Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes physical dental implant components and their mechanical properties and testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No.
The device is a prosthetic component (abutments and screws) used to support dental restorations, not to treat a disease or condition. While it supports a bodily function (chewing), it is an artificial replacement part rather than a direct therapeutic intervention on a disease state.

Diagnostic

No

The device description indicates that the BTI Interna Dental Implant System UnicCa® - Prosthetic Components are used to support restorations on dental implants, which is a therapeutic function, not a diagnostic one. The performance studies listed are for sterilization, biocompatibility, and material characterization, not for diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components (abutments, screws, interfaces) made of specific materials (titanium, titanium alloy) and provided sterile. The performance studies focus on physical properties, sterilization, packaging, and biocompatibility, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is "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." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose a condition.
Device Description: The description details various prosthetic components like abutments and screws that are physically implanted or attached to implants within the mouth. This aligns with a surgical or restorative device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely mechanical and structural.

Therefore, the BTI Interna Dental Implant System UnicCa® - Prosthetic Components are considered a medical device used for dental restoration, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandible or maxilla

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A series of non-clinical testing has been presented 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 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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K203252

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K053355, K070533, K211952

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.)

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.

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.

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 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

2

Indications for Use

510(k) Number (if known) K213106

Device Name

BTI Interna Dental Implant System UnicCa - Prosthetic Components

Indications for Use (Describe)

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.

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

4

IV. 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).

5

V. INDICATIONS FOR USE

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.

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

6

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 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

7

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.

