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 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.

AI/ML Overview

This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.

Feature / Test Category	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Product Classification	Identical product codes (DZE, NHA) and regulation number (21 CFR 872.3640), Class II.	Identical.
Indications for Use	Identical to primary predicate device (K151391) for general use in partial/total replacement of teeth, specific uses for 5.5-6.5mm implants (two-stage, delayed loading, straight abutments, fixed restorations), and Tiny® 3.0 implants (maxillary lateral, mandibular lateral/central incisors, immediate loading with good primary stability/appropriate occlusal load).	Identical to primary predicate device. Includes specific indications for 5.5-6.5mm long UnicCa® implants and Tiny® 3.0 UnicCa® implants that match the predicate.
Implant Design	Similar designs, sterilization, and packaging as identified predicate devices (K022258, K053355, K061383) for use as dental implants.	Similar designs, sterilization and packaging are included in subject and the identified predicate devices, intended for similar use.
Platform Diameter (mm)	Range of implant platform diameters covered by identified predicate devices (e.g., Interna: 4.1, 5.5; Externa: 3.5, 4.1, 5.5).	Similar. A new platform diameter for the Interna connection (Interna Narrow, 3.5 mm) is included, but the range is covered by predicate devices. Interna Universal Plus is identical to predicate.
Implant Length (mm)	5.5 - 18 mm, matching predicate K151391.	Identical (Interna Narrow: 5.5 – 15 mm; Interna Universal Plus: 7.5 – 11.5 mm, which falls within the predicate's 5.5-18 mm range).
Implant Body Diameter (mm)	3.0 - 6.0 mm, matching predicates K151391, K022258, K053355.	Identical (Interna Narrow: 3.3 – 4.75 mm; Interna Universal Plus: 6.0 mm, which falls within the predicate's 3.0-6.0 mm range).
Implant Material	Commercially pure titanium (Grade 4).	Identical.
Implant Surface Treatment	Calcium surface treatment.	Identical to primary predicate (K151391).
Restoration	Single and multiple restorations.	Identical.
Connection Design	Engaging, non-engaging.	Identical.
Abutment Prosthetic Diameter (mm)	Range of diameters covered by identified predicate devices (K022258, K053355, K061383), e.g., 3.5 - 6.5 mm.	Similar. The subject device's range (3.5 - 5.1 mm) is covered.
Abutment Gingival Height (mm)	Range of gingival heights covered by identified predicate and reference devices (K022258, K053355, K061383, K130808), e.g., 1 - 4 mm.	Similar. The subject device's range (0.5 - 4 mm) is covered.
Abutment Angulation	Straight (0°) with divergence allowance supported by bench testing.	Identical. Divergence allowance in subject device is supported by bench testing provided.
Abutment Material	Commercially pure titanium (Grade 4).	Identical to identified predicate devices.
Prosthetic Screws Material	Ti6Al4V, or other materials in predicate (e.g., gold/palladium alloy in K022258).	Identical to K053355 (Ti6Al4V).
Packaging, Sterilization, Shelf-Life	Similar packaging and sterilization processes, sterile by gamma irradiation or non-sterile for end-user sterilization.	Similar packaging as the identified predicate devices. Healing abutments/Transepithelial abutments: sterile by gamma irradiation, thermoform tray with peel top lid. Temporary Titanium abutments, Titanium abutments, Healing Caps, Aesthetic Interfaces and Screws: non-sterile, to be sterilized by end user (moist heat), thermosealed bag.
Biocompatibility	Conformance with ISO 10993-1, with satisfactory results for all biological endpoints relative to a long-term implant.	All biological endpoints relative to a long-term implant as identified in the FDA guidance have been addressed with satisfactory results.
Corrosion, Surface Hydrophilicity, TOF-SIMS	Leveraged from predicate K151391. Performance should be comparable.	Leveraged from K151391.
Fatigue Testing	Conformance with ISO 14801 and FDA guidance document, showing substantial equivalence to predicate for intended use.	Test results show that the proposed device is substantially equivalent to the predicate device for its intended use.
Comparative Area Analyses (Bone Resorption, Bone-to-Implant Contact)	Subject implants and reference device should show substantial equivalence in these aspects.	Results showed that subject device is substantially equivalent.
Sterilization Validation	Sterility assurance level (SAL) of 10-6, according to ISO 11137-1, ISO 11137-2 and ISO 17665-1.	Validation performed to a SAL of 10-6, according to specified ISO standards.
Packaging/Sterile Barrier/Shelf-Life Validation	Conformance with ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1886, ASTM 1929 and ASTM F2096.	Validation performed according to specified ISO and ASTM standards.
Transport Validation	Conformance with ISTA 3A.	Validation performed according to ISTA 3A.
Endotoxin Testing	Conformance with ANSI/AAMI ST72.	Testing performed according to ANSI/AAMI ST72.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document mentions "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." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided as the submission relies on non-clinical, bench testing.

