(308 days)
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.
In the case of 5.5 - 6.5mm long UnicCa® implants: These implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.
In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.
The purpose of this 510(k) is to allow B.T.I. Biotechnology Institute, S.L. to expand the product offering for the Universal and Universal Plus Interna® implant platforms. Specifically, the currently cleared Universal Interna® implants with diameters ranging from 4.0 to 4.25 mm and the 6.0 mm diameter Universal Plus Interna® implants will be provided in shorter lengths of 5.5 and 6.5 mm. The implants subject of this premarket notification, collectively referred to as BTI Extra-Short Dental Implant System UnicCa®, are summarized in Table 5-1.
This document is a 510(k) Premarket Notification from the FDA, determining substantial equivalence for a dental implant system. As such, it does not contain information about a study that proves the device meets specific acceptance criteria in the manner of a clinical trial for a novel device or software. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics.
Therefore, many of your requested points related to acceptance criteria for a study proving performance, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable here. This document leverages existing predicate devices and non-clinical testing to argue that the new, shorter versions of the implant are safe and effective.
Here's a breakdown of the information that is available or implicitly addressed, and what is not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission doesn't present a table of acceptance criteria and performance results in the context of a "study proving the device meets criteria" as one might expect for a new AI or diagnostic device. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (K151391 as primary, K133049 and K170392 as reference devices) through a comparison of technological characteristics and non-clinical testing.
The "acceptance criteria" here are implicitly that the new device configuration (shorter lengths of existing implants) should be as safe and effective as the predicate devices, as demonstrated by:
- Identical Indications for Use
- Identical Operating Principle
- Identical Materials
- Identical Surface Treatment
- Identical Shelf Life
- Identical Packaging and Sterilization materials and processes
- Compliance with relevant ISO standards and FDA guidance for non-clinical testing.
The "reported device performance" is not expressed in measured outcomes against specific clinical performance thresholds, but rather in the statement of "substantial equivalence" based on the comparisons provided.
Relevant Data from Tables 5-3 and 5-4, representing the "performance" by demonstrating similarity to predicates:
| Characteristic | Subject Device (BTI Extra-Short Dental Implant System UnicCa®) | Primary Predicate (K151391, BTI Dental Implant System UnicCa®) | Substantial Equivalence Discussion / Performance Implication |
|---|---|---|---|
| Product Classification | Class II, 21 CFR 872.3640, Product Code DZE | Class II, 21 CFR 872.3640, Product Code DZE | Identical. Implies similar regulatory oversight and general safety/effectiveness expectations. |
| Indications for Use | Same as predicate, with specific instructions for 5.5-6.5mm UnicCa® implants (two-stage, delayed loading, straight abutments, fixed restorations) and Tiny® 3.0 UnicCa® implants (maxillary lateral incisors & mandibular lateral/central incisors, immediate loading with good primary stability). | Same as subject device. | Identical. This is a primary driver for substantial equivalence, implying the device performs the same function under the same clinical conditions. |
| Implant Design/Geometry | Threaded, root form | Threaded, root form | Identical. Implies similar mechanical integration with bone. |
| Material | Commercially pure titanium grade 4 | Commercially pure titanium grade 4 | Identical. Implies similar biocompatibility and mechanical properties. |
| Abutment Compatibility/Connection | Internal (Interna) | Internal (Interna) and External (Externa) | Identical for the Interna connection. The subject device is an expansion of the Interna platform, maintaining compatibility. External connection is not part of this submission. |
