B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM

K022258 · B.T.I. Biotechnology Institute, Sl. · DZE · Sep 11, 2003 · Dental

Device Facts

• Record ID: K022258
• Device Name: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
• Applicant: B.T.I. Biotechnology Institute, Sl.
• Product Code: DZE · Dental
• Decision Date: Sep 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. It is designated to become osseointegrated elements allowing the attachment of a partial or a complete prosthodontic appliance.

Device Story

BTI Dental Implant System consists of endosseous titanium implants, prosthetic components, and surgical/prosthetic auxiliary tools. Implants serve as artificial tooth roots; surgically placed in jawbone to achieve osseointegration. Once integrated, implants support partial or complete prosthodontic appliances to restore chewing function. Used by dental professionals in clinical settings. System includes various diameters (3.3mm to 5.5mm) and lengths (7.0mm to 18.0mm) to accommodate different anatomical requirements. Benefits include improved masticatory function and stabilization of dental prosthetics for patients with tooth loss.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Endosseous dental implants constructed of titanium. Dimensions: diameters 3.3-5.5 mm, lengths 7.0-18.0 mm. System includes surgical and prosthetic auxiliary elements. Mechanical fixation via osseointegration.

Indications for Use

Indicated for patients with missing teeth, including single tooth, partial, or fully edentulous cases, requiring restoration of chewing function or fixation of overdentures.

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

• Osseotite Dental Implants (K013570)

Submission Summary (Full Text)

{0}------------------------------------------------

K0.2258

FP 1 2003

#### 510(k) Notification BTI Dental Implant System

## 4. 510(k) Summary

# Manufacturer's Information

| Submitter's name: | B.T.I. Biotechnology Institute, S.L |
|-------------------|----------------------------------------------------------------------------------------|
| Address: | Parque Tecnologico de Alava<br>Leonardo da Vinci 14B<br>01510 Miñano (Alava)<br>España |
| Contact's name: | Alfredo Gómez |
| phone: | [phone] |

fax: [phone]

## Device Name

| Common Name: | Implant |
|----------------------|------------------------------|
| Trade Name: | B.T.I. Dental Implant System |
| Classification name: | Endosseous Implant |

#### Predicative Device

The B.T.I. Dental Implant Systems are substantially equivalent to the following device: Osseotite Dental Implants manufactured by Implant Innovation Inc, . (31) number K013570.

## Device Description

The BTI Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant and 4.5 to 5.5 mm for wide platform. Lengths range from 7,0 to 18,0 mm. Narrow platform implants are 3,3 wide in the surgical area, with lengths ranqing from 10,0 to 15,0 mm.

### Intended Use

To replace missing tooth roots for single tooth, partial tooth and fully edentulous patients.

It is designated to become osseointegrated elements allowing the attachment of a partial or a complete prosthodontic appliance.

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Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's logo, which is a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

Public Health Service

SEP 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

B.T.I. Biotechnology Institute S.L. C/O Mr. Alfredo Gomez Ouality Assurance and Certifications Deputy Manager Parque Tecnologico de Alava Leonardo Da Vinci, 14B 01510 Minano (Alava)- ESPANA

Re: K022258

Trade/Device Name: B.T.I Biotechnology Institute, S.L. Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE . Dated: June 11, 2003 Received: June 13, 2003

Dear Mr. Gomez:

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 such 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. Gomez

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Susan Runno

Susan Runner, DDS, MA Interim 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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Page 1 of 1

510(k) Number (if known): __ K 0222 58

Device Name: BTI DENTAL IMPLANT SYSTEM

Indications For Use:

Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.

The intended use of the system is the restoration of missing teeth in partially or fine intended as belients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulen for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospitali, Infection Control, Dental Device

(Optional Format 3-10-98)

510(k) Number: K022258