BTI INTERNA DENTAL IMPLANT SYSTEM

K053355 · B.T.I. Biotechnology Institute, Sl. · DZE · Mar 14, 2006 · Dental

Device Facts

• Record ID: K053355
• Device Name: BTI INTERNA DENTAL IMPLANT SYSTEM
• Applicant: B.T.I. Biotechnology Institute, Sl.
• Product Code: DZE · Dental
• Decision Date: Mar 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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 fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

Device Story

The BTI Interna Dental Implant System consists of endosseous titanium implants, prosthetic elements, and auxiliary surgical/prosthetic tools. Used by dental professionals in clinical settings to replace missing teeth or stabilize overdentures. The implants are surgically placed into the jawbone to serve as anchors for prosthetic restorations, thereby restoring chewing function. The system is designed for use in partially or fully edentulous patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Endosseous titanium dental implants; surgical diameters range from 3.3 mm to 5.0 mm; lengths range from 7.0 mm to 18.0 mm; includes prosthetic and auxiliary surgical elements.

Indications for Use

Indicated for partially or fully edentulous patients requiring restoration of missing teeth or fixation of overdentures to restore or enhance chewing capacity.

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

• BTI Dental Implant System (K022258)

Submission Summary (Full Text)

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MAR 1 4 2006

510 (K) SUBMISSION BT Interna Dental Implant System

Kos 3355

# Attachment 5

### 510 (K) SUMMARY

## SAFETY AND EFFECTIVENESS INFORMATION

### BTI INTERNA DENTAL IMPLANT SYSTEM

SUBMITTER'S NAME. ADDRESS AND TELEPHONE NUMBER:

B.T.J. Biotechnology Institute, S.L. Parque Tecnológico de Álava Leonardo da Vinci, 14 B Miñano (Álava) 01510 Spain PH: [phone] FAX: [phone]

CONTACT PERSON

Alfredo Gómez Mengod Quality Assurance Manager

SUMARY PREPARATION DATE:

November 2005

3004417597

ESTABLISHMENT REGISTRATION No:

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION NAME:

BTI INTERNA DENTAL IMPLANT SYSTEM

Dental implant

IMPLANT, ENDOSSEOUS, ROOT-FORM

PRODUCT CODE: DZE

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#### DEVICE CLASSIFICATION: Class II

#### PREDICATE DEVICE

The BTI Interna Dental Implant System is claimed to be substantially equivalent in material, design, and function to the BTI Dental Implant System cleared by FDA under 510 (k) K022258 on Sep 11, 2003

#### DEVICE DESCRIPTION

The BTI Interna 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. 4.0 for Universal Plus Platform and 4.5 to 5.0 mm for wide platform. Lengths range from 7,0 to 18,0 mm.

#### INTENDED 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 fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

#### SUBSTANTIAL EQUIVALENCE

The BTI Interna Dental Implant System is considered to be substantially equivalent to BTI Dental Implant System

#### CONCLUSION

The BTI Interna Dental Implant System is considered to be substantially equivalent in design, material and function to the BTI Dental Implant System.

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MAR 1 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alfredo Gómez Mengod Quality Assurance Manager B.T.I. Biotechnology Institute, S.L. Parque Tecnológico de Álava Leonardo da Vinci, 14 B Miñano (Alava), 01510 Spain

Re: K053355

Trade/Device Name: BTI Interna Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 16, 2006 Received: February 21, 2006

Dear Mr. Mengod:

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. Mengod

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be ad rised that that your device complies with other requirements mean that I Drima and regulations and regulations administered by other Federal agencies. or the ret of with all the Act's requirements, including, but not limited to: registration r od intiles compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF ref Lav 807), eguality 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) I rus reter wrification. The FDA finding of substantial equivalence of your device to a premaired 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), n free 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 maj Vetant Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ours

Chiu Lin, Ph.D. 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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510 (K) SUBMISSION BTI Interna Dental Implant System

## Attachment 2

## Indications for Use

510(k) Number (if known): K053355

Device Name: BTI Interna 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 fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

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)

Susan Kunne

! lony, General Hospi
Lumal DOVICES

k053353

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