Ticare Dental Implant Systems by Mozo Grau S.A.

Ticare Dental Implant Systems are endosseous dental implanted in the maxilla or mandble jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro implants are indicated to support permanently fixed restorations.

Ticare Inhex and Osseous implants of 6 mm length are in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.

Device Description

The subject device is a dental implant system including threaded, root-form endosseous dental implants of various diameters and lengths, straight, angled, tapered, UCLA and ball abutments + retention cap as well as healing abutments, cover screws and retaining screws to secure prosthetic restorations. Implants are commercially pure Grade IV titanium except for InHex "Mini" and InHex Quattro "Mini" implants which are Grade V titanium alloy. Abutments and screws are grade V titanium alloy 6Al 4V. Retention cap is Vestakeep D4 R. All implants have an RBM surface. Abutments must be matched to implant design and platform size. Provisional and temporary abutments are for use no more than 2-3 months. Some Inhex abutment designs have a narrow neck alternative version to allow the clinician more choices for soft tissue management.

Osseous dental implants have an external hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13 and 15mm. Standard platform comes in diameters of 3.4, 3.75, and 4.25mm with lengths of 8, 10, 11.5, 13, 15mm (no 8mm in 3.4). There is also a 5.0 standard platform implant which comes in lengths of 6, 8, 10, 11.5, 13 and 15mm. Maxi comes in a diameter of 5.0mm and lengths of 6, 8, 10, 11.5, 13 and 15mm.

InHex dental implants have an internal hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13, 15mm. Standard platform comes in diameters of 3.75, and 4.25mm in lengths of 6 (not in 3.75), 8, 10, 11.5, 13 and 15mm. There is also a 5.0mm diameter implant in standard platform which only comes in a 6mm length. Maxi platform comes in a diameter of 5.0mm with lengths of 9, 10, 11.5, 13, 15mm.

The Osseous Quattro and InHex Quattro implant thread design enables them to be used in softer bone types. Osseous Quattro dental implants have an external hex connection in standard platform and are available in diameters 3.75mm and 4.25mm and lengths of 8, 10, 11.5, 13 and 15mm. InHex Quattro dental implants have an internal hex connection in mini and standard platform and are available in diameters of 3.3mm (mini platform), 3.75mm and lengths 8 (not in 3.3), 10, 11.5, 13 and 15mm.

Maxi platform implants and abutments are for use in the molar region. Mini platform implants and abutments are for use in lateral incisors and lower central incisors. Standard platform implants and abutments are for use in all tooth locations.

Osseous straight abutments come in six designs. Prepable abutments come in hexed with a gingival height of 2mm in standard, mini, and maxi platforms. Tall straight abutments come in hexed with gingival heights of 0.5, 1, 2, 3, 4mm in standard, mini and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard and mini platforms. Multitask abutments comes in maxi platform and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard, mini, and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard platform.

Inhex straight abutments come in six designs. Prepable abutments come in hexed (not in mini) with a gingival height of 2mm in standard, mini, and maxi platforms. There is an additional hexed standard platform prepable abutment with a smooth exterior for cementing. Tall straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3, 4mm (4mm not in mini) in standard, mini and maxi platforms. There are also tall abutments with smooth surfaces for 5.0 implants which come in gingival heights of 3 or 4mm for both standard and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard, mini and maxi platforms. Multitask abutments comes in standard and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard and maxi platform. Inhex narrow neck tall straight abutments hexed and non-hexed come in mini platform with gingival heights of 2, 3mm and maxi & standard platforms with gingival heights of 2, 3, 4mm. Narrow neck short straight abutments hexed come in mini platform with gingival heights of 2, 3m and maxi & standard platforms with gingival heights of 2, 3, 4mm.

Osseous healing screws come in gingival heights of 2, 3, 4, 5, 6, 7mm (no 2mm in mini) in standard, mini, and maxi platforms. Osseous aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. There is an additional model in standard platform which has a tapered seating area.

