BTI Extra-Short Dental Implant System UnicCa

K202825 · B.T.I. Biotechnology Institute, Sl. · DZE · Jul 29, 2021 · Dental

Device Facts

• Record ID: K202825
• Device Name: BTI Extra-Short Dental Implant System UnicCa
• Applicant: B.T.I. Biotechnology Institute, Sl.
• Product Code: DZE · Dental
• Decision Date: Jul 29, 2021
• 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

Self-tapping, threaded, root-form titanium dental implants; used for tooth replacement; anchored in bone to support fixed/removable prosthetics. Operated by dental surgeons in clinical settings. Implants feature hydrophilic surface treatment. Subject device expands existing product line with shorter lengths (5.5-6.5mm). Output is a stable base for prosthetic restoration; improves mastication function. Clinical decision-making relies on surgeon assessment of primary stability and occlusal load.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), fatigue testing (ISO 14801), and comparative area/bone resorption analysis.

Technological Characteristics

Material: Commercially pure titanium grade 4 (ISO 5832-2, ASTM F67). Design: Threaded, root-form, self-tapping. Surface: Calcium-treated hydrophilic. Sterilization: Gamma radiation (SAL 10^-6). Dimensions: 4.0-6.0mm diameter, 5.5-6.5mm length. Connection: Internal (Interna).

Indications for Use

Indicated for partial or total tooth replacement in edentulate patients. 5.5-6.5mm implants: two-stage surgery, delayed loading, straight abutments, fixed restorations only. Tiny® 3.0 implants: maxillary lateral incisors, mandibular lateral/central incisors only; immediate loading if primary stability/occlusal load appropriate.

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 UnicCa® Interna® Implants (K151391)
• BTI Dental Implant System UnicCa® (cleared May 2, 2016)

Reference Devices

• 3i T3(R) External Hex Dental Implants (K133049)
• S.I.N. Implant System (K170392)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

B.T.I. Biotechnology Institute, S.L. Jose Rivero Qualified Person Leonardo da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN

Re: K202825

Trade/Device Name: BTI Extra-Short Dental Implant System UnicCa® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 25, 2021 Received: July 2, 2021

Dear Jose Rivero:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K202825

Device Name

BTI Extra-Short 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 Unic a® 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)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### I. SUBMITTER

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

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

### Establishment registration number: 3004417597

Phone: [phone] Fax: [phone]

Contact Person: Mr. José Ramón Rivero Date Prepared: July 29, 2021

### II. DEVICE

Name of Device: BTI Extra-Short 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

The primary predicate devices are the BTI Dental Implant System UnicCa® Interna® Implants which were subject of K151391, BTI Dental Implant System UnicCa® (cleared on May 2, 2016).

Additionally, the following reference devices have been identified to bridge the gap in implant dimensions (i.e., for the narrower/shorter implants) that are outside the scope of currently cleared BTI UnicCa® Interna® implants. These reference devices are marketed in dimensions similar to those included in this submission:

- K133049, 31 T3(R) External Hex Dental Implants (Biomet 31), January 8, 2014. ●
- K170392, S.I.N. Implant System (S.I.N. Sistema De Implante Nacional S.A.), ● December 5, 2017.

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### IV. DEVICE DESCRIPTION

The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to allow B.T.I. Biotechnology Institute, S.L. to expand the product offering for the Universal and Universal Plus Interna® implant platforms. Specifically, the currently cleared Universal Interna® implants with diameters ranging from 4.0 to 4.25 mm and the 6.0 mm diameter Universal Plus Interna® implants will be provided in shorter lengths of 5.5 and 6.5 mm. The implants subject of this premarket notification, collectively referred to as BTI Extra-Short Dental Implant System UnicCa®, are summarized in Table 5-1.

Table 5-1. Overview of BTI Extra-Short Dental Implant System UnicCa®, platforms, diameters and lengths subject of this premarket notification:

| Connection | Platform | Diameter (mm) | Length (mm) |
|------------|----------------|---------------|-------------|
| Interna® | Universal | 4.0 | 5.5 |
| | Universal | 4.25 | 5.5 |
| | Universal Plus | 6.0 | 5.5 / 6.5 |

This submission does not include any new abutments. The subject device is compatible with abutments previously cleared under K053355, K061383, and K070533.

### 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: These implants should be used in a twostage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

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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. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The BTI Extra-Short Dental Implant System UnicCa® have the following similarities to the UnicCa® implants which previously received 510(k) concurrence via K151391:

- have identical indications for use,
- use identical operating principle, ●
- incorporate identical materials,
- have the identical surface treatment, ●
- have identical shelf life, and
- are packaged and sterilized using the identical materials and processes. .

Table 5-2 represents diameters and lengths of the Interna® connection cleared within K151391 (and K173257 which extended the range of implant sizes) and the dental implants subject of this current Traditional 510(k) submission.