8

	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	BTI Interna
Dental Implant
System UnicCa®-
Prosthetic
Components.	K203252
Multi-unit
Abutments for
CONELOGⓇ	K053355
BTI Interna Dental
Implant System	K070533
Endosseous dental
implant angled
abutments	K211952
BTI Interna Narrow/Plus
Dental Implant System
UnicCaⓇ	Substantial
Equivalence
Discussion
Product
Classification	Regulation No.: 21
CFR 872.3630
Product Code:
NHA
Device Class II	Regulation No.: 21
CFR 873.3630
Product Code: NHA.
Device Class II	Regulation No.: 21 CFR
872.3640
Product Code: DZE
Device Class II	Regulation No.:
21 CFR 872.3630
Product Code: NHA
Device Class II	Regulation No.: 21 CFR
872.3640
Product Code: DZE
Device Class II	Identical to primary
predicate device
Indications for Use	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.	The BioHorizons
Multi-unit
Abutments for
CONELOG® are
intended to function
in the mandible or
maxilla to
support single and
multiple-unit
temporary or
definitive
restorations on
CONELOG dental
implants	Dental implant system
comprising endosseous
titanium implants and
prosthetic elements to be
attached to the implants, as
well as auxiliary elements
for surgical and prosthetic
procedures.
The intended use of the
system is the restoration of
missing teeth in partially or
fully edentulous patients
and/or the fixation of
overdentures to restore or
enhance the chewing
capacity of patients.	Endosseous dental
implant angled
abutments are
premanufactured
prosthetic components
directly connected to the
Endosseous dental
implant and are
intended for use as aids
in prosthetic
rehabilitation. They can
be used in singled and
multi-unit restorations
where angled correction
is required.	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	Equivalent to
primary predicate
device.
	Subject Device	Primary Predicate
Device	Reference Device	Reference Device	Reference Device	Substantial
Equivalence
Discussion
	BTI Interna
Dental Implant
System UnicCa®-
Prosthetic
Components.	K203252	K053355	K070533	K211952
		Multi-unit
Abutments for
CONELOGⓇ	BTI Interna Dental
Implant System	Endosseous dental
implant angled
abutments	BTI Interna Narrow/Plus
Dental Implant System
UnicCaⓇ
Reason for Predicate/ Reference
Device		Indications for Use	Abutment/implant
connection design and
implant platform
compatibility.	Angled
abutments Titanium
design, material, and usage.	mandibular lateral and
central incisors. Immediate
loading is recommended
when there is good primary
stability and an
appropriate occlusal load.
Designs	Transepithelial
Abutments,
Interfaces, Angled
Titanium
abutments,
Aesthetic
Abutments and
Screws.	Multi-Unit Straight
abutment, Multi-Unit
Angled Abutment,
Copings, prosthetic
screws and
temporary cap.	Healing abutments and
caps, Temporary abutments,
Titanium and Gold
Abutments,
Transepithelial
abutments, Cylinders, and
Screws.	Angled Titanium
abutments	Healing abutments,
Temporary abutments,
Titanium Abutments,
Transepithelial
abutments, Aesthetic
Interfaces and Screws
Restoration	Single & Multiple	Single unit & Multi-
unit	Single & Multiple	Single & Multiple	Single & Multiple	Identical to
reference devices.
Compatible Implant Platform
(Diameter Ø=mm)	Interna Universal/
Plus
Ø= 4.1
Wide Platform
Ø = 5.5	Ø = 3.3- 4.3	Interna Universal/
Plus
Ø = 4.1
Wide Platform Ø = 5.5	Interna Universal/Plus
Ø =4.1
Externa Universal
Ø =4.1
Externa Wide
Ø = 5.5
Tiny
Ø=3.7
Narrow
Ø=4.2	Interna Narrow
Ø = 3.5
Interna Universal Plus
Ø = 4.1	Identical to
reference device
K053355
Implant to Abutment connection	Internal	Internal	Internal	Internal, External	Internal	Equivalent to
primary predicate
		Subject Device	Primary Predicate
Device	Reference Device	Reference Device	Reference Device
		BTI Interna
Dental Implant
System UnicCa®-
Prosthetic
Components.	K203252	K053355	K070533	K211952	Substantial
Equivalence
Discussion
							device and identical
to reference devices.
		Engaging/
Non-engaging	Engaging	Engaging/
Non-engaging	Non-Engaging	Engaging/
Non Engaging	Identical
to
reference
device
K053355
and
equivalent
to
reference
device
K211952.
	Prosthetic
Diameter (mm)	4.1 to 6.5	4.8	4.1 to 6.5
(Selected
components
design)	3.7 to 5.5
(Selected
components
design)	4.1 and 5.5
(Selected
components
design)	Identical
to
reference
device
K053355.
	Abutment Angulation	0°, 15°	0°, 17°, 30°	0°	15°	0°	Identical
to
reference
device
K070533.
	Gingival Height	Up to 4mm	2-4mm	Up to 4mm
(Selected
components
design)	Up to 4mm
(Selected
components
design)	Up to 4mm
(Selected
components design)	Identical to
reference devices.
Material	Abutments & Aesthetic
Interfaces	CP Titanium
Grade 4	Titanium Alloy
ASTM F136	CP Titanium
Grade 4	CP Titanium
Grade 4	CP Titanium
Grade 4	Identical
to
reference devices.
Same
manufacturing
material.
	Screws	Titanium Alloy
Ti-6Al-4V	Titanium Alloy
ASTM F136	Titanium CP
Grade 4		Titanium Alloy
Ti-6Al-4V	Identical
to
reference device
K211952.
Same
manufacturing
material.
Surface	Abutments & Aesthetic
Interfaces	Titanium Nitride	N.A.	-	-	Titanium Nitride	Identical
to
reference
device
K211952.
Coating	Screws	DLC Coating	N.A.	-	-	DLC Coating
(Tungsten Carbide/ Carbon
and Chromium)	Same
surface
coatings.
	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device
	BTI Interna
Dental Implant
System UnicCa®-
Prosthetic
Components.	K203252	K053355	K070533	K211952	Substantial
Equivalence
Discussion
	(Tungsten Carbide/
Carbon and
Chromium)	Multi-unit
Abutments for
CONELOG®	BTI Interna Dental
Implant System	Endosseous dental
implant angled
abutments	BTI Interna Narrow/Plus
Dental Implant System
UnicCa®
Sterilization	Sterile by gamma
radiation	Sterile by irradiation	Titanium abutments and
Screws: Non- sterile. To be
sterilized by end user-moist
heat.	Angled Titanium
Abutments: Non-
sterile. To be sterilized
by end user-moist heat	Transepithelial
abutments:
Sterile by gamma radiation
Titanium
Abutments,
Aesthetic Interfaces and
screws: non-sterile. To be
sterilized by end user-moist
heat.	Equivalent to
reference device
K211952.
Subject devices are
all provided by
sterile radiation and
same packaging to
those transepithelial
abutments cleared
under K211952.
Packaging	Thermoform tray
with peel top lid.	Unknown	Titanium abutments and
Screws: Thermosealed bag	Angled Titanium
Abutments:
Thermosealed bag.	Transepithelial
abutments: Thermoform
tray with peel top lid.
Titanium
Abutments,
Aesthetic Interfaces and
screws: Thermosealed bag

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

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