Inhex healing screws come in gingival heights of 1, 2, 3, 4, 5, 6, 7mm (no 1mm in maxi) in standard and maxi platform. Inhex mini platform healing screws come in gingival heights of 3 or 4mm.There is an additional shorter design of healing screw for 5.0mm implants in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platform. Inhex aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. Narrow neck healing screws come in mini platform with gingival heights of 2, 3, 4mm and maxi & standard platform with gingival heights of 2, 3, 4, 5mm.

Osseous angled abutments come in 15° and 20° in standard, maxi, and mini platforms.

Inhex angled abutments come in 15° and 20° in gingival heights of 1, 3, 5mm for standard and maxi platforms and gingival height of 2mm for mini platform. For 5mm implants there is also a shouldered design of 15° and 20° abutment in gingival heights of 1, 3, 5mm for standard and maxi platforms.

Osseous UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, maxi and mini platforms. Osseous UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the gingival collar portion are not intended to be modified.

Inhex UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, and maxi platforms. Inhex UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the portion from the gingival collar portion to the bottom of the UCLA are not intended to be modified.

Osseous ball attachments in standard, maxi and mini platforms come in gingival heights of 1, 2, 3, 4, 5.5mm (no 1mm in maxi or mini). The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.

Inhex ball attachments in standard and maxi platforms come in gingival heights of 1, 2, 3, 4, 5.5mm. The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.

Osseous tapered abutments come in six different cone configurations on the top. 10° tapered abutments come in standard platform gingival heights of 2, 3, 4, 5mm with cone type 2, mini platform gingival heights 3, 4, 5mm cone type 1 and maxi platform gingival heights of 2, 3, 4, 5mm with cone type 3. 30° tapered abutments come in gingival heights of 4 or 5mm in standard platform with cone type 4 and maxi platform with cone type 5. Straight tapered abutments come in standard platform with cone type 6 in gingival heights of 2, 3, 4, 5mm. Angled tapered abutments come in standard platform with cone type 6 with 17° in gingival heights 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.

Inhex tapered abutments come in five of the possible six cone configurations. 10° tapered abutments come in standard platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2 and mini platform gingival heights 1, 2, 3mm in cone type 1. 10° tapered non-hexed abutments come in maxi platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2. 30° tapered abutments in cone type 4 gingival heights 1, 2, 3, 4, 5mm come in standard platform and non-hexed maxi platform. Straight tapered abutments in cone type 6 with gingival heights 2, 3, 4, 5mm come in standard and maxi platform. Angled tapered abutments with cone type 6 come in standard and maxi platform with 17° in gingival heights of 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Narrow neck 10° tapered abutments come in mini platform with gingival heights of 2, 3mm and standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 10° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments come in standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.

Healing abutments for tapered abutments include ones for 10° tapered abutment in standard and maxi platforms which is used with both Osseous and Inhex, angled tapered abutments for Osseous and Inhex, and 30° angled tapered abutment specific ones which fit Osseous maxi platform or Osseous standard and Inhex standard & maxi platforms.

Covers for provisional restoration of tapered abutments come in designs for 10° tapered abutments for Osseous and Inhex, mini and standard platform specific designs for 10° tapered abutments for Osseous and Inhex, and a design for 30° angled tapered abutments for Osseous and Inhex.

Posts for use with tapered abutments come in temporary and permanent restoration versions. Temporary ones come in standard and maxi platform versions for 10° and 30° tapered abutments which can be used with Osseous or Inhex. A temporary restoration post is also available for angled tapered abutments of Osseous or Inhex and an Osseous specific mini platform for 10° tapered abutments. Posts for permanent restoration come in versions for angled tapered abutments used for Osseous and Inhex, 10° tapered abutments used for Osseous and Inhex in standard platform, 30° tapered abutments used for Osseous and Inhex in maxi and standard platforms, non-hexed for 10° tapered abutments used for Osseous and Inhex in maxi platform, and non-hexed for 10° tapered abutment for Osseous mini platform. Titanium interfaces (shorter posts) are available for 10° and 30° tapered abutments for Osseous and Inhex, angled tapered abutments for Osseous and Inhex and 10° tapered abutments for Osseous mini platform.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for Ticare Dental Implant Systems. It is a regulatory document seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets acceptance criteria.

