BIOMATE DENTAL IMPLANT SYSTEM

K142174 · Biomate Medical Devices Technology Co., Ltd. · DZE · Mar 20, 2015 · Dental

Device Facts

• Record ID: K142174
• Device Name: BIOMATE DENTAL IMPLANT SYSTEM
• Applicant: Biomate Medical Devices Technology Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Mar 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

Device Story

Biomate Dental Implant System consists of threaded, root-form endosseous implants and associated abutments (solid, simple, angled, temporary, ball, healing) and screws. Implants are surgically placed into the upper or lower jaw by dental professionals to serve as artificial roots for prosthetic teeth. System supports both conventional two-stage and single-stage surgical procedures, including immediate loading when primary stability is sufficient. Device restores patient chewing function and replaces missing teeth. Clinical benefit derived from providing stable foundation for prosthetic appliances.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993 series), sterilization validation (ISO 11137, ISO 11737), and fatigue testing (ISO 14801).

Technological Characteristics

Threaded, root-form, bone-level implants. Material: Commercially pure titanium (ASTM F67, Grade 4). Surface: Laser-modified (PDL™ Surface). Diameters: 3.3, 4.1, 4.8, 5.5 mm. Lengths: 8, 10, 12, 14 mm. Connection: Internal Hex. Sterilization: Gamma irradiation.

Indications for Use

Indicated for patients requiring dental implants for single or multiple unit prosthetic attachment to restore chewing function. Suitable for upper and lower jaw arches. Can be used in conventional 2-stage surgical processes or single-stage processes for immediate loading, provided good primary stability and appropriate occlusal loading are achieved.

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

• EZ PLUS IMPLANT SYSTEMS (K070562)
• BIOHORIZONS INTERNAL IMPLANT SYSTEM (K073268)

Submission Summary (Full Text)

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

March 20, 2015

Biomate Medical Devices Technology Co., Ltd. Mr. Wayne Chen Quality Assurance Engineer 1F. No. 59, Luke 2nd Rd., Luzhu District Kaohsiung City, 820 TAIWAN

Re: K142174

Trade/Device Name: Biomate Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: February 7, 2015 Received: February 19, 2015

Dear Mr. Chen:

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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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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 : K142174

Device Name: Biomate Dental Implant System

Indications for Use:

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loadinq. Patients must be subject for dental treatment with endosseous implants.

Prescription Use ____ v________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Date Prepared

March 19, 2015

#### 2. Submitter's Information

| Name of Sponsor: | Biomate Medical Devices Technology |
|------------------|--------------------------------------|
| | Co., Ltd. |
| Address: | 1F. No.59, Luke 2nd Rd., Luzhu Dist. |
| | Kaohsiung City, Taiwan. |
| Contact Name: | Wayne Chen |
| Telephone No.: | [phone], ext. 881 |
| Fax No.: | [phone] |
| Email Address: | [e-mail] |

#### 3. Trade Name, Common Name, Classification

| Trade Name: | Biomate Dental Implant System |
|----------------------------|--------------------------------|
| Common Name: | Implant, Endosseous, Root-form |
| Classification Name: | Implant, Endosseous, Root-form |
| Classification Panel: | Dental |
| Classification Regulation: | 21 CFR 872.3640 |
| Product Code: | DZE |
| Subsequent Product Code: | NHA |
| Device Class: | II |

### 4. Identification of Predicate Device(s)

The identified predicates within this submission are as follows:

| 510(k) Number | K070562 (primary predicate) | K073268 |
|---------------|-----------------------------|----------------------------------------|
| Applicant | Mega'Gen Co., Ltd | BIOHORIZONS IMPLANT<br>SYSTEMS, INC. |
| Device Name | EZ PLUS IMPLANT SYSTEMS | BIOHORIZONS INTERNAL IMPLANT<br>SYSTEM |

### 5. Description of the Device

The BIOMATE Dental Implant System consists of threaded dental implants in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm lengths. The implants

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#### Biomate Medical Devices Technology Co., Ltd.

are made of commercial pure titanium and coated with the laser-modified Surface. BIOMATE Dental Implant System is comprised of Bone Type Implant, Solid Abutment, Simple Abutment, Angled Abutment, Temporary Abutment, Ball Abutment, Screw, Cover Screw, Healing Abutment. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to be used to replace missing teeth.

