S-MINI IMPLANT SYSTEM

K112540 · Neobiotech Co., Ltd. · DZE · Feb 3, 2012 · Dental

Device Facts

• Record ID: K112540
• Device Name: S-MINI IMPLANT SYSTEM
• Applicant: Neobiotech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Feb 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

S-MiNi Implant System is a one-piece endosseous dental implant combining implant and abutment sections. Fabricated from unalloyed Titanium (Grade 4) with RBM surface treatment. Two configurations: Cement type for temporary support of artificial teeth during healing of permanent implants; Ball type for overdenture support in edentulous jaws. Used in dental surgery by clinicians. Device provides temporary stabilization to restore chewing function. Clinical benefit includes temporary prosthetic support during osseointegration of permanent implants.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via visual inspection, size verification, package seal efficacy, compressive load testing, and retention force testing.

Technological Characteristics

One-piece endosseous dental implant; Material: Unalloyed Titanium (Grade 4) per ASTM F 67; Surface treatment: RBM (Resorbable Blast Media); Sterilization: Gamma; Form factor: Various diameters (1.6-3.5mm) and lengths (7.0-15.0mm).

Indications for Use

Indicated for partially or fully edentulous patients requiring temporary prosthetic support. Cement type: missing maxillary lateral incisors or mandibular central/lateral incisors. Ball type: overdenture support in mandibles and maxillae. For temporary use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MS Implant (Narrow Ridge) (K080594)
• Intermezzo TM Implant System (K051018)
• MS Implant (Denture) (K072959)
• DIO Protem Implant System (K080126)

Submission Summary (Full Text)

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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: [phone] Fax:

# Contact /US agent:

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

Phone: [phone] Fax: [phone]

## 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.

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.

#### 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 | IntermezzoTMImplant<br>System |
| 510(k) | N/A | K080594 | K051018 |
| Manufacturer | neobiotech Co.,<br>Ltd | OSSTEM<br>Implant., Ltd | MegaGen Co., Ltd |
| Shape | Image: S-MiNi Implant | Image: MS Implant | Image: Intermezzo Implant |
| Intended use | Identical to the<br>predicate | The MS System is<br>intended to use in<br>the treatment of<br>missing<br>mandibular central<br>and lateral<br>incisors to support<br>prosthetic device,<br>such as artificial<br>teeth, in order to<br>restore chewing<br>function in<br>partially<br>edentulous. | The Intermezzo TM<br>Implant Systems are<br>intended to load<br>immediately in<br>partially or fully<br>edentulous mandibles<br>and maxillae to serve<br>as temporary support<br>for provisional<br>prosthetic device<br>during the healing<br>phase of permanent<br>endosseous dental<br>implants. |
| Comparison of<br>Material | Titanium Grade 4<br>of ASTM F 67 | Ti-6AL-4V ELI<br>Alloy of ASTM F<br>136 | 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 |
|-------------------|------------|---------------------------------|------------------------|-----------------------------|
| Device<br>design | Cuff(mm) | 2 | 2.5 | - |
| | Post(mm) | 10 | 7 | - |
| | Lengrh(mm) | 7.0/8.5/10.0/11.5/<br>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 | | Gamma<br>Sterilization | Gamma<br>Sterilization | Gamma Sterilization |

ﻠﻴﺮﺍﺕ 场

ਿੰਗ ਸਿੰਘ ਸੀ।

1981 238 1

| | | | Ball type | |
|---------------------------|------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| product Name | | S-MiNi Implant | MS Implant<br>(Denture) | DIO Protem Implant<br>system |
| 510(k) | | N/A | K072959 | K080126 |
| Manufacturer | | neobiotech Co.,<br>Ltd | OSSTEM<br>Implant., Ltd | MegaGen Co., Ltd |
| Shape | | Image: S-MiNi Implant | Image: MS Implant | Image: DIO Protem Implant |
| Intended use | | Identical to the<br>predicate | The MS System<br>(Denture) is<br>intended to be<br>place in the bone of<br>the upper or lower<br>jaw arches to<br>provide support the<br>prosthetic devices<br>to restore the<br>patient's chewing<br>function, including<br>the denture<br>stabilization. MS<br>System (Denture)<br>is intended for<br>single use only. | The DIO Protem<br>Implant Systems are<br>intended to load<br>immediately in partially<br>or fully edentulous<br>mandibles and maxillae<br>to serve as temporary<br>support for provisional<br>prosthetic device during<br>the healing phase of<br>permanent endosseous<br>dental implants. |
| Comparison of<br>Material | | Titanium Grade 4<br>of ASTM F 67 | Ti-6AL-4V ELI<br>Alloy of ASTM F<br>136 | Ti-6AL-4V ELI Alloy<br>of ASTM F 136 |
| Device<br>design | 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/<br>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 | | Gamma<br>Sterilization | Gamma<br>Sterilization | 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 [phone] or [phone] 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

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.

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:

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