OneQ-SL s-Clean Implant System

K153639 · Dentis Co., Ltd. · DZE · Apr 8, 2016 · Dental

Device Facts

• Record ID: K153639
• Device Name: OneQ-SL s-Clean Implant System
• Applicant: Dentis Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Device Story

OneQ-SL s-Clean Implant System consists of titanium endosseous dental implants; surgically placed in maxilla or mandible to provide prosthetic support for crowns, bridges, or overdentures. System features internal hex connection, tapered/straight body, and SLA (sand-blasted, large-grit, acid-etched) surface treatment. Used by dentists/oral surgeons in clinical settings for one or two-stage surgical procedures. Implants are provided gamma-sterilized with cover screws. Healthcare providers use the device as a root-form foundation for dental restorations; clinical benefit includes restoration of chewing function in edentulous patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993 series), fatigue testing per FDA guidance, shelf-life validation (ASTM F1980-07), and sterilization validation (ISO 11137-1).

Technological Characteristics

Material: CP Titanium Grade 4. Surface: SLA (Sand-blasted, Large-grit, Acid-etched). Connection: Internal hex. Form factor: Tapered/straight body, bone-level, submerged. Sterilization: Gamma. Connectivity: None (mechanical device).

Indications for Use

Indicated for partially or fully edentulous patients (mandible/maxilla) requiring single or multiple unit restorations (cemented, overdenture) or fixed bridgework support. Dedicated for one or two-stage surgical procedures; intended for 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

• Dentis Dental Implant System (K073486)
• Dentis Dental Implant System (K150344)
• OneQ-SL Implant System (K142313)
• Rescue Internal Dental Implant System (K063216)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a stacked formation.

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

April 8, 2016

Dentis Co., Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K153639

Trade/Device Name: OneQ-SL s-Clean Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 3, 2016 Received: March 11, 2016

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 Federal Register.

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

Page 2 - Ms. April 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 devicerelated adverse events) (21 CFR 803); good 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.

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/ResourcesforYou/Industry/default.htm. 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.

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

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

### Indications for Use

510(k) Number (if known) K153639

Device Name

OneQ-SL s-Clean Implant System

#### Indications for Use (Describe)

The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

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

Prescription Use (Part 21 CFR 801 Subpart D)

D 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black, bold letters on the right. The abstract shape is a curved shape with a circle at the top, resembling a stylized flame or drop.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

#### 510(K) Summary

#### Submitter

Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu. 42718 South Korea Phone: [phone] Fax: [phone]

### Official Correspondent

Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: [e-mail] Phone: [phone] Fax: [phone]

### Device Information

Trade Name: OneQ-SL s-Clean Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous dental implant Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 4/7/2016

#### Description

The OneO-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied by gamma sterilized that is same with almost all dental implant. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatment. This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.

The OneQ-SL s-Clean Implant system diameter and lengths are below:

- The OneQ-SL s-Clean Fixtures Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:

| Division | Platform Diameters<br>(Fixture Diameters) | Body Diameters | Lengths |
|----------|-------------------------------------------|----------------|---------------------|
| Regular | Ø3.7 | Ø3.5 | |
| | Ø3.9 | Ø3.6 | |
| | Ø4.2 | Ø3.7 | 7, 8, 10, 12, 14 mm |
| | Ø4.7 | Ø4.2 | |
| | Ø5.2 | Ø4.7 | |
| Wide | Ø6.0 | Ø4.8 | 7, 8, 10, 12 mm |

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

Image /page/4/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a stylized flame or a curved shape with a circular element at the top. The overall impression is that of a company logo or brand mark.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

| | Ø7.0 | Ø5.8 |
|--|------|------|
| | Ø8.0 | Ø6.8 |

The fixture and cover screw are made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.

#### Indications for Use

The OneO-SL s-Clean 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

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

Image /page/5/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic. The graphic is a curved shape with a circle at the top.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

### Predicate Devices & Comparison

The subject device is substantially equivalent to the following predicate devices:

- K150344/K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
- K142313, OneQ-SL Implant System manufactured by Dentis. Co., Ltd. .
- K063216, Rescue Internal Dental Implant System by Megagen Co., Ltd. ●

| Division | Subject Device | Predicate | | Predicate | Predicate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OneQ-SL s-Clean<br>Implant System | Dentis Dental Implant<br>System | Dentis Dental Implant<br>System | OneQ-SL Implant System | Rescue Internal Dental<br>Implant System |
| 510(k) Number | N/A | K073486 | K150344 | K142313 | K063216 |
| Manufacturer | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. | MEGAGEN Co., Ltd. |
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr. 4 | CP Titanium Gr. 4 |
| Design<br>(Fixture Type) | Image: Two implants<br>- Internal Hex-connected<br>- Submerged Fixture<br>-Bone level<br>- Tapered & straight<br>body<br>- 3 sided cutting edge<br>with self-tapping | Image: Implant<br>-Internal Hex-<br>Connected<br>-Submerged Fixture<br>-Bone level, Tapered<br>body<br>- 4 sided cutting edge<br>with self-tapping | Image: Implant<br>-Internal Hex-Connected<br>-Submerged Fixture<br>-Bone level, Tapered<br>body<br>- 4 sided cutting edge<br>with self-tapping | Image: Two implants<br>- Internal Octa-connected<br>- Non Submerged Fixture<br>- Tapered & straight body<br>- 3 sided cutting edge with<br>self-tapping | Image: Implant<br>-Internal Hex-connected<br>-Submerged Fixture<br>-Bone level, Straight<br>body<br>-4 sided cutting ecge<br>and self-tapping |
| Fixture Diameter | Regular: Ø 3.7, Ø 3.9,<br>Ø 4.2, Ø 4.7, Ø 5.2<br>Wide: Ø 6.0, Ø 7.0, Ø 8.0 | Ø 3.5, Ø 3.7, Ø 4.1, Ø<br>4.3, Ø 4.8, Ø 5.1, Ø<br>5.5, Ø 6.0, Ø 6.5, Ø<br>7.0 | Ø 3.7, Ø 4.1, Ø 4.3, Ø 4.8 | Regular(4.8 Platform):<br>Ø 3.7, Ø 4.2, Ø 4.7, Ø 5.2<br>Wide(6.5 Platform): Ø 4.7,<br>Ø 5.2, Ø 6.0, Ø 7.0 | Ø 6.0, Ø 6.5, Ø 7.0, Ø 8.0 |
| Fixture Length | Regular: 7, 8, 10 ,12, 14<br>mm<br>Wide: 7, 8, 10 ,12 mm | 7, 8, 9, 10, 12, 14 mm | 7, 8, 10, 12, 14 mm | Regular: 7, 8, 10, 12, 14mm<br>Wide(Ø4.7, Ø5.2): 7, 8,<br>10, 12, 14mm | 7.0~12.5mm |
| | | | | Wide( $\varnothing$ 6.0, $\varnothing$ 7.0): 7, 8, 10, 12mm | |
| Indication for use | The OneQ-SL s-Clean<br>Implant System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in<br>support of single or<br>multiple unit<br>restorations including;<br>cemented retained,<br>screw retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. This<br>system is dedicated for<br>one and two stage<br>surgical procedures.<br>This system is<br>intended for delayed<br>loading. | The Dentis Dental<br>Implant System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in<br>support of single or<br>multiple-unit<br>restorations including;<br>cemented retained,<br>screw retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. This<br>system is dedicated<br>for one and two stage<br>surgical procedures<br>and not dedicated for<br>immediate loading.<br>This system is<br>intended for delayed<br>loading. | The Dentis Dental<br>Implant System is an<br>endosseous dental<br>implant is indicated for<br>surgical placement in the<br>upper and lower jaw<br>arches, to provide a root<br>form means for single or<br>multiple-units prosthetic<br>appliance attachment to<br>restore a patient's<br>chewing function.<br>Implants can be placed<br>with a conventional two<br>stage surgical process<br>with an option for<br>transmucosal healing or<br>they can be placed in a<br>single stage surgical<br>process for immediate<br>loading. Immediate<br>loading is restricted to<br>the anterior mandible<br>based on four splinted<br>interforminal placed<br>implants. | The OneQ-SL Implant<br>System is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. This system is<br>intended for delayed<br>loading. | The Rescue Internal<br>Implant System is<br>intended to be surgically<br>placed in the maxillary<br>or mandibular molar<br>areas for the purpose<br>providing prosthetic<br>support for dental<br>restorations(Crown,<br>bridges and<br>overdentures) in<br>partially or fully<br>edentulous individuals.<br>These implants are<br>intended to be used<br>where smaller implants<br>have failed. |
| Surface<br>Treatment | SLA | RBM | RBM | SLA | RBM |
| Gamma<br>Sterilized | Yes | Yes | Yes | Yes | Yes |
| Product Code | DZE | DZE, NHA | DZE, NHA | DZE | DZE, NHA |

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

Image /page/6/Picture/0 description: The image shows the logo for Dentis. The logo features an orange swirl design on the left side. To the right of the swirl is the word "DENTIS" in a bold, sans-serif font.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

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

Image /page/7/Picture/0 description: The image contains the logo for DENTIS. The logo features an orange abstract shape on the left, resembling a flame or a stylized leaf. To the right of the shape, the word "DENTIS" is written in bold, black capital letters. The overall design is simple and professional.

99. Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

#### Substantial Equivalence Discussion

The OneQ-SL s-Clean Implant System has a substantially equivalent intended use as the identified predicates. The subject device 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, and they are all constructed of titanium.

The subject and predicate devices are similar in indication for use, material, connection structure, packaging, function, using abutments, performance, design, technology and dimensions. The OneQ-SL s-Clean Implant system is compatible with abutment in s-Clean part of the Dentis Dental Implant System. This subject device is same with SLA surface treatment of OneQ-SL Implant System of the K142313 that have had same material, manufacturing process, packaging, sterilization condition and surface characteristic.

The differences between the subject device and predicate devices are fixture's diameters and similar thread shape.

The subject device platform diameters are Ø3.7, Ø3.9, Ø4.2, Ø4.7, Ø5.2, Ø6.0, Ø7.0 and Ø8.0. The predicate device platform diameters are Ø3.5, Ø3.7, Ø4.1, Ø 4.3, Ø4.8, Ø 5.1, Ø5.5, Ø6.0, Ø6.5, and Ø7.0 (K073486).

The predicate device platform diameters are Ø 3.7. Ø 5.2. Ø 6.0 and Ø 7.0. (K142313).

The subject device's thread is composed of double thread types and predicate device (K150344)'s threads are composed of micro thread and macro thread of buttress thread type. Reference predicate K063216 supports the substantial equivalence of the subject device's wide fixture with a diameter of 8.0mm.

This implant system has been subjected to several performance and product validations prior to release. Nonclinical tests, including biocompatibility have been performed to ensure the device comply with the applicable International and US regulations.

Differences in technological characteristics do not raise different questions compared to the predicate devices.

#### Non-Clinical Test Data

The subject device was tested to evaluate its substantial equivalence according to the following standards.

- Gamma Sterilization Validation Test performed in accordance with ISO11137-1
- Shelf life Validation Test performed in accordance with ISO 11607-1, -2, ASTM F1980-07 ●
- Biocompatibility tests performed in accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5, ● ISO 10993-6, ISO 10993-10 and ISO 10993-11.

Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the Dental Implant System (K150344) in s-Clean tapered Fixture and the angled abutment in support. Therefore, Submitted fatigue test report can be used as a proof of OneQ-SL c-Clean implant system.

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a curved check mark with a circle at the top. The graphic is gradient, with the color fading from dark orange to light orange.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

#### Summary of clinical testing

No clinical testing was performed for this submission.

#### Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the OneQ-SL s-Clean Implant System is substantially equivalent to the predicate devices as described herein.