BR Type Implant System

K171179 · Biotem Co., Ltd. · DZE · Feb 9, 2018 · Dental

Device Facts

• Record ID: K171179
• Device Name: BR Type Implant System
• Applicant: Biotem Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR Type Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Device Story

Dental implant system comprising fixtures and abutments; surgically placed in maxilla or mandible bone; supports single/multiple-unit restorations, overdentures, or fixed bridgework. Fixtures feature RBM (Resorbable Blast Media) surface treatment with acid etch. Abutments include cover screws, healing, angled, and cemented designs. Used by dental clinicians in clinical settings. Device provides mechanical foundation for prosthetic restoration; facilitates osseointegration during healing period. Benefits patient by restoring masticatory function and aesthetics in edentulous sites.

Clinical Evidence

Bench testing only. Performance validated via sterilization validation (ISO 11137, ISO 17665), surface characterization (SEM/chemical analysis), shelf-life/packaging validation (ASTM F1980, F88, F1140, F1929, F2096, F1608), and comparative fatigue testing (ISO 14801). Biocompatibility confirmed via cytotoxicity (ISO 10993-5) and sensitization (ISO 10993-10) testing.

Technological Characteristics

Materials: CP Ti Grade 4 (ASTM F67). Surface: RBM (Resorbable Blast Media) with acid etch. Connection: External Hexagon. Sterilization: Gamma (fixtures), Steam (abutments). Dimensions: Fixture diameters 3.3mm-6.0mm, lengths 7.5mm-15.0mm. Abutments: Angled (15°, 25°), Cemented, Healing, Cover Screws. Standalone mechanical device.

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple-unit restorations (cemented or overdenture) or terminal/intermediate abutment support for fixed bridgework. Suitable for single and 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

• US System (K062030)

Reference Devices

• SPI Dental Implant System (K172240)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full agency name on the right. The seal features an emblem with a staff entwined by a serpent, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Biotem Co.,Ltd. % Joyce Bang Consultant Provision Consulting Group Inc. 1370 Valley Vista Dr. Suite 200 Diamond Bar, California 91765

Re: K171179

Trade/Device Name: BR Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2017 Received: January 10, 2018

Dear Joyce Bang:

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.

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 of medical device-related adverse events) (21 CFR 803); good

February 9, 2018

{1}------------------------------------------------

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171179

Device Name BR Type Implant System

#### Indications for Use (Describe)

The BR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR Type Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Type of Use (*Select one or both, as applicable*)

| <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) SUMMARY

## Submitter:

Hong Koo Yeo Biotem Co., Ltd. 57, Sasang-ro , 401 beon-gil , Sasang-gu, Busan , Korea Tel : [phone] Fax : [phone]

### Official Correspondent/ US Agent:

Joyce Bang Consultant, Provision Consulting Group, Inc. 1370 Valley Vista Dr. Suite 200, Diamond Bar, CA 91765 [phone] Ext.1131 [e-mail] [e-mail]

Date Prepared: 02/08/2018

#### Device Information:

Device Name: BR Type Implant System Classification Name: Endosseous Dental Implant Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640

Predicate Device: K062030, US System manufactured by Osstem Implant Co., Ltd.

Reference Device: K172240, SPI Dental Implant System manufactured by MSI France

#### Indication for use

The BR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR Type Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

#### Device Description

#### Fixture

The BR Implant System is a dental implant system made of CP Ti Gr 4 / ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The surface of the implants has been treated with R.B.M (Resorbable Blast Media) with acid etch. The BR Type Implant System is offered in the following sizes.

{4}------------------------------------------------

| Platform | Body Diameter | Total Length (mm) |
|----------|---------------|----------------------------------|
| Ø 3.5 | Ø 3.3 | 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 4.1 | Ø 3.7 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 4.1 | Ø 4.0 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 5.0 | Ø 5.0 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 5.1 | Ø 5.0 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 5.1 | Ø 6.0 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |

# Abutment

Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

| Abutments | Connection | Sizes | | |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------|-----------------------|
| | | Angulation (°) | Cuff Heights (mm) | Platform diameter (Ø) |
| Angled abutment | Assembled with Fixture and angled Abutment by connecting abutment body with set screw. The connection type is External Hexagon shape. | 15, 25 | 2, 4 | 4.0, 5.0, 6.0 |
| Cemented Abutment | Assembled with fixture and cemented abutment by connecting abutment body with set screw. The connection type is External Hexagon shape. | 0 | 1,2,3,4 | 4.0, 5.0, 6.0 |
| Healing Abutment | Assembled with Fixture and Healing Abutment by inserting the screw part. And the connection is External Hexagon shape. | 0 | 2,3,4,5,7 | 4.0, 5.0, 6.0 |
| Cover Screw | Assembled with Fixture by inserting screw part. And the connection is External Hexagon shape | 0 | 2.7 | 3.5, 4.1, 5.0, 5.1 |

