(393 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to replace missing teeth and restore mastication function, which is a therapeutic purpose.
No
The BTI Dental Implant System UnicCa® is a dental implant system used for the partial or total replacement of teeth. It acts as an anchor for prosthetic solutions and is used in oral implant surgery. Its function is to provide structural support, 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 component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 in bone.
- 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 outside the body to analyze biological samples. This device is a surgical implant used inside the body.
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, NHA
Device Description
BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and 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 expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included. The dental implants subject of this submission are summarized in the table below:
| Connection | Platform | Platform diameter (mm) | Diameter (mm) | Length (mm) |
|---|---|---|---|---|
| Interna | Narrow | 3.5 | 3.3 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| 3.5 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | |||
| 3.75 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | |||
| 4.0 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 | |||
| 4.25 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 | |||
| 4.75 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 | |||
| Universal Plus | 4.1 | 6.0 | 7.5 / 8.5 / 10 / 11.5 |
The Compatible abutments in this submission are to be used with the Interna Narrow implants, and encompasses Healing abutments, Healing Screws, titanium abutments, Titanium abutments, Transepithelial abutments, Healing Caps, Interfaces and Screws.
The BTI Interna Narrow/Plus Dental Implant System UnicCa® has identical indications for use, operating principle, incorporates identical or similar materials, has identical implant surface treatment, and possesses the same shelf-life, packaging and sterilization processes than the identified predicate devices.
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
Not Found
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 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. 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 K151391).
- Fatigue Testing based on ISO 14801 Dentistry. Implants. Dynamic fatique 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 BTI Interna Narrow/Plus Dental Implant System UnicCa®. Test results show that the proposed device is substantially equivalent to the predicate device for its intended use.
- Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device. Additionally, immediate bone to implant contact per surgical protocol for these implants and reference device has been assessed. Results showed that subject device is substantially equivalent.
- Sterilization Validation to a sterility assurance level (SAL) of 10-6, according to ISO 11137-1, ISO 11137-2 and ISO 17665-1.
- Packaging/Sterile Barrier/Shelf-Life validation according to ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1886, ASTM 1929 and ASTM F2096.
- Transport validation according to ISTA 3A.
- Endotoxin Testing according to ANSI/AAMI ST72 Bacterial endotoxins- Test methods, routine monitoring, and alternatives to batch testing.
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.
K151391, K022258, K053355, K061383
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.
K133049, K170392, K130808, K132219, K133421, K161655, K162848, K171757, K173968, K170588
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/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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN
Re: K211952
Trade/Device Name: BTI Interna Narrow/Plus Dental Implant System UnicCa® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 10, 2021 Received: June 21, 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 mediation-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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211952
Device Name
BTI Interna Narrow/Plus 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: 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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510(k) SUMMARY - K211952
1. APPLICANT INFORMATION
Name and address: 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: Mr. José Ramón Rivero Date prepared: 7/21/2022
2. DEVICE NAME AND CLASSIFICATION
Name of Device: BTI Interna Narrow/Plus Dental Implant System UnicCa® Primary Product Code: DZE Secondary Product Code: NHA Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant, Endosseous dental implant abutment. Regulatory Class: II
3. PREDICATE DEVICES
The primary predicate device is the BTI Dental Implant System UnicCa® Interna®, which was subject of K151391 (cleared on May 2, 2016). In addition, the following predicates/reference devices have been identified for respective implants and prosthetic components described within this premarket notification:
- B.T.I. Biotechnology Institute, S.L. Dental Implant System, cleared under K022258, ●
- BTI Interna Dental Implant System, cleared under K053355, ●
- BTI Sterile Dental Drills Kit, BTI Abutments and Caps, cleared under K061383, ●
- BIOMET 3i ™, cleared under K133049, ●
- S.I.N. Dental Implant System, cleared under K170392, ●
- Straumann Healing Abutments, Healing Caps, and Closure Screws, cleared under K130808. ●
- Straumann® Variobase™ Abutments, cleared under K132219, ●
- Straumann® Magellan Abutment System, cleared under K133421, ●
- On1 Concept, cleared under K161655,
- Straumann® CARES® Golden Ti/TiN Abutments, cleared under K162848, ●
- Straumann® Screw Retained Abutments, cleared under K171757, and ●
- Straumann® Variobase™ for Bridge/Bar Cylindrical, cleared under K173968. ●
- DESS Dental Smart Solutions, cleared under K170588. ●
4
4. DEVICE DESCRIPTION
BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and 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 expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included. The dental implants subject of this submission are summarized in the table below:
| Connection | Platform | Platform diameter (mm) | Diameter (mm) | Length (mm) |
|---|---|---|---|---|
| Interna | Narrow | 3.5 | 3.3 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 |
| 3.5 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | |||
| 3.75 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | |||
| 4.0 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 | |||
| 4.25 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 | |||
| 4.75 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 | |||
| Universal Plus | 4.1 | 6.0 | 7.5 / 8.5 / 10 / 11.5 |
The Compatible abutments in this submission are to be used with the Interna Narrow implants, and encompasses Healing abutments, Healing Screws, titanium abutments, Titanium abutments, Transepithelial abutments, Healing Caps, Interfaces and Screws.
The BTI Interna Narrow/Plus Dental Implant System UnicCa® has identical indications for use, operating principle, incorporates identical or similar materials, has identical implant surface treatment, and possesses the same shelf-life, packaging and sterilization processes than the identified predicate devices.
5. 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.
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.
6. TECHNOLOGICAL CHARACTERISTICS
The proposed UnicCa® Interna Narrow/Plus Dental Implant System UnicCa® has the following similarities to those which previously received 510(k) concurrence via K053355, K061383 and K151391:
- has identical indications for use,
- uses identical operating principle,
- incorporates identical or similar materials,
- has identical implant surface implant treatment and ●
- . is packaged and sterilized using identical materials and processes.
To bridge the gap in dimensional changes and surface coatings, additional devices of other commercially available dental implant lines, intended for similar use as the subject device are identified; specifically, the following ones:
- BIOMET 3i ™. cleared under K133049. -
- -S.I.N. Dental Implant System, cleared under K170392,
- Straumann Healing Abutments, Healing Caps, and Closure Screws, cleared under K130808. -
- Straumann® Variobase™ Abutments, cleared under K132219, -
- Straumann Magellan™ Abutment System, cleared under K133421, -
- On1 Concept, cleared under K161655, -
- Straumann® CARES® Golden Ti/TiN Abutments, cleared under K162848, -
- -Straumann® Screw Retained Abutments, cleared under K171757 and
- Straumann® Variobase™ for Bridge/Bar Cylindrical, cleared under K173968. -
- DESS Dental Smart Solutions, cleared under K170588. -
A comparison of the device features, indications for use, bench testing and other information shows that the proposed BTI Interna Narrow/Plus Dental Implant System UnicCa® is substantially equivalent to the predicate devices. Table 5-3 compares the subject device to selected predicate devices.
The subject dental implants are substantially equivalent to those BTI dental implants currently cleared under K151391. Additional devices BIOMET 3i™ and S.I.N. Dental Implant System are identified for support of those implants whose dimensional combination are not covered by those BTI implants already cleared.
The subject Closure Screws are substantially equivalent to those cleared in BTI 510(k) K022258. Additional predicate, Straumann Healing Abutments, cleared under K130808, is identified for support of substantial equivalence of abutment gingival height. The Closure Screws packaging is identical to that in K151391.
The subject Healing abutments are substantially equivalent to those cleared in BTI 510(k) K061383. Additional BTI predicate K022258 is included for support of substantial equivalence of abutment Ø3.5
6
mm. The Straumann Healing Abutments, cleared under K130808 are identified for support of the reduced design of the subject Healing abutments.
