(308 days)
No
The summary describes a physical dental implant system and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as an oral implant system used for partial or total replacement of teeth to improve or restore a patient's mastication function, which is a therapeutic purpose.
No
The device description indicates that the BTI Dental Implant System UnicCa® is a dental implant used for the partial or total replacement of teeth. Its function is to act as an anchor for prosthetic solutions, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a self-tapping, threaded, root form dental titanium implant, which is a physical hardware component. The 510(k) focuses on expanding the product offering of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "oral implant surgery" to replace teeth and act as an anchor for prosthetic solutions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "self-tapping, threaded, root form dental titanium implant." This is a physical implant designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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 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.
Product codes
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch (upper or lower jaw)
Indicated Patient Age Range
edentulate patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of non-clinical testing has been presented in order to demonstrate that the proposed device is substantially equivalent to the predicate devices. Tests performed are as follows:
- Biocompatibility testing in conformance with ISO 10993-1:2018 Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA guidance entitled Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. All biological endpoints relative to a long-term implant as identified in the FDA guidance have been addressed with satisfactory results.
- Corrosion Testing, Surface Hydrophilicity and TOF-SIMS Analysis (leveraged from BTI 510(k) K151391).
- Fatigue Testing based on ISO 14801:2016 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants and FDA guidance document Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued on May 12, 2004 has been evaluated for the predicate device. Analysis in this submission showed that the subject device did not represent a new worst case for dynamic fatigue testing.
- Comparative area analyses for full external area and for bone resorption of 3 mm have been performed for subject implants and reference device. Additionally, immediate bone to implant contact per surgical protocol for the subject implants and reference device has been assessed. Results showed that subject device is substantially equivalent.
- Sterilization Validation (leveraged from K151391).
- Packaging/Sterile Barrier/Shelf-Life Validation (leveraged from BTI 510(k) K173257).
- Endotoxin Testing: The presence of bacterial endotoxins is addressed according to ANSI/AAMI ST72:2019 Bacterial endotoxins- Test methods, routine monitoring, and alternatives to batch testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
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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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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: (+34) 945 297 030 Fax: (+34) 945 297 031
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.
4
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.
5
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.
7
| 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
(Current Submission)
BTI Extra-Short Dental Implant
System UnicCa® | Primary Predicate
K151391, BTI Dental Implant System
UnicCa® | Substantial Equivalence
Discussion |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | Device Class II
Regulation No.:21 CFR 872.3640.
Product code: DZE; Endosseous dental
implant. | Device Class II
Regulation No.:21 CFR 872.3640.
Product code: DZE; Endosseous dental
implant. | Identical. |
| Characteristics | Subject Device
(Current Submission)
BTI Extra-Short Dental Implant
System UnicCa® | Primary Predicate
K151391, BTI Dental Implant System
UnicCa® | Substantial Equivalence
Discussion |
| 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 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. | 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. | Identical. |
| | Implant Design/Geometry | Threaded, root form. | Threaded, root form. |
| | Material | Commercially pure titanium grade 4. | Commercially pure titanium grade 4. |
| Characteristics | Subject Device
(Current Submission)
BTI Extra-Short Dental Implant
System UnicCa® | Primary Predicate
K151391, BTI Dental Implant System
UnicCa® | Substantial Equivalence
Discussion |
| Abutment Compatibility/
Connection | Internal (Interna). | Internal (Interna) and External
(Externa). | Identical. Primary predicate
also includes implants with
External connection. |
| Dimensions (mm) | Interna
Diameter: 4.0 to 6.0
Lengths: 5.5 and 6.5 | Interna
Diameter: 3.3 to 6.0
Lengths: 5.5 to 18.0 | Similar. The diameters and
lengths in current submission
for Interna connection are
already encompassed in
Primary Predicate. |
| | Externa
Not applicable. | Externa
Diameter: 3.0 to 5.5
Lengths: 7.0 to 18.0 | |
| Roughness | Neck: Sq1= 0.7 ± 0.1 µm;
Sdr2= 50± 10%
Thread: Sq≥ 1.2 μm;
Sdr≥ 200%
Valleys: Sq= 1.0 ± 0.2 µm;
Sdr= 85± 15% | Neck: Sq= 0.7 ± 0.1 µm;
Sdr= 50± 10%
Thread: Sq≥ 1.2 μm;
Sdr≥ 200%
Valleys: Sq= 1.0 ± 0.2 µm;
Sdr= 85± 15% | Identical. |
| Mechanical
properties | Material
(Titanium)
In compliance with ISO 5832-2 and
ASTM F67. | In compliance with ISO 5832-2 and
ASTM F67. | Identical. |
| | Fatigue
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
(Current Submission)
BTI Extra-Short Dental Implant
System UnicCa® | Primary Predicate
K151391, BTI Dental Implant System
UnicCa® | Substantial Equivalence
Discussion |
| Shelf-Life | Same. 5 years. | 5 years. | Identical. |
8
9
! Sq: Root Square Mean Roughness.
