The BTI Interna Dental Implant System UnicCa® - Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System.

Device Description

The purpose of this 510(k) is to obtain marketing clearance for expanding the catalogue of abutments and prosthetic components for the Universal Plus and Wide platform of the BTI Interna® Dental Implant System. The premarket notification includes a set of different abutments and screws: UNIT transepithelial abutments, Aesthetic Interfaces, Square Aesthetic Abutments, Angled Titanium Abutments and MULTI-IM transepithelial abutment screws compatible with the cited previous platforms of the BTI Implant System Unicca® in its internal engaging connection version. The implant to abutment connection of all set of abutments range from 4.1mm to 5.5mm. All subject devices are provided sterile via Gamma Radiation. All abutment configurations are not to be used with compatible BTI Interna implant bodies placed at angle (no angular correction), with the exception of the subject Angled Titanium Abutments.

The subject device Transepithelial abutments are straight abutments designed for single (UNIT) and multiple (MULTI-IM) screw-retained restorations. These transepithelial abutments are provided in a range of gingival height from 1.0mm to 4.0mm. All designs have a prosthetic diameter of 5.5mm.

Aesthetic Interfaces are the compatible attachments used to support definitive restorations over transepithelial abutments. Two models are available: Square Aesthetic Interfaces used in single restorations and Aesthetic Interfaces for multiple restorations. Square Aesthetic Interfaces are characterized by an engaging connection to UNIT transepithelial abutments and by four anti rotation lobes placed in prosthetic parts. Aesthetic Interfaces has a conical design with a non-engaging connection to MULTI-IM transepithelial abutments. Prosthetic diameter of aesthetic interfaces can be 5.5mm or 6.5mm, and prosthetic height, 3.5mm or 4.2mm. Aesthetic Interfaces are attached to the transepithelial abutments with their specific retention screws, MULTI-IM transepithelial abutments screws.

The proposed device Square Aesthetic Abutments are straight abutments design for single and multiple restorations in screwed or cemented restorations via traditional casting techniques. The engaging /non-engaging implant abutment connection has a diameter of 4.1mm or 5.5mm, depending on the compatibility with the implant. Square Aesthetic abutments are available in a range of gingival heights from 0.5 to 3.5mm.

Angled Titanium Abutments are premanufactured abutments directly used into the implant in single and multiple cemented restorations. These devices compensate up to 15° misalignment of implants between implant axis and prosthesis axis. Angled Titanium abutments are available in two gingival heights (2 or 4mm) and are compatible with Wide Implant Platform.

All abutments and interfaces are made of unalloyed conforming to ASTM F67 and are coated with titanium nitride (TiN). MULTI-IM transepithelial screws are manufactured in titanium alloy in accordance with ASTM F136, and the surface of the screw thread is coated with tungsten carbide/carbon and chromium (WC/C).

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. The document is a 510(k) summary for a dental implant system, detailing its substantial equivalence to predicate devices based on non-clinical testing and comparative analysis of technological characteristics. There is no mention of specific acceptance criteria for performance metrics that would typically be evaluated in a study, nor is there a description of a clinical or non-clinical study designed to prove the device meets such criteria.

Summary

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10/20/2022

B.T.I. Biotechnology Institute, SL. Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Technologico de Alava Minano, Alava 01510 SPAIN

Re: K213106

Trade/Device Name: BTI Interna Dental Implant System UnicCa® - Prosthetic Components Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 19, 2022 Received: September 21, 2022

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,

for Andrew 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213106

Device Name

BTI Interna Dental Implant System UnicCa - Prosthetic Components

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)

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510 (K) SUMMARY - K213106

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: October 20, 2022

II. DEVICE

Trade/Proprietary Name: BTI Interna Dental Implant System UnicCa® -Prosthetic Components.

Common or Usual Name: Endosseous Dental Implant Abutment Regulation number: 21 CFR 872.3630 Classification Name: Endosseous Dental Implant Abutments Regulatory Class: II Product Code: NHA

III. PREDICATE DEVICE

The primary predicate device is the Multi-unit Abutments for CONELOG® from BioHorizons Implant Systems, Inc, which was subject of K203252 (cleared March 16, 2021).