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:

This is not applicable. The device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable as the device is a physical dental implant system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:

Biocompatibility: Conformance with ISO 10993-1.
Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
Sterilization Validation: Conformance with ISO 11137 series.
Physical measurements and material specifications are compared to those of the predicate devices.

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.

9. How the ground truth for the training set was established:

This information is not applicable for the reasons stated in point 8.

Summary

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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.

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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 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

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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)

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)

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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. ●

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4. DEVICE DESCRIPTION

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

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.

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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

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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.

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	SUBJECT DEVICE	PREDICATE DEVICE	ADDITIONAL PREDICATE			SUBSTANTIAL EQUIVALENCE
FEATURE	BTI Interna Narrow/PlusDental Implant SystemUnicCa® (K211952)	BTI Dental ImplantSystem UnicCa®(K151391)	B.T.I. BiotechnologyInstitute, S.L. DentalImplant System(K022258)	BTI Interna DentalImplant System(K053355)	BTI Sterile Dental DrillsKit, BTI Abutments andCaps (K061383)
ProductClassification	Product code: DZE, NHARegulation No.: 21 CFR872.3640Device Class II	Product code: DZERegulation No.:21 CFR872.3640.Device Class II	Product Code: DZERegulation No.: 21 CFR872.3430Device Class II	Product Code: DZERegulation No.: 21 CFR872.3640Device Class II	Product Code: NHA, EJLRegulation No.: 21 CFR872.3630 and 21 CFR873.3640Device Class II	Identical.
Indications forUse	The BTI Dental ImplantSystem UnicCa® for oralimplant surgery is to beused for the partial or totalreplacement of teeth inedentulate patients. Onceattached to the bone, theimplants act as an anchorfor various fixed orremovable prostheticsolutions that can be usedto improve or restore apatient's masticationfunction.	The BTI Dental ImplantSystem UnicCa® for oralimplant surgery is to beused for the partial or totalreplacement of teeth inedentulate patients. Onceattached to the bone, theimplants act as an anchorfor various fixed orremovable prostheticsolutions that can be usedto improve or restore apatient's masticationfunction.	Dental implant systemcomprising endosseoustitanium implants andprosthetic elements to beattached to the implants,as well as auxiliaryelements for surgical andprosthetic procedures.The intended use of thesystem is the restoration ofmissing teeth in partially orfully edentulous patientsand/or the fixation ofoverdentures to restore orenhance the chewingcapacity of patients.	Dental implant systemcomprising endosseoustitanium implants andprosthetic elements to beattached to the implants,as well as auxiliaryelements for surgical andprosthetic procedures.The intended use of thesystem is the restoration ofmissing teeth in partially orfully edentulous patientsand/or the fixation ofoverdentures to restore orenhance the chewingcapacity of patients.	Dental burs are intendedto drill bone tissue andprovisionally soft tissuesduring, before and after asurgical intervention ofdental implants.Endosseous dentalimplant abutments areintended to model thegingivaltissue during the processof healing after the first orsecond surgery and to beattached to the implant tohold single or multipleteeth restorations.	Identical to primarypredicate device.
	In the case of 5.5-6.5mmlong UnicCa® implants:These implants should beused in a two-stagesurgical procedure. Theseimplants are indicated fordelayed loading. Theseimplants are indicated onlyfor straight abutments andto support permanently fixedrestorations.	In the case of 5.5-6.5mmlong UnicCa® implants:These implants should beused in a two-stagesurgical procedure. Theseimplants are indicated fordelayed loading. Theseimplants are indicated onlyfor straight abutments andto support permanently fixedrestorations.
	In the case of Tiny® 3.0UnicCa® implants: Theseimplants shall be used onlyto replace maxillary lateralincisors and mandibularlateral and central incisors. Immediateloading is recommended	In the case of Tiny® 3.0UnicCa® implants: Theseimplants shall be used onlyto replace maxillary lateralincisors and mandibularlateral and central incisors.Immediate loading isrecommended when there
