BTI Dental Implant System UnicCa

K151391 · B.T.I. Biotechnology Institute, Sl. · DZE · May 2, 2016 · Dental

Device Facts

• Record ID: K151391
• Device Name: BTI Dental Implant System UnicCa
• Applicant: B.T.I. Biotechnology Institute, Sl.
• Product Code: DZE · Dental
• Decision Date: May 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations . In the case of Tiny® 3.0 UnicCa® 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 System UnicCa® is a self-tapping, threaded, root-form titanium dental implant. It features a surface treatment using soluble calcium chloride salt to enhance hydrophilicity. Used in oral implant surgery by clinicians to replace missing teeth; implants serve as anchors for fixed or removable prosthetic solutions. The device is implanted into the jawbone to restore mastication function. The system includes various diameters (3.0–6.0 mm) and lengths (5.5–18.0 mm) with Interna® or Externa® connections. Clinical benefit includes improved or restored chewing capacity. The device is supplied sterile via gamma radiation.

Clinical Evidence

Observational retrospective study of 170 patients with 430 UnicCa® implants. Subjects >18 years old, partially or completely edentulous, with minimum 6-month follow-up. Primary endpoint: implant survival (stable prosthesis, no pain/infection/pathology, no bone loss >2-3mm). Results: 99.5% implant-based survival and 98.8% subject-based survival at 6 months. No adverse events reported. Survival rates compare favorably to literature range (90-98%).

Technological Characteristics

Material: Commercially pure titanium grade 4 (ISO 5832-2, ASTM F67). Design: Threaded, root-form. Surface: Calcium chloride salt-treated for enhanced hydrophilicity. Connections: Interna® and Externa®. Dimensions: 3.0–6.0 mm diameter, 5.5–18.0 mm length. Sterilization: Gamma radiation (SAL 10^-6).

Indications for Use

Indicated for partial or total tooth replacement in edentulous patients. Tiny® 3.0 implants indicated only for maxillary lateral incisors and mandibular lateral/central incisors. 5.5–6.5mm implants indicated for two-stage surgery and delayed loading with straight abutments for fixed restorations.

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)

Reference Devices

• BTI Interna Dental Implant System (K053355)
• BTI Dental Implant 5.5 – 6.5 (K091387)
• BTI Dental Implant Tiny® Ø 3.0 (K092112)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an emblem with three stylized human profiles facing right, stacked on top of each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 2, 2016

B.T.I. Biotechnology Institute, S.L. Ms. Fernanda Olabarria Ros Regulatory Affairs Manager Parque Tecnologico De Álava, Leonardo DaVinci 14 01510 Miñano (Álava) SPAIN

Re: K151391

Trade/Device Name: BTI Dental Implant System UnicCa® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: February 19, 2016 Received: February 22, 2016

Dear Ms. Ros:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Ms. Fernanda Olabarria Ros

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMS No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151391

Device Name BTI Dental Implant System UnicCa®

Indications for Use (Describe)

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations .

In the case of Tiny® 3.0 UnicCa® 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.

| Type of Use (Select one or both, as applicable) |
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| <div><span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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## 5.0 510(k) Summary

## I. SUBMITTER

# B.T.I. Biotechnology Institute, SL.

Parque Tecnológico de Álava C/Leonardo Da Vinci 14 01510 Miñano (Alava) Spain

Phone: [phone] Fax: [phone]

Contact Person: Ms. Fernanda Olabarría Date Prepared: April 20, 2016

### II. DEVICE

Name of Device: BTI Dental Implant System UnicCa® Common or Usual Name: Root-form Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE

## III. PREDICATE DEVICE

| Primary Predicate | Reference Predicates | | |
|----------------------------------------|---------------------------------------------|--|--|
| | K053355; BTI Interna Dental Implant System. | | |
| K022258;<br>BTI Dental Implant System. | K091387; BTI Dental Implant 5.5 – 6.5. | | |
| | K092112; BTI Dental Implant Tiny® Ø 3.0. | | |

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## IV. DEVICE DESCRIPTION

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant. Comprises two types of connections: Externa® and Interna® with a range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm) for various platforms, we refer to Table 5-1. BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

Table 5-1. Overview of BTI Dental Implant System UnicCa® connections, platforms, diameters and lengths:

| Connection | Platform | Diameter<br>(mm) | Length (mm) |
|------------|----------------|------------------|-----------------------------------------------|
| Interna® | Wide | 5.0 | [6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Wide | 5.5 | [5.5 / 6.5] |
| | Wide | 6.0 | [5.5 / 6.5] |
| | Universal Plus | 4.5 | [5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal Plus | 5.0 | [5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal Plus | 5.5 | [5.5 / 6.5] |
| Interna® | Universal | 3.3 | [8.5 / 10 / 11.5 / 13 / 15] |
| | Universal | 3.5 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal | 3.75 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal | 4.0 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18] |
| | Universal | 4.25 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| Externa® | Wide | 5.0 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Wide | 5.5 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal Plus | 4.5 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal Plus | 5.0 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal | 3.75 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Universal | 4.0 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18] |
| Externa® | Tiny® | 3.0 | [11.5 / 13 / 15] |
| | Tiny® | 3.3 | [8.5 / 10 / 11.5 / 13 / 15] |
| | Tiny® | 3.5 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |
| | Tiny® | 3.75 | [7.5 / 8.5 / 10 / 11.5 / 13 / 15] |

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## V. INDICATIONS FOR USE

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations .

In the case of Tiny® 3.0 UnicCa® implants: 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.

# VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject dental implants are identical to the currently marketed BTI Dental Implant Systems in indications for use, materials and design.

The BTI Dental Implant System UnicCa® is manufactured using the same procedures and processes as currently utilized for the predicate BTI Dental Implants, with exception that an additional manufacturing step has been added which consists of applying a soluble calcium chloride salt which is deposited at the outermost part of the surface of the implants. The predicate implant surface is known as Optima®, the implant with surface treatment is referred to as UnicCa®. This treatment enhances hydrophilic profile of the implant, easing its wetting characteristics to polar liquids.

A comparison of the device features, indications for use, laboratory data and other information demonstrate that the modified BTI Dental Implant System UnicCa® is substantially equivalent to the predicate devices.

In the following pages, a comparison table has been provided, Table 5-2.

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| Characteristics | Current Submission<br>BTI Dental Implant System<br>UnicCa®<br>(K151391) | Primary Predicate<br>BTI Dental Implant<br>System<br>(K022258) | BTI Dental<br>Implant System<br>(K053355) | Reference Predicates<br>BTI Dental<br>Implant 5.5-6.5<br>(K091387) | BTI Dental<br>Implant Tiny®<br>(K092112) | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Indications for Use | The BTI Dental Implant System<br>UnicCa® for oral implant surgery<br>is to be used for the partial or<br>total replacement of teeth in<br>edentulate patients. Once attached<br>to the bone, the implants act as an<br>anchor for various fixed or<br>removable prosthetic solutions<br>that can be used to improve or<br>restore a patient's mastication<br>function.<br>In the case of 5.5 - 6.5mm long<br>UnicCa® implants should be used<br>in a two-stage surgical procedure.<br>These implants are indicated for<br>delayed loading.<br>These implants are indicated only<br>for straight abutments and to<br>support permanently fixed<br>restorations. | The intended use of the<br>system is the<br>restoration of missing<br>teeth in partially or<br>fully edentulous<br>patients and/or the<br>fixation of<br>overdentures to restore<br>or enhance the chewing<br>capacity of patients. | Dental implant<br>system comprising<br>endosseous<br>titanium implants<br>and prosthetic<br>elements to be<br>attached to the<br>implants, as well<br>as auxiliary<br>elements for<br>surgical and<br>prosthetic<br>procedures. The<br>intended use of the<br>system is the<br>restoration of<br>missing teeth in<br>partially or fully<br>edentulous patients<br>and/or the fixation<br>of overdentures to<br>restore or enhance<br>the chewing<br>capacity of<br>patients. | BTI Dental implants<br>5.5 - 6.5 mm are<br>intended to be used<br>to restore missing<br>teeth in partially or<br>fully edentulous<br>patients and/or for<br>the fixation of<br>overdentures to<br>restore or enhance<br>the chewing capacity<br>of patients. The<br>device should be<br>used in a two-stage<br>surgical procedure.<br>These implants are<br>not indicated for<br>immediate loading.<br>These implants are<br>not indicated to<br>support removable<br>resilient retained<br>restorations or angled<br>abutments. | BTI Dental Implant<br>Tiny® 3.0 are<br>intended to be used to<br>restore missing teeth<br>in partially or fully<br>edentulous patients<br>and/or the fixation of<br>overdentures'to restore<br>or enhance the<br>chewing capacity of<br>patients.<br>These implants shall<br>be used only to<br>replace maxillary<br>lateral incisors and<br>mandibular lateral and<br>central incisors.<br>Immediate loading is<br>recommended when<br>there is good primary<br>stability and an<br>appropriate occlusal<br>load. | |
| | Current Submission | Primary Predicate | Reference Predicates | | | |