| Dimensions (mm) | Interna: Diameter: 4.0 to 6.0, Lengths: 5.5 and 6.5 (New shorter lengths for specific platforms) | Interna: Diameter: 3.3 to 6.0, Lengths: 5.5 to 18.0 | Similar. The new diameters and lengths are already encompassed in the primary predicate's overall range or are explicitly being added as shorter versions of existing platforms, evaluated for safety (e.g., fatigue). |
| Roughness | Neck: Sq = 0.7 ± 0.1 µm; Sdr = 50 ± 10%. Thread: Sq ≥ 1.2 µm; Sdr ≥ 200%. Valleys: Sq = 1.0 ± 0.2 µm; Sdr = 85 ± 15%. | Neck: Sq = 0.7 ± 0.1 µm; Sdr = 50 ± 10%. Thread: Sq ≥ 1.2 µm; Sdr ≥ 200%. Valleys: Sq = 1.0 ± 0.2 µm; Sdr = 85 ± 15%. | Identical. Implies similar osseointegration characteristics. |
| Mechanical properties (Material) | In compliance with ISO 5832-2 and ASTM F67 | In compliance with ISO 5832-2 and ASTM F67 | Identical. Ensures material strength and biocompatibility compliance. |
| Mechanical properties (Fatigue) | Evaluated according to ISO 14801. Analysis showed subject device did not represent a new worst case. | Evaluated under ISO 14801. | Identical evaluation method. The critical point is that the shorter implant configurations were not determined to be a new worst-case in fatigue, implying they maintain acceptable mechanical performance. |
| Hydrophilicity | Calcium surface treatment | Calcium surface treatment | Identical. Implies similar biological response and osseointegration. |
| Sterile/Sterilization/SAL/Packaging/Shelf-Life | Yes, Gamma radiation, 1 x 10-6, vial with clamp, 5 years. | Yes, Gamma Radiation, 1 x 10-6, vial with clamp, 5 years. | Identical. Ensures continued sterility and product integrity over shelf life. |
| Biocompatibility | Conformance with ISO 10993-1:2018 and FDA guidance. All biological endpoints for a long-term implant addressed with satisfactory results. | (Leveraged from K151391) - not explicitly itemized in table, but stated in Section VII. | Demonstrated through compliance. Indicates the device is biologically safe for its intended long-term use. |
| Comparative Area Analyses | Performed for full external area and for bone resorption of 3 mm, and immediate bone to implant contact per surgical protocol. Results showed subject device is substantially equivalent. | (Referenced implicitly from predicate's established performance) | Confirms that the geometric changes (shorter length) do not negatively impact critical biological interactions like bone contact and resorption behavior compared to the predicate/reference devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a clinical test set with patient data. The "tests" are non-clinical (biocompatibility, corrosion, fatigue, comparative area analyses, sterilization, packaging, endotoxin). The sample sizes for these engineering bench tests are not specified in the summary document.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data or patient data is mentioned or used for proving substantial equivalence of these specific design changes. The data provenance would be from the B.T.I. Biotechnology Institute, S.L. in Spain (the submitter) for the non-clinical testing performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission relies on non-clinical engineering and biological testing, not on human expert review of clinical cases to establish ground truth for a test set. Substantial equivalence is determined by the FDA reviewing the provided engineering, material, and performance data against established predicate devices and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication of a test set occurred.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a dental implant (physical device), not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the sense of clinical ground truth. For a physical device like a dental implant seeking substantial equivalence for a dimension change, the "ground truth" for the non-clinical testing performed (biocompatibility, fatigue, etc.) is the adherence to material specifications (e.g., Titanium CP4), compliance with established international standards (ISO 10993-1, ISO 14801, ISO 11137-1/2, ISO 17665-1/2, ANSI/AAMI ST72), and the established safety and performance profile of the predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
In summary, this FDA 510(k) clearance is based on demonstrating substantial equivalence of new, shorter versions of an existing dental implant system to established predicate devices through a comprehensive battery of non-clinical (bench) testing and comparison of physical and material characteristics, rather than through new clinical trials or performance studies against specific acceptance criteria for a novel device or software.
