ONEPLANT DENTAL IMPLANT SYSTEM by WARANTEC CO., LTD.

ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.

Device Description

Dental implant systems are devices made of a material such as titanium 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, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.

AI/ML Overview

This 510(k) summary (K081748) for the ONEPLANT Dental Implant System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, this submission is for a traditional medical device (dental implants) and focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means the manufacturer is showing that their new device is as safe and effective as devices already on the market, by comparing its materials, design, intended use, and functional characteristics.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. I will fill in what can be gleaned from the provided text, and explicitly state when information is not available or not relevant for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device performance study. This submission is for a physical medical device (dental implants). The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices in terms of materials, design, and intended use. The "reported device performance" refers to the characteristics that allow it to be considered equivalent, rather than quantitative performance metrics from a clinical trial.

Characteristic	Acceptance Criteria (Predicate Devices)	Reported Device Performance (ONEPLANT)
Intended Use	To provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function; for use in partially or fully edentulous mandibles and maxillae, to support single or multiple-unit restorations (cemented/screw-retained, overdenture, fixed bridgework).	Designed for use in dental implant surgery; intended for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations (cemented/screw-retained, overdenture, fixed bridgework). (Substantially equivalent)
Design	Internal Connection: Morse Taper, Internal Octagon	Internal Connection: Morse Taper, Internal Octagon (Substantially equivalent)
Fixture Material	Titanium G4	Titanium G4 (Substantially equivalent)
Fixture Platform Dia.	3.5-5.5mm (ranges from predicates)	3.3, 3.6, 4.3, 5.3mm (Similar dimensions)
Fixture Length	7-15mm (ranges from predicates)	8.5, 10, 11.5, 13, 15mm (Similar dimensions)
Abutment Material	Titanium G5	Titanium G5 (Substantially equivalent)
Abutment Type	Various	Various (Substantially equivalent)
Certification	KGMP, CE, FDA 510(k) (for predicates)	KGMP (for ONEPLANT) - This indicates they have some initial certification, and the 510(k) process is to obtain FDA clearance, hence the lack of "FDA 510k" listed before clearance. (Not an equivalence point for the 510(k) itself, but a regulatory status)

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

Not applicable. This submission does not involve a "test set" in the context of an AI/ML device or a clinical performance study with patient data. It is a comparison of product specifications and materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts from a test set. The comparison is based on the technical specifications of the devices themselves.

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

Not applicable. No adjudication method for a test set was used.

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 is not an AI/ML device, and no MRMC study was performed.

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

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

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

Not applicable as there is no "ground truth" derived from patient data or clinical outcomes in this substantial equivalence submission. The "ground truth" for the comparison is the established characteristics and performance of the predicate devices based on their prior clearances and regulatory compliance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set.

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

Not applicable. This is not an AI/ML device; there is no training set or associated ground truth establishment.

Summary regarding K081748:

This 510(k) submission for the ONEPLANT Dental Implant System is a substantial equivalence submission for a traditional medical device (dental implants). It is not for an AI/ML device and therefore does not include or require the types of performance studies and data analyses that would be found in a submission for an AI/ML product. The "study" proving the device meets acceptance criteria is the comparison table demonstrating that the ONEPLANT system has similar design, materials, and intended use as the legally marketed predicate devices (DENTIUM and Osstem Implant systems). The conclusion explicitly states: "In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table above."

Summary

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K081748

RYC

MAR 2 7 2009

510(K) Summary K08 WARANTEC Co., Ltd. 307, Sunil Technopia, #440, Sangdaewon-dong, Jungwon-gu, Sungnam-si, Gyeonggi-do, 462-726, Korea TEL. +82-31-777-3026~8 FAX. +82-31-777-3025 Contact: Song, Chung-Hun/ President Date prepared: June 10, 2008

307, Sunil Technopia, #440, Sangdaewon-dong,
Jungwon-gu, Sungnam-si,
Gyeonggi-do, 462-726, Korea
TEL. +82-31-777-3026~8
FAX. +82-31-777-3025
Contact: Song, Chung-Hun/ President
Date prepared: June 10, 2008

Trade Name: ONEPLANT Dental Implant System

1. Common Name: Dental Implant
1. Classification Name and Device Class: implant, endosseous, root-form DZE and Abutment, implant, dental, endosseous NHA; Class II per regulations 872.3640 and 872.3630
1. The legally marketed device to which we are claiming equivalence [807.92(a)(3)) : DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368; Osstem Implant K051576
1. Dental implant systems are devices made of a material such as Description of device: titanium 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, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.
1. Indications for use: ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.
1. Comparison Table: Below.

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K081748

2 d 2

Manufacturer/510(k)Number	DENTIUMMultiple: K070228;K052957; K060501;K052823; K041368	Osstem ImplantK051576	WARANTEC
Website	www.implantium.com	www.osstem.com	www.oneplant.co.kr
Type name	IMPLANTIUM	GS System	ONEPLANT
Intended use	It is to provide support forprosthetic device, such asartificial teeth, and torestore the patient'schewing function	GS System is indicated foruse in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. GS System isfor one stage surgicalprocedures. It is notintended for immediateload.	ONEPLANT is designedfor use in dental implantSurgery. These areintended for use inpartially or fullyedentulous mandibles andmaxillae to support forsingle or multiple-unitrestorations such ascemented retained, screwretained, or over denturerestorations and terminalor intermediate abutmentsupport for fixedbridgework.
Design	Internal ConnectionMorse Taper,Internal Octagon	Internal ConnectionMorse Taper,Internal Octagon	Internal ConnectionMorse Taper,Internal Octagon
Fixture	Material	Titanium G4	Titanium G4	Titanium G4
	PlatformDia.	3.6, 4.0, 4.5, 5.0, 5.5mm	3.5, 4.0, 4.5, 5.0mm	3.3, 3.6, 4.3, 5.3mm
	Length	8, 10, 12, 14mm	7, 8.5, 10, 11.5, 13, 15mm	8.5, 10, 11.5, 13, 15mm
Abutment	Material	Titanium G5	Titanium G5	Titanium G5
	Type	Various	Various	Various
Certification	KGMP, CE, FDA 510k	KGMP, CE, FDA 510k	KGMP

1. Conclusion: In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table above.
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Public Health Service

MAR 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Warantec Company, Limited C/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015

Re: K081748

Trade/Device Name: Oneplant Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 16, 2009 Received: March 19, 2009

Dear Mr. Kamm:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Kamm

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sugette Y. Michie Dues

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K081748

Indications for Use

510(k) Number (if known):

Device Name: Oneplant Dental Implant System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Moore

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081744

Page 15 of 740

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.