BTI Interna Narrow/Plus Dental Implant System UnicCa

K211952 · B.T.I. Biotechnology Institute, Sl. · DZE · Jul 21, 2022 · Dental

Device Facts

Record IDK211952
Device NameBTI Interna Narrow/Plus Dental Implant System UnicCa
ApplicantB.T.I. Biotechnology Institute, Sl.
Product CodeDZE · Dental
Decision DateJul 21, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

Self-tapping, threaded, root-form dental titanium implants; used for tooth replacement. Implants anchor fixed or removable prosthetic solutions to restore mastication. System includes Interna Narrow and Universal Plus platforms; diameters 3.3-6.0mm; lengths 5.5-18.0mm. Features calcium-based surface treatment for hydrophilicity. Used by dentists/oral surgeons in clinical settings. Implants placed in bone; abutments (healing, titanium, transepithelial) and prosthetic components attached to support restorations. Output is a stable foundation for dental prosthetics. Benefits include improved masticatory function and tooth replacement.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), fatigue testing (ISO 14801), corrosion testing, surface hydrophilicity analysis, TOF-SIMS analysis, sterilization validation (ISO 11137, ISO 17665), packaging/shelf-life validation (ISO 11607, ASTM standards), transport validation (ISTA 3A), and endotoxin testing (ANSI/AAMI ST72). Comparative area analyses for bone resorption and bone-to-implant contact were performed.

Technological Characteristics

Root-form dental implants made of Grade 4 commercially pure titanium. Features calcium-based surface treatment. Connections: Interna (Narrow/Universal Plus) and Externa. Dimensions: 3.3-6.0mm diameter, 5.5-18.0mm length. Abutments include titanium, transepithelial, and healing components. Sterilization: Gamma irradiation (sterile components) or moist heat (non-sterile components). Packaging: Thermoform trays or thermosealed bags. No software or energy source.

