(311 days)
No
The 510(k) summary describes a physical dental implant system and its intended use, device description, and performance studies (biocompatibility, bench testing, sterilization, human factors). There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The focus is on the material properties, design, and surgical application of the implant.
Yes
Explanation: The device is a dental implant system used for the partial or total replacement of teeth in edentulous patients, which directly addresses a medical condition to restore mastication function, thereby classifying it as a therapeutic device.
No
Explanation: The device is a dental implant system used for the partial or total replacement of teeth. Its function is to act as an anchor for prosthetic solutions, not to diagnose a condition or disease.
No
The device description clearly states it is a "self-tapping, threaded, root form dental titanium implant," which is a physical hardware device.
No, 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 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: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies listed are related to the physical properties of the implant (biocompatibility, fatigue, corrosion, sterilization, packaging) and its handling in a surgical setting. They do not involve the analysis of biological samples.
Therefore, based on the provided information, the BTI Dental Implant System UnicCa® is a surgical implant device, not an In Vitro Diagnostic device.
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
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. to expand the product offering for the Wide and Universal Plus 5.5 mm and 6.0 mm diameter Interna® implants to extend implant length up to 15 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, jaw bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental setting
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)
Biocompatibility Testing
Biocompatibility was established within BTI Dental Implant System UnicCa® 510(k) K151391 in conformance with ISO 10993-1:2009. Sample preparation for testing was made based on ISO 10993-12:2012. As there have been no changes in the materials of manufacture compared with the predicate system, biocompatibility testing included within K151391 is directly applicable to the modified device subject of this submission.
Tests performed:
- Cytotoxicity Test (ISO 10993-5:2009)
- 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)
- Wetting Solution - Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
Bench Testing
Bench testing was presented within previous BTI Dental Implant System UnicCa® 510(k) K151391, to demonstrate that the devices met the required specifications for complete design verification tests, which included: Fatigue Testing based on EN ISO 14801:2008 (Dentistry. 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.
Based on risk analysis activities, previous testing performed encompasses the size range extension proposed for the Interna® implant as described within this current submission and therefore no additional bench testing has been performed.
Shelf life and package integrity to provide for an expiry of 5 years was validated previously within BTI Dental Implant System UnicCa® 510(k) K151391. This test was not repeated since all aspects of packaging and sterile barrier materials, process and process parameters are identical for all implants within the BTI Dental Implant System UnicCa® product family.
Sterilization validation successfully concluded that the gamma irradiation process, when performed per associated process specifications, can reliably sterilize the subject device to a SAL of 10-6. Product integrity and characteristics are not affected by sterilization process, supporting the finding of substantial equivalence with predicate device. All aspects of the Gamma sterilization validation process and test remained unchanged as cleared under K151391.
Furthermore, the Limulus Amebocyte Lysate (LAL) bacterial endotoxin tests performed as per ANSI ST72, USP and USP on the subject device yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device for medical devices not intended to contact cerebrospinal fluid.
Human Factors Study
A Human Factors study was performed to assess handling of the proposed a single-barrier packaging and users' ability to maintain sterility of the implant in aseptic field. The study concluded that the tested packaging is adequate for use in dental setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 17, 2018
B.T.I. Biotechnology Institute, S.L. Fernanda Ros Regulatory Affairs Manager Leonardo Da Vinci 14, Parque Tecnologico De Alava Minano, 01510 SPAIN
Re: K173257
Trade/Device Name: BTI Dental Implant System UnicCa® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: July 16, 2018 Received: July 18, 2018
Dear Fernanda 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173257
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 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 as 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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FORM FDA 3881 (8/14)
Page 1 of 1
3
510(K) SUMMARY K173257
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: August 16, 2018
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
The primary predicate device is BTI Dental Implant System UnicCa®, K151391, concurrence date: May 2nd, 2016.
Reference predicates are identified that encompass similar larger diameter/longer length dental implants proposed for the subject UnicCa® device. The reference predicates include the NobelActive® Interna Hex (Nobel Biocare AB - reference K142260 cleared on May 11, 2015) and the Biomet OSSEOTITE II Internal Hex (Biomet 3i - reference K100724 cleared on April 1, 2011)
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. to expand the product offering for the Wide and Universal Plus 5.5 mm and 6.0 mm diameter Interna® implants to extend implant length up to 15 mm. Specifically, the implants described within this submission are summarized in Table 5-1.
Table 5-1. Overview of size range extension of BTI Dental Implant System UnicCa® Interna® implant, platforms, diameters and lengths:
| Connection | Platform | Diameter
(mm) | Length (mm) |
|------------|----------------|------------------|---------------------------------|
| Interna® | Wide | 5.5 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 6.0 | 7.5 / 8.5 / 10 / 11.5 / 13 |
| | Universal Plus | 5.5 | 7.5 / 8.5 / 10 / 11.5 / 13 |
The modifications described herein do not alter the overall design of the BTI Dental Implant System UnicCa® or product intended use, nor do the changes alter the fundamental scientific technology. In addition, the material used, the energy type, environmental specifications, performance specifications, ergonomics of the patient-user interface, packaging and expiration dating, manufacturing and sterilization remains unchanged from the predicate device.
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.
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 modified UnicCa® Interna® BTI Dental Implant Systems, have the following similarities to those which previously received 510(k) concurrence via K151391:
- . have the same indication for use,
- use the same operating principle, ●
- incorporate the same basic implant design, ●
- incorporate the same materials, ●
- have the same surface treatment, ●
- have the same shelf life, and ●
- are packaged and sterilized using the same materials and processes. ●
The only modification consists of a dimensional change in the Interna® connection implants. Under the same basic implant design, the diameter is increased over lengths already cleared by K151391. Table 5-2 represents diameters and lengths of the Interna® connection cleared within K151391 and the dental implants subject of this current Traditional 510(k) submission. Even if considered as a dimensional change, the additional size offerings described herein are within the range previously cleared for the BTI Dental Implant System UnicCa® (K151391). Therefore, it might be considered as a range extension of the already cleared BTI Dental Implant System UnicCa®(K151391).
6
Table 5-2. Range of platform, diameter and lengths of the predicate UnicCa® Interna® implant previously cleared within K151391 and additional size offerings subject of this 510(k) submission (new size offerings identified in bold text).
| Connection | Platform | Diameter
(mm) | Length (mm) |
|------------|----------------|------------------|---------------------------------------------|
| InternaⓇ | Wide | 5.0 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 5.5 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| | | 6.0 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 |
| | Universal Plus | 4.5 | 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 / 7.5 / 8.5 / 10 / 11.5 / 13 |
| | 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 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18 |
| | | 4.25 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
A comparison of the device features, indications for use, laboratory data and other information demonstrate that the modified BTI Dental Implant System UnicCa® Interna® implant is substantially equivalent to the predicate device. In the following pages, a comparison table has been provided, Table 5-3.
7
Table 5-3. Comparison of the modifed Interna® BTI Dental Implant System UnicCa® with predicate BTI Dental Implant System UnicCa®:
| Subject Device / Current Submission | Predicate | ||
|---|---|---|---|
| Characteristics | Modified BTI Dental Implant System UnicCa® | ||
| Interna® Implant | K151391, BTI Dental Implant System UnicCa® | ||
| 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. | 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 | |||
| areindicated 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 | |||
| andmandibular lateral and central incisors. Immediate | |||
| loading is recommended when there is good primary | |||
| stability and an appropriate occlusal load. |
8
| Subject Device / Current Submission | Predicate | ||
|---|---|---|---|
| Characteristics | Modified BTI Dental Implant System UnicCa® | ||
| Interna® Implant | K151391, BTI Dental Implant System UnicCa® | ||
| 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 | |||
| Implant | |||
| Design/Geometry | Threaded, root form | Threaded, root form | |
| Material | Commercially pure titanium grade 4 | Commercially pure titanium grade 4 | |
| Abutment | |||
| Compatibility/ | |||
| Connection | Internal (Interna) | Internal (Interna) and External (Externa) | |
| Dimensions (mm) | Interna | Diameter: 5.5 and 6.0 | |
| Lengths: | |||
| 7.5 to 15 | Diameter: 3.3 to 6.0 | ||
| Lengths: | |||
| 5.5 to 18.0 | |||
| Externa | Not applicable | Diameter: 3.0 to 5.5 | |
| Lengths: | |||
| 7.0 to 18.0 | |||
| Roughness | Neck: Sq1= $0.7 \pm 0.1 \mu m$ ; | ||
| Sdr2= 50± 10% | Neck: Sq3= $0.7 \pm 0.1 \mu m$ ; | ||
| Sdr4= 50± 10% |
¹ Sq: Root Square Mean Roughness.
² Sdr= Developped surface.
9
| Characteristics | Subject Device / Current Submission | Predicate |
|---|---|---|
| Modified BTI Dental Implant System UnicCa® | ||
| Interna® Implant | K151391, BTI Dental Implant System UnicCa® | |
| Thread: Sq≥ 1.2 μm; | ||
| Sdr≥ 200% | Thread: Sq≥ 1.2 μm; | |
| Sdr≥ 200% | ||
| Valleys: Sq= 1.0 ± 0.2 μm; | ||
| Sdr= 85± 15% | Valleys: Sq= 1.0 ± 0.2 μm; | |
| Sdr= 85± 15% | ||
| Mechanical | ||
| Properties | Material | |
| (Titanium) | ||
| . In compliance with ISO 5832-2 and ASTM F67. | In compliance with ISO 5832-2 and ASTM F67. | |
| Fatigue | ||
| . Equivalent; platform (diameter and length) dependent. | Equivalent; platform (diameter and length) dependent. | |
| Hydrophilicity | . Calcium surface treatment | Calcium surface treatment |
| Supplied Sterile | . Yes | Yes |
| Sterilization | . Gamma Radiation | Gamma Radiation |
| SAL | . 1 x 10-6 | 1 x 10-6 |
| Packaging | . Unique container | |
| (vial with clamp) | Unique container | |
| (vial with clamp) | ||
| Shelf-Life | . 5 years | |
| (based on accelerated studies, 2 years real time data from on-going stability studies) | 5 years | |
| (based on accelerated studies, 1 year real time data from on-going stability studies) |
10
A comparison of the device dimensional characteristics and indications for use demonstrate that the modified BTI Dental Implant System UnicCa® Interna® implant is substantially equivalent to the NobelActive Interna Hex (Nobel Biocare AB) and Biomet OSSEOTITE II Internal Hex (Biomet 3). In the following pages, a comparison table has been provided, Table 5-4.
