UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure

K161987 · Dio Corporation · DZE · Feb 21, 2017 · Dental

Device Facts

• Record ID: K161987
• Device Name: UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
• Applicant: Dio Corporation
• Product Code: DZE · Dental
• Decision Date: Feb 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The UF(II) Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0mm, 3.3mm diameter UF(II) Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.

Device Story

UF(II) Narrow Implant System consists of endosseous dental implants designed for surgical replacement of specific incisors. Implants are placed into maxillary or mandibular bone by dental surgeons during two-stage procedures. System supports immediate placement in extraction sites or healed ridges; requires delayed loading. Device functions as structural support for prosthetic teeth. Clinical benefit includes restoration of dental function and aesthetics for patients with missing incisors.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through mechanical testing, including fatigue testing, to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Endosseous dental implant system. Materials: Titanium alloy (Grade 4 or 5). Design: Narrow diameter (3.0mm, 3.3mm) screw-type implant. Sterilization: Gamma irradiation. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring replacement of maxillary lateral incisors and mandibular incisors using 3.0mm or 3.3mm diameter endosseous dental implants. Suitable for immediate placement in extraction sites or healed alveolar ridges. Intended for delayed loading protocols.

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

• UF(II) Implant System (K152636)

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

February 21, 2017

DIO Corporation Peter Kang Business Manager DIO USA 3470 Wilshire Blvd. #620 Los Angeles, California 90010

Re: K161987

Trade/Device Name: UF(II) Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 16, 2017 Received: January 27, 2017

Dear Peter Kang:

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 - Peter Kang

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 (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/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,

# Michael J. Ryan -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

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Image /page/2/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters "DIO" in gray, with the "O" in pink and having a pink dot above it. Below the letters is the text "Implant Solution" in gray.

## Indication for Use

510(K) Number (if known): K161987

Device Name: UF(II) Narrow Implant System

#### Indications for Use:

The UF(II) Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

- The intended use for the 3.0mm, 3.3mm diameter UF(II) Narrow Implant is limited to the replacement । of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar i ridge.
- It is intended for delayed loading. ၊

X AND/OR Over The-Counter Use_ Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)