Therefore, the requested information cannot be fully provided as it pertains to a study demonstrating performance against acceptance criteria, which is not the primary focus of this type of regulatory submission.

However, I can extract information regarding the non-clinical testing performed to support substantial equivalence, which serves as a proxy for demonstrating that the device meets certain performance specifications.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in a direct table format as acceptance criteria vs. specific quantitative performance values for each test. Instead, the document states that tests "met the criteria of the standards" or "demonstrated substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not explicitly stated for each individual test. The document mentions "worst-case scenario" for selection of implants/abutments for certain tests (e.g., shortest implant, largest abutments).
Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Mozo Grau, S.A., based in Spain.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable as the document describes non-clinical bench testing, not clinical studies involving expert annotation or ground truth establishment in a medical imaging context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is related to clinical interpretation and ground truth establishment, which did not occur in this non-clinical 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:

Not applicable. This is a non-clinical submission for a dental implant system, not an AI/software device involving human readers or comparative effectiveness studies of that nature.

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

Not applicable, as this is not an AI/software device.

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

Not applicable. The "ground truth" in this context is adherence to validated engineering and material standards for dental implants.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning model.

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

Not applicable.

However, I can summarize the non-clinical testing performed as evidence of meeting performance expectations (implicitly serving as 'acceptance criteria' in a regulatory context for substantial equivalence):

Summary of Non-Clinical Data / Testing Performed:

The Ticare Dental Implant Systems underwent various bench tests to demonstrate conformance to performance specifications and requirements, following the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of these tests were reported to have met the criteria of the standards and demonstrated substantial equivalence to the predicate devices.

Non-Clinical Tests Performed (and how they relate to acceptance):

Test Category	Standard(s) / Description	Reported Performance / Outcome (Implicit Acceptance)
Mechanical / Durability	Fatigue testing: Under worst-case scenario in accordance with ISO 14801.	"met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
Sterilization	Gamma Sterilization Validation: ISO 11137-1 and ISO 11137-2 (for devices delivered sterile). A Sterility Assurance Level (SAL) of 10^-6 was validated.	"The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device."
	Steam Sterilization Validation: ISO 17665-1 (for devices delivered non-sterile, e.g., abutments, for end-user sterilization). Two steam sterilizations were conducted on worst-case abutments.	"The results showed equivalence to the predicate device."
Shelf-Life	Shelf-life testing: ASTM F1980 (for accelerated aging of sterile barrier systems and medical devices).	"The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life is guaranteed up to 5 years, and the devices will function adequately as intended without any degradation during the shelf-life."
Packaging Integrity	Packaging Tests: ASTM F88 (seal strength of flexible barrier materials) and ASTM F1929 (dye penetration for seal leaks).	"The results guarantee shelf life up to 5 years under transport and storage conditions during the shelf-life of <55ºC and humidity <75%."
Absence of Microbial Growth (Post-sterilization)	Sterility Tests: ISO 11737-2 (Microbiological methods).	"no microbial growth being detected."
Biocompatibility	Biocompatibility Tests: ISO 10993-1, ISO 10993-5 (cytotoxicity) and ISO 10993-23 (intracutaneous reactivity). Performed on several samples from Mozo Grau Dental Implant System and Abutments chosen as worst-case scenarios for materials, surfaces, and geometry.	"The result demonstrated the biocompatibility of the materials used."
Endotoxin Level	Bacterial Endotoxin Testing (LAL): USP <85> and USP <161>. Performed on worst-case product.	"The test results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device."
Surface Characterization	SEM (Scanning Electron Microscope) and EDS (Energy-dispersive X-ray spectroscopy): To evaluate final cleaning after surface treatment.	"Implants are completely clean with no residues from the blasting processes on the implant surface, confirming the effectiveness of the cleaning process applied to Mozo Grau dental implants."
Dimensional & Mechanical (Short Implants)	Dimensional and mechanical tests: Performed for the shortest implant (6 mm long) from Mozo Grau's system, compared to K172576. This included Bone-to-Implant Contact (BIC) under bone level and 3mm resorption conditions, insertion/removal torque, and pull-out strength.	"All test results have indicated that the subject device is less critical, having more BIC in all conditions, higher insertion and removal torque and higher pull-out forces, indicating favorable substantial equivalence." (i.e., performance met or exceeded predicate/expectations, indicating safety and effectiveness comparable to existing devices).
MR Safety	Non-clinical worst-case MRI review: Evaluation of metallic Ticare devices in the MRI environment using scientific rationale and published literature. Rationale addressed magnetically induced displacement force and torque.	This review was performed to support the safety labeling related to MRI compatibility. (No direct "acceptance criteria met" statement, but the performance of the review supports the safe use.)

