ANYONETM INTERNAL IMPLANT SYSTEM

K123988 · Megagen Implant Co., Ltd. · DZE · Aug 15, 2013 · Dental

Device Facts

• Record ID: K123988
• Device Name: ANYONETM INTERNAL IMPLANT SYSTEM
• Applicant: Megagen Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Device Story

AnyOne™ Internal Implant System consists of machined titanium, screw-form endosseous dental implants and associated abutments. Implants are surgically placed in maxillary or mandibular molar areas by clinicians to provide prosthetic support for crowns, bridges, or overdentures. System includes various fixtures (normal thread, deep thread, special length) and abutments (e.g., healing, angled, zirconia, gold). Surface treatment uses S.L.A. (Sand-blasted, Large grit, Acid-etched) process. Implants replace missing teeth, restoring chewing function. Smaller implants support immediate loading when primary stability is achieved; larger implants are for delayed loading. Clinicians select appropriate size based on patient anatomy and clinical requirements. System provides screw and cement-retained restoration options.

Clinical Evidence

Bench testing only. Fatigue testing performed in accordance with ISO 14801 standard.

Technological Characteristics

Materials: CP4 Titanium and Ti-6Al-4V-ELI. Surface: S.L.A. (Sand-blasted, Large grit, Acid-etched). Design: Screw-form, root-form endosseous dental implant with internal hex connection. Sterilization: Gamma. Dimensions: Diameters 3.9-8.3mm; Lengths 7.0-14.5mm. No software or electronic components.

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular molar areas. Smaller implants (<6.0 mm) indicated for immediate loading with primary stability; larger implants indicated 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

• XPEED AnyRidge Internal Implant System (K122231)

Submission Summary (Full Text)

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#### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### Submitter:

Dong Guk Ha MegaGenImplant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: [phone] Fax: [phone]

#### Device Information:

Device Name: AnyOne™ Internal Implant System Classification Name: Implant, Endosseous, Root-Form Common Nmae: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 1 1/20/2012

#### Contact /US agent: April Lee

KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: [phone] Fax: [phone]

**AUG 15 2013**

#### General Description

The AnyOne™ Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form endosseous dental implant. The AnyOne™ Internal Implant System contains three types of fixtures, normal thread type, and special length type. This system is made from CP4 Titanium and Ti-6A1-4V-ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration. This system has 3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm diameters for normal thread, 4.8, 5.8, 6.8, 7.8, 8.3mm diameters for deep thread, and 4.8, 5.3, 6.3, 7.3mm for special length fixtures. In addition, this system has 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for normal thread, 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for deep thread, and 7.0mm for special length fixtures.

Contained various abutments in the AnyOne™ Internal Implant System are straight and angled dental implant abutments intended to be connected to the fixture with screw, and to restore a patient's chewing function. The abutments contain Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling, Abutment, Zirconia Abutment, Gold Abutment, CCM Abutment, Temporary Abutment, Solid Abutment,

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Burn-out Cylinder, Octa Abutment, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Plastic Cylinder, Flat Abutment, Ball Abutment, Meg-Rhein, ZrGEN Abutment, Multi-unit Abutment, Fuse Abutment, Flat CCM Cylinder, Flat Cover Screw, Flat Healing Abutment, Flat EZ Post Cylinder, Flat Temporary Cylinder, Flat Plastic Cylinder, and Flat Gold Cylinder. The fixtures, prosthetics, and surgical instruments are produced, and packaged separately. All included

devices in the system are covered by this submission.

## Indication for use

The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

## Predicate devices

- XPEED AnyRidge Internal Implant System (K122231) .
# Substantial Equivalence Comparison

The AnyOne™ Internal Implant System has a substantially equivalent intended use as the identified predicate. The AnyOne™ Internal 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, and they are all constructed of titanium. The subject and predicate device are similar in size and materials.

There is no difference between the subject device and the predicate with respect to indications and technology.

| | Subject Device | Predicate Device |
|---------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|
| 510(k) Number | Not available yet | K122231 |
| Device Name | AnyOne™Internal Implant<br>System | XpeedAnyRige Internal Implant<br>System |
| Manufacturer | MegaGen Implant Co., Ltd | MegaGen Implant Co., Ltd |
| Indications for Use | Mandible and Maxilla Endosseous<br>Dental Implant & Accessories | Mandible and Maxilla<br>Endosseous Dental Implant &<br>Accessories |

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| Design | AnyOne™ Internal Implant<br>System, abutments and accessories<br>have been designed, manufactured<br>and tested in compliance with<br>FDA's Class II special controls<br>guidance document root-form<br>endosseous dental implants and<br>endosseous dental implant<br>abutments<br>Internal Hex | XpeedAnyRidge Internal<br>Implant System, abutments and<br>accessories have been designed,<br>manufactured and tested in<br>compliance with FDA's Class II<br>special controls guidance<br>document root-form endosseous<br>dental implants and endosseous<br>dental implant abutments<br>Internal Hex | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Material | CP4 Titanium and Ti-6Al-4V-ELI | CP4 Titanium and Ti-6Al-4V-ELI | |
| Sterilization | Gamma sterilization | Gamma sterilization | |
| Fixture Diameter | Internal type<br>3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm<br>(for normal thread)<br>4.8, 5.8, 6.8, 7.8, 8.3mm<br>(for deep thread)<br>4.8, 5.3, 6.3, 7.3mm<br>(for special length) | Internal type<br>4.0, 4.4, 4.9, 5.4, 5.9mm<br>(For normal ridge)<br>6.4, 6.9, 7.4, 7.9, 8.4mm<br>(For low ridge) | |
| Fixture Height | Internal type<br>7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm<br>(for normal and deep thread)<br>7.0mm<br>(for special length) | Internal type<br>7.7, 9.2, 10.7, 12.2,<br>14.20, 17.2mm<br>(For normal ridge)<br>7.9, 9.4, 10.9, 12.4, 14.4mm<br>(For low ridge) | |
| Abutment | Diameters | Ø 3.8 - 10.0mm | Ø 4.0 - 10.0 mm |
| | Lengths | 7.7 - 18.7mm | 8.4 - 16.4 mm |
| Angulations of Angled<br>abutments | 15, 25° | 15, 25° | |
| Product Code | DZE, NHA | DZE, NHA | |
| Surface treatment | SLA | SLA | |

# Non-Clinical Test Data

The fatigue testing was performed in accordance with ISO 14801 standard.

# Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification concludes that the AnyOne™ Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the figure. The figure is black, and the text is also black.

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

August 15. 2013

MegaGen Implant Company, Limited C/O Ms. April Lee KoDent, Incorporated 325 North Puente Street, Unit B BREA CA 92821

Re: K123988

Trade/Device Name: AnvOne™ Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 8. 2013 Received: August 12, 2013

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 fiability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division 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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#### Indication for Use

K123988 510(K) Number (if known):

Device Name: AnyOne™ Internal Implant System

#### Indications for Use:

The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

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

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

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

Sheena A. Green -S 2013.08.15 09:17:05 -04'00

for M. Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesi Devices Division of Anesthoolorology. Devices

510(k) Number: