BTI DENTAL IMPLANT TINY 2.5-3.0

K092112 · B.T.I. Biotechnology Institute, Sl. · DZE · Oct 6, 2009 · Dental

Device Facts

• Record ID: K092112
• Device Name: BTI DENTAL IMPLANT TINY 2.5-3.0
• Applicant: B.T.I. Biotechnology Institute, Sl.
• Product Code: DZE · Dental
• Decision Date: Oct 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BTI Dental Implants Tiny® Ø3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients. These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

Device Story

BTI Dental Implant Tiny® Ø3.0 is a self-tapping, threaded, root-form dental implant. Fabricated from titanium; available in 3.0mm diameter and lengths of 11.5, 13, and 15mm. Used by dental professionals in clinical settings to replace specific missing teeth (maxillary lateral incisors, mandibular lateral/central incisors) or fixate overdentures. Implant is surgically placed into the jawbone to restore chewing capacity. Immediate loading is recommended given sufficient primary stability and appropriate occlusal load.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Root-form, self-tapping, threaded dental implant. Material: Titanium. Diameter: 3.0mm. Lengths: 11.5, 13, 15mm. Mechanical fixation principle.

Indications for Use

Indicated for partially or fully edentulous patients requiring restoration of missing teeth or fixation of overdentures. Specifically limited to replacement of maxillary lateral incisors and mandibular lateral and central incisors.

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 Narrow (K080396)

Submission Summary (Full Text)

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## 510(k) Summary As Required By 21 CFR 807.92 5.

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| Submitter: | Biotechnology Institute, SL.<br>Parque Tecnológico de Alava<br>C/Leonardo Da Vinci 14B, 1B.<br>01510 Miñano (Alava)<br>Spain | OCT - 6 2009 |
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| Contact Person: | Alfredo Gómez<br>Regulatory Affairs Department<br>Biotechnology Institute, SL.<br>Parque Tecnológico de Alava<br>C/Leonardo Da Vinci 14B, 1B.<br>01510 Miñano (Alava)<br>Spain | |
| Date Prepared: | July 09, 2009 | |
| Device Trade Name: | BTI Dental Implant Tiny® Ø3.0 | |
| Common Name: | IMPLANT, ENDOSSEOUS, ROOT-FORM | |
| Substantial Equivalence: | K022258 BTI Dental Implant System<br>K053355 BTI Interna Dental Implant System<br>K080396 OsseoSpeedTM Narrow | |
| Device Description: | The BTI Dental Implant Tiny® Ø3.0 is a self tapping, threaded, root-<br>form dental implant intended for restoring missing teeth in partially<br>or fully edentulous patients to restore the chewing capacity of<br>patients. It is made of titanium and offers a variety of sizes including<br>diameter: 3.0mm and lengths: 11.5, 13, 15mm | |
| Intended Use: | BTI Dental Implants Tiny® Ø3.0 are intended to be used to restore<br>missing teeth in partially or fully edentulous patients and/or the<br>fixation of overdentures to restore or enhance the chewing capacity<br>of patients.<br>These implants shall be used only to replace maxillary lateral incisors<br>and mandibular lateral and central incisors.<br>Immediate loading is recommended when there is good primary<br>stability and an appropriate occlusal load. | |
| Technological Aspects: | A comparison of the device features, intended use and other<br>information demonstrate that the BTI Dental Implant Tiny® Ø3.0<br>substantially equivalent to the predicate devices. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its wing, representing service, science, and protection. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - 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

## OCT - 6 2009

Re: K092112

Trade/Device Name: BTI Dental Implant Tiny® 3.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 22, 2009 Received: September 24, 2009

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 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. 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 (OS) 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/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

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## Indications for Use

510(k) Number (if known):_K092112

Device Name:_BTI Dental implant Tiny® 3.0

Indications For Use:

BTI Dental Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

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)

Kein Nulley for WSR
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092112