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Mozo Grau, S.A. Beatriz Santos Quality Manager Calle Santiago López González 7 47197 Valladolid SPAIN

May 16, 2024

Re: K233137

Trade/Device Name: Ticare Dental Implant Systems Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 15, 2024 Received: April 15, 2024

Dear Beatriz Santos:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K233137

Device Name Ticare Dental Implant Systems

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

510(k) SUMMARY SECTION 05 -

DATE OF SUBMISSION:	2024-05-16
SUBMITTER NAME:	MOZO GRAU, S.A.
SUBMITTER ADDRESS:	Calle Santiago Lopez Gonzalez 747197 ValladolidSPAIN

CONTACT:	Beatriz Santos, Quality Manager
TELEPHONE:	+34 983 309 602
e-mail:	beatrizs@mozo-grau.com

DEVICE TRADE NAME: Ticare Dental Implant Systems

COMMON NAME: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments

REGULATION DESCRIPTION: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
REGULATION NUMBER: 21 CRF 872.3640
REGULATION CLASS: Class II

PRIMARY PRODUCT CODE: DZE SECONDARY PRODUCT CODE: NHA

PREDICATE DEVICE INFORMATION

Primary Predicate:

K151391 BTI Dental Implant System UnicCa®

Reference Predicates:

K142260 NobelActive® K111216 Biomet 3i OSSEOTITE® 2 Dental Implants K172576 Biohorizons K142167 Medentika K202344 Nobel Biocare AB K022258 B.T.I. Biotechnology Institute

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 -510(k) SUMMARY

K161435 Nobel Biocare AB K192522 Biomet 3i LLC K210220 KontactTM Dental Implant System K990277 O-Ring Abutment System K130999 OsseoSpeed TM Profile EV

INTENDED USE / INDICATIONS FOR USE:

The intended purpose of the subject device is:

Ticare Dental Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Ticare Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

The indications for use of the subject device are:

Ticare Dental Implant Systems are endosseous dental implants intended to the maxilla or mandible jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible and should not be used in the molar region. Ticare Osseous Quattro and Inhex Quattro implants are indicated to support permanently fixed restorations.

Ticare Inhex and Osseous implants of 6 mm length are intended for use in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 - 510(k) SUMMARY

DEVICE DESCRIPTION

Page 3 | 35

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SECTION 05 -510(k) SUMMARY

platforms. Multitask abutments comes in maxi platform and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard, mini, and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard platform.

Osseous angled abutments come in 15° and 20° in standard, maxi, and mini platforms.

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 -510(k) SUMMARY

and diameter of the gingival collar portion are not intended to be modified.