In addition, the following reference devices have been identified for respective abutments/ prosthetic components described within this premarket notification:

K053355, BTI Interna Dental Implant System O
K070533, BTI Endosseous Dental Implant Angled Abutments O
K211952, BTI Interna Narrow/Plus Dental Implant System UnicCa® O

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IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

VI. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

BTI Interna Dental Implant System UnicCa®- Prosthetic Components is substantially equivalent in terms of indications for use to the primary predicate device K203252. Slight differences in the language of the subject device Indications for Use Statement (IFUS) and reference devices do not affect the intended use for supporting a prosthesis to restore the patient's mastication functions. Minor differences between the IFUS for the subject devices and the primary predicate device include specific device names and compatible implant lines. Minor differences between the subject device IFUS and that of reference devices are related to design features and compatible implant lines. Furthermore, those reference devices mentioned are identified to overcome operating principle, fundamental design, materials, surface coating applied on abutment surface and screw thread - TiN and WC/C, packaging and sterilization to the predicate device.

Table 1 provides a comparison of the indication for use, device features, and other information to demonstrate that the subject device, is substantially equivalent to the primary predicate device and reference devices.

The proposed Transepithelial abutments are substantially equivalent to the transepithelial abutments cleared under K211952. The subject device and reference device K211952 both include straight abutment designs with engaging/non-engaging features, The subject transepithelial abutments and those cleared under K211952 are also substantially equivalent in terms of manufacturing materials, surface coating applied on the transepithelial sleeve and screw, TiN and DLC coating, respectively, in prosthesis attachment (screw-retained), abutment to implant interface (internal connection), packaging (Thermoform tray with peel top lid) and sterilization (gamma irradiation).

The subject device Aesthetic Interfaces and MULTI-IM transepithelial abutment screws are substantially equivalent to the Aesthetic Interfaces and retention screws for Narrow platform cleared under K211952 in terms of design, materials (CP Ti Grade 4 and Ti-6Al-4V), surface coating (TiN and DLC coating) and manufacturing workflow.

Square Aesthetic Abutments design are substantially equivalent to titanium abutment design cleared under K211952 both include straight abutments. The subject device and those titanium abutments cleared under K211952 are also substantially equivalent in terms of manufacturing material (CP Ti Grade 4), in prosthesis attachment (cemented or screw

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retained) and abutment to implant interface (internal connection, enganging/non-enganging design). Both devices are also used in single or multiple restorations via casting techniques.

The subject device Angled Titanium Abutment are substantially equivalent to those Angled Titanium Abutments cleared under BTI K070533, same design and same angulation, and the clearance K211952 supports surface coating. . These Angled Titanium Abutments do not present a new worst-case for fatigue testing as compared to the prior clearances for the same system of implants and abutments, so no new fatigue testing was conducted.

The reference device K053355 is for support dimensional differences in the implant platform compatibility, Universal/Plus and/or Wide platform.

Regarding sterilization, the subject devices (aesthetic interfaces, retention screws, square aesthetic abutments and angled titanium abutments) are supplied sterile by gamma radiation in a thermoformed tray with peel-off top lid. This sterilization method and packaging configuration is identical to the transepithelial abutments cleared in K211952. The additional subject abutments which are now provided sterile do not present a new worstcase for sterilization validation.

VII. NON-CLINICAL TESTING

A series of non-clinical testing has been presented to demonstrate that the proposed device is substantially equivalent to the predicate devices. Tests performed are as follows:

Sterilization Validation to a sterility assurance level (SAL) of 106 according to ISO . 11137-1, ISO 11137-2, and ISO 17665-1.
Endotoxin Testing according to ANSI/AAMI ST72 Bacterial endotoxins- Test ● methods, routine monitoring, and alternatives to batch and methods consistent with USP <85> Bacterial Endotoxins Test and the FDA guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued on January 21, 2016.
Packaging Validation according to ISO11607-1 and ISO 11607-2. ●
Shelf-life according to ASTM F88 and F1929 ●
Biocompatibility testing in conformance with ISO 10993-1.
Characterization of TiN and WC/C coating surfaces on BTI devices including ● thickness, roughness, SEM images, abrasion testing, adhesion testing by static tensile test according to ASTM F1147, adhesion testing by dynamic shear bonding strength per ASTM F1160.
Non-clinical worst-case MRI review was performed to evaluate the Subject device ● components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O. , Jana G. Delfino and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Allovs Used in Medical Devices." Journal Testing and Evaluation 49.2 (2019):783-795), based on

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K213106- BTI Interna Dental Implant System UnicCa®- Prosthetic Components 510(K) Summary

the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment', including magnetically induced displacement force and torque.

