Diameter:3.0, 3.3Fixture Length:8.5, 10, 11.5, 13.0,15.0
ImplantMaterial	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)
ImplantEndosseousSurface	S.L.A.	S.L.A.	S.L.A.
ImplantPlacement	Bone Level	Bone Level	Bone Level
Sterilization	Gamma Sterilization	Gamma Sterilization	GammaSterilization
Shelf Life	8 years	5 years	5 years

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Substantial Equivalence Discussion

1. General Indications:
  Both the subject device and the predicate device share similar overarching indications for use. They are both designed for surgical placement in the upper and lower jaw arches, with the primary goal of providing a root form means for prosthetic attachment to restore a patient's chewing function.
1. Implant Sizes and Surgical Procedures:
  Both systems offer a range of implant sizes to accommodate various clinical scenarios. The smaller implants of both systems (03.4 ~ Ø5.5 mm) can be placed using a conventional twostage surgical process, with the option for transmucosal healing. Additionally, both systems provide the flexibility of a single-stage surgical process for immediate loading when there is good primary stability, with appropriate occlusal loading.

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1. Molar Region and Delayed Loading:
  The larger implants in both systems (Ø6.0 ~ Ø7.0 mm) are specifically indicated for the molar region and involve a conventional two-stage surgical process with an option for transmucosal healing, accompanied by delayed loading. This demonstrates a parallel approach to addressing the unique requirements of the molar region.

Discussion:

The comparisons highlight the substantial equivalence between the S-Plant Dental Implant System and the DIO UF HSA Internal Sub-Merged Implant System. The similarities in their indications for use, implant sizes, and surgical procedures demonstrate that the differences between the two devices are not substantial enough to raise any safety or efficacy concerns.

The minor variations in implant dimensions and specific procedural details are well within the acceptable range for dental implant systems, considering the diverse clinical needs and preferences of practitioners. Both systems provide suitable options for immediate loading and delayed loading based on clinical conditions, indicating flexibility in accommodating various patient cases.

The S-Plant Dental Implant System is similar to the predicate device (K122519) in terms of its design, dimensions, material, surface treatment, intended use, and technological characteristics, The S-Plant Dental Implant System also includes diameters (3.4mm and 3.6mm) that are not covered by the predicate device, but they fall within the range between the diameter of the reference device (K161987) and the diameter of the predicate device. Therefore, upon comparing the subject device with both the predicate and reference devices, there have been no new substantial equivalence concerns identified for the S-Plant Dental Implant System in terms of safety and effectiveness.

	Subject Device	Reference Device
Type	Cover Screw	Cover Screw
SecondaryProductCode	NHA	NHA
K Number	K231429	K141457
Manufacturer	IDIS	Dentium Company Limited
Description	Cover Screws are used to protect theinternal portion of the implant,preventing soft tissue growth into theimplant, facilitating provisionalrestorations when necessary, and	Cover Screws are used to protect theinternal portion of the implant.

Substantial Equivalent Comparison Chart with Reference Device for Cover Screw

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	enabling the transition to finalrestoration components onceosseointegration is complete.
Material	Titanium Alloy(Ti-6Al-4V, ASTM F136)	Titanium Alloy(Ti-6Al-4V, ASTM F136)
	Diameter(mm)	3.6

Substantial Equivalent Comparison Discussion: Proposed Cover Screw and the predicated cover screw have common in design, function, indications for use, material, and dimensions; therefore, the proposed Cover Screw is substantially equivalent to the predicated cover screw (K141457).

Substantial Equivalent Comparison Chart with Reference Device for Abutments

	Subject Device	Reference Device
Abutment Type	Dual Abutment	Dual Abutment
SecondaryProduct Code	NHA	NHA
K Number	K231429	K182091
Manufacturer	IDIS	Osstem Implant Co., Ltd.
Design	Image: Subject Device Design	Image: Reference Device Design
Indications forUse	Dual abutments are intended foruse with a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures.	The Osstem Abutment System isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, or overdentures.
Principle ofOperation	Using making for general cement-type prosthesis.	Using making for general cement-type prosthesis.
Material	Titanium Alloy(Ti-6Al-4V, ASTM F136)	Titanium Alloy(Ti-6Al-4V, ASTM F136)

1. Dual Abutment

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D(Ø)	G/H	Post	D(Ø)	G/H	Post
4	1,2,3,4,5	5.5,7	4	1,2,3,4,5,6,7	5.5,7
4.5	1,2,3,4,5	5.5,7	4.6	6,7	5.5,7
4.5	1,2,3,4,5	5.5,7	5	6,7	4,5.5,7
5	1,2,3,4,5	4,5.5,7	6	6,7	4,5.5,7
6	1,2,3,4,5	4,5.5,7	7	1,2,3,4,5,6,7	4
7	1,2,3,4,5	5.5	7	6,7	5.5

Substantial Equivalent Comparison Discussion: Proposed Dual Abutment and the Reference Device Dual Abutment have common in design, functions for use, material, and dimensions; therefore, the proposed Dual Abutment is substantially equivalent to the predicated Dual Abutment (K182091).

