TSI; ERI

K090174 · Oco Biomedical · DZE · Sep 14, 2009 · Dental

Device Facts

• Record ID: K090174
• Device Name: TSI; ERI
• Applicant: Oco Biomedical
• Product Code: DZE · Dental
• Decision Date: Sep 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

Device Story

TSI & ERI are endosseous, root-form dental implants; used for tooth replacement or prosthetic stabilization. Implants are self-tapping, threaded screws made of commercially pure titanium or titanium alloy; feature light grit-blasted or roughened surface. TSI includes 2mm collar; ERI includes 1mm collar; both available in 3.25, 4.0, 5.0mm diameters and 8-16mm lengths. Placed surgically in mandible/maxilla by dental professionals. Device functions as artificial root structure to restore chewing function. Immediate loading permitted only upon achievement of primary stability.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Commercially pure titanium or titanium alloy. Surface: Light grit-blasted or roughened. Design: Self-tapping threaded screw. Dimensions: 3.25-5.0mm diameters; 8-16mm lengths. TSI (2mm collar) and ERI (1mm collar). Sterilization: Standard methods.

Indications for Use

Indicated for patients requiring single or multiple tooth replacement or prosthetic stabilization in the anterior or posterior mandible/maxilla. Suitable for immediate or delayed loading, provided good primary stability and appropriate occlusal loading are achieved.

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

• Immediate Stabilizing Implant (ISI) (K033392)
• OCO 5.0mm Taper Implant (K023336)
• MeggaGen ExFeel (K052369)

Submission Summary (Full Text)

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K090174

# p 1 4 2009

510(k) Summary

Date: January 9th, 2009

Contact Person: David D. Dalise President Owner OCO Biomedical, Inc.

Trade Name: TSI & ERI Common Name: Dental Implant Classification Name: Dental Implant Endosseous, Root-Form

#### Substantial Equivalence to:

Immediate Stabilizing Implant (ISI) OCO 5.0mm Taper Implant MeggaGen ExFeel

K033392 (Cleared 12/11/03) K023336 (Cleared 10/9/02) K052369 (Cleared 1/10/06)

#### Description of Device:

The TS1 & ERI implants are self-tapping, commercially pure. CP Titanium or Titanium Alloy threaded screws. with light grit blasting or roughened surface treatment. The TSI includes a 2mm collar and is available in 3.25, 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm len gths. The ERI includes a 1 mm collar and is available in 3.25. 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm lengths.

#### Indications for Use:

The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes.

Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

#### Substantial Equivalence:

OCO Biomedical. Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices. the TSI & ERI are substantially equivalent in indications and design principles to predicate devices previously cleared by the FDA: Immediate Stabilizing Implant (ISI) K033392 (Cleared 12/11/03), and OCO 5.0mm Taper Implant K023336 (Cleared 109/02). and MegaGen ExFeel K052369 (Cleared 1/10/06).

The TSI & ERI have the following similarities to the predicate devices: -has the same intended use

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-incorporates the same materials and design -is packaged and sterilized using the same materials and processes

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SFP 1 4 2009

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

Mr. Jack Bloom OCO Biomedical, Incorporated 8500 Washington Street NE. Suite A-1. Albuquerque, New Mexico 87113

Re: K090174

Trade/Device Name: TSI & ERI Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 27, 2009 Received: August 31, 2009

Dear Mr. Bloom:

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.

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- Mr. Bloom

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 vours.

for

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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## · Indications For Use

510(k) Number: K090174

Device Name: TSI & ERI

Indications for use:

The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes.

Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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

Susan Bonner

ivision Sign-Off) ***ision of Anesthesiology, General Hospital intection Control, Dental Devices

:10(k) Number: 20901374