HC-BIOS DENTAL IMPLANT

K110425 · Hung Chun Bio-S Co., Ltd. · DZE · Jul 27, 2012 · Dental

Device Facts

• Record ID: K110425
• Device Name: HC-BIOS DENTAL IMPLANT
• Applicant: Hung Chun Bio-S Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HC-Bios Dental Implant System 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, and to restore the patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Device Story

Endosseous root-form dental implant system; includes fixtures, abutments, and screws. Surgically placed in jaw bone by dental professionals to support prosthetic teeth and restore chewing function. System utilizes two-stage or single-stage surgical procedures. Requires initial stability > 40 Ncm for single-stage placement. Not intended for immediate loading. Benefits include restoration of oral function and prosthetic support.

Clinical Evidence

Bench testing only. Performance assessed via in vitro and in vivo preclinical physical, mechanical, and biocompatibility testing. Tests conducted per ISO 10993-5, 10, 11, 12, 11137-1, 14801, ASTM F 543, and ASTM F 1980. Results met pre-defined acceptance criteria.

Technological Characteristics

Materials: Grade 4 titanium, AISI 316L stainless steel. Components: Fixture, abutment, mount screw, cover screw, impression coping, analog, impression coping screw, plastic impression cap. Standards: ISO 10993, ISO 11137-1, ISO 14801, ASTM F 543, ASTM F 1980. Dimensions: 3.5-7.0 mm diameter, 7-14 mm length.

Indications for Use

Indicated for patients requiring dental prosthetic support in upper or lower jaw arches. Suitable for type I, II, or III bone. Contraindicated for immediate loading; requires initial stability > 40 Ncm for single-stage procedures.

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

• Dentium Co., Ltd Implantium (K041368)

Submission Summary (Full Text)

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K11 0425

Hung-Chun Bio-S Co., Ltd. 510(k) Notification

HC-Bios Dental Implant System

#### 510(k) Summary

- 5.1 Type of Submission: Traditional
5.2 Submission Date: Dec 28, 2010

5.3 Revised Date: May 21, 2012

5.4 Submitter: Hung Chun Bio-S Co., Ltd.

5F, No.98, Luke 5th Rd., Lujhu Township, Kaohsiung Country, 82151 Address: Taiwan Phone: [phone] [phone] Fax: Contact person: Ken Liu Establishment Registration Number: N/A

# 5.5 Identification of the Device:

| Proprietary/Trade Name: | HC-Bios Dental Implant System |
|-------------------------|--------------------------------|
| Common Name: | Implant, Endosseous, Root-form |
| Classification Name: | Implant, Endosseous, Root-form |
| Device Classification: | II |
| Regulation Number: | 872.3640 |
| Panel: | Dental |
| Product Code: | DZE |

### 5.6 Identification of the Predicate Device:

Predicate Device Name: Dentium Co., Ltd Implantium Dentium Company Limited Manufacturer: K041368 510(k) Number:

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# 5.7 Intended Use and Indications for Use of the subject device:

The HC-Bios Dental Implant System is a device made of pure titanium metal and titanium alloy 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, and to restore the patient's chewing function.

#### 5.8 Device Description

The HC-Bios Dental Implant System is a device made of pure titanium metal and titanium alloy 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, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

#### 5.9 Non-clinical Testing

A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the HC-Bios Dental Implant System. The tests were conducted in accordance with ISO 10993-10, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 11137-1, ISO 14801, ASTM F 543, and ASTM F 1980. All the test results demonstrate the performance of HC-Bios Dental Implant System meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the HC-Bios Dental Implant System is substantially equivalent to the predicate devices.

## 5.10Safety and Effectiveness

The result of bench testing indicates that the new device is substantially equivalent to the predicate device.

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Hung-Chun Bio-S Co., Ltd. 510(k) Notification

## 5.11Substantial Equivalent Devices

The HC-Bios Dental Implant System submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the Dentium Co., Ltd Implantium which is the subject of K041368. Differences between the devices cited in this section do not raise any new issue of safety or effectiveness.

| Item | Predicate Device<br>(Dentium Co., Ltd Implantium) | Proposed Device<br>(HC-Bios Dental Implant System) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Code or Federal<br>Regulations | 872.3640 | 872.3640 |
| Prescription Medical<br>Devices | Yes | Yes |
| Intended Use | The device is intended to be<br>surgically placed in the bone of the<br>upper or lower jaw arches to<br>provide support for prosthetic<br>devices, and to restore the patient's<br>chewing function. | The device is intended to be<br>surgically placed in the bone of the<br>upper or lower jaw arches to<br>provide support for prosthetic<br>devices, and to restore the patient's<br>chewing function. |
| Consisted<br>Instruments | Fixture(implant)<br>Abutment<br>Cover screw<br>Healing abutment<br>Attachment(impression part) | Dental Implants<br>Cover/Healing Screw<br>Abutment<br>Abutment Impression parts<br>Implant impression parts |
| Material | titanium metal<br>titanium alloy | Grade 4 titanium<br>AISI 316L Stainless Steel |
| Dimensions of<br>Implants | Four diameters (3.4 to 4.8 mm)<br>Four lengths (8, 10, 12, 14 mm) | Five diameters (3.5 to 7.0 mm)<br>Five lengths (7, 8, 9.5, 11, 14 mm) |
| Performance | ISO 10993 | ISO 10993-5, ISO 10993-10, ISO |
| Standard | ISO 14801 | 10993-11, ISO 10993-12, ISO<br>11137-1, ISO 14801, ASTM F 543,<br>ASTM F 1980 |

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# 5.12 Conclusion

After analyzing safety and performance testing data, it can be concluded that HC-Bios Dental Implant System is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 2 7 2012

Hung Chun Bio-S Company, Limited C/O Mr. Michael Lee Acmebiotechs Company, Limited No.45 Minsheng Road Danshui Town Taipei County China Taiwan 251

Re: K110425

Trade/Device Name: HC-Bios Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 22, 2012 Received: May 22, 2012

## Dear Mr. 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 Federal Register.

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## Page 2 - Mr. 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 1 5809.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.

Nh. 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

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11 0425

Hung-Chun Bio-S Co., Ltd. 510(k) Notification

HC-Bios Dental Implant System

Indications for Use

510(k) Number (if known):

Device Name: HC-Bios Dental Implant System

Indications for Use:

The HC-Bios Dental Implant System 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, and to restore the patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K110425

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