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B.T.I. Biotechnology Institute, S.L. Jose Rivero Qualified Person Leonardo da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN
Re: K202825
Trade/Device Name: BTI Extra-Short Dental Implant System UnicCa® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 25, 2021 Received: July 2, 2021
Dear Jose Rivero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
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Indications for Use
510(k) Number (if known) K202825
Device Name
BTI Extra-Short Dental Implant System UnicCa®
Indications for Use (Describe)
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.
In the case of 5.5 - 6.5mm long Unic a® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.
In the case of Tiny® 3.0 UnicCa® implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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I. SUBMITTER
B.T.I. Biotechnology Institute, SL.
Parque Tecnológico de Álava C/Leonardo Da Vinci 14 01510 Miñano (Alava) Spain
Establishment registration number: 3004417597
Phone: (+34) 945 297 030 Fax: (+34) 945 297 031
Contact Person: Mr. José Ramón Rivero Date Prepared: July 29, 2021
II. DEVICE
Name of Device: BTI Extra-Short Dental Implant System UnicCa® Common or Usual Name: Root-form Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE
III. PREDICATE DEVICE
The primary predicate devices are the BTI Dental Implant System UnicCa® Interna® Implants which were subject of K151391, BTI Dental Implant System UnicCa® (cleared on May 2, 2016).
Additionally, the following reference devices have been identified to bridge the gap in implant dimensions (i.e., for the narrower/shorter implants) that are outside the scope of currently cleared BTI UnicCa® Interna® implants. These reference devices are marketed in dimensions similar to those included in this submission:
- K133049, 31 T3(R) External Hex Dental Implants (Biomet 31), January 8, 2014. ●
- K170392, S.I.N. Implant System (S.I.N. Sistema De Implante Nacional S.A.), ● December 5, 2017.
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IV. DEVICE DESCRIPTION
The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.
The purpose of this 510(k) is to allow B.T.I. Biotechnology Institute, S.L. to expand the product offering for the Universal and Universal Plus Interna® implant platforms. Specifically, the currently cleared Universal Interna® implants with diameters ranging from 4.0 to 4.25 mm and the 6.0 mm diameter Universal Plus Interna® implants will be provided in shorter lengths of 5.5 and 6.5 mm. The implants subject of this premarket notification, collectively referred to as BTI Extra-Short Dental Implant System UnicCa®, are summarized in Table 5-1.
Table 5-1. Overview of BTI Extra-Short Dental Implant System UnicCa®, platforms, diameters and lengths subject of this premarket notification:
| Connection | Platform | Diameter (mm) | Length (mm) |
|---|---|---|---|
| Interna® | Universal | 4.0 | 5.5 |
| Universal | 4.25 | 5.5 | |
| Universal Plus | 6.0 | 5.5 / 6.5 |
This submission does not include any new abutments. The subject device is compatible with abutments previously cleared under K053355, K061383, and K070533.
V. INDICATIONS FOR USE
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.
In the case of 5.5 - 6.5mm long UnicCa® implants: These implants should be used in a twostage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.
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In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
VI. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The BTI Extra-Short Dental Implant System UnicCa® have the following similarities to the UnicCa® implants which previously received 510(k) concurrence via K151391:
- have identical indications for use,
- use identical operating principle, ●
- incorporate identical materials,
- have the identical surface treatment, ●
- have identical shelf life, and
- are packaged and sterilized using the identical materials and processes. .
Table 5-2 represents diameters and lengths of the Interna® connection cleared within K151391 (and K173257 which extended the range of implant sizes) and the dental implants subject of this current Traditional 510(k) submission.
Table 5-2. Range of platform, diameter and lengths of the predicate UnicCa® Internas implant previously cleared within K151391 and additional size offerings subject of this 510(k) submission (new size offerings subject of this premarket notification identified in bold text).
| Connection | Platform | Diameter Ø (mm) | Length ↑ (mm) |
|---|---|---|---|
| Interna® | Universal | 3.3 | 8.5 / 10 / 11.5 / 13 / 15 |
| 3.5 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | ||
| 3.75 | 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | ||
| 4.0 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18 | ||
| 4.25 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | ||
| Universal Plus | 4.5 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | |
| 5.0 | 5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | ||
| 5.5 | 5.5 / 6.5 | ||
| 6.0 | 5.5 / 6.5 | ||
| Wide | 5.0 | 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15 | |
| 5.5 | 5.5 / 6.5 | ||
| 6.0 | 5.5 / 6.5 |
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A comparison of the device features, indications for use, bench testing and other information demonstrate that the BTI Extra-Short Dental Implant System UnicCa® is substantially equivalent to the primary predicate device (K151391).
Table 5-3 compares the subject devices with the primary predicate (K151391). To bridge the gap in differences in implant dimensions; i.e., specifically for the implants that have dimensions outside those currently cleared for the UnicCa® product line, BTI has identified reference devices, Table 5-4, which have similar dimensions to the narrower and shorter implants proposed as well as similar design and intended use as the implants presented within this submission. The differences in dimensions have been demonstrated to not be unique to the subject device.
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| Table 5-3. Comparison of the BTI Extra-Short Dental Implant System UnicCa® with primary predicate BTI Dental Implant | |
|---|---|
| System UnicCa® (K151391) |
| Characteristics | Subject Device(Current Submission)BTI Extra-Short Dental ImplantSystem UnicCa® | Primary PredicateK151391, BTI Dental Implant SystemUnicCa® | Substantial EquivalenceDiscussion |
|---|---|---|---|
| Product Classification | Device Class IIRegulation No.:21 CFR 872.3640.Product code: DZE; Endosseous dentalimplant. | Device Class IIRegulation No.:21 CFR 872.3640.Product code: DZE; Endosseous dentalimplant. | Identical. |
| Characteristics | Subject Device(Current Submission)BTI Extra-Short Dental ImplantSystem UnicCa® | Primary PredicateK151391, BTI Dental Implant SystemUnicCa® | Substantial EquivalenceDiscussion |
| Indications for use | The BTI Dental Implant SystemUnicCa® for oral implant surgery is tobe used for the partial or totalreplacement of teeth in edentulatepatients. Once attached to the bone, theimplants act as an anchor for variousfixed or removable prosthetic solutionsthat can be used to improve or restore apatient's mastication function.In the case of 5.5 – 6.5mm longUnicCa® implants: These implantsshould be used in a two-stage surgicalprocedure. These implants are indicatedfor delayed loading. These implants areindicated only for straight abutments andto support permanently fixedrestorations.In the case of Tiny® 3.0 UnicCa®implants: These implants shall be usedonly to replace maxillary lateral incisorsand mandibular lateral and centralincisors. Immediate loading isrecommended when there is goodprimary stability and an appropriateocclusal load. | The BTI Dental Implant SystemUnicCa® for oral implant surgery is tobe used for the partial or totalreplacement of teeth in edentulatepatients. Once attached to the bone, theimplants act as an anchor for variousfixed or removable prosthetic solutionsthat can be used to improve or restore apatient's mastication function.In the case of 5.5 - 6.5mm longUnicCa® implants should be used in atwo-stage surgical procedure. Theseimplants are indicated for delayedloading. These implants are indicatedonly for straight abutments and tosupport permanently fixed restorations.In the case of Tiny® 3.0 UnicCa®implants: These implants shall be usedonly to replace maxillary lateral incisorsand mandibular lateral and centralincisors. Immediate loading isrecommended when there is goodprimary stability and an appropriateocclusal load. | Identical. |