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 -510(k) SUMMARY

diverge from the occlusion axis by no more than 30°.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, Ticare Osseous and InHex Dental Implant Systems are compared with the following previously cleared devices:

Primarv Predicate:

BTI Dental Implant System UnicCa® (K151391) Reference Predicates: NobelActive® (K142260) OSSEOTITE® Dental Implants (K111216) BioHorizons Implant Systems (K172576) Medentika GmbH (K142167) Nobel Biocare AB (K202344)

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 - -510(k) SUMMARY

B.T.I. Biotechnology Institute (K022258) Nobel Biocare AB (K161435) Biomet 3i LLC (K192522) K210220 KontactTM Dental Implant System K990277 O-Ring Abutment System K130999 OsseoSpeed TM Profile EV

The intended use of the subject and the predicate devices are compared in the following table:

PRODUCT	INDICATION FOR USE	EQUIVALENCE
Ticare DentalImplant Systems	Ticare Dental Implant Systems areendosseous dental implants intended to beimplanted in the maxilla or mandible jaw boneto serve as a union between the jaw bone anda dental prosthesis for partial or totalreplacement of teeth in edentulous patients.They are indicated for single-stage or two-stage procedures to support screw-retainedrestorations and can be used for immediateloading when good primary stability isachieved and with appropriate occlusalloading.
	Small diameter (3.3mm) implants are indicatedto replace a lateral incisor in the maxilla and/ora central or lateral incisor in the mandible andshould not be used in the molar region. TicareOsseous Quattro and Inhex Quattro implantsare indicated to support permanently fixedrestorations.	(Subject device)
	Ticare Inhex and Osseous implants of 6 mmlength are intended for use in a two-stagesurgical procedure and are indicated fordelayed loading to support permanently fixedrestorations. These implants are indicated onlyfor straight abutments.

