HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM

K121047 · Kj Meditech Co., Ltd. · DZE · Oct 4, 2012 · Dental

Device Facts

• Record ID: K121047
• Device Name: HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
• Applicant: Kj Meditech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hero II Dental Implant System and the IS Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Story

Dental implant systems (Hero II and IS) consisting of titanium 6AL 4V ELI alloy fixtures and abutments; surgically placed in maxilla or mandible bone to replace missing teeth. Features R.B.M (Resorbable Blast Media) surface treatment; internal hexagon abutment connection; straight-walled neck; tapered body design. Used by dental professionals in clinical settings for single/multiple-unit restorations or fixed bridgework. Fixtures are sterilized via gamma irradiation. System supports delayed loading protocols.

Clinical Evidence

Bench testing only. Includes sterilization validation (ISO 11737-1/2, ISO 17665-1/2), accelerated shelf-life testing, and chemical/SEM image analysis to confirm absence of residuals post-RBM treatment.

Technological Characteristics

Material: Titanium 6AL 4V ELI alloy. Surface: R.B.M (Resorbable Blast Media). Design: Threaded, root-form, bone-level, internal hexagon abutment connection, internal beveled interface, straight-walled neck, tapered body. Sterilization: Gamma irradiation (fixtures), steam sterilization. Shelf life: 3 years.

Indications for Use

Indicated for partially or fully edentulous patients (maxillae/mandibles) requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. Suitable for single or two-stage surgical procedures with delayed loading.

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

• GS FIXTURE SYSTEM (K072896)

Submission Summary (Full Text)

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KIA1047

4 2012

OCT

## 510(k) Summary

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 07/31/2012

- 1. Submitter

| | Submitter |
|---------|------------------------------------------------|
| Name | KJ Meditech Co., Ltd. |
| Address | 959-21 Daechon-dong, Buk-gu,Gwang-ju, 500-470, |
| | South Korea |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Huykki Moon, CEO |

2. U.S Agent/Contact Person

LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Juhee Chung Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device

Trade Name: Hero II Dental Implant System IS Dental Implant System Common Name: Dental Implant Classification Name: Endosseous Dental Implant System Product Code: DZE, NHA Classification regulation: 21CFR872.3640

2. Predicate Device:

GS FIXTURE SYSTEM by OSSTEM IMPLANT CO., LTD (K072896)

- 3. Description:
The Hero II Dental Implant system and the IS Dental Implant System are dental

510(k) Submission.

510(k) summary , 1 / 3 page

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implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media). The size information is as below.

#### Hero-II Fixture

Ø 3.75mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 4.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 4.50mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 5.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm 0 6.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm

#### IS Fixture

Ø 3.75 x (L) 8.5mm, 10.0mm, 11.5mm, & 13.0mm 0 4.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm Ø 4.5 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm Ø 5.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm Ø 6.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm

#### Abutments

Diameter Ø4mm ~ Ø7mm Cuff height 1~4mm Height 4~7mm

- 4. Indication for use:
The Hero II Dental Implant System and the IS Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

- 5. Basis for Substantial Equivalence
The Hero II Dental Implant system and the IS Dental Implant system have the same intended use as the identified predicate device (K072896). The Hero II / IS Dental Implant system and GS FIXTURE SYSTEM are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with RBM roughened surfaces. They all share same internal hexagon abutment connection system with internal beveled interface. The subject and predicate devices are both bone-level implants that share similar body shape design such as straight walled neck and tapered body design.

510(k) Submission.

510(k) summary , 2 / 3 page

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The subject and predicate devices are similar in size, materials, surface treatment, and are sterilized via gamma irradiation for fixtures.

#### 6. Non-Clinical Testing

- ·Sterilization validating testing has been performed in accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- ·The three year of shelf life has been validated through accelerating testing.
- · Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
- 7. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the same surface treatments.

Overall, the Hero II Dental Implant system and the IS Dental Implant system have the following similarities to the predicate device:

- * have the same intended use,
- * use the same operating principle.
- * incorporate the same basic design,
- * incorporate the same material and the surface treatment.

Based on the similarities, we conclude that the Hero II Dental Implant system and the IS Dental Implant system are substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

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

OCT
4 2012

KJ Meditech Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833

Re: K121047

Trade/Device Name: Hero II Dental Implant System IS Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 26, 2012 Received: September 27, 2012

Dear Ms. Chung:

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- Ms. Chung

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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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# Indications for Use

510(k) Number (if known):

Hero II Dental Implant System Device Name: IS Dental Implant System

### Indications For Use:

The Hero II Dental Implant System and the IS Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Prescription Use . V (Per 21 CFR 801 Subpart D)

AND

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)

Susa Quares

ivision Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antostrol, Dental Devices

510(k) Number: