OneQ-SL Implant System

K142313 · Dentis Co., Ltd. · DZE · Dec 10, 2015 · Dental

Device Facts

• Record ID: K142313
• Device Name: OneQ-SL Implant System
• Applicant: Dentis Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Dec 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OneQ-SL 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.

Device Story

OneQ-SL Implant System consists of CP Titanium Grade 4 endosseous dental implants; surgically placed into mandible or maxilla bone; intended for delayed loading to support dental restorations. Fixtures feature internal octa-connection, non-submerged design, and SLA (sand-blasted, large-grit, acid-etched) surface treatment. Available in various diameters and lengths. Used by dental professionals in clinical settings to provide stable abutment for single/multiple-unit restorations or overdentures. Benefits include restoration of oral function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical bench testing, including fatigue testing (ISO 14801), cytotoxicity (ISO 10993-5), packaging validation (ISO 11607), and sterilization validation (ISO 11137).

Technological Characteristics

Material: CP Titanium Grade 4. Surface: SLA (sand-blasted, large-grit, acid-etched). Design: Internal octa-connected, non-submerged, tapered/straight body. Sterilization: Gamma radiation. Standards: ISO 14801 (fatigue), ISO 10993-5 (cytotoxicity), ISO 11607 (packaging), ISO 11137 (sterilization).

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support in the mandible or maxilla. 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

• ET/SS Implant System (K120847)

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

December 10, 2015

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

Re: K142313

Trade/Device Name: OneQ-SL Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 3, 2015 Received: November 10, 2015

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.

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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

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# Indications for Use

510(k) Number (if known) K142313

Device Name OneO-SL Implant System

Indications for Use (Describe)

The OneQ-SL 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 intended for delayed loading.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) Summary

#### Submitter

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

# Device Information

Trade Name: OneQ-SL Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 12/09/2015

# Description

The OneQ-SL 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.

The OneQ-SL Implant system includes;

- . The i-Clean OneQ Fixtures Internal Octa-connected, non-submerged fixture

| Platform Diameter | Implant Nominal (Coronal)<br>Diameter (mm) | Implant Apical<br>Diameter (mm) | Lengths Available<br>(mm) |
|-------------------|--------------------------------------------|---------------------------------|---------------------------|
| Regular: Ø 4.8 mm | 3.7 | 3.55 | 7, 8, 10, 12, 14 |
| | 4.2 | 3.7 | 7, 8, 10, 12, 14 |
| | 4.7 | 4.2 | 7, 8, 10, 12, 14 |
| | 5.2 | 4.7 | 7, 8, 10, 12, 14 |
| Wide: Ø 6.5 mm | 4.2 | 3.7 | 7, 8, 10, 12, 14 |
| | 4.7 | 4.2 | 7, 8, 10, 12, 14 |
| | 5.2 | 4.7 | 7, 8, 10, 12, 14 |
| | 6.0 | 4.8 | 7, 8, 10, 12 |
| | 7.0 | 5.75 | 7, 8, 10, 12 |

The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.

### Indication for Use

The OneQ-SL 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, screw

# Official Correspondent

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

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retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.

# Predicate Devices & Comparison

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

- K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd. ●

| | Subject Device | Predicate Device |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OneQ-SL Regular / Wide Type<br>Fixture | ET/SS Implant System<br>(SSII/III SA Fixture) |
| 510(k) Number | K142313 | K120847 |
| Manufacturer | DENTIS CO., LTD. | OSSTEM Implant Co., Ltd. |
| Intended Use | Mandible and Maxilla Endosseous<br>Dental Implant & Accessories. | Mandible and Maxilla Endosseous<br>Dental Implant & Accessories. |
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 |
| Design<br>(Fixture Type) | - Internal Octa-connected<br>- Non-Submerged Fixture<br>- Tapered & straight body | - Internal Octa-connected<br>- Non-Submerged Fixture<br>- Straight & Tapered Body |
| Platform Diameter(Coronal) | 4.8~6.5 | 4.8~6.0 |
| Fixture Diameter | Regular: Ø 3.7, Ø 4.2, Ø 4.7, Ø 5.2<br>Wide: Ø 4.2, Ø 4.7, Ø 5.2, Ø 6.0,<br>Ø 7.0 | SSII SA Fixture: Ø 4.1-4.9<br>SSIII SA Fixture: Ø 3.75-5.0 |
| Fixture Length | Regular: 7, 8, 10 ,12, 14 mm<br>Wide: 7, 8, 10 ,12, 14mm<br>14mm not for all diameters | 6~15 mm |
| Indication for use | The OneQ-SL Implant System is<br>indicated for use in partially or fully<br>edentulous mandibles and maxillae,<br>in support of single or multiple-unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and terminal<br>or intermediate abutment support for<br>fixed bridgework. This system is<br>intended for delayed loading. | ET/SS Implant System is indicated<br>for use in partially or fully edentulous<br>mandibles and maxillae, in support of<br>single or multiple-unit restorations<br>including; cemented retained, screw<br>retained, or overdenture<br>restorations, and final or temporary<br>abutment support for fixed<br>bridgework. It is intended for delayed<br>loading. |
| Surface Treatment | SLA | SLA |
| Gamma Sterilized | Yes | Yes |
| Product Code | DZE | DZE |

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# Substantial Equivalence Discussion

The OneQ-SL 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 indications, design, technology, functions, dimensions and materials.

The differences between the subject device and predicate devices are slight differences in fixture's diameters and lengths.

Differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate device.

# Non-Clinical Test Data

The subject device was tested to evaluate its performance according to the following standards:

- Packaging Test performed in accordance with ISO11607-1:2006 and ISO11607-2:2006 ●
- . Sterilization Validation Test performed in accordance with ISO11137-1:2006 and ISO11137-2:2013
- Fatigue Test performed in accordance with ISO14801:2007
- Cytotoxicity Test performed according to ISO 10993-5:2009 .

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 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.

### Summary of clinical testing

No additional 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 Implant Co., Ltd. Concludes that the OneQ-SL Implant System is substantially equivalent to the predicate devices as described herein.