ATLAS IMPLANT SYSTEM- MINI PLUS

K090049 · Cowellmedi Co., Ltd. · DZE · Apr 20, 2009 · Dental

Device Facts

• Record ID: K090049
• Device Name: ATLAS IMPLANT SYSTEM- MINI PLUS
• Applicant: Cowellmedi Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atlas Implant System - Mini Plus is intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Device Story

The Atlas Implant System - Mini Plus is an endosseous root-form dental implant. It is surgically placed into the bone of the upper or lower jaw arches by a dental professional. The device serves as a temporary support for provisional prosthetic devices during the healing phase of permanent implants. It is intended for immediate loading in partially or fully edentulous patients. The implant provides stability for temporary prosthetics, facilitating patient function during the osseointegration period of permanent implants.

Clinical Evidence

Bench testing only. Mechanical testing was performed in accordance with the FDA guidance document 'Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' (May 12, 2004) to demonstrate mechanical strength equivalent to predicate devices.

Technological Characteristics

Endosseous root-form dental implant; material: CP Titanium Grade 4; conforms to ASTM and ISO standards; mechanical fixation; non-powered; sterile.

Indications for Use

Indicated for partially or fully edentulous patients requiring temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants in the mandible or maxilla.

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

• Intermezzo™ Implant System (K051018)
• IMTEC Sendax MDI and MDI Plus (K031106)
• Maximus™ OS Implant (K041938)

Submission Summary (Full Text)

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APR 2 0 2009

K090049

# 510(K) Summary

Submitter

Cowellmedi Co., Ltd. Kim Young Tae 155-4, Gamjeon - 2 Dong, Sasang-Gu, 617-801, Busan, South Korea Phone: [phone] Fax: [phone]

Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: [e-mail] Phone: [phone] Fax: [phone]

#### Device Information

Product Name: Atlas Implant System - Mini Plus Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II

#### Device Description

The Atlas Implant System - Mini Plus is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

#### Indication for Use

The Atlas Implant System - Mini Plus is intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

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### Materials

ﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ

Aranth

These devices are manufactured from CP Titanium Grade 4 following ASTM and ISO standards.

### Predicate Devices

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

- Intermezzo™ Implant System (K051018) manufactured by Megagen Implant Co., Ltd. .
- IMTEC Sendax MDI and MDI Plus (K031106) manufactured by IMTEC Corporation. .
- Maximus™ OS Implant (K041938) manufactured by BioHorizons Implant Systems, Inc. t

# Comparison to Predicate Devices

Testing and other comparisons have established that the subject of Atlas Implant System - Mini Plus is substantially equivalent in design, materials, indications and intended use, packaging, and performance to other predicate devices of the type currently marketed in the U.S.

### Performance Data

All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the Atlas Implant System - Mini Plus possess mechanical strength at least equivalent to the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

# APR 2 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cowellmedi Company, Limited Mr. Jung Bae Bang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K090049

Trade/Device Name: Atlas Implant System -Mini Plus Regulation Number: 21 CFR 872.3640 Regulatory Class: II Product Code: DZE Dated: April 15, 2009 Received: April 15, 2009

Dear Mr. 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 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 device-related 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.

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# Page 2- Mr. Bang

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Turner
Susan Turner, D.D.S., M.A.

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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# Indication for Use

# 510(K) Number (if known): K090049

Device Name: Atlas Implant System - Mini Plus

# Indication for Use:

The Atlas Implant System - Mini Plus is intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter

(Per 21 CFR 801 Subpart C)

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

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

Page 1 of 1

Kira Hurley So. Mse

sinn Sion-C Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090049