11
Table 5-4. Comparison of the modifed Interna® BTI Dental Implant System UnicCa® with reference predicate NobelActive Interna Hex (Nobel Biocare AB) and Biomet OSSEOTITE II Internal Hex (Biomet 3)
| | Subject Device / Current
Submission | Reference Predicate | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Modified BTI Dental Implant
System UniCca® Interna® Implant | K142260, NobelActive® Interna Hex | K100724, Biomet OSSEOTITE II
Internal Hex | |
| 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. | NobelActive® implants are endosseous
implants intended to be surgically
placed in the upper or lower jaw bone
for anchoring or supporting tooth
replacements to restore patient esthetics
and chewing function. NobelActive®
implants are indicated for single or
multiple unit restorations in splinted or
non-splinted applications. This can be
achieved by a 2-stage or 1-stage
surgical technique in combination with
immediate, early or delayed loading
protocols, recognizing sufficient
primary stability and appropriate
occlusal loading for the selected
technique. NobelActive® 3.0 implants
are intended to replace a lateral incisor
in the maxilla and/or a central or lateral
incisor in the mandible. NobelActive®
3.0 implants are indicated for single
unit restorations only. | BIOMET 3i Dental Implants are
intended for surgical placement in
either jaw and used for anchoring or
supporting single- and multiple-unit
prostheses. BIOMET 3i Dental
Implants can be immediately loaded
when primary stability and proper
occlusion have been established. | |
| Characteristics | Subject Device / Current Submission | Reference Predicate | | |
| Dimensions (mm) | Diameter | Modified BTI Dental Implant System UniCca® Interna® Implant | K142260, NobelActive® Interna Hex | K100724, Biomet OSSEOTITE II Internal Hex |
| | Length | 5.5 and 6.0 | 3.0, 3.5, 4.3, 5.0, 5.5 | 3.25, 4.0, 5.0 and 6.0 |
| | | 7.5 to 15 | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 and 18.0 | Ø 3.25: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0
Ø4.0: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0,
20.0
Ø5.0: 8.5, 10.0, 11.5, 13.0, 15.0
Ø6.0: 8.5, 10.0, 11.5, 13.0, 15.0 |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility was established within BTI Dental Implant System UnicCa® 510(k) K151391. 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. As there have been no changes in the materials of manufacture compared with the predicate system, biocompatibility testing included within K151391 is directly applicable to the modified device subject of this submission.
| Biocompatibility Testing | Standard | |
|---|---|---|
| Cytotoxicity Test | ISO 10993-5:2009 | |
| Delayed Hypersensitivity | ISO 10993-10:2010 | |
| Implant | Intracutaneous Reactivity | ISO 10993-10:2010 |
| Acute Systemic Toxicity | ISO 10993-11:2006 | |
| Container | Cytotoxicity Test | ISO 10993-5:2009 |
| Wetting | Establishment of allowable limits for | |
| leachable substances | ISO 10993-17:2002 | |
| Solution |
Table 5-5. Biocompatibility Testing List:
Bench Testing
Bench testing was presented within previous BTI Dental Implant System UnicCa® 510(k) K151391, to demonstrate that the devices met the required specifications for complete design verification tests, which included: Fatigue Testing based on EN ISO 14801:2008 (Dentistry. 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. Based on risk analysis activities, previous testing performed encompasses the size range extension proposed for the Interna® implant as described within this current submission and therefore no additional bench testing has been performed.
Shelf life and package integrity to provide for an expiry of 5 years was validated previously within BTI Dental Implant System UnicCa® 510(k) K151391. This test was not repeated since all aspects of packaging and sterile barrier materials, process and process parameters are identical for all implants within the BTI Dental Implant System UnicCa® product family.
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Sterilization validation successfully concluded that the gamma irradiation process, when performed per associated process specifications, can reliably sterilize the subject device to a SAL of 10-6. Product integrity and characteristics are not affected by sterilization process, supporting the finding of substantial equivalence with predicate device. All aspects of the Gamma sterilization validation process and test remained unchanged as cleared under K151391.
Furthermore, the Limulus Amebocyte Lysate (LAL) bacterial endotoxin tests performed as per ANSI ST72, USP and USP on the subject device yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device for medical devices not intended to contact cerebrospinal fluid.
Human Factors Study
A Human Factors study was performed to assess handling of the proposed a single-barrier packaging and users' ability to maintain sterility of the implant in aseptic field. The study concluded that the tested packaging is adequate for use in dental setting.
VII. CONCLUSIONS
The comparison of similarities and differences between the modified device and the respective predicate devices demonstrate that the proposed and predicate devices are substantially equivalent.