PRIMARYPREDICATEBTI Dental ImplantSystem UnicCa®K151391	The BTI Dental Implant System UnicCa® fororal implant surgery is to be used for thepartial or total replacement of teeth inedentulate patients. Once attached to thebone, the implants act as an anchor forvarious fixed or removable prostheticsolutions that can be used to improve orrestore a patient's mastication function.In the case of 5.5 – 6.5mm long UnicCa®implants should be used in a two-stagesurgical procedure. These implants areindicated for delayed loading. These implantsare indicated only for straight abutments andto support permanently fixed restorations.In the case of Tiny® 3.0 UnicCa® implants:These implants shall be used only to replacemaxillary lateral incisors and mandibularlateral and central incisors. Immediate loadingis recommended when there is good primarystability and an appropriate occlusal load.	EquivalentThe indications for use ofthe subject device arealigned with theindications for use of theprimary predicate,including the indicationsfor shorter implants (e.g.6mm length) and smalldiameter implants (e.g.3.3mm).
REFERENCEPREDICATENobelActive®K142260	NobelActive® implants are endosseousimplants intended to be surgically placed in theupper or lower jaw bone for anchoring orsupporting tooth replacements to restorepatient esthetics and chewing function.NobelActive® implants are indicated for singleor multiple unit restorations in splinted or non-splinted applications. This can be achieved bya 2-stage or 1-stage surgical technique incombination with immediate, early or delayedloading protocols, recognizing sufficientprimary stability and appropriate occlusalloading for the selected technique.NobelActive® 3.0 implants are intended toreplace a lateral incisor in the maxilla and/or acentral or lateral incisor in the mandible.NobelActive® 3.0 implants are indicated forsingle unit restorations only.	EquivalentIndications for use of thesubject device arealigned with theindication of thepredicate devices.
REFERENCEPREDICATE	BIOMET 3i dental implants are intended forsurgical placement in the upper or lower jaw toprovide a means for prosthetic attachment in	EquivalentIndications for use of the
Dental ImplantsK111216	edentulous spans with multiple single teethutilizing delayed or immediate loading, or witha terminal or intermediary abutment for fixed orremovable bridgework, and to retain overdentures.OSSEOTITE® 2 Dental Implants are intendedfor immediate function on single tooth and/ormultiple tooth applications when good primarystability is achieved, with appropriate occlusalloading, in order to restore chewing function.	aligned with theindication of thepredicate devices.
REFERENCEPREDICATEBioHorizons TaperedShort ImplantsK172576	BioHorizons Tapered Short Implants areintended for use in the mandible or maxilla asan artificial root structure for single toothreplacement or for fixed bridgework anddental retention. The implants may berestored using delayed loading, or with aterminal or intermediate abutment for fixed orremovable bridgework, and for overdentures.	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the subjectdevice. Specific featuresof this referencepredicate (tapered shortimplants) are similar to asubset of specificreferences within thesubject device family.
REFERENCEPREDICATEMedentika AbutmentSystemK142167	Medentika abutments are intended for usewith dental implants as a support for single ormultiple tooth prostheses in the maxilla ormandible of a partially or fully edentulouspatient.Abutments are compatible with the followingimplant systems:Nobel Biocare Replace Select E -Series 3.5,4.3, 5.0, 6.0Nobel Biocare NobelActive F -Series 3.5, 4.3,5.0Biomet 3i Osseotite® Certain H -Series 3.25,4.0, 5.0Biomet 3i Osseotite I -Series 3.25, 3.75, 4.0,5.0Nobel Biocare Branemark K -Series 3.3, 3.75,4.0, 5.0Straumann Bone Level L -Series 3.3, 4.1, 4.8Straumann Standard N -Series 3.3, 4.1, 4.8Zimmer Tapered Screw-vent R -Series 3.33.7, 4.1, 4.7, 6.0	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the abutmentsincluded in the subjectdevice. Specific featuresof this referencepredicate (taperedabutments) are similar toa subset of specificabutment referenceswithin the subject devicefamily.
REFERENCEPREDICATEKontact™ DentalImplant SystemK210220	Astra Tech OsseoSpeed S -Series 3.5, 4.0,4.5, 5.0Dentsply Friadent Frialit/Xive T -Series 3.4,3.8, 4.5, 5.5Dentsply Friadent Ankylos Y -Series 3.5, 4.5,5.5, 7.0KontactTM Dental Implant System isindicated for use in partially or fullyendentulous patients to support maxillary ormandibular single unit, multiple-unit, oroverdenture dental restorations. KontactTMDental Implant System is indicated forimmediate loading when good primarystability is achieved and the occlusal loadingis appropriate.	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the abutmentsincluded in the subjectdevice
REFERENCEPREDICATETiUltra Implants andXeal AbutmentsK202344	NobelActive TiUltraNobelActive TiUltra implants are endosseousimplants intended to be surgically placed inthe upper or lower jaw bone for anchoring orsupporting tooth replacements to restorepatient esthetics and chewing function.NobelActive TiUltra implants are indicated forsingle or multiple unit restorations in splintedor non-splinted applications.This can be achieved by a 2-stage or 1-stagesurgical technique in combination withimmediate, early or delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.NobelActive TiUltra 3.0 implants are intendedto replace a lateral incisor in the maxillaand/or a central or lateral incisor in themandible.Nobel Active TiUltra 3.0 implants areindicated for single-unit restorations only.NobelReplace CC TiUltraNobelReplace CC TiUltra implants areendosseous dental implants intended to besurgically placed in the bone of the upper orlower jaw arches to provide support forprosthetic devices such as an artificial tooth	EquivalentIndications for use of thesubjectdevicearealignedwiththeindication of thisreferencepredicatedevice.Specific features of thisreferencepredicate(Inhex abutments withdiameters ranging from3mm to 7mm and postswith tapered abutmentswith wide diameters,4.8mm) are similar to asubset of specificabutment referenceswithin the subject devicefamily.