| Characteristics | BTI Dental Implant System<br>UnicCa®<br>(K151391) | BTI Dental Implant<br>System<br>(K022258) | BTI Dental<br>Implant System<br>(K053355) | BTI Dental<br>Implant 5.5-6.5<br>(K091387) | BTI Dental<br>Implant Tiny®<br>(K092112) | |
| | In the case of Tiny® 3.0 UnicCa®<br>implants: These implants shall be<br>used only to replace maxillary<br>lateral incisors and mandibular<br>lateral and central incisors.<br>Immediate loading is<br>recommended when there is good<br>primary stability and an<br>appropriate occlusal load. | | | | | |
| | The indications for use statement for the BTI Dental Implant System UnicCa® has been written to encompass the<br>indications for use statements provided with the primary predicate system (K022258) and other previously cleared<br>connections, platforms, diameters and lengths acting as a single consolidated system.<br>In this sense, no labeling change that affects the indications for use of the device has been implemented. Information<br>relevant to a specific use of an implant included in previously cleared premarket notifications for BTI Dental Implants<br>are carried forward and included within the labeling for the BTI Dental Implant System UnicCa®. The product continues<br>to be specifically indicated for patients undergoing oral implant surgery for the partial or total replacement of teeth in<br>edentulate patients. | | | | | |
| Characteristics | Current Submission<br>BTI Dental Implant System<br>UnicCa®<br>(K151391) | Primary Predicate<br>BTI Dental Implant<br>System (K022258) | Reference Predicates | | | |
| | | | BTI Dental<br>Implant System<br>(K053355) | BTI Dental<br>Implant 5.5-6.5<br>(K091387) | BTI Dental<br>Implant Tiny®<br>(K092112) | |
| Product Classification | Device Class II<br>Regulation No.:<br>21 CFR 872.3640.<br>Product code: DZE;<br>Endosseous dental implant | Device Class II<br>Regulation No.:<br>21 CFR 872.3640.<br>Product code: DZE;<br>Endosseous dental<br>implant | Device Class II<br>Regulation No.: 21 CFR 872.3640.<br>Product code: DZE; Endosseous dental implant | | | |
| Implant Design/Geometry | Threaded, root form | Threaded, root form | Threaded, root form | | | |
| Material | Commercially pure titanium<br>grade 4 | Commercially pure<br>titanium grade 4 | Commercially pure titanium grade 4 | | | |
| Abutment Compatibility/<br>Connection | Internal (Interna) and External<br>(Externa) | External (Externa) | External<br>(Externa) | Internal (Interna) | External (Externa) | |
| Dimensions (mm) | Interna | Diameter: 3.3<br>to 6.0<br>Lengths:<br>5.5 to 18.0 | Diameter:<br>3.3 to 5.5<br>Length:<br>7.0 to 18.0 | Diameter:<br>3.3 to 5.0<br>Length:<br>7.0 to 18.0 | Diameter:<br>4.5 to 6.0<br>Lengths:<br>5.5 to 6.5 | Diameter:<br>3.0<br>Lengths:<br>11.5 to 15.0 |
| | Externa | Diameter: 3.0<br>to 5.5<br>Lengths:<br>7.0 to 18.0 | Diameter:<br>3.3 to 5.5<br>Length:<br>7.0 to 18.0 | Diameter:<br>3.3 to 5.0<br>Length:<br>7.0 to 18.0 | Diameter:<br>4.5 to 6.0<br>Lengths:<br>5.5 to 6.5 | Diameter:<br>3.0<br>Lengths:<br>11.5 to 15.0 |
| Roughness | Same | $Neck: Sq = 0.7 ± 0.1 µm; Sdr^2= 50± 10%$<br>$Thread: Sq≥ 1.2 µm;$<br>$Sdr≥ 200%$ | Same | | | |
| Characteristics | | Current Submission | Primary Predicate | Reference Predicates | | |
| | | BTI Dental Implant System<br>UnicCa®<br>(K151391) | BTI Dental Implant<br>System (K022258) | BTI Dental<br>Implant System<br>(K053355) | BTI Dental<br>Implant 5.5-6.5<br>(K091387) | BTI Dental<br>Implant Tiny®<br>(K092112) |
| | | | Valleys: Sq= $1.0 \pm 0.2$ µm; Sdr= $85 \pm 15$ % | | | |
| Mechanical<br>Properties | Material<br>(Titanium) | Same; in compliance with ISO<br>5832-2 and ASTM F67. | Same; in compliance<br>with ISO 5832-2 and<br>ASTM F67. | Same; in compliance with ISO 5832-2 and ASTM F67. | | |
| | Fatigue | Equivalent; platform<br>(diameter and length)<br>dependent. | Equivalent; platform<br>(diameter and length)<br>dependent. | Equivalent; platform (diameter and length) dependent. | | |
| Hydrophilicity | | Enhanced | | | | |
| Supplied Sterile | | Yes | Yes | Yes | | |
| Sterilization | | Gamma Radiation | e- beam | e- beam | | |
| SAL | | 1 x 10-6 | 1 x 10-6 | 1 x 10-6 | | |
| Packaging |…