2. Healing Abutment

	Subject Device	Reference Device
Abutment Type	Healing Abutment	Healing Abutment
Secondary Product Code	NHA	NHA
K Number	K231429	K203360
Manufacturer	IDIS	Hiossen, Inc.
Design	Image: Subject Device Design	Image: Reference Device Design
Indications for Use	Healing abutments are used tomake a natural soft tissue shapebefore setting up prosthetics andremoving cover screw afterosseointegration.	Used to make a natural soft tissueshape before setting up prostheticsand removing cover screw afterosseointegration.
Material	Titanium Alloy(Ti-6Al-4V, ASTM F136)	Pure Titanium Grade 4 (ASTM F67)
Diameters (mm)	4.0, 4.5, 5.0, 6.0, 7.0	4.0 ~ 8.0
Lengths	3.0~7.0	3.0~7.0

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Substantial Equivalent Comparison Discussion: Proposed Healing Abutment and the Reference Device Healing Abutment have common in design, function, indications for use, material, and dimensions; the proposed Healing Abutment is substantially equivalent to the reference device Healing Abutment (K203360).

	Subject Device	Reference Device
Type	Abutment Screw	Abutment Screw
Secondary ProductCode	NHA	NHA
K Number	K231429	K182091
Manufacturer	IDIS	Osstem Implant Co., Ltd.
Description	Abutment Screw is used toconnect an abutment to the fixture	Abutment Screw is used to connectan abutment to the fixture
Material	Titanium Alloy(Ti-6A1-4V, ASTM F136)	Titanium Alloy(Ti-6Al-4V, ASTM F136)
Diameter (mm)	2.25, 2.5	2, 2.05
Length (mm)	9.0, 10.2	7.5, 9.6

3. Abutment Screw

Substantial Equivalence Discussion for Abutment Screw

The Proposed Abutment Screw and the reference device Abutment Screw share similar indications for use and material composition. Although the diameter and length of the screws differ slightly, the gap range is minimal, measuring less than 1-1.5mm. Consequently, this variance does not give rise to any concerns about the safety and effectiveness of the Proposed Abutment Screw. To sum up, the Proposed Abutment Screw can be deemed substantially equivalent to the reference device Abutment Screw (K182091).

Non-Clinical Test Data

The subject device was tested to evaluate its performance as below.

ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in . dentistrv
ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and . testing
ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for ● genotoxicity, carcinogenicity and reproductive toxicity
. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-6:2016, Biological evaluation of medical devices Part 6: Tests for local . effects after implantation
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for . irritation and skin sensitization

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ISO 10993-11:2018, Biological evaluation of medical devices Part 11: Tests for . systemic toxicity
ISO 10993-12:2012. Biological evaluation of medical devices Part 12: Sample . preparation and reference materials

The non-clinical test data submitted for the S-Plant Dental Implant System validates its substantial equivalence to the predicate device's safety and effectiveness are ensured through sterilization validation, involving both gamma radiation and gravity displacement moist heat, in addition to shelf-life determination conducted through accelerated aging studies. Surface modification testing, utilizing EDS and SEM evaluations, further confirms the consistency and appropriateness of the S.L.A treated surface.

These non-clinical assessments adhere rigorously to recognized standards, including ISO 11137-1, ISO 11137-2, ANSI/AAMI ST79, and ASTM F1980, reinforcing the reliability and validity of our data. The outcomes collectively support the substantial equivalence of the S-Plant Dental Implant System to the predicate device.

The results of these comprehensive tests have met the criteria set by industry standards, establishing substantial equivalence with the predicate device. The non-clinical testing procedures followed the guidelines outlined in the FDA document "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The conclusive results of the non-clinical testing clearly demonstrate that the S-Plant Dental Implant System is substantially equivalent to the predicate device.

MR Conditional Labeling:

Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., 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 to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The 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.

Conclusions

The S-Plant Dental Implant System is similar to the predicate device (K122519) in terms of its design, dimensions, material, surface treatment, intended use, and technological characteristics. The S-Plant Dental Implant System also includes diameters (3.4mm and 3.6mm) that are not covered by the predicate device, but they fall within the range between the diameter of the reference device (K161987) and the diameter of the predicate device. Therefore, upon comparing the subject device with both the predicate and reference devices, there have been no new

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substantial equivalence concerns identified for the S-Plant Dental Implant System in terms of safety and effectiveness.

Each subject abutment type and screw type is substantially equivalent to its reference device. The documentation submitted in this premarket notification demonstrates the S-Plant Dental Implant System is substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.