(342 days)
No
The summary describes a physical dental implant system and its intended use, without mentioning any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being used for the "partial or total replacement of teeth in edentulate patients" and to "improve or restore a patient's mastication function," which clearly indicates a therapeutic purpose.
No
The BTI Dental Implant System UnicCa® is described as a device for "partial or total replacement of teeth" and acts as an "anchor for various fixed or removable prosthetic solutions". Its function is to restore mastication function, not to diagnose a condition.
No
The device description clearly states it is a "self-tapping, threaded, root form dental titanium implant," which is a physical hardware device, not software.
Based on the provided text, 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 prosthetics. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a surgical and prosthetic purpose.
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: 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The subjects were over 18 years old, were partially or completely edentulous and required treatment with dental implants.
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)
Clinical Testing: BTI conducted an observational retrospective study for BTI Dental Implant System UnicCa. 170 patients with 430 BTI UniCA implants were evaluated. The analysis demonstrated rates of 99.5% and 98.8% respectively for implant- and subject-based survival at 6 months post implant insertion. Implant survival was based upon a stable prosthesis without pain, infections, or any pathology and absence of radiopaque images around the implant, loss of implant, fracture, bone loss > 2-3mm, or infection. No complications or adverse events related to the use of BTI UniCa implants were reported. In comparison, commonly observed survival estimates reported in the literature generally range from 90% to 98%.As a consequence, it is considered that BTI Dental Implant System UnicCa® is substantially equivalent to the declared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
implant- and subject-based survival at 6 months post implant insertion (99.5% and 98.8% respectively)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect of
this information collection, including suggestions for reducing this burden, to:
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Food and Drug Administration Office
of Chief Information Officer Paperwork
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'An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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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: (+34) 945 297 030 Fax: (+34) 945 297 031
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; | |||
| BTI Dental Implant System. | K091387; BTI Dental Implant 5.5 – 6.5. | ||
| K092112; BTI Dental Implant Tiny® Ø 3.0. |
4
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
(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] |
5
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.
6
| Characteristics | Current Submission
BTI Dental Implant System
UnicCa®
(K151391) | Primary Predicate
BTI Dental Implant
System
(K022258) | BTI Dental
Implant System
(K053355) | Reference Predicates
BTI Dental
Implant 5.5-6.5
(K091387) | BTI Dental
Implant Tiny®
(K092112) | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 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. | The intended use of the
system is the
restoration of missing
teeth in partially or
fully edentulous
patients and/or the
fixation of
overdentures to restore
or enhance the chewing
capacity of patients. | Dental implant
system comprising
endosseous
titanium implants
and prosthetic
elements to be
attached to the
implants, as well
as auxiliary
elements for
surgical and
prosthetic
procedures. The
intended use of the
system is the
restoration of
missing teeth in
partially or fully
edentulous patients
and/or the fixation
of overdentures to
restore or enhance
the chewing
capacity of
patients. | BTI Dental implants
5.5 - 6.5 mm are
intended to be used
to restore missing
teeth in partially or
fully edentulous
patients and/or for
the fixation of
overdentures to
restore or enhance
the chewing capacity
of patients. The
device should be
used in a two-stage
surgical procedure.
These implants are
not indicated for
immediate loading.
These implants are
not indicated to
support removable
resilient retained
restorations or angled
abutments. | BTI Dental Implant
Tiny® 3.0 are
intended to be used to
restore missing teeth
in partially or fully
edentulous patients
and/or the fixation of
overdentures'to restore
or enhance the
chewing capacity of
patients.
These implants shall
be used only to
replace maxillary
lateral incisors and
mandibular lateral and
central incisors.
Immediate loading is
recommended when
there is good primary
stability and an
appropriate occlusal
load. | |
| | Current Submission | Primary Predicate | Reference Predicates | | | |
| Characteristics | BTI Dental Implant System
UnicCa®
(K151391) | BTI Dental Implant
System
(K022258) | BTI Dental
Implant System
(K053355) | BTI Dental
Implant 5.5-6.5
(K091387) | BTI Dental
Implant Tiny®
(K092112) | |
| | 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 indications for use statement for the BTI Dental Implant System UnicCa® has been written to encompass the
indications for use statements provided with the primary predicate system (K022258) and other previously cleared
connections, platforms, diameters and lengths acting as a single consolidated system.
In this sense, no labeling change that affects the indications for use of the device has been implemented. Information
relevant to a specific use of an implant included in previously cleared premarket notifications for BTI Dental Implants
are carried forward and included within the labeling for the BTI Dental Implant System UnicCa®. The product continues
to be specifically indicated for patients undergoing oral implant surgery for the partial or total replacement of teeth in
edentulate patients. | | | | | |
| Characteristics | Current Submission
BTI Dental Implant System
UnicCa®
(K151391) | Primary Predicate
BTI Dental Implant
System (K022258) | Reference Predicates | | | |
| | | | BTI Dental
Implant System
(K053355) | BTI Dental
Implant 5.5-6.5
(K091387) | BTI Dental
Implant Tiny®
(K092112) | |
| 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 872.3640.