2 Sdr= Developped surface.
² Sdr= Developed surface.
10
Table 5-4 provides a comparison of the BTI Extra-Short Dental Implant System UnicCa® with the selected reference devices.
| Characteristics | Subject Device
(Current Submission) | Reference device | Reference device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BTI Extra-Short Dental Implant
System UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| Product
Classification | Device Class II
Regulation No.:21 CFR 872.3640.
Product code: DZE; Endosseous dental
implant | Device Class II
Regulation No.:21 CFR 872.3640.
Product code: DZE; Endosseous dental
implant | Device Class II
Regulation No.:21 CFR 872.3630 and
872.3640.
Product code: DZE; Endosseous dental
implant and NHA, Endosseous dental
implant abutment |
| | Subject Device
(Current Submission) | Reference device | Reference device |
| Characteristics | BTI Extra-Short Dental Implant
System UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| 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 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. | 3i T3* Dental Implants are intended for
surgical placement in the upper or lower
jaw to provide a means for prosthetic
attachment in single tooth restorations
and in partially or fully edentulous spans
with multiple single teeth utilizing
delayed or immediate loading, or as a
terminal or intermediary abutment for
fixed or removable bridgework, and to
retain overdentures.
3i T3® Dental Implants are intended for
immediate function on single tooth
and/or multiple tooth
applications when good primary stability
is achieved, with appropriate occlusal
loading, in order to restore chewing
function. | S.I.N. Dental Implant System is intended
for placement in the maxillary or
mandibular arch to provide support for
single-unit or multi-unit restorations.
When a one-stage surgical approach is
applied, the S.I.N. Dental Implant System
is intended for immediate loading when
good primary stability is achieved and with
appropriate occlusal loading. Implants
with lengths less than 7 mm are intended
for delayed loading only. |
| Material | Titanium CP4 | Titanium CP4 | Titanium CP4 |
| Connection | Internal | External | Internal |
| | Subject Device
(Current Submission) | Reference device | Reference device |
| Characteristics | BTI Extra-Short Dental Implant
System UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| Dimensions (mm) | Diameter: 4.0 -6.0 | Diameter: 3.25-6.0 mm | Diameter: 2.9 - 6.0 mm |
| | Lengths: 5.5 and6.5 | Length: 6.5-18.0 mm | Length: 5.0-15.0 mm |
| Surface | Calcium surface treatment | Discrete crystalline deposition of | Acid-etched |
| | | calcium phosphate surface treatment | HA |
| Supplied Sterile | Yes | Yes | Yes |
| Sterilization | Gamma radiation | Irradiation | Radiation sterilization validation according
to ISO 11137-1 and 11137-2 and steam
sterilization validation according to ISO
17665-1 and ISO 17665-2 |
| Packaging | Container (vial with clamp) | (Not known) | Packaged in a radiation sterilizable
package consisting of a primary container,
with implant and auxiliary parts, sealed
with a peel-off wrapping and grouped in
storage packs |
| Shelf-Life | 5 years | (Not known) | (Not known) |
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VII. NON-CLINICAL TESTING
A series of non-clinical testing has been presented in order to demonstrate that the proposed device is substantially equivalent to the predicate devices. Tests performed are as follows:
- Biocompatibility testing in conformance with ISO 10993-1:2018 Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA guidance entitled Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. All biological endpoints relative to a long-term implant as identified in the FDA guidance have been addressed with satisfactory results.
- Corrosion Testing, Surface Hydrophilicity and TOF-SIMS Analysis (leveraged from ● BTI 510(k) K151391).
- . Fatigue Testing based on ISO 14801:2016 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants and FDA guidance document Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued on May 12, 2004 has been evaluated for the predicate device. Analysis in this submission showed that the subject device did not represent a new worst case for dynamic fatigue testing.
- Comparative area analyses for full external area and for bone resorption of 3 mm have ● been performed for subject implants and reference device. Additionally, immediate bone to implant contact per surgical protocol for the subject implants and reference device has been assessed. Results showed that subject device is substantially equivalent.
- Sterilization Validation (leveraged from K151391). ●
- Packaging/Sterile Barrier/Shelf-Life Validation (leveraged from BTI 510(k) ● K173257).
- Endotoxin Testing: The presence of bacterial endotoxins is addressed according to ● ANSI/AAMI ST72:2019 Bacterial endotoxins- Test methods, routine monitoring, and alternatives to batch testing.
VIII. CLINICAL TESTING
Clinical testing is not required for the dimensional range extension.
IX. CONCLUSIONS
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The comparison of similarities and differences between the modified device and the respective predicate device demonstrate that the proposed and predicate device are substantially equivalent.