The subject Temporary Titanium Abutments are substantially equivalent to the corresponding BTI Temporary Abutments cleared under K053355. Additional BTI Temporary abutments cleared under K022258 are identified as it included similar Temporary Titanium abutments of Ø3.5 mm and for support of those used with Transepithelial abutments.
The subject Titanium Abutments (Titanium Bioabutments and Square Aesthetic Abutments) are substantially equivalent to the corresponding design cleared for BTI Titanium abutments in K053355. Straumann® Variobase™ Abutments, cleared under K132219, Straumann® Variobase™ for Bridge/Bar Cylindrical, cleared under K173968, and Straumann® CARES Golden Ti/TiN Abutments, cleared under K162848, are identified because they included similar abutment heights and surface treatment (Titanium Nitride, TiN) as the proposed device.
The subject Transepithelial Abutments (Unit, Multi-im) are substantially equivalent to those design of BTI Transepithelial abutments already cleared under K061383, and those Titanium Abutments engaging design with dental implant cleared under K053355. Straumann® Screw Retained Abutments, cleared under K171757, is identified for support of the Ø3.5 mm, and Straumann® CARES® Golden Ti/TiN Abutments, cleared under K162848, for support of the coating material (Titanium Nitride, TiN). DESS Dental Smart Solutions is identified because it included a similar DLC coating applied to the retention screw thread in subject device.
The subject Healing caps are substantially equivalent to those BTI protection caps design cleared under K022258. On1 Concept, cleared under K161655, is identified for support of substantial equivalence for Heights of 3.0 and 4.0 mm.
The subject Interfaces are substantially equivalent to the BTI design cleared under K022258. Straumann Magellan™ Abutment System, cleared under K133421 is identified for support of prosthetic Ø3.5 mm, and On1 Concept for support of prosthetic Ø5 and Ø5.1 mm. Straumann® CARES® Golden Ti/TiN Abutments, cleared under K162848 is identified because it included similar surface treatment (Titanium Nitride, TiN) to that applied on subject Interfaces.
The subject Screws are substantially equivalent to that BTI screw design cleared under K022258 and K053355. DESS Dental Smart Solutions is identified for support of the DLC coating applied to the screw thread.
7
| SUBJECT DEVICE | PREDICATE DEVICE | ADDITIONAL PREDICATE | SUBSTANTIAL EQUIVALENCE | |||
|---|---|---|---|---|---|---|
| FEATURE | BTI Interna Narrow/Plus | |||||
| Dental Implant System | ||||||
| UnicCa® (K211952) | BTI Dental Implant | |||||
| System UnicCa® | ||||||
| (K151391) | B.T.I. Biotechnology | |||||
| Institute, S.L. Dental | ||||||
| Implant System | ||||||
| (K022258) | BTI Interna Dental | |||||
| Implant System | ||||||
| (K053355) | BTI Sterile Dental Drills | |||||
| Kit, BTI Abutments and | ||||||
| Caps (K061383) | ||||||
| Product | ||||||
| Classification | Product code: DZE, NHA | |||||
| Regulation No.: 21 CFR | ||||||
| 872.3640Device Class II | Product code: DZE | |||||
| Regulation No.:21 CFR | ||||||
| 872.3640. | ||||||
| Device Class II | Product Code: DZE | |||||
| Regulation No.: 21 CFR | ||||||
| 872.3430 | ||||||
| Device Class II | Product Code: DZE | |||||
| Regulation No.: 21 CFR | ||||||
| 872.3640 | ||||||
| Device Class II | Product Code: NHA, EJL | |||||
| Regulation No.: 21 CFR | ||||||
| 872.3630 and 21 CFR | ||||||
| 873.3640 | ||||||
| Device Class II | Identical. | |||||
| 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. | 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. | 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. | 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. | Dental burs are intended
to drill bone tissue and
provisionally soft tissues
during, before and after a
surgical intervention of
dental implants.