VIII. CLINICAL TESTING

Clinical testing is not required.

IX. CONCLUSIONS

BTI Interna Implant System UnicCa® - Prosthetic Components has same intended use, has similar technological characteristics, are made of identical or similar materials to those clearances identified as primary predicate and reference devices. The subject device and the references devices cover similar range of dimensions, similar packaging, and similar sterilization method. In conclusion the data of the current submission demonstrate that the subject device is substantially equivalent to the predicate and references devices.

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	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	BTI InternaDental ImplantSystem UnicCa®-ProstheticComponents.	K203252Multi-unitAbutments forCONELOGⓇ	K053355BTI Interna DentalImplant System	K070533Endosseous dentalimplant angledabutments	K211952BTI Interna Narrow/PlusDental Implant SystemUnicCaⓇ	SubstantialEquivalenceDiscussion
ProductClassification	Regulation No.: 21CFR 872.3630Product Code:NHADevice Class II	Regulation No.: 21CFR 873.3630Product Code: NHA.Device Class II	Regulation No.: 21 CFR872.3640Product Code: DZEDevice Class II	Regulation No.:21 CFR 872.3630Product Code: NHADevice Class II	Regulation No.: 21 CFR872.3640Product Code: DZEDevice Class II	Identical to primarypredicate device
Indications for Use	The BTI InternaDental ImplantSystem UnicCa® -ProstheticComponents areintended to functionin the mandible ormaxilla to supportsingle and multiple-unit temporary ordefinitiverestorations on theBTI Interna®Dental ImplantSystem.	The BioHorizonsMulti-unitAbutments forCONELOG® areintended to functionin the mandible ormaxilla tosupport single andmultiple-unittemporary ordefinitiverestorations onCONELOG dentalimplants	Dental implant systemcomprising endosseoustitanium implants andprosthetic elements to beattached to the implants, aswell as auxiliary elementsfor surgical and prostheticprocedures.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.	Endosseous dentalimplant angledabutments arepremanufacturedprosthetic componentsdirectly connected to theEndosseous dentalimplant and areintended for use as aidsin prostheticrehabilitation. They canbe used in singled andmulti-unit restorationswhere angled correctionis required.	The BTI Dental ImplantSystem UnicCa® for oralimplant surgery is to beused for the partial or totalreplacement ofteeth in edentulate patients.Once attached to the bone,the implants act as ananchor for various fixed orremovableprosthetic solutions thatcan be used to improve orrestore a patient'smastication function.In the case of 5.5 - 6.5mmlong UnicCa® implantsshould be used in a two-stage surgical procedure.These implants areindicated for delayedloading. These implants areindicated only for straightabutments and to supportpermanently fixedrestorations.In the case of Tiny® 3.0UnicCa® implants: Theseimplants shall be used onlyto replace maxillary lateralincisors and	Equivalent toprimary predicatedevice.
	Subject Device	Primary PredicateDevice	Reference Device	Reference Device	Reference Device	SubstantialEquivalenceDiscussion
	BTI InternaDental ImplantSystem UnicCa®-ProstheticComponents.	K203252	K053355	K070533	K211952
		Multi-unitAbutments forCONELOGⓇ	BTI Interna DentalImplant System	Endosseous dentalimplant angledabutments	BTI Interna Narrow/PlusDental Implant SystemUnicCaⓇ
Reason for Predicate/ ReferenceDevice		Indications for Use	Abutment/implantconnection design andimplant platformcompatibility.	Angledabutments Titaniumdesign, material, and usage.	mandibular lateral andcentral incisors. Immediateloading is recommendedwhen there is good primarystability and anappropriate occlusal load.