Table 5-2. Range of platform, diameter and lengths of the predicate UnicCa® Internas implant previously cleared within K151391 and additional size offerings subject of this 510(k) submission (new size offerings subject of this premarket notification identified in bold text).

| Connection | Platform | Diameter Ø (mm) | Length ↑ (mm) |
|------------|----------------|-----------------|---------------------------------------------|
| Interna® | Universal | 3.3 | 8.5 / 10 / 11.5 / 13 / 15 |
| | | 3.5 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 3.75 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 4.0 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18 |
| | | 4.25 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | Universal Plus | 4.5 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 5.0 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 5.5 | 5.5 / 6.5 |
| | | 6.0 | 5.5 / 6.5 |
| | Wide | 5.0 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 5.5 | 5.5 / 6.5 |
| | | 6.0 | 5.5 / 6.5 |

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A comparison of the device features, indications for use, bench testing and other information demonstrate that the BTI Extra-Short Dental Implant System UnicCa® is substantially equivalent to the primary predicate device (K151391).

Table 5-3 compares the subject devices with the primary predicate (K151391). To bridge the gap in differences in implant dimensions; i.e., specifically for the implants that have dimensions outside those currently cleared for the UnicCa® product line, BTI has identified reference devices, Table 5-4, which have similar dimensions to the narrower and shorter implants proposed as well as similar design and intended use as the implants presented within this submission. The differences in dimensions have been demonstrated to not be unique to the subject device.

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| Table 5-3. Comparison of the BTI Extra-Short Dental Implant System UnicCa® with primary predicate BTI Dental Implant | |
|----------------------------------------------------------------------------------------------------------------------|--|
| System UnicCa® (K151391) | |

| Characteristics | Subject Device<br>(Current Submission)<br>BTI Extra-Short Dental Implant<br>System UnicCa® | Primary Predicate<br>K151391, BTI Dental Implant System<br>UnicCa® | Substantial Equivalence<br>Discussion |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | Device Class II<br>Regulation No.:21 CFR 872.3640.<br>Product code: DZE; Endosseous dental<br>implant. | Device Class II<br>Regulation No.:21 CFR 872.3640.<br>Product code: DZE; Endosseous dental<br>implant. | Identical. |
| Characteristics | Subject Device<br>(Current Submission)<br>BTI Extra-Short Dental Implant<br>System UnicCa® | Primary Predicate<br>K151391, BTI Dental Implant System<br>UnicCa® | Substantial Equivalence<br>Discussion |
| Indications for use | The BTI Dental Implant System<br>UnicCa® for oral implant surgery is to<br>be used for the partial or total<br>replacement of teeth in edentulate<br>patients. Once attached to the bone, the<br>implants act as an anchor for various<br>fixed or removable prosthetic solutions<br>that can be used to improve or restore a<br>patient's mastication function.<br><br>In the case of 5.5 – 6.5mm long<br>UnicCa® implants: These implants<br>should be used in a two-stage surgical<br>procedure. These implants are indicated<br>for delayed loading. These implants are<br>indicated only for straight abutments and<br>to support permanently fixed<br>restorations.<br><br>In the case of Tiny® 3.0 UnicCa®<br>implants: These implants shall be used<br>only to replace maxillary lateral incisors<br>and mandibular lateral and central<br>incisors. Immediate loading is<br>recommended when there is good<br>primary stability and an appropriate<br>occlusal load. | The BTI Dental Implant System<br>UnicCa® for oral implant surgery is to<br>be used for the partial or total<br>replacement of teeth in edentulate<br>patients. Once attached to the bone, the<br>implants act as an anchor for various<br>fixed or removable prosthetic solutions<br>that can be used to improve or restore a<br>patient's mastication function.<br><br>In the case of 5.5 - 6.5mm long<br>UnicCa® implants should be used in a<br>two-stage surgical procedure. These<br>implants are indicated for delayed<br>loading. These implants are indicated<br>only for straight abutments and to<br>support permanently fixed restorations.<br><br>In the case of Tiny® 3.0 UnicCa®<br>implants: These implants shall be used<br>only to replace maxillary lateral incisors<br>and mandibular lateral and central<br>incisors. Immediate loading is<br>recommended when there is good<br>primary stability and an appropriate<br>occlusal load. | Identical. |
| | Implant Design/Geometry | Threaded, root form. | Threaded, root form. |
| | Material | Commercially pure titanium grade 4. | Commercially pure titanium grade 4. |
| Characteristics | Subject Device<br>(Current Submission)<br>BTI Extra-Short Dental Implant<br>System UnicCa® | Primary Predicate<br>K151391, BTI Dental Implant System<br>UnicCa® | Substantial Equivalence<br>Discussion |
| Abutment Compatibility/<br>Connection | Internal (Interna). | Internal (Interna) and External<br>(Externa). | Identical. Primary predicate<br>also includes implants with<br>External connection. |
| Dimensions (mm) | Interna<br>Diameter: 4.0 to 6.0<br>Lengths: 5.5 and 6.5 | Interna<br>Diameter: 3.3 to 6.0<br>Lengths: 5.5 to 18.0 | Similar. The diameters and<br>lengths in current submission<br>for Interna connection are<br>already encompassed in<br>Primary Predicate. |
| | Externa<br>Not applicable. | Externa<br>Diameter: 3.0 to 5.5<br>Lengths: 7.0 to 18.0 | |
| Roughness | Neck: Sq1= 0.7 ± 0.1 µm;<br>Sdr2= 50± 10%<br>Thread: Sq≥ 1.2 μm;<br>Sdr≥ 200%<br>Valleys: Sq= 1.0 ± 0.2 µm;<br>Sdr= 85± 15% | Neck: Sq= 0.7 ± 0.1 µm;<br>Sdr= 50± 10%<br>Thread: Sq≥ 1.2 μm;<br>Sdr≥ 200%<br>Valleys: Sq= 1.0 ± 0.2 µm;<br>Sdr= 85± 15% | Identical. |
| Mechanical<br>properties | Material<br>(Titanium)<br>In compliance with ISO 5832-2 and<br>ASTM F67. | In compliance with ISO 5832-2 and<br>ASTM F67. | Identical. |
| | Fatigue<br>Evaluated according to ISO 14801. | Evaluated under ISO 14801. | Identical. |
| Hydrophilicity | Calcium surface treatment | Calcium surface treatment | Identical. |
| Supplied Sterile | Yes | Yes | Identical. |
| Sterilization | Gamma radiation | Gamma Radiation | Identical. |
| SAL | 1 x 10-6 | 1 x 10-6 | Identical. |
| Packaging | Container (vial with clamp) | Container (vial with clamp) | Identical. |
| Characteristics | Subject Device<br>(Current Submission)<br>BTI Extra-Short Dental Implant<br>System UnicCa® | Primary Predicate<br>K151391, BTI Dental Implant System<br>UnicCa® | Substantial Equivalence<br>Discussion |
| Shelf-Life | Same. 5 years. | 5 years. | Identical. |