FEATURE	SUBJECT DEVICE	PREDICATE DEVICE	ADDITIONAL PREDICATE	ADDITIONAL PREDICATE	ADDITIONAL PREDICATE	SUBSTANTIAL EQUIVALENCE
Reason forpredicateinclussion	BTI Interna Narrow/PlusDental Implant SystemUnicCa® (K211952)	BTI Dental ImplantSystem UnicCa®(K151391)	B.T.I. BiotechnologyInstitute, S.L. DentalImplant System(K022258)	BTI Interna DentalImplant System(K053355)	BTI Sterile Dental DrillsKit, BTI Abutments andCaps (K061383)
plant design	primary stability and anappropriate occlusal load.	and an appropriateocclusal load.	Healing abutment andHealing cap design,Interfaces, usage andscrew design and material.	Definitive andTransepithelial abutmentdesign, usage, connectionto implant and materialsused.	Transepithelial abutmentdesign, sterilization andpackaging	Similar designs, sterilizationand packaging are includedin subject and the identifiedpredicate devices, intendedfor similar use.
Platformdiameter (mm)	Interna Narrow: 3.5Interna Universal Plus: 4.1	Interna: 4.1, 5.5Externa: 3.5, 4.1, 5.5	Externa Narrow: 3.5Externa Universal: 4.1Externa Wide: 5.5	Interna Universal: 4.1Interna Wide: 5.5		Similar. A new platformdiameter for the Internaconnection (Interna Narrow)is included. However, therange of implant platformdiameters are covered bythe identified predicatedevices. Interna UniversalPlus identical to thepredicate device.
Implant length(mm)	Interna Narrow: 5.5 - 15Interna Universal Plus: 7.5- 11.5	5.5 - 18	7.0 - 18	7.0 - 18		Identical
Implant bodydiameter (mm)	Interna Narrow: 3.3 – 4.75Interna Universal Plus: 6.0	Interna: 3.3 – 6.0Externa: 3.0 – 5.5	3.3 - 5.5	3.3 - 5.0		Identical
Implant material	Commercially puretitanium (Grade 4)	Commercially puretitanium (Grade 4)	Commercially pure titanium(Grade 4)	Commercially puretitanium (Grade 4)		Identical.
Implant surfacetreatment	Calcium surface treatment	Calcium surface treatment	Calcium surface treatment	(not applicable)		Identical to primarypredicate.
Abutment design
Restoration	Single and multiple	Single and multiple	Single and multiple	Single and multiple	Single and multiple	Identical.
Connectiondesign	Engaging, non-engaging.	Engaging, non-engaging	Engaging, non-engaging	Engaging, non-engaging	Engaging, non-engaging	Identical.
FEATURE	SUBJECT DEVICEBTI Interna Narrow/PlusDental Implant SystemUnicCa® (K211952)	PREDICATE DEVICEBTI Dental ImplantSystem UnicCa®(K151391)	ADDITIONALPREDICATEB.T.I. BiotechnologyInstitute, S.L. DentalImplant System(K022258)	ADDITIONALPREDICATEBTI Interna DentalImplant System(K053355)	ADDITIONALPREDICATEBTI Sterile Dental DrillsKit, BTI Abutments andCaps (K061383)	SUBSTANTIALEQUIVALENCE
Abutmentprostheticdiameter (mm)	3.5 - 5.1	-	3.5 - 6.5	4 - 6.5	4.1, 5.5	Similar. Range of diameterscovered by the identifiedpredicate devices.
Abutmentgingival height(mm)	0.5 - 4	-	2 - 4	1 - 4	1 - 4	Similar. Range of gingivalheights covered by theidentified predicate devicesand reference devices.
Abutmentangulation	Straight (0°)(Except for Multi-imabutments that allow forup to 20° divergence perimplant).	-	Straight (0°)(Divergence allowance notspecified).	Straight (0°)(Divergence allowance notspecified).	Straight (0°)(Divergence allowance notspecified).	Identical. Divergenceallowance in subject deviceis supported by benchtesting provided.
Abutmentmaterial	Commercially puretitanium (Grade 4)	-	Commercially pure titanium(Grade 4), titanium Grade3	Commercially puretitanium (Grade 4)	Commercially puretitanium (Grade 4)	Identical to identifiedpredicate devices.
ProstheticScrews material	Ti6Al4V	-	Commercially pure titanium(Grade 4), gold/palladiumalloy	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/PlusDental Implant SystemUnicCa® (K211952)	BTI Dental ImplantSystem UnicCa®(K151391)	B.T.I. BiotechnologyInstitute, S.L. DentalImplant System(K022258)	BTI Interna DentalImplant System(K053355)	BTI Sterile Dental DrillsKit, BTI Abutments andCaps (K061383)
	Healing abutments andTransepithelial abutments:Provided sterile by gammairradiation.Packaging: Thermoformtray with peel top lid.		Temporary abutments,Titanium abutments,Healing Caps, Interfacesand Screws:Provided non-sterile.Packaging: thermosealedbag.	Temporary abutments,Titanium abutments, andScrews:Provided non-sterile, to besterilized by end user –moist heat.Packaging: thermosealedbag.	Healing abutments andTransepithelial abutments:Provided sterile by gammairradiation.Packaging: Thermoformtray with peel top lid	Similar packaging as theidentified predicate devices.
	Temporary Titaniumabutments, Titaniumabutments, Healing Caps,Aesthetic Interfaces andScrews:Provided non-sterile, to besterilized by end user –moist heat.Packaging: thermosealedbag.

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

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510(k) Summary
K211952

B.T.I. Biotechnology Institute, S.L

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510(k) Summary
K211952

B.T.I. Biotechnology Institute, S.

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510(k) Summary
K211952

B.T.I. Biotechnology Institute, S.

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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.

Regulation Number and Section

§ 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.