The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case of Customized Hand Milling Abutment, its wall thickness is 2mm and height is 12mm. It can be reduced into Max. 7mm. The margin of the product can be modified up to Max 20°. In case of Non-Hex Cementation Abutment, it is a bridge type. Two or more products must be used. Under part of abutment is made in order to avoid restriction in connecting work.

Device Description

The CSM submerged - R implant system includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper jaw and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "CSM submerged-R Implant System," a dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with performance metrics.

Based on the provided document, here's what can be extracted and what information is missing regarding acceptance criteria and a study proving their fulfillment:

The document states that the device was tested and demonstrates mechanical strength and fatigue comparable to predicate devices. However, it does not provide specific numerical acceptance criteria for these tests, nor does it detail a study with performance data against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria and Reported Device Performance (as inferred from the document)

Performance Metric	Acceptance Criteria (Stated/Inferred)	Reported Device Performance (Stated/Inferred)
Mechanical Strength	At least equivalent to the predicate devices (implied by "possess mechanical strength at least equivalent to the predicate devices")	"demonstrated that the CSM submerged-R Implant System possess mechanical strength at least equivalent to the predicate devices." (No specific numerical values provided)
Fatigue Performance	Meets its predefined acceptance criteria and performs in accordance with its intended use, demonstrating substantial equivalence to predicate devices.	"Fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the CSM submerged-R Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use." (No specific numerical values or comparison data provided, only a statement of equivalence and meeting criteria.)
Biocompatibility	Complies with FDA's Class II special controls guidance document (implied by design, material, surface treatment)	"made from pure titanium and the surface treatment is done with RBM." This is consistent with predicate devices and guidance. (No specific study details or results provided.)
Sterilization Efficacy	Effective sterilization via gamma irradiation (implied by method)	"Sterilized via gamma irradiation." (No specific study details or results provided.)

Note: The document focuses on demonstrating substantial equivalence to a predicate device (SQ IS System, K090825) through comparison of design, materials, indications, and performance characteristics (like mechanical testing results being "equivalent"). It does not provide specific numerical acceptance criteria or detailed study results that would typically be found in a performance test report. The "predefined acceptance criteria" for fatigue testing are mentioned but not detailed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "mechanical testing" and "fatigue testing" but does not provide any details on the number of implants or test specimens used for these tests.
Data Provenance: Not specified for the mechanical or fatigue testing. The document states that the testing was done "consistent with the recommendations in the FDA guidance document," implying it was conducted by the manufacturer, CSM Implant, or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This document describes a medical device (dental implant), not an AI/software device that requires expert adjudication for ground truth related to diagnostic performance. The performance tests (mechanical strength, fatigue) are engineering tests, not clinical evaluations relying on expert interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, this is an engineering device, not a diagnostic tool requiring image interpretation or similar expert-based adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is not an AI/software device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This is a physical dental implant, not an algorithm or software. The performance testing is inherent to the device itself.

7. Type of Ground Truth Used

The "ground truth" for the mechanical and fatigue testing would be the physical measurements and results obtained from standardized mechanical and fatigue tests, typically conforming to ISO or ASTM standards (e.g., ISO 14801 for dynamic fatigue testing of dental implants). The document refers to "predefined acceptance criteria" for fatigue testing, which would be based on these engineering standards and comparative data with the predicate.

8. Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above, this is a physical device and does not have a "training set" in the context of machine learning.

Summary

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KIII120

CSM Implant

510(K) Summary

Submitter

CSM Implant Cho Sung Am B205 Techno-Building, Kyoungpook National Univ. #573-13, Bokhyun-dong, Buk-Gu, Daegu, Korea Phone: 82-53-952-8261 Fax: 82-53-954-8261

Official Correspondent

Kodent Inc. April Lee 325 N. Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116

Device Information

Trade Name: CSM submerged-R Implant System

Common Name: Endosseous Dental Implant

Classification Name: Implant, Endosseous, Root-Form

Product Code: DZE

Regulation Number: 872.3640

Device Class: Class II

Date Prepared: Aug, 2010

General Description

This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.

