APOLONIA LASER IMPLANT SYSTEM

K102635 · Csm Implant Co., Ltd. · DZE · Mar 22, 2011 · Dental

Device Facts

• Record ID: K102635
• Device Name: APOLONIA LASER IMPLANT SYSTEM
• Applicant: Csm Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Mar 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

Device Story

CSM submerged-L Implant System consists of titanium fixtures and abutments; surgically inserted into upper/lower jawbone to replace tooth roots; provides stable foundation for prosthetic restorations. Features internal connection (11° morse taper and hexagon type). Used in dental clinics by dentists; restores mastication function for patients with damaged natural teeth. Mechanical strength validated via fatigue testing per FDA guidance.

Clinical Evidence

Bench testing only. Mechanical fatigue testing performed per FDA guidance 'Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' (May 12, 2004) demonstrated mechanical strength equivalent to predicate.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM-F136). Connection: Internal (11° morse taper and Hexagon). Surface treatment: RBM (Resorbable Blasting Media) + Laser. Sterilization: Gamma. Dimensions: 3.5-6.0 mm diameter, 7-14 mm length.

Indications for Use

Indicated for patients with partial or fully edentulous mandibles and maxilla requiring single or multiple-unit restorations; 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

• Biohorizos Internal Implant system (K073268)

Submission Summary (Full Text)

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### 510(K) Summary

MAR 2 2 2011

# Submitter:

Cho Sung Am CSM Implant Co., Ltd. 702-020, B205 Techno B/D, Kyung-Buk National University 573-13, Bokhyun-dong, Buk-gu, Daegu, South Korea Phone: [phone] Fax: [phone]

# US Agent / Official Contact:

Joyce Bang Kodent Inc. 325 N Puente st. Unit B Brea, CA 92821 Phone: [phone] Fax: [phone] Email: [e-mail]

# Device Information

Trade Name: CSM submerged-L 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: Aug, 2010

#### General Description

The CSM submerged-L Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations.

This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.

# Indication for Use

CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

# Predicate Devices & Comparison

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

- Biohorizos Internal Implant system(K073268) .

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(102635

Testing and other comparisons have established that the subject of CSM submerged-L Implant System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.

# 6.2 Substantial equivalence chart

| | Subject Device | | Predicate Device | |
|--|------------------------------|-----------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | 510(K) Number | | N/A | K073268 |
| | Device Name | | CSM submerged-L Implant<br>System | BioHorizons Internal Implant<br>System |
| | Manufacturer | | CSM Implant | BioHorizons Implant Systems,<br>Inc. |
| | Indications for Use | | Mandible and Maxilla Endosseous<br>Dental Implant &<br>Accessories | Mandible and Maxilla<br>Endosseous Dental Implant &<br>Accessories |
| | Design | | Similar to internal Implant Design<br>with a narrower shape towards the<br>bottom | Similar to internal implant<br>design with a narrower shape<br>towards the bottom |
| | Endosseous Implant Material | | Ti-6Al-4V ELI<br>ASTM-F136 | Ti-6Al-4V ELI<br>ASTM-F136 |
| | Implant Sterile | | Yes | Yes |
| | Implant Sterilization Method | | Gamma | Gamma |
| | Surface Treatment | | RBM (Resorbable Blasting<br>Media) + Laser | RBT (Resorbable Blast<br>Texture)/HA (Hydroxylapatite) +<br>Laser-Lok |
| | Implant | Diameters | 3.5 - 6.0 mm | 3.5 - 6.0 mm |
| | | Lengths | 7 - 14 mm | 9 - 15 mm |
| | Attachments | | Various abutments and<br>components | Various abutment and<br>component |
| | Abutment<br>Material | | Ti-6Al-4V ELI<br>ASTM-F136 | Ti-6Al-4V ELI<br>ASTM-F136 |
| | Product Code | | DZE | DZE |

# 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 CSM submerged-L Implant System possess mechanical strength at least equivalent to the predicate devices.

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K102635

### CSM submerged-L Implant System

Among the information and data presented in this 510(k) submission to support the substantial equivalence of the CSM submerged-L Implant System to the specified predicate devices, fatigue testing demonstrated that there is substantial equivalence in the performance between the CSM submerged-L Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use.

#### Safety and Effectiveness

CSM submerged-L Implant System is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The CSM submerged-L Implant System, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.

#### Conclusion

The CSM submerged-L Implant System, subject of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, CSM submerged-L Implant System and its predicate devices are believed to be substantially equivalent.

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# Indication for Use

K102635

510(K) Number (if known):

Device Name: CSM submerged-L Implant System

CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

Prescription Use _

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

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

N

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

CSM Implant Company, Limited C/O Ms. Joyce Bang Kodent, Incorporated 325 North Puente Street, Unit B Brea, California 92821

MAR 2 2 2011

Re: K102635

Trade/Device Name: CSM Submerged-L Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: March 9, 2011 Received: March 16, 2011

Dear Ms. 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 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. Bang

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Wh fo

Anthony D. Watson, B.S., M.S., M.B.A. 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

KIN2603 510(K) Number (if known):

Device Name: CSM submerged-L Implant System

CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

Prescription Use X AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(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

(Division Sign-Off) (Division Sign-Oir)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anton Dental Devices

510(k) Number: K102635

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