SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. SimpleLine II is for single stage surgery

Device Description

The SimpleLine II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

AI/ML Overview

This document describes a 510(k) submission for the SimpleLine II endosseous dental implant, seeking clearance based on substantial equivalence to a predicate device. The information provided focuses on the physical characteristics and performance testing of the device, rather than a clinical study evaluating an AI algorithm's performance. Therefore, many of the requested categories related to AI study design, ground truth, and expert evaluation are not applicable to this document.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance (Dental Implant)

Acceptance Criteria	Reported Device Performance
Fatigue Limit of Predicate Device (Implantium II) - specific N value is implied to be > 250N	The fatigue limit of SimpleLine II is over 250N. (Fracture, cracks, or severe distortion of any parts were not detected).
No Fracture, Cracks, or Severe Distortion of Any Parts after specified fatigue testing conditions	Fracture, cracks, or severe distortion of any parts were not detected.
Same device characteristics as predicate device (Implantium II) regarding material, surface treatment, design.	SimpleLine II has the same device characteristics as the predicate device Implantium II. The material, surface treatment is the same, and the design and use concept are similar. (Note: The document also states "The differences between them are shape and shelf life," which contradicts the claim of "same design.")

Explanation: The acceptance criteria for this dental implant are based on a direct comparison to a legally marketed predicate device (Implantium II) for fatigue characteristics and general design parameters. The primary performance test is a fatigue test.

Study Details (Based on the Provided Text)

Given the nature of the document (510(k) summary for a physical medical device, not an AI algorithm), the following information is either not applicable or can only be inferred in the context of device testing (not a clinical or AI study).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the fatigue test. It is implied that at least one specimen was tested, as it refers to "specimen" in the singular ("Tilting angles of specimen is 30"). However, standard engineering tests typically involve multiple samples to ensure statistical validity. The exact number of implants tested isn't provided.
- Data Provenance: The device company, Dentium Co., Ltd., is located in Suwon-si, Gyeonggi-do, Korea. The testing was presumably conducted there or at a contracted facility. The fatigue testing is prospective, as it's a test performed on the device itself.
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)
- N/A. This is not an AI or diagnostic study requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" for a fatigue test is the physical outcome of the test (fracture, deformation, cycles to failure).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically used in clinical trials or diagnostic studies involving human interpretation or uncertain outcomes. The fatigue test results are objective mechanical measurements.
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
- N/A. This is not a study involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical device undergoing mechanical testing, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Mechanical Test Results: The "ground truth" is the objective physical state of the implant after the fatigue test: whether fracture, cracks, or severe distortion occurred, and the applied load at which it was still intact. This is based on direct observation and measurement, not expert consensus or pathology in a medical sense.
The sample size for the training set
- N/A. This is not an AI algorithm, so there is no training set.
How the ground truth for the training set was established
- N/A. This is not an AI algorithm, so there is no training set ground truth.

Summary

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¥102308

NOV 2 2 2010

Dentium ______________________________________________________________________________________________________________________________________________________________________

510(k) Summary

28th July, 2010

1. Company

	Submitter
Name	Dentium Co., Ltd.
Address	27-5 Iui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-766, Korea
Phone / Fax	+82 31 207 2200 / +82 31 207 3883
Contact person	Lee, Sungwon / R&Dswlee@implantium.com

2. Device Name

Proprietary name:	SimpleLine II
Common name:	Endosseous Dental Implant
Classification name:	Implant, Endosseous, Root-Form
	DZE, 21CFR872.3640

3. Predicated Device

Dentium Co., Ltd / Implantium II K060501

4. Description

The SimpleLine II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The SimpleLine II is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The differences between them are shape and shelf life.

The SimpleLine II is substantially equivalent in design, function, surface treatment, material and intended use to the fixture of Dentium Co., Ltd. Implantium II

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Dentium ______________________________________________________________________________________________________________________________________________________________________

5. Indication for Use

The SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function.

6. Performance Testing

Test performed in air at 24℃, at 14Hz frequency for at least 5x106 cycles. Tilting angles of specimen is 30. Applied loads are 597N, 448N, 299N, 250N. The fatigue limit is over 250N (Fracture or cracks or severe distortion of any parts were not detected. It is the same fatigue limit of predicate device Implantium II.

7. Review

SimpleLine II has the same device characteristics as the predicate device Implantium The material, surface treatment is same and the design, use concept is similar. II.

8. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentium Co., Ltd. concludes that SimpleLine II is safe and effective and substantially equivalent to predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized symbol with three curved lines, possibly representing people or services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dentium Company. Limited C/O Mr. Eunk Zyung Son Dentium USA 6761 Katella Avenue Cypress, California 90630

NOV 2 2 2010

Re: K102308

Trade/Device Name: SimpleLine II Regulation Number: 21 CFR 872,3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 9, 2010 Received: November 12, 2010

Dear Mr. Son:

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. 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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Page 2- Mr. Son

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K102308

NOV 2 2 2 2010

Dentium

Indications for Use

510(k) Number:

SimpleLine II Device Name: .

Indications for Use:

V Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K102308

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.