INNO SLA SUBMERGED IMPLANT SYSTEM

K132242 · Cowellmedi Co., Ltd. · DZE · Dec 6, 2013 · Dental

Device Facts

• Record ID: K132242
• Device Name: INNO SLA SUBMERGED IMPLANT SYSTEM
• Applicant: Cowellmedi Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Dec 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INNO SLA Submerged 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. The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of providing prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

Device Story

INNO SLA Submerged Implant System consists of titanium (Grade 4) endosseous dental implants and associated abutments; surgically placed in maxillary or mandibular bone by dental professionals; provides prosthetic support for artificial teeth (crowns, bridges, overdentures); features S.L.A. (Sand-blasted Large grit Acid-etched) surface treatment; intended for delayed loading; supports restoration of chewing function in edentulous patients.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: CP Titanium Grade 4 (ASTM F67). Surface: S.L.A. (Sand-blasted Large grit Acid-etched). Design: Submerged, root-form. Fixture diameters: 3.7-6.0mm. Lengths: 7.0-14mm. Sterilization: Gamma. Connectivity: None.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdentures) or fixed bridgework support in mandibles and maxillae. Implants >5.0mm indicated for molar areas where smaller implants failed. 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

• Cowell Implant System (K100850)
• Implantium II (K060501)

Submission Summary (Full Text)

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# K132247

## 510(k) Submission - INNO SLA Submerged Implant System

Cowellmedi Co., Ltd.

### 510(K) Summary

#### Submitter

Cowellmedi Co., Ltd. Kyu Su Kim 155-4, Gamjeon-dong, Sasang-gu, Busan, 617-801 Republic of Korea Phone: [phone] Fax: [phone]

Official Correspondent Kodent Inc. April Lee 325 N. Puente st. Unit B Brea, CA 92821 Email: [e-mail] Phone: [phone] Fax: [phone]

Date prepared: 7/15/2013

#### Indications for Use

The INNO SLA Submerged 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 abulment support for fixed bridgework, this system is intended for delayed loading.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of providing prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

### General Description

The INNO SLA Submerged Implant System is a dental implant made of titanium(Grade 4) 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. The differences between the subject device and the predicate device are shape and surface treatment. The INNO SLA Submerged Implant System has one-stage and two-stage surgery. The surface treatment method of the subject device is S.L.A(Sand-blasted Large grit Acid-etched).

The fixture diameters are 3.7. 4.2, 4.6, 5.1, and 6.0mm and the implant lengths are 7.0, 7.5, 8, 9.5. 10. 11.5. 12. and 14mm in this system. The available lengths for each diameter of the fixtures are the following:

- 03.7mm with lengths of 8mm, 10mm, 12mm, and 14mm
- 04.2mm with lengths of 8mm, 10mm, 12mm, and 14mm .
- 04.6mm with lengths of 8mm, 10mm, 12mm, and 14mm ●
- 05. 1mm with lengths of 7mm, 8mm, 12mm, 12mm, and 14mm .
- 06.0mm with lengths of 7mm, 7.5mm, 9.5mm, and 11.5mm .

The abutments are made of titanium alloy and plastic and it is intended for use to made temporary prosthesis. It consists of Abutment and Coping Screw. The Abutment diameters are 3.7 ~ 6.5mm, and

DEC 6 2013

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lengths 7.9 ~ 17.7mm.

## Predicate Devices & Comparison

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

- Cowell Implant System by Cowellmedi Co., Ltd. (K100850) .
- Implantium II by Dentium Co., Ltd. (K060501) .

| | Subject device | Predicate device | Predicate Device |
|-------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | INNO SLA<br>Submerged Implant<br>System | Cowell Implant System | Implantium II |
| 510(k) number | N/A | K100850 | K060501 |
| Manufacturer | Cowellmedi Co.,<br>Ltd. | Cowellmedi Co., Ltd | Dentium Co., Ltd. |
| Intended use | Identical to<br>predicate | The INNO SLA Submerged<br>Implant System is indicated<br>for use in partially or fully<br>edentulous mandibles and<br>maxillae, in support of single<br>or multiple-unit restorations<br>including: cemented retained,<br>screw retained, or<br>overdenture restorations, and<br>terminal or intermediate<br>abutment support for fixed<br>bridgework, this is intended<br>for delayed loading.<br>The implants with diameters<br>larger than 5.0mm are<br>intended to be surgically<br>placed in the maxillary or<br>mandibular molar areas for<br>the purposed of providing<br>prosthetic support for dental<br>restorations (Crown, bridge,<br>and overdentures) in partially<br>or fully edentulous<br>individuals. These implants<br>are intended to be used where<br>smaller implants have failed. | Implantium II is<br>intended to be<br>surgically placed in the<br>bone of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetics devices,<br>such as artificial teeth.<br>and to restore the<br>patient's chewing<br>function. |
| Material | CP Titanium, Gr.4<br>ASTM F67 | CP Titanium, Gr.4<br>ASTM F67 | CP Titanium, Gr.4<br>ASTM F67 |
| Design | Submerged | Submerged | Submerged |
| Fixture Design | Image: INNO SLA Submerged Implant System Fixture Design | Image: Cowell Implant System Fixture Design | Image: Implantium II Fixture Design |
| | | | |
| Implant diameter | 3.7, 4.2, 4.6, 5.1, 6.0mm | 3.6, 3.7, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5mm | 3.6 - 7.0 mm |
| Implant length | 7, 7.5, 8, 9.5, 10, 11.5, 12, 14mm | 8, 9, 10, 11, 12, 14, 16, 18mm | 7 - 14 mm |
| Components | Various abutments<br>and components | Various abutments and<br>components | Various abutments and<br>components |
| Surface treatment | SLA | RBM | SLA |
| Gamma sterilized | Yes | Yes | Yes |
| Product Code | DZE | DZE | DZE |

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#### Comparison Analysis

The INNO SLA Submerged Implant System has a substantially equivalent intended use as the identified predicate. The INNO SLA Submerged 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.

INNO SLA Submerged Implant System is substantially equivalent in materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.

Only the difference between the subject device and the predicate is the surface treatment method and the Fixture's external design.

Any differences in technology characteristics are accompanied by information that demonstrated the device is safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate

#### Non-Clinical Data

No additional testing was performed for the subject device.

#### Conclusion

The INNO SLA Submerged Implant System, subject device 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, INNO SLA Submerged Implant System and its predicate devices are substantially equivalent.

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Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 6, 2013

Cowellmedi Company, Limited C/O Ms. April Lee Consultant Kodent, Incorporated 325 North Puente Street, Unit B Brea, CA 92821

Re: K132242

Trade/Device Name: INNO SLA Submerged Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 30, 2013 Received: November 1, 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 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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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 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/ResourcesforYou/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer -S

for

Erin I. Keith, 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

510(K) Number (if known): K132242

Device Name: INNO SLA Submerged Implant System

The INNO SLA Submerged 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.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

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

Mary S. Runner -

S
Susan Run DDS, MA 2013.12.05
09:41:26-05'00'