Product code: DZE; Endosseous dental implant | | | |
| Implant Design/Geometry | Threaded, root form | Threaded, root form | Threaded, root form | | | |
| Material | Commercially pure titanium
grade 4 | Commercially pure
titanium grade 4 | Commercially pure titanium grade 4 | | | |
| Abutment Compatibility/
Connection | Internal (Interna) and External
(Externa) | External (Externa) | External
(Externa) | Internal (Interna) | External (Externa) | |
| Dimensions (mm) | Interna | Diameter: 3.3
to 6.0
Lengths:
5.5 to 18.0 | Diameter:
3.3 to 5.5
Length:
7.0 to 18.0 | Diameter:
3.3 to 5.0
Length:
7.0 to 18.0 | Diameter:
4.5 to 6.0
Lengths:
5.5 to 6.5 | Diameter:
3.0
Lengths:
11.5 to 15.0 |
| | Externa | Diameter: 3.0
to 5.5
Lengths:
7.0 to 18.0 | Diameter:
3.3 to 5.5
Length:
7.0 to 18.0 | Diameter:
3.3 to 5.0
Length:
7.0 to 18.0 | Diameter:
4.5 to 6.0
Lengths:
5.5 to 6.5 | Diameter:
3.0
Lengths:
11.5 to 15.0 |
| Roughness | Same | $Neck: Sq = 0.7 ± 0.1 µm; Sdr^2= 50± 10%$
$Thread: Sq≥ 1.2 µm;$
$Sdr≥ 200%$ | Same | | | |
| Characteristics | | Current Submission | Primary Predicate | Reference Predicates | | |
| | | BTI Dental Implant System
UnicCa®
(K151391) | BTI Dental Implant
System (K022258) | BTI Dental
Implant System
(K053355) | BTI Dental
Implant 5.5-6.5
(K091387) | BTI Dental
Implant Tiny®
(K092112) |
| | | | Valleys: Sq= $1.0 \pm 0.2$ µm; Sdr= $85 \pm 15$ % | | | |
| Mechanical
Properties | Material
(Titanium) | Same; in compliance with ISO
5832-2 and ASTM F67. | Same; in compliance
with ISO 5832-2 and
ASTM F67. | Same; in compliance with ISO 5832-2 and ASTM F67. | | |
| | Fatigue | Equivalent; platform
(diameter and length)
dependent. | Equivalent; platform
(diameter and length)
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 | | Unique container
(vial with clamp) | Primary (vial+blister)
- Secondary (carboard
box) | Primary (vial+blister) + Secondary (carboard box) | | |
| Shelf-Life | | 5 years
(based on accelerated studies,
1 year real time data from on-
going stability studies) | 5 years | 5 years | | |
Table 5-2. Comparison of the BTI Dental Implant System UnicCa® with Predicate BTI Dental Implant Systems:
7
8
1 Sq: Root Square Mean Roughness.
² Sdr= Developped surface.
^2Sdr= Developed surface.
9
10
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility tests, in conformance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process were performed. Sample preparation for testing was made based on ISO 10993-12:2012.
| Biocompatibility Testing | Standard | |||
|---|---|---|---|---|
| Cytotoxicity Test | ISO 10993-5:2009 | |||
| Implant | Delayed Hypersensitivity | ISO 10993-10:2010 | ||
| Intracutaneous Reactivity | ISO 10993-10:2010 | |||
| Acute Systemic Toxicity | ISO 10993-11:2006 | |||
| Container | Cytotoxicity Test | ISO 10993-5:2009 | ||
| Solution | Establishment of allowable limits for | ISO 10993-17:2002 | ||
| leachable substances |
Table 5-3. Biocompatibility Testing List:
Bench Testing
Bench testing has been performed for those attributes that may be impacted by the modifications made to the subject device which demonstrates that the proposed modified device met the required specifications for complete design verification tests. Fatigue Testing based on UNE-EN-ISO 14801:2008 (Dentistry. which included: Implants. Dynamic fatigue test for endosseous dental implants; ISO 14801:2007), Corrosion Testing, Surface Hydrophilicity TOF-SIMS Analysis, Packaging / Shelf-life Validation and Sterilization Evaluations.
Additionally, as a consequence of the modification of the packaging, a new sterilization method by gamma radiation is applied.
Sterilization validation successfully concluded that the gamma irradiation process, when performed per associated process specifications, can reliably sterilize the subject device to a Sterility Assurance Level of 106. Product integrity and characteristics are not affected by sterilization process, supporting the finding of substantial equivalence with primary and reference predicates.
11
Clinical Testing
BTI conducted an observational retrospective study for BTI Dental Implant System UnicCa The subjects were over 18 years old, were partially or completely edentulous and required treatment with dental implants and were treated with one or more with at least 6 months of follow-up. Patients whose UniCa implants were still not loaded were excluded. 170 patients with 430 BTI UniCA implants were evaluated. The analysis demonstrated rates of 99.5% and 98.8% respectively for implant- and subject-based survival at 6 months post implant insertion. Implant survival was based upon a stable prosthesis without pain, infections, or any pathology and absence of radiopaque images around the implant, loss of implant, fracture, bone loss > 2-3mm, or infection. No complications or adverse events related to the use of BTI UniCa implants were reported. In comparison, commonly observed survival estimates reported in the literature generally range from 90% to 98%.As a consequence, it is considered that BTI Dental Implant System UnicCa® is substantially equivalent to the declared predicate devices.
VII. CONCLUSIONS
The results of the clinical and non-clinical testing and comparison of similarities and differences between the modified devices and the respective predicate devices demonstrate that the proposed and predicate devices are substantially equivalent.