{5}------------------------------------------------

# Substantial Equivalence Comparison Chart

| | Subject Device | Predicate Device |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K171179 | K062030 |
| Device Name | BR Type Implant System | US System |
| Manufacturer | Biotem Co., Ltd. | Osstem Implant Co., Ltd. |
| Indications for Use | indicated for use in partially or fully<br>edentulous mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including; cemented retained,<br>screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. BR Type<br>Implant System is for single and two<br>stage surgical procedures. It is intended<br>for delayed loading. | US system and SSII mini are indicated for<br>use in partially or fully<br>edentulous mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including; cemented retained<br>screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. US System<br>is for two stage surgical procedures. It is<br>not for one stage surgery or immediate<br>load. The SSII mini is for one and two<br>stage surgical procedures. It is not for<br>immediate load. |
| Design | External Hex Type | External Hex Type |
| Material | CP Ti Grade 4<br>ASTM F67 | CP Ti Gr 4<br>ASTM F67 |
| Sterilization | Gamma sterilization | Gamma sterilization |
| | $Ø$ 3.5, x $Ø$ 3.3 x 2.4mm x (8.5mm, 10mm,<br>11.5mm, 13mm, 15mm) | $Ø$ 3.5, x $Ø$ 3.3 x 2.4mm x (8.5mm, 10mm,<br>11.5mm, 13mm, 15mm) |
| Fixture<br>Platform( $Ø$ ) x Body<br>diameter( $Ø$ ) x hex(mm) x<br>length(mm) | $Ø$ 4.1, x ( $Ø$ 3.75, $Ø$ 4.0) x 2.7mm x (7.5mm,<br>8.5mm, 10mm, 11.5mm, 13mm, 15mm)<br>$Ø$ 5.1, x ( $Ø$ 5.0, $Ø$ 6.0) x 3.4mm x (7.5mm,<br>8.5mm, 10mm, 11.5mm, 13mm, 15mm)<br>$Ø$ 5.0, x $Ø$ 5.0 x 2.7mm x (7.5mm, 8.5mm,<br>10mm, 11.5mm, 13mm, 15mm) | $Ø$ 4.1, x $Ø$ 4.0 x 2.7mm x (7mm, 8.5mm,<br>10mm, 11.5mm, 13mm)<br>$Ø$ 5.1, x $Ø$ 5.0 x 3.4mm x (6mm, 7mm,<br>8.5mm, 10mm, 11.5mm, 13mm)<br>$Ø$ 5.0, x $Ø$ 5.0 x 2.7mm x (6mm, 7mm,<br>8.5mm, 10mm, 11.5mm, 13mm) |
| Angled abutment<br>Platform( $Ø$ ) x cuff size(mm) x<br>Length(mm) x Angulation(°) | $Ø$ 4.0 x (2mm, 4mm) x (7mm) x (15°, 25°)<br>$Ø$ 5.0 x (2mm, 4mm) x (7mm) x (15°, 25°)<br>$Ø$ 6.0 x (2mm, 4mm) x (7mm) x (15°, 25°) | $Ø$ 4.0 x (2mm, 4mm) x (7mm) x (15°, 25°)<br>$Ø$ 5.0 x (2mm, 4mm) x (7mm) x (15°, 25°)<br>$Ø$ 6.0 x (2mm, 4mm) x (7mm) x (15°, 25°) |
| Cemented Abutment<br>Platform( $Ø$ ) x cuff size(mm) x<br>length(mm) | $Ø$ 4.0 x (2mm, 4mm) x (6mm ,7.5mm)<br>$Ø$ 5.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,<br>5.5mm, 7mm)<br>$Ø$ 6.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,<br>5.5mm) | $Ø$ 4.0 x (2mm, 4mm) x (7.5mm)<br>$Ø$ 5.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,<br>5.5mm, 7mm)<br>$Ø$ 6.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,<br>5.5mm) |
| Healing Abutment<br>Platform( $Ø$ ) x cuff size(mm) | $Ø$ 4.0 x (2mm, 4mm)<br>$Ø$ 5.0 x (2mm, 3mm, 4mm, 5mm, 7mm)<br>$Ø$ 6.0 x (2mm, 3mm, 4mm, 5mm) | $Ø$ 4.0 x (3mm, 5.5mm)<br>$Ø$ 5.0 x (2mm, 3mm, 4mm, 5.5mm, 7mm)<br>$Ø$ 6.0 x (3mm, 5.5mm) |
| Surface treatment | RBM | RBM |
| Product Code | DZE, NHA | DZE, NHA |

{6}------------------------------------------------

The difference in the Indications for Use Statement regarding "immediate loading" and "delayed loading" have been made to reflect the more recent clearances to include positive indications in the Indications for Use Statement.

The BR Type Implant System has a substantially equivalent intended use as the identified predicate (K062030). Both are used for mandible and maxilla endosseous dental implant and accessories. The BR Type Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments. The subject and predicate devices are both bone-level implants that share similar neck design and cutting edge. The subject and predicate devices are similar in size, surface treatment and materials. The Ø5.0 and Ø6.0 fixtures (implants) with the length of 15mm technological features (diameter and length) are similar to the reference device K172240.

# Non-Clinical Test data

The subject device was tested to evaluate its performance as below.

- Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance with ISO 11137, ISO 11737-1& ISO 11737-2 for gamma sterilization
- Steam Sterilization validation for non-sterile devices (abutments) has been performed in accordance with ISO 17665-1 and ISO 17665-2.
- Surface Characteristics Test Report Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
- Shelf-life and packaging material has been validated according to ISO 11607, ISO 11137 and ISO 11737. Accelerated aging, strength, and integrity were performed to ASTN F1980, ASTM D882, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and ASTM F1608. Shelf life for the fixture was determined to be 3 years.
- Comparative Fatigue testing of the subject device and predicate device has been performed in accordance with ISO 14801:2007.
- · Cytotoxicity Test performed according to ISO 10993-5:2009
- · Sensitization test performed according to ISO 10993-10:2010

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

#### Conclusions

Overall, the BR Type Implant System has the following similarities to the predicate devices:

- *has the same intended use,
- *uses the same operating principle,
- *incorporates the same basic design,

{7}------------------------------------------------

*incorporates similar material and the surface treatment.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, we conclude that the BR Type Implant System is substantially equivalent to the predicate device.