| Implant Design/Geometry | Threaded, root form. | Threaded, root form. | |
| Material | Commercially pure titanium grade 4. | Commercially pure titanium grade 4. | |
| Characteristics | Subject Device(Current Submission)BTI Extra-Short Dental ImplantSystem UnicCa® | Primary PredicateK151391, BTI Dental Implant SystemUnicCa® | Substantial EquivalenceDiscussion |
| Abutment Compatibility/Connection | Internal (Interna). | Internal (Interna) and External(Externa). | Identical. Primary predicatealso includes implants withExternal connection. |
| Dimensions (mm) | InternaDiameter: 4.0 to 6.0Lengths: 5.5 and 6.5 | InternaDiameter: 3.3 to 6.0Lengths: 5.5 to 18.0 | Similar. The diameters andlengths in current submissionfor Interna connection arealready encompassed inPrimary Predicate. |
| ExternaNot applicable. | ExternaDiameter: 3.0 to 5.5Lengths: 7.0 to 18.0 | ||
| Roughness | Neck: Sq1= 0.7 ± 0.1 µm;Sdr2= 50± 10%Thread: Sq≥ 1.2 μm;Sdr≥ 200%Valleys: Sq= 1.0 ± 0.2 µm;Sdr= 85± 15% | Neck: Sq= 0.7 ± 0.1 µm;Sdr= 50± 10%Thread: Sq≥ 1.2 μm;Sdr≥ 200%Valleys: Sq= 1.0 ± 0.2 µm;Sdr= 85± 15% | Identical. |
| Mechanicalproperties | Material(Titanium)In compliance with ISO 5832-2 andASTM F67. | In compliance with ISO 5832-2 andASTM F67. | Identical. |
| FatigueEvaluated according to ISO 14801. | Evaluated under ISO 14801. | Identical. | |
| Hydrophilicity | Calcium surface treatment | Calcium surface treatment | Identical. |
| Supplied Sterile | Yes | Yes | Identical. |
| Sterilization | Gamma radiation | Gamma Radiation | Identical. |
| SAL | 1 x 10-6 | 1 x 10-6 | Identical. |
| Packaging | Container (vial with clamp) | Container (vial with clamp) | Identical. |
| Characteristics | Subject Device(Current Submission)BTI Extra-Short Dental ImplantSystem UnicCa® | Primary PredicateK151391, BTI Dental Implant SystemUnicCa® | Substantial EquivalenceDiscussion |
| Shelf-Life | Same. 5 years. | 5 years. | Identical. |
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! Sq: Root Square Mean Roughness.
2 Sdr= Developped surface.
² Sdr= Developed surface.
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Table 5-4 provides a comparison of the BTI Extra-Short Dental Implant System UnicCa® with the selected reference devices.
| Characteristics | Subject Device(Current Submission) | Reference device | Reference device |
|---|---|---|---|
| BTI Extra-Short Dental ImplantSystem UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) | |
| ProductClassification | Device Class IIRegulation No.:21 CFR 872.3640.Product code: DZE; Endosseous dentalimplant | Device Class IIRegulation No.:21 CFR 872.3640.Product code: DZE; Endosseous dentalimplant | Device Class IIRegulation No.:21 CFR 872.3630 and872.3640.Product code: DZE; Endosseous dentalimplant and NHA, Endosseous dentalimplant abutment |
| Subject Device(Current Submission) | Reference device | Reference device | |
| Characteristics | BTI Extra-Short Dental ImplantSystem UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| Indications foruse | The BTI Dental Implant SystemUnicCa® for oral implant surgery is tobe used for the partial or totalreplacement of teeth in edentulatepatients. Once attached to the bone, theimplants act as an anchor for variousfixed or removable prosthetic solutionsthat can be used to improve or restore apatient's mastication function.In the case of 5.5 – 6.5mm longUnicCa® implants: These implantsshould be used in a two-stage surgicalprocedure. These implants are indicatedfor delayed loading. These implants areindicated only for straight abutmentsand to support permanently fixedrestorations.In the case of Tiny® 3.0 UnicCa®implants: These implants shall be usedonly to replace maxillary lateral incisorsand mandibular lateral and centralincisors. Immediate loading isrecommended when there is goodprimary stability and an appropriateocclusal load. | 3i T3* Dental Implants are intended forsurgical placement in the upper or lowerjaw to provide a means for prostheticattachment