BTI DENTAL IMPLANT 5.5-6.5

K091387 · B.T.I. Biotechnology Institute, Sl. · DZE · Jan 22, 2010 · Dental

Device Facts

• Record ID: K091387
• Device Name: BTI DENTAL IMPLANT 5.5-6.5
• Applicant: B.T.I. Biotechnology Institute, Sl.
• Product Code: DZE · Dental
• Decision Date: Jan 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure. These implants are not indicated for immediate loading. These implants are not indicated to support removable resilient retained restorations or angled abutments.

Device Story

Self-tapping, threaded endosseous dental implant; titanium construction. Used in two-stage surgical procedures by dental professionals to restore missing teeth or fixate overdentures. Implant provides structural foundation for dental prosthetics; enhances patient chewing capacity. Device is purely mechanical; no electronic or software components.

Technological Characteristics

Material: Titanium. Design: Self-tapping, threaded endosseous root-form implant. Diameters: 4.5, 5.0, 5.5, 6.0 mm. Lengths: 5.5, 6.5 mm. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for partially or fully edentulous patients requiring tooth restoration or overdenture fixation to improve chewing capacity. Contraindicated for immediate loading, removable resilient retained restorations, and angled abutments.

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)
• BTI Interna Dental Implant System (K053355)
• OsseoSpeedTM 4.0S - 6mm (K063779)

Submission Summary (Full Text)

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

# KO91387

#### 510(k) Summary As Required By 21 CFR 807.92

Biotechnology Institute, SL. Submitter: Parque Tecnológico de Alava C/Leonardo Da Vinci 14B, 1B. 01510 Miñano (Alava) Spain

JAN 22 2010

Alfredo Gómez Contact Person: Regulatory Affairs Department Biotechnology Institute, SL. Parque Tecnológico de Alava C/Leonardo Da Vinci 14B, 1B. 01510 Miñano (Alava) Spain .

Date Prepared: May 08, 2009

BTI Dental implant 5.5-6.5 Device Trade Name:

IMPLANT, ENDOSSEOUS, ROOT-FORM Common Name:

Substantial Equivalence: K022258 BTI Dental Implant System K053355 BTI Interna Dental Implant System K063779 OsseoSpeedTM 4.0S - 6mm

The BTI Dental Implant 5.5-6.5 is a self tapping, threaded Device Description: dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameters: 4.5, 5.0, 5.5, 6.0 and lengths: 5.5, 6.5

BTI Dental implants 5.5 - 6.5 mm are intended to be used to Intended Use: restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure.

These implants are not indicated for immediate loading.

These implants are not indicated to support removable resilient retained restorations or angled abutments.

Technological Aspects:

A comparison of the device features, intended use and other information demonstrate that the BTI Dental implants 5.5 -6.5mm substantially equivalent to the predicate devices.

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Alfredo Gómez Regulatory Affairs Specialist B.T. I. Biotechnology Institute, S.L. Parque Tecnológico de Alava Leonardo Da Vinci, 14B 01510 Miñano (Alava) SPAIN

JAN 22 2010

Re: K091387

Trade/Device Name: BTI Dental Implant 5.5 - 6.5 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 17, 2009 Received: January 11, 2010

Dear Mr. Gómez:

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 régistration, 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.

{2}------------------------------------------------

#### Page 2- Mr. Gómez

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/Reporta Problem/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 vours.

Ah for

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

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known): __K091387

Device Name: BTI Dental Implant 5.5 - 6.5

Indications For Use:

BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure.

These implants are not indicated for immediate loading.

These implants are not indicated to support removable resilient retained restorations or angled abutments.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) |
|--------------------------------------------------------|
| |
| (Division Sign-Off) |
| ee |
| Division of Anesthesiology, General Hospital |

Infection Control, Dental Devices

510(k) Number: K091387

Page 1 of