REFERENCEPREDICATEBTI Dental ImplantSystemK022258	in order to restore patient esthetics andchewing function.The NobelReplace CC TiUltra implants areindicated for single or multiple unitrestorations. The NobelReplace CC TiUltraimplants can be used in splinted or non-splinted applications. The NobelReplace CCTiUltra implant may be placed immediatelyand put into immediate function provided thatinitial stability requirements detailed in themanual are satisfied.NobelParallel CC TiUltraNobelParallel CC TiUltra implants areendosseous implants intended to besurgically placed in the upper or lower jawbone for anchoring or supportingreplacements to restore patient esthetics andchewing function.NobelParallel CC TiUltra implants areindicated for single or multiple restorations insplinted or non-splinted applications. This canbe achieved by a 2-stage or 1-stage surgicaltechniques in combination with immediate,early or delayed loading protocols,recognizing sufficient primary stability andappropriate occlusal loading for the selectedtechnique.Implants with <7 mm length are for delayedloading only when appropriate stability hasbeen achieved.Dental implant system comprisingendosseous titanium implants and prostheticelements to be attached to the implants, aswell as auxiliary elements for surgical andprosthetic procedures.The intended use of the system is therestoration of missing teeth in partially or fullyedentulous patients and/or the fixation ofoverdentures to restore or enhance thechewing capacity of patients.	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the subjectdevice. Specific featuresof this referencepredicate (post withtapered abutments fordiameters up to 4.1mm)are similar to a subset ofspecific abutment
		references withinthesubject device family.
REFERENCEPREDICATETemporary SnapAbutmentK161435	The Temporary Snap Abutment is intended tobe used to fabricate and support provisionalrestorations that aid in creating an estheticemergence through the gingiva during thehealing period and prior to final restoration.The Temporary Snap Abutment can be usedfor cement retained or screw-retainedprovisional restorations. The abutments canbe used for single-unit and multi-unitrestorations. Use of the Temporary SnapAbutment is not to exceed one hundred andeighty(180) days.	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the subjectdevice. Specific featuresof thisreferencepredicate are similar to asubset of specificabutment referenceswithin the subject devicefamily (UCLA abutmentswith diameters from4.5mm to 6 mm).
REFERENCEPREDICATETSV BellaTek®Express andBellaTek® FlexAbutmentsK192522	TSV BellaTek® Express and BellaTek® FlexAbutments are intended for use asaccessories to endosseous dental implants tosupport a prosthetic device in a partially orcompletely edentulous patient. A dentalabutment is intended for use to support singleand multiple tooth prosthesis, in the mandibleor maxilla. The prosthesis can be screwretained or cement retained.All digitally designed superstructures and/orhybrid abutment crowns for use with TSVBellaTek Express or BellaTek Flex Abutmentsare intended to be sent to a Biomet 3ivalidated milling center for manufacture.	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the subjectdevice. Specific featuresof thisreferencepredicate are similar to asubset of specificabutment referenceswithin the subject devicefamily (Osseousabutments withdiameters from 3.4mm to6 mm).
REFERENCEPREDICATEOsseoSpeedTMProfile EVK130999	Implants:The ASTRA TECH Implant System - OsseoSpeedProfile EV implants are intended for both one- andtwo-stage surgical procedures in the followingsituations and with the following clinicalprotocols:* replacing missing teeth in single or multiple unitapplications in the mandible or maxilla.* immediate placement in extraction sites and insituations with a partially or completely healedalveolar ridge	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the subjectdevice. Specific featuresof thisreferencepredicate are similar to asubset of specificabutment references
	* especially indicated for use in soft boneapplications where implants with other implantsurface treatments may be less effective* immediate and early loading for all indications* together with immediate loading protocol in allindications, except in single tooth situations in softbone (type IV) where implant stability may bedifficult to obtain and immediate loading may notbe appropriate* only together with Profile EV components,Implant Driver Profile EV, Radiographic ImplantGuides ProfileEV and non-Indexed prosthetic componentsAbutments:ASTRA TECH Inriplant SyStemTM -OsseoSpeedTm EV abutments are intended to beused in conjunction with ASTRA TECH ImplantSystemTrM - OsseoSpeedTM EV in fullyedentulous or partially edentulous maxillaryand/or mandibular arches.The ATLANTISTM Abutment is intended for usewith an endosseous implant to support a prostheticdevice in a partially or completely edentulouspatient. It is intended for use to support single andmultiple tooth prostheses, in the mandible ormaxilla. The prosthesis can be cemented, screwretained or friction fit to the abutment. Theabutment screw is intended to secure the abutmentto the endosseous implant.	within the subject devicefamily (UCLA abutmentswith diameters from3.4mm to 4.5 mm).
REFERENCEPREDICATEO-Ring AbutmentSystemK990277	The BioHorizons O-Ring Abutment System isintended to provide a direct a directattachment for tissue-supported overdenturesretained by two or more implants with up to a10-degree divergence.	SimilarThe general indicationsfor use of this referencepredicate are similar tothose of the abutmentsincluded in the subjectdevice