Endosseous dental
implant abutments are
intended to model the
gingival
tissue during the process
of healing after the first or
second surgery and to be
attached to the implant to
hold single or multiple
teeth restorations. | Identical to primary
predicate device. |
| | 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 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 | 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 | | | | |
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE | SUBSTANTIAL EQUIVALENCE |
| Reason for
predicate
inclussion | BTI Interna Narrow/Plus
Dental Implant System
UnicCa® (K211952) | BTI Dental Implant
System UnicCa®
(K151391) | B.T.I. Biotechnology
Institute, S.L. Dental
Implant System
(K022258) | BTI Interna Dental
Implant System
(K053355) | BTI Sterile Dental Drills
Kit, BTI Abutments and
Caps (K061383) | |
| plant design | primary stability and an
appropriate occlusal load. | and an appropriate
occlusal load. | Healing abutment and
Healing cap design,
Interfaces, usage and
screw design and material. | Definitive and
Transepithelial abutment
design, usage, connection
to implant and materials
used. | Transepithelial abutment
design, sterilization and
packaging | Similar designs, sterilization
and packaging are included
in subject and the identified
predicate devices, intended
for similar use. |
| Platform
diameter (mm) | Interna Narrow: 3.5
Interna Universal Plus: 4.1 | Interna: 4.1, 5.5
Externa: 3.5, 4.1, 5.5 | Externa Narrow: 3.5
Externa Universal: 4.1
Externa Wide: 5.5 | Interna Universal: 4.1
Interna Wide: 5.5 | | Similar. A new platform
diameter for the Interna
connection (Interna Narrow)
is included. However, the
range of implant platform
diameters are covered by
the identified predicate
devices. Interna Universal
Plus identical to the
predicate device. |
| Implant length
(mm) | Interna Narrow: 5.5 - 15
Interna Universal Plus: 7.5
- 11.5 | 5.5 - 18 | 7.0 - 18 | 7.0 - 18 | | Identical |
| Implant body
diameter (mm) | Interna Narrow: 3.3 – 4.75
Interna Universal Plus: 6.0 | Interna: 3.3 – 6.0
Externa: 3.0 – 5.5 | 3.3 - 5.5 | 3.3 - 5.0 | | Identical |
| Implant material | Commercially pure
titanium (Grade 4) | Commercially pure
titanium (Grade 4) | Commercially pure titanium
(Grade 4) | Commercially pure
titanium (Grade 4) | | Identical. |
| Implant surface
treatment | Calcium surface treatment | Calcium surface treatment | Calcium surface treatment | (not applicable) | | Identical to primary
predicate. |
| Abutment design | | | | | | |
| Restoration | Single and multiple | Single and multiple | Single and multiple | Single and multiple | Single and multiple | Identical. |
| Connection
design | Engaging, non-engaging. | Engaging, non-engaging | Engaging, non-engaging | Engaging, non-engaging | Engaging, non-engaging | Identical. |
| FEATURE | SUBJECT DEVICE
BTI Interna Narrow/Plus
Dental Implant System
UnicCa® (K211952) | PREDICATE DEVICE
BTI Dental Implant
System UnicCa®
(K151391) | ADDITIONAL
PREDICATE
B.T.I. Biotechnology
Institute, S.L. Dental
Implant System
(K022258) | ADDITIONAL
PREDICATE
BTI Interna Dental
Implant System
(K053355) | ADDITIONAL
PREDICATE
BTI Sterile Dental Drills
Kit, BTI Abutments and
Caps (K061383) | SUBSTANTIAL
EQUIVALENCE |
| Abutment
prosthetic
diameter (mm) | 3.5 - 5.1 | - | 3.5 - 6.5 | 4 - 6.5 | 4.1, 5.5 | Similar. Range of diameters
covered by the identified
predicate devices. |
| Abutment
gingival height
(mm) | 0.5 - 4 | - | 2 - 4 | 1 - 4 | 1 - 4 | Similar. Range of gingival
heights covered by the
identified predicate devices
and reference devices. |
| Abutment
angulation | Straight (0°)
(Except for Multi-im
abutments that allow for
up to 20° divergence per
implant). | - | Straight (0°)
