Cement Type - The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

-Ball Type The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.

Device Description

The S-MiNi System has two types, cement type and ball type.

The S-MiNi Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is a made of Unalloyed Titanium (G4). The surface was granted with microscopic roughness through the RBM surface treatment.

AI/ML Overview

The provided document is a 510(k) summary for the S-MiNi Implant System, a medical device for dental implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical results. Therefore, much of the requested information regarding sample sizes, expert involvement, adjudication methods, and ground truth types is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "Performance Standards" and states that "Bench tests including visual, size, package, package seal efficacy, compressive load, and retention force testing, were performed successfully." However, it does not provide specific quantitative acceptance criteria or detailed results of these tests. Instead, it relies on demonstrating equivalence to predicate devices.

Acceptance Criteria (Not Explicitly Stated Quantitatively)	Reported Device Performance
Bench Tests:
Visual inspection	Performed successfully
Size verification	Performed successfully
Package integrity	Performed successfully
Package seal efficacy	Performed successfully
Compressive load	Performed successfully
Retention force	Performed successfully
Material Composition:
Cement Type: Titanium Grade 4 (ASTM F 67)	S-MiNi Cement Type: Titanium Grade 4 (ASTM F 67) (Identical to reference material, but different from predicate)
Ball Type: Titanium Grade 4 (ASTM F 67)	S-MiNi Ball Type: Titanium Grade 4 (ASTM F 67) (Identical to reference material, but different from predicate)
Biocompatibility:	Yes
Sterilization:	Gamma Sterilization
Intended Use:	Identical to predicates
Device Design (Dimensions):	Comparable to predicates across various diameters, cuffs/posts, and lengths (See detailed comparison tables in the original document)
Surface Treatment:	RBM

2. Sample Sizes Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in this 510(k) submission. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices primarily through comparison of technical characteristics and existing performance data for the predicates, rather than de novo clinical testing of the new device. The "successful performance" mentioned refers to bench tests, not a clinical test set that would typically require patient data.
Data Provenance: The document generally does not refer to clinical data or patient data provenance. The comparison is based on the technical specifications and intended use of the S-MiNi Implant System against its identified predicate devices. The manufacturer is Neobiotech Co., Ltd. from Korea.

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

Not applicable. Ground truth establishment by experts for a test set is typically associated with clinical studies or performance evaluation where a "true" diagnosis or condition needs to be determined for comparison with the device's output. This 510(k) submission does not include such a study.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as #3.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role, and the AI's impact on reader performance is being evaluated. The S-MiNi Implant System is a physical dental implant.

6. Standalone Performance Study:

No. The document's "Performance Standards" section notes that "Bench tests... were performed successfully." This indicates some standalone testing, but it's not a comprehensive standalone clinical performance study that would typically generate metrics like sensitivity/specificity, etc. The primary method of demonstrating safety and effectiveness in a 510(k) is through comparison to predicates, not solely standalone performance.

7. Type of Ground Truth Used:

Not applicable in the context of a "test set" as typically understood for diagnostic or AI-driven devices. For the bench tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring dimensions against design specs, applying forces up to defined limits).

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/ML model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML model.

In summary, the provided text is a 510(k) summary for a dental implant, which demonstrates substantial equivalence to predicate devices based on comparable technical characteristics, materials, intended use, and successful bench testing. It does not contain information about clinical studies with human readers, expert ground truth establishment for a clinical test set, or AI/ML model training as requested in the input prompt.

Summary

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KIJિટ્રપતિ

510(K) SUMMARY

Submitter:

Hee Seok Jung neobiotech Co., Ltd. e-space #103, 104-1, 104-2, 105, 106, 205, 212, 312 10th floor, Guro-dong, Guro-gu, Seoul, Korea 152-789 Phone: 82-53-857-5770 82-53-857-5432 Fax:

Contact /US agent:

April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821

Phone: 714-525-0114 Fax: 714-525-0116

Device Information:

Device Name: S-MiNi Implant System Classification Name: Implant, Endosseous, Root-Form Common Nmae: Endosseous Dental Implant Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date of Submission: 8/25/2011

Device Description

The S-MiNi System has two types, cement type and ball type.

Indication for use

The S-MiNi Implant System is divided into two types:

Cement Type

The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the · mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

Ball Type -

The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.

FEB - 3 2012

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Performance Standards

Bench tests including visual, size, package, package seal efficacy, compressive load, and retention force testing, were performed successfully.