Designs	TransepithelialAbutments,Interfaces, AngledTitaniumabutments,AestheticAbutments andScrews.	Multi-Unit Straightabutment, Multi-UnitAngled Abutment,Copings, prostheticscrews andtemporary cap.	Healing abutments andcaps, Temporary abutments,Titanium and GoldAbutments,Transepithelialabutments, Cylinders, andScrews.	Angled Titaniumabutments	Healing abutments,Temporary abutments,Titanium Abutments,Transepithelialabutments, AestheticInterfaces and Screws
Restoration	Single & Multiple	Single unit & Multi-unit	Single & Multiple	Single & Multiple	Single & Multiple	Identical toreference devices.
Compatible Implant Platform(Diameter Ø=mm)	Interna Universal/PlusØ= 4.1Wide PlatformØ = 5.5	Ø = 3.3- 4.3	Interna Universal/PlusØ = 4.1Wide Platform Ø = 5.5	Interna Universal/PlusØ =4.1Externa UniversalØ =4.1Externa WideØ = 5.5TinyØ=3.7NarrowØ=4.2	Interna NarrowØ = 3.5Interna Universal PlusØ = 4.1	Identical toreference deviceK053355
Implant to Abutment connection	Internal	Internal	Internal	Internal, External	Internal	Equivalent toprimary predicate
		Subject Device	Primary PredicateDevice	Reference Device	Reference Device	Reference Device
		BTI InternaDental ImplantSystem UnicCa®-ProstheticComponents.	K203252	K053355	K070533	K211952	SubstantialEquivalenceDiscussion
							device and identicalto reference devices.
		Engaging/Non-engaging	Engaging	Engaging/Non-engaging	Non-Engaging	Engaging/Non Engaging	IdenticaltoreferencedeviceK053355andequivalenttoreferencedeviceK211952.
	ProstheticDiameter (mm)	4.1 to 6.5	4.8	4.1 to 6.5(Selectedcomponentsdesign)	3.7 to 5.5(Selectedcomponentsdesign)	4.1 and 5.5(Selectedcomponentsdesign)	IdenticaltoreferencedeviceK053355.
	Abutment Angulation	0°, 15°	0°, 17°, 30°	0°	15°	0°	IdenticaltoreferencedeviceK070533.
	Gingival Height	Up to 4mm	2-4mm	Up to 4mm(Selectedcomponentsdesign)	Up to 4mm(Selectedcomponentsdesign)	Up to 4mm(Selectedcomponents design)	Identical toreference devices.
Material	Abutments & AestheticInterfaces	CP TitaniumGrade 4	Titanium AlloyASTM F136	CP TitaniumGrade 4	CP TitaniumGrade 4	CP TitaniumGrade 4	Identicaltoreference devices.Samemanufacturingmaterial.
	Screws	Titanium AlloyTi-6Al-4V	Titanium AlloyASTM F136	Titanium CPGrade 4		Titanium AlloyTi-6Al-4V	Identicaltoreference deviceK211952.Samemanufacturingmaterial.
Surface	Abutments & AestheticInterfaces	Titanium Nitride	N.A.	-	-	Titanium Nitride	IdenticaltoreferencedeviceK211952.
Coating	Screws	DLC Coating	N.A.	-	-	DLC Coating(Tungsten Carbide/ Carbonand Chromium)	Samesurfacecoatings.
	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	BTI InternaDental ImplantSystem UnicCa®-ProstheticComponents.	K203252	K053355	K070533	K211952	SubstantialEquivalenceDiscussion
	(Tungsten Carbide/Carbon andChromium)	Multi-unitAbutments forCONELOG®	BTI Interna DentalImplant System	Endosseous dentalimplant angledabutments	BTI Interna Narrow/PlusDental Implant SystemUnicCa®
Sterilization	Sterile by gammaradiation	Sterile by irradiation	Titanium abutments andScrews: Non- sterile. To besterilized by end user-moistheat.	Angled TitaniumAbutments: Non-sterile. To be sterilizedby end user-moist heat	Transepithelialabutments:Sterile by gamma radiationTitaniumAbutments,Aesthetic Interfaces andscrews: non-sterile. To besterilized by end user-moistheat.	Equivalent toreference deviceK211952.Subject devices areall provided bysterile radiation andsame packaging tothose transepithelialabutments clearedunder K211952.
Packaging	Thermoform traywith peel top lid.	Unknown	Titanium abutments andScrews: Thermosealed bag	Angled TitaniumAbutments:Thermosealed bag.	Transepithelialabutments: Thermoformtray with peel top lid.TitaniumAbutments,Aesthetic Interfaces andscrews: Thermosealed bag

Table 1: Comparison of BT Interna Dental InicCa®- Prosthetic components with selected predicate and reference devices.

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K213106- BTI Interna Dental Implant System UnicCa®- Prosthetic Components 510(K) Summary

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)