Indications for Use

Indicated for partial or total tooth replacement in edentulate patients. 5.5-6.5mm implants require two-stage surgery and delayed loading with straight abutments for fixed restorations. Tiny® 3.0 implants indicated only for maxillary lateral incisors and mandibular lateral/central incisors; immediate loading recommended with good primary stability.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 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<br>Dental Implant System<br>UnicCa® (K211952) | BTI Dental Implant<br>System UnicCa®<br>(K151391) | B.T.I. Biotechnology<br>Institute, S.L. Dental<br>Implant System<br>(K022258) | BTI Interna Dental<br>Implant System<br>(K053355) | BTI Sterile Dental Drills<br>Kit, BTI Abutments and<br>Caps (K061383) | | | Product<br>Classification | Product code: DZE, NHA<br>Regulation No.: 21 CFR<br>872.3640Device Class II | Product code: DZE<br>Regulation No.:21 CFR<br>872.3640.<br>Device Class II | Product Code: DZE<br>Regulation No.: 21 CFR<br>872.3430<br>Device Class II | Product Code: DZE<br>Regulation No.: 21 CFR<br>872.3640<br>Device Class II | Product Code: NHA, EJL<br>Regulation No.: 21 CFR<br>872.3630 and 21 CFR<br>873.3640<br>Device Class II | Identical. | | Indications for<br>Use | The BTI Dental Implant<br>System UnicCa® for oral<br>implant surgery is to be<br>used for the partial or total<br>replacement of teeth in<br>edentulate patients. Once<br>attached to the bone, the<br>implants act as an anchor<br>for various fixed or<br>removable prosthetic<br>solutions that can be used<br>to improve or restore a<br>patient's mastication<br>function. | The BTI Dental Implant<br>System UnicCa® for oral<br>implant surgery is to be<br>used for the partial or total<br>replacement of teeth in<br>edentulate patients. Once<br>attached to the bone, the<br>implants act as an anchor<br>for various fixed or<br>removable prosthetic<br>solutions that can be used<br>to improve or restore a<br>patient's mastication<br>function. | Dental implant system<br>comprising endosseous<br>titanium implants and<br>prosthetic elements to be<br>attached to the implants,<br>as well as auxiliary<br>elements for surgical and<br>prosthetic procedures.<br><br>The intended use of the<br>system is the restoration of<br>missing teeth in partially or<br>fully edentulous patients<br>and/or the fixation of<br>overdentures to restore or<br>enhance the chewing<br>capacity of patients. | Dental implant system<br>comprising endosseous<br>titanium implants and<br>prosthetic elements to be<br>attached to the implants,<br>as well as auxiliary<br>elements for surgical and<br>prosthetic procedures.<br><br>The intended use of the<br>system is the restoration of<br>missing teeth in partially or<br>fully edentulous patients<br>and/or the fixation of<br>overdentures to restore or<br>enhance the chewing<br>capacity of patients. | Dental burs are intended<br>to drill bone tissue and<br>provisionally soft tissues<br>during, before and after a<br>surgical intervention of<br>dental implants.<br><br>Endosseous dental<br>implant abutments are<br>intended to model the<br>gingival<br>tissue during the process<br>of healing after the first or<br>second surgery and to be<br>attached to the implant to<br>hold single or multiple<br>teeth restorations. | Identical to primary<br>predicate device. | | | In the case of 5.5-6.5mm<br>long UnicCa® implants:<br>These implants should be<br>used in a two-stage<br>surgical procedure. These<br>implants are indicated for<br>delayed loading. These<br>implants are indicated only<br>for straight abutments and<br>to support permanently fixed<br>restorations. | In the case of 5.5-6.5mm<br>long UnicCa® implants:<br>These implants should be<br>used in a two-stage<br>surgical procedure. These<br>implants are indicated for<br>delayed loading. These<br>implants are indicated only<br>for straight abutments and<br>to support permanently fixed<br>restorations. | | | | | | | In the case of Tiny® 3.0<br>UnicCa® implants: These<br>implants shall be used only<br>to replace maxillary lateral<br>incisors and mandibular<br>lateral and central incisors. Immediate<br>loading is recommended | In the case of Tiny® 3.0<br>UnicCa® implants: These<br>implants shall be used only<br>to replace maxillary lateral<br>incisors and mandibular<br>lateral and central incisors.<br>Immediate loading is<br>recommended when there | | | | | | FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE | ADDITIONAL PREDICATE | SUBSTANTIAL EQUIVALENCE | | Reason for<br>predicate<br>inclussion | BTI Interna Narrow/Plus<br>Dental Implant System<br>UnicCa® (K211952) | BTI Dental Implant<br>System UnicCa®<br>(K151391) | B.T.I. Biotechnology<br>Institute, S.L. Dental<br>Implant System<br>(K022258) | BTI Interna Dental<br>Implant System<br>(K053355) | BTI Sterile Dental Drills<br>Kit, BTI Abutments and<br>Caps (K061383) | | | plant design | primary stability and an<br>appropriate occlusal load. | and an appropriate<br>occlusal load. | Healing abutment and<br>Healing cap design,<br>Interfaces, usage and<br>screw design and material. | Definitive and<br>Transepithelial abutment<br>design, usage, connection<br>to implant and materials<br>used. | Transepithelial abutment<br>design, sterilization and<br>packaging | Similar designs, sterilization<br>and packaging are included<br>in subject and the identified<br>predicate devices, intended<br>for similar use. | | Platform<br>diameter (mm) | Interna Narrow: 3.5<br>Interna Universal Plus: 4.1 | Interna: 4.1, 5.5<br>Externa: 3.5, 4.1, 5.5 | Externa Narrow: 3.5<br>Externa Universal: 4.1<br>Externa Wide: 5.5 | Interna Universal: 4.1<br>Interna Wide: 5.5 | | Similar. A new platform<br>diameter for the Interna<br>connection (Interna Narrow)<br>is included. However, the<br>range of implant platform<br>diameters are covered by<br>the identified predicate<br>devices. Interna Universal<br>Plus identical to the<br>predicate device. | | Implant length<br>(mm) | Interna Narrow: 5.5 - 15<br>Interna Universal Plus: 7.5<br>- 11.5 | 5.5 - 18 | 7.0 - 18 | 7.0 - 18 | | Identical | | Implant body<br>diameter (mm) | Interna Narrow: 3.3 – 4.75<br>Interna Universal Plus: 6.0 | Interna: 3.3 – 6.0<br>Externa: 3.0 – 5.5 | 3.3 - 5.5 | 3.3 - 5.0 | | Identical | | Implant material | Commercially pure<br>titanium (Grade 4) | Commercially pure<br>titanium (Grade 4) | Commercially pure titanium<br>(Grade 4) | Commercially pure<br>titanium (Grade 4) | | Identical. | | Implant surface<br>treatment | Calcium surface treatment | Calcium surface treatment | Calcium surface treatment | (not applicable) | | Identical to primary<br>predicate. | | Abutment design | | | | | | | | Restoration | Single and multiple | Single and multiple | Single and multiple | Single and multiple | Single and multiple | Identical. | | Connection<br>design | Engaging, non-engaging. | Engaging, non-engaging | Engaging, non-engaging | Engaging, non-engaging | Engaging, non-engaging | Identical. | | FEATURE | SUBJECT DEVICE<br>BTI Interna Narrow/Plus<br>Dental Implant System<br>UnicCa® (K211952) | PREDICATE DEVICE<br>BTI Dental Implant<br>System UnicCa®<br>(K151391) | ADDITIONAL<br>PREDICATE<br>B.T.I. Biotechnology<br>Institute, S.L. Dental<br>Implant System<br>(K022258) | ADDITIONAL<br>PREDICATE<br>BTI Interna Dental<br>Implant System<br>(K053355) | ADDITIONAL<br>PREDICATE<br>BTI Sterile Dental Drills<br>Kit, BTI Abutments and<br>Caps (K061383) | SUBSTANTIAL<br>EQUIVALENCE | | Abutment<br>prosthetic<br>diameter (mm) | 3.5 - 5.1 | - | 3.5 - 6.5 | 4 - 6.5 | 4.1, 5.5 | Similar. Range of diameters<br>covered by the identified<br>predicate devices. | | Abutment<br>gingival height<br>(mm) | 0.5 - 4 | - | 2 - 4 | 1 - 4 | 1 - 4 | Similar. Range of gingival<br>heights covered by the<br>identified predicate devices<br>and reference devices. | | Abutment<br>angulation | Straight (0°)<br>(Except for Multi-im<br>abutments that allow for<br>up to 20° divergence per<br>implant). | - | Straight (0°)<br>(Divergence allowance not<br>specified). | Straight (0°)<br>(Divergence allowance not<br>specified). | Straight (0°)<br>(Divergence allowance not<br>specified). | Identical. Divergence<br>allowance in subject device<br>is supported by bench<br>testing provided. | | Abutment<br>material | Commercially pure<br>titanium (Grade 4) | - | Commercially pure titanium<br>(Grade 4), titanium Grade<br>3 | Commercially pure<br>titanium (Grade 4) | Commercially pure<br>titanium (Grade 4) | Identical to identified<br>predicate devices. | | Prosthetic<br>Screws material | Ti6Al4V | - | Commercially pure titanium<br>(Grade 4), gold/palladium<br>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<br>Dental Implant System<br>UnicCa® (K211952) | BTI Dental Implant<br>System UnicCa®<br>(K151391)…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%