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! Sq: Root Square Mean Roughness.
2 Sdr= Developped surface.

² Sdr= Developed surface.

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Table 5-4 provides a comparison of the BTI Extra-Short Dental Implant System UnicCa® with the selected reference devices.

| Characteristics | Subject Device<br>(Current Submission) | Reference device | Reference device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BTI Extra-Short Dental Implant<br>System UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| Product<br>Classification | Device Class II<br>Regulation No.:21 CFR 872.3640.<br>Product code: DZE; Endosseous dental<br>implant | Device Class II<br>Regulation No.:21 CFR 872.3640.<br>Product code: DZE; Endosseous dental<br>implant | Device Class II<br>Regulation No.:21 CFR 872.3630 and<br>872.3640.<br>Product code: DZE; Endosseous dental<br>implant and NHA, Endosseous dental<br>implant abutment |
| | Subject Device<br>(Current Submission) | Reference device | Reference device |
| Characteristics | BTI Extra-Short Dental Implant<br>System UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| Indications for<br>use | The BTI Dental Implant System<br>UnicCa® for oral implant surgery is to<br>be used for the partial or total<br>replacement of teeth in edentulate<br>patients. Once attached to the bone, the<br>implants act as an anchor for various<br>fixed or removable prosthetic solutions<br>that can be used to improve or restore a<br>patient's mastication function.<br><br>In the case of 5.5 – 6.5mm long<br>UnicCa® implants: These implants<br>should be used in a two-stage surgical<br>procedure. These implants are indicated<br>for delayed loading. These implants are<br>indicated only for straight abutments<br>and to support permanently fixed<br>restorations.<br><br>In the case of Tiny® 3.0 UnicCa®<br>implants: These implants shall be used<br>only to replace maxillary lateral incisors<br>and mandibular lateral and central<br>incisors. Immediate loading is<br>recommended when there is good<br>primary stability and an appropriate<br>occlusal load. | 3i T3* Dental Implants are intended for<br>surgical placement in the upper or lower<br>jaw to provide a means for prosthetic<br>attachment in single tooth restorations<br>and in partially or fully edentulous spans<br>with multiple single teeth utilizing<br>delayed or immediate loading, or as a<br>terminal or intermediary abutment for<br>fixed or removable bridgework, and to<br>retain overdentures.<br><br>3i T3® Dental Implants are intended for<br>immediate function on single tooth<br>and/or multiple tooth<br>applications when good primary stability<br>is achieved, with appropriate occlusal<br>loading, in order to restore chewing<br>function. | S.I.N. Dental Implant System is intended<br>for placement in the maxillary or<br>mandibular arch to provide support for<br>single-unit or multi-unit restorations.<br>When a one-stage surgical approach is<br>applied, the S.I.N. Dental Implant System<br>is intended for immediate loading when<br>good primary stability is achieved and with<br>appropriate occlusal loading. Implants<br>with lengths less than 7 mm are intended<br>for delayed loading only. |
| Material | Titanium CP4 | Titanium CP4 | Titanium CP4 |
| Connection | Internal | External | Internal |
| | Subject Device<br>(Current Submission) | Reference device | Reference device |
| Characteristics | BTI Extra-Short Dental Implant<br>System UnicCa® | Osseotite BIOMET 3I, LLC (K133049)…