#### 6. Intended Use

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. lmplants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

#### 7. Technological Characteristics

The threaded, root-form, bone level implants are offered in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm length for bone type implant. The implants are made with commercial pure titanium (ASTM F67, Grade 4) and laser- modified surface ( PDL™ Surface). There are no significant differences between Biomate Dental Implant System and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

#### 8. Substantial Equivalence

The Biomate Dental Implant System has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Design Verification activities were performed on Biomate Dental Implant System and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between Biomate Dental Implant System and the predicate device(s) that would adversely affect the use of the product. Biomate concludes that Biomate Dental Implant System is substantially equivalent to predicate devices. Comparative data is shown in Table 1.

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#### 9. Summary of Non-clinical Tests

Non- clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments". Tests were performed and the data demonstrate that the device is in compliance with the following standards and guidance: Biocompatibility testing- ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10933-12, sterilization validation and sterility testing - ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, and fatigue testing -ISO 14801.

#### 10. Clinical Tests

The submission does not contain clinical data.

#### 11. Conclusion

Biomate Dental Implant System has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Based on the information and non- clinical tests provided in this premarket notification, we conclude that Biomate dental Implant System is substantially equivalent to predicate devices.

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## Biomate Medical Devices Technology Co., Ltd.

## Table 1. Comparative Data

| Item | Predicate K070562 (primary predicate) | Predicate K073268 | Subject device |
|-----------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Name of device | EZ Plus Implant Systems | BioHorizons Internal Implant System | Biomate Dental Implant System |
| Classifications/ code | Class II, 872.3640, DZE | Class II, 872.3640, DZE | Class II, 872.3640, DZE |
| Prescription use | YES | YES | YES |
| Implant Type | Threaded, Screw-form/Root-form<br>Bone level | Screw-form Bone level | Threaded, Root-form<br>Bone level |
| Implant surface treatment | - | Treat with tricalcium phosphate blast<br>media or hydroxylapatite coating, optional<br>laser surface treatment | laser surface treatment |
| Implant to abutment<br>connection | Internal and External Hex | - | Internal Hex |
| Diameter (mm) | 3.3, 4.0, 5.0 | 3.5, 4.0, 5.0, 6.0 | 3.3, 4.1, 4.8, 5.5 |
| Length(mm) | 8, 10, 11, 13, 15, 18 | 9, 10.5, 12, 15 | 8, 10, 12, 14 |
| Implant Material | Commercial pure titanium | Ti-6Al-4V | Commercially pure titanium |
| Abutment Material | - | - | Commercially pure titanium |
| Abutment Angulation | 25° | - | 0, 15, 25° |
| Sterilization | Gamma | Gamma irradiation | Gamma irradiation |
| Intended Use | The EZ Plus Implant Systems are<br>intended to be surgically placed in the | BioHorizons Internal Implants are<br>intended for used in the mandible or | An endosseous dental implant is<br>indicated for surgical placement in the |

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| upper or lower jaw to support prosthetic<br>devices, such as artificial teeth, and to<br>restore a patient's chewing function. This<br>may be accomplished using either a two<br>stage surgical procedure or a single stage<br>surgical procedure. Large angle<br>abutments (e.g. 25°) on small diameter<br>implants of the EZ Plus internal<br>connection system are intended for the<br>anterior region of the mouth and not<br>intended for use in the posterior region of<br>the mouth due to limited strength of the<br>implant. | maxilla as artificial root structure for single<br>tooth replacement or for fixed bridgework<br>and dental retention.<br><br>BioHorizons Internal Implants may be<br>restored immediately<br><br>1) with a temporary prosthesis that is not<br>in functional occlusion, or<br><br>2) when splinted together for multiple tooth<br>replacement, or when stabilized with an<br>overdenture supported by multiple<br>implants. | upper and lower jaw arches, to provide<br>a root form means for single or multiple<br>unit prosthetic appliance attachment to<br>restore a patient's chewing function.<br>Implants can be placed with a<br>conventional 2 stage surgical process<br>with an option for transmucosal healing<br>or they can be placed in a single stage<br>surgical process for immediate loading.<br>It is intended for immediate loading<br>when good primary stability is achieved<br>and with appropriate occlusal loading.<br>Patients must be subject for dental<br>treatment with endosseous implants |
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