in single tooth restorationsand in partially or fully edentulous spanswith multiple single teeth utilizingdelayed or immediate loading, or as aterminal or intermediary abutment forfixed or removable bridgework, and toretain overdentures.3i T3® Dental Implants are intended forimmediate function on single toothand/or multiple toothapplications when good primary stabilityis achieved, with appropriate occlusalloading, in order to restore chewingfunction. | S.I.N. Dental Implant System is intendedfor placement in the maxillary ormandibular arch to provide support forsingle-unit or multi-unit restorations.When a one-stage surgical approach isapplied, the S.I.N. Dental Implant Systemis intended for immediate loading whengood primary stability is achieved and withappropriate occlusal loading. Implantswith lengths less than 7 mm are intendedfor delayed loading only. |
| Material | Titanium CP4 | Titanium CP4 | Titanium CP4 |
| Connection | Internal | External | Internal |
| Subject Device(Current Submission) | Reference device | Reference device | |
| Characteristics | BTI Extra-Short Dental ImplantSystem UnicCa® | Osseotite BIOMET 3I, LLC (K133049) | S.I.N. Dental Implant System (K170392) |
| Dimensions (mm) | Diameter: 4.0 -6.0 | Diameter: 3.25-6.0 mm | Diameter: 2.9 - 6.0 mm |
| Lengths: 5.5 and6.5 | Length: 6.5-18.0 mm | Length: 5.0-15.0 mm | |
| Surface | Calcium surface treatment | Discrete crystalline deposition of | Acid-etched |
| calcium phosphate surface treatment | HA | ||
| Supplied Sterile | Yes | Yes | Yes |
| Sterilization | Gamma radiation | Irradiation | Radiation sterilization validation accordingto ISO 11137-1 and 11137-2 and steamsterilization validation according to ISO17665-1 and ISO 17665-2 |
| Packaging | Container (vial with clamp) | (Not known) | Packaged in a radiation sterilizablepackage consisting of a primary container,with implant and auxiliary parts, sealedwith a peel-off wrapping and grouped instorage packs |
| Shelf-Life | 5 years | (Not known) | (Not known) |
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VII. NON-CLINICAL TESTING
A series of non-clinical testing has been presented in order to demonstrate that the proposed device is substantially equivalent to the predicate devices. Tests performed are as follows:
- Biocompatibility testing in conformance with ISO 10993-1:2018 Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA guidance entitled Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. All biological endpoints relative to a long-term implant as identified in the FDA guidance have been addressed with satisfactory results.
- Corrosion Testing, Surface Hydrophilicity and TOF-SIMS Analysis (leveraged from ● BTI 510(k) K151391).
- . Fatigue Testing based on ISO 14801:2016 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants and FDA guidance document Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, issued on May 12, 2004 has been evaluated for the predicate device. Analysis in this submission showed that the subject device did not represent a new worst case for dynamic fatigue testing.
- Comparative area analyses for full external area and for bone resorption of 3 mm have ● been performed for subject implants and reference device. Additionally, immediate bone to implant contact per surgical protocol for the subject implants and reference device has been assessed. Results showed that subject device is substantially equivalent.
- Sterilization Validation (leveraged from K151391). ●
- Packaging/Sterile Barrier/Shelf-Life Validation (leveraged from BTI 510(k) ● K173257).
- Endotoxin Testing: The presence of bacterial endotoxins is addressed according to ● ANSI/AAMI ST72:2019 Bacterial endotoxins- Test methods, routine monitoring, and alternatives to batch testing.
VIII. CLINICAL TESTING
Clinical testing is not required for the dimensional range extension.
IX. CONCLUSIONS
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The comparison of similarities and differences between the modified device and the respective predicate device demonstrate that the proposed and predicate device are substantially equivalent.
§ 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.