(Divergence allowance not
specified). | Straight (0°)
(Divergence allowance not
specified). | Straight (0°)
(Divergence allowance not
specified). | Identical. Divergence
allowance in subject device
is supported by bench
testing provided. |
| Abutment
material | Commercially pure
titanium (Grade 4) | - | Commercially pure titanium
(Grade 4), titanium Grade
3 | Commercially pure
titanium (Grade 4) | Commercially pure
titanium (Grade 4) | Identical to identified
predicate devices. |
| Prosthetic
Screws material | Ti6Al4V | - | Commercially pure titanium
(Grade 4), gold/palladium
alloy | Ti6Al4V | - | Identical to K053355. |
| Packaging, sterilization and shelf-life | | | | | | |
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE | SUBSTANTIAL EQUIVALENCE |
| Abutments | BTI Interna Narrow/Plus
Dental Implant System
UnicCa® (K211952) | BTI Dental Implant
System UnicCa®
(K151391) | B.T.I. Biotechnology
Institute, S.L. Dental
Implant System
(K022258) | BTI Interna Dental
Implant System
(K053355) | BTI Sterile Dental Drills
Kit, BTI Abutments and
Caps (K061383) | |
| | Healing abutments and
Transepithelial abutments:
Provided sterile by gamma
irradiation.
Packaging: Thermoform
tray with peel top lid. | | Temporary abutments,
Titanium abutments,
Healing Caps, Interfaces
and Screws:
Provided non-sterile.
Packaging: thermosealed
bag. | Temporary abutments,
Titanium abutments, and
Screws:
Provided non-sterile, to be
sterilized by end user –
moist heat.
Packaging: thermosealed
bag. | Healing abutments and
Transepithelial abutments:
Provided sterile by gamma
irradiation.
Packaging: Thermoform
tray with peel top lid | Similar packaging as the
identified predicate devices. |
| | Temporary Titanium
abutments, Titanium
abutments, Healing Caps,
Aesthetic Interfaces and
Screws:
Provided non-sterile, to be
sterilized by end user –
moist heat.
Packaging: thermosealed
bag. | | | | | |
Table 5-3 Comparison of the BT/ Interna Narrow/Plus Dental Implant System UnicCa® with the selected reference device
B.T.I. Biotechnology Institute, S.L
8
510(k) Summary
K211952
B.T.I. Biotechnology Institute, S.L
|
9
510(k) Summary
K211952
B.T.I. Biotechnology Institute, S.
10
510(k) Summary
K211952
B.T.I. Biotechnology Institute, S.
11
7. PERFORMANCE 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 Biological evaluation of medical ● devices - Part 1: Evaluation and testing within a risk management process. 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 ● K151391).
- Fatigue Testing based on ISO 14801 Dentistry. Implants. Dynamic fatique 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 BTI Interna Narrow/Plus Dental Implant System UnicCa®. Test results show that the proposed device is substantially equivalent to the predicate device for its intended use.
- Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device. Additionally, immediate bone to implant contact per surgical protocol for these implants and reference device has been assessed. Results showed that subject device is substantially equivalent.
- Sterilization Validation to a sterility assurance level (SAL) of 10-6, according to ISO 11137-1, ● ISO 11137-2 and ISO 17665-1.
- Packaging/Sterile Barrier/Shelf-Life validation according to ISO 11607-1, ISO 11607-2, ● ASTM F88, ASTM F1886, ASTM 1929 and ASTM F2096.
- Transport validation according to ISTA 3A. ●
- . Endotoxin Testing according to ANSI/AAMI ST72 Bacterial endotoxins- Test methods, routine monitoring, and alternatives to batch testing.
8. CONCLUSIONS
The comparison of similarities and differences between the proposed range extension and the respective predicate devices demonstrate that the subject device is substantially equivalent to the identified predicate devices.