Indication for Use

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Predicate Devices & Comparison

The subject device is substantially equivalent to the following predicate device:

SQ IS System manufactured by Neobiotech Co., Ltd. (K090825) .
Testing and other comparisons have established that the subject of CSM submerged-R Implant System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.

Comparison Chart

	Subject Device	Predicate Device
510(K) Number	N/A	K090825
Device Name	CSM submerged-R ImplantSystem	SQ IS System
Manufacturer	CSM Implant	Neobiotech Co., Ltd.
Indications for Use	Mandible and MaxillaEndosseous Dental Implant &Accessories	Mandible and MaxillaEndosseous Dental Implant &Accessories
Design	Submerged Implant Design	Submerged Implant Design
Implant Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma
Surface Treatment	RBM(Resorbable Blasting Media)	RBM(Resorbable Blasting Media)
Implant Diameters	3.52 ~ 5.32 mm	3.5 ~ 8.0 mm
Implant Lengths	8 ~ 14 mm	7 ~ 15 mm
Abutment diameters	4.0 ~ 6.5 mm	3.5 ~ 8.0mm
Abutment lengths	5.5 ~ 7.5mm	4.0~8.0mm
Attachments	Various abutments andcomponents	Various abutments andcomponents
Implant material	Ti-6Al-4V ELIASTM-F136	Ti-6Al-4V ELIASTM-F136
Cover ScrewMaterial	CP. Ti. Gr. 4ASTM-F67	CP. Ti. Gr. 4ASTM-F67
Product Code	DZE. NHA	DZE. NHA

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Substantial equivalence chart summary

The CSM submerged-R Implant System has a substantially equivalent intended use as the identified predicate, SQ IS System (K093321) manufactured by Neobiotech Co., Ltd. and is made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. CSM submerged-R Implant System and predicate device are made from pure titanium and the surface treatment is done with RBM.

These predicate devices and CSM submerged-R Implant System have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment. The subject and predicate devices are similar in size, surface treatment, and both are sterilized via gamma irradiation. When compared with predicate devices, no new questions of safety or effectiveness have been raised for the CSM submerged-R Implant System.

Performance Data

All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the CSM submerged-R Implant System possess mechanical strength at least equivalent to the predicate devices.

Among the information and data presented in this 510(k) submission to support the substantial equivalence of the CSM submerged-R Implant System to the specified predicate devices, fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the CSM submerged-R Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use.

Safety and Effectiveness

CSM submerged-R Implant System is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The CSM submerged-R Implant System, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.

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Conclusion

The CSM submerged-R Implant System, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, CSM submerged-R Implant System and its predicate devices are believed to be substantially equivalent.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. There is a logo to the left of the text.

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

CSM Implant Company, Limited C/O Ms. April Lee Consultant 325 North Puente Street, Unit B Brea, California 92821

OCT 1 4 2011

· Re: K111120

Trade/Device Name: CSM submerged-R Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 27, 2011 Received: October 3, 2011

Dear Ms. Lec:

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 ffor 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 - Ms. Lee

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.gov/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/Resourcesfor You/Industrv/default.htm.

Sincerely yours.

hn 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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Indication for Use

510(K) Number (if known):	K1111120
---------------------------	----------

Device Name: CSM submerged-R Implant System

The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case of Customized Hand Milling Abutment, its wall thickness is 2mm and height is 12mm. It can be reduced into Max. 7mm. The margin of the product can be modified up to Max 20°. In case of Non-Hex Cementation Abutinent, it is a bridge type. Two or more products must be used. Under part of abutment is made in round shape in order to avoid restriction in connecting work.

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

Over-The-Counter

(Per 21 CFR 801 Subpart C)

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

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	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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.