Predicate devices

Cement Type .
MS Implant(Narrow Reidge) by OSSTEM Implant., Ltd, K080594 Intermezzo TM Implant System by Megagen Co., ltd. K051018
Ball Type .
MS Implant (Denture) by OSSTEM Implant., Ltd., K072959

DIO Protem Implant System by DIO Department, DSI, Inc., K080126

Comparison Chart

		Cement type
product Name	S-MiNi Implant	MS Implant	IntermezzoTMImplantSystem
510(k)	N/A	K080594	K051018
Manufacturer	neobiotech Co.,Ltd	OSSTEMImplant., Ltd	MegaGen Co., Ltd
Shape	Image: S-MiNi Implant	Image: MS Implant	Image: Intermezzo Implant
Intended use	Identical to thepredicate	The MS System isintended to use inthe treatment ofmissingmandibular centraland lateralincisors to supportprosthetic device,such as artificialteeth, in order torestore chewingfunction inpartiallyedentulous.	The Intermezzo TMImplant Systems areintended to loadimmediately inpartially or fullyedentulous mandiblesand maxillae to serveas temporary supportfor provisionalprosthetic deviceduring the healingphase of permanentendosseous dentalimplants.
Comparison ofMaterial	Titanium Grade 4of ASTM F 67	Ti-6AL-4V ELIAlloy of ASTM F136	CP Titanium G3

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	Dia(Ø)	2.0/2.5/3.0/3.5	2.5/3.0	1.6/2.0/2.5/3.1
Devicedesign	Cuff(mm)	2	2.5	-
	Post(mm)	10	7	-
	Lengrh(mm)	7.0/8.5/10.0/11.5/13.0/15.0	10.0/13.0/15.0	7.0/8.5/10.0/11.5/13.0/15.0
Surface Treatment		RBM	RBM	RBM
Biocompatibility		Yes	Yes	Yes
Sterilization		GammaSterilization	GammaSterilization	Gamma Sterilization

ﻠﻴﺮﺍﺕ 场

ਿੰਗ ਸਿੰਘ ਸੀ।

1981 238 1

			Ball type
product Name		S-MiNi Implant	MS Implant(Denture)	DIO Protem Implantsystem
510(k)		N/A	K072959	K080126
Manufacturer		neobiotech Co.,Ltd	OSSTEMImplant., Ltd	MegaGen Co., Ltd
Shape		Image: S-MiNi Implant	Image: MS Implant	Image: DIO Protem Implant
Intended use		Identical to thepredicate	The MS System(Denture) isintended to beplace in the bone ofthe upper or lowerjaw arches toprovide support theprosthetic devicesto restore thepatient's chewingfunction, includingthe denturestabilization. MSSystem (Denture)is intended forsingle use only.	The DIO ProtemImplant Systems areintended to loadimmediately in partiallyor fully edentulousmandibles and maxillaeto serve as temporarysupport for provisionalprosthetic device duringthe healing phase ofpermanent endosseousdental implants.
Comparison ofMaterial		Titanium Grade 4of ASTM F 67	Ti-6AL-4V ELIAlloy of ASTM F136	Ti-6AL-4V ELI Alloyof ASTM F 136
Devicedesign	Dia(Ø)	2.0/2.5/3.0/3.5	2.5/3.0	2.0/2.5
	Cuff(mm)	3.0/4.0	2.0/4.0	2.0/4.0
	Length(mm)	7.0/8.5/10.0/11.5/13.0/15.0	10.0/13.0/15.0	8.0/10.0/12.0/14.0
Surface Treatment		RBM	RBM	RBM
Biocompatibility		Yes	Yes	Yes
Sterilization		GammaSterilization	GammaSterilization	Gamma Sterilization

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Summary of Substantial Equivalence Comparison

The Cement type of S-MiNi Implant system is the same device characteristics as the predicate devices, The MS System(Narrow Ridge) and Intermezzo ™ Implant System; intended use, material, design and use concept are similar.

The Ball type of S-MiNi Implant system is the same device characteristics as the predicate devices, The MS System(Denture) and DIO Protem Implant System; intended use, design and use concept are similar.

Based on the comparison of intended use and technical features, S-MiNi Implant System are substantially equivalent to the predicate device.

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 neobiotech Co., Ltd. concludes that the S-MiNi Implant system is substantially equivalent to predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

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

Neobiotech Company, Limited Ms. April Lee Consultant Kodent Incorporated 325 N. Puente Street, Unit B Brea, California 92821

FEB - 3 2012

Re: K112540

Trade/Device Name: S-MiNi Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 3, 2012 Received: February 2, 2012

Dear Ms. Lee:

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 Eederal 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 ucm 1 15809.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/Industry/default.htm.

Sincerely vours.

for Anthony J. Watson

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): K \ 1254)

Device Name: S-MiNi Implant System

Indications for Use:

The S-MiNi Implant System is divided into two types:

Cement Type -

The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

-Ball Type

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

OverThe-Counter Use (21 CFR 807 Subpart C)

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

(Division Sign-Off)

Division of Anesthesiology, General Hospital
Hospital Hospital 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.