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Table 05.01 Comparison of Intended Uses

The comparison of the subject device with the primary predicate device is summarized in the following table:

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SECTION 05 - 510(k) SUMMARY

	TICARE DENTAL IMPLANT SYSTEM		Predicate device
			Primary predicateBTI Dental Implant SystemUnic Ca®		Equivalence Discussion

Manufacturer	Mozo Grau S.A		Biotechnology Institute, S.L
510 (k) N°	Pending	K151391
Implant Design	Image: Threaded root form		Image: Threaded root form		EquivalentBoth subject and predicate devices present internal and external connections with a range of specific diameters and lengths to be combined with abutments within the same system, including angled abutments, to support dental prosthetic restorations.
	Threaded root form		Threaded root form
Restoration	Single-unitMulti-unit		Single-unitMulti-unit		Identical
Surgery Type	One or two stage (in particular for short implants, e.g. 6mm)		One stage and two-stage (for shorter implants, e.g., 5.5 - 6.5 mm)		EquivalentGenerally, both options are indicated for implant placement. 2- stage procedures are indicated for shorter implants in both cases.
Connection Type	Internal and External Connection		Internal and External connection		EquivalentBoth subject and predicate devices present internal and external connections with a range of specific diameters and lengths to be combined with abutments within the same system, including angled abutments, to support dental prosthetic restorations.
Implant DiameterRanges(mm)	Internal3.3, 3.75, 4.25 and 5 mm	External3.3, 3.4, 3.75, 4.25 and 5.0	Internal3.3 to 6.0	External3.0 to 5.5	EquivalentSubject device diameters are within the range of diameters of the predicate device or larger. Larger dimeters do not represent

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SECTION 05 -510(k) SUMMARY

		mm			worst case in terms of performance
Implant Length	Internal	External	Internal	External	Equivalent
(mm)	Ø3.3: L10,L11.5, L13 andL15 mm	Ø3.3: L10,L11.5, L13and L15 mm	5.5 to 18 mm	7 to 18 mm	Subject implant lengths are within the range of the predicatedevice for internal connection.
	Ø3.75: L8, L10,L11.5, L13 andL15	Ø3.4: L10,L11.5, L13and L15 mm
	Ø4.25: L6, L8,L10, L11.5, L13and L15	Ø3.75: L8,L10, L11.5,L13 and L15mm
	Ø5: L6, L9,L10, L11.5, L13and L15	Ø4.25: L8,L10, L11.5,L13 and L15mm
		Ø5: L6, L8,L10, L11.5,L13 and L15
Straight	Internal:	External:	Internal:	External:	Equivalent
Abutment Diameter,mm	3.7, 4.0, 5.0, 6.0	3.8, 4.0, 5.0,6.0	4.1, 5.0 5.5	4.1, 5.0 5.5	Subject straight abutment diameter are similar to the range ofdiameters for the predicate device.
AngledAbutmentAngle	Internal:15° and 20°	External:15° and 20°	Internal:17°	External:17°	SimilarSubject Angled abutment for single-unit restorations withmaximum angulation (20°) is greater than the predicate angledabutment with maximum angulation (17°).

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SECTION 05 -510(k) SUMMARY

Implant	Comercially pure titanium Grade IV, except InHex "Mini" and InHex Quattro "Mini" implants which are Grave V titanium alloy.	Commercially Pure titanium Grade IV	SimilarTitanium materials meeting standard specifications are used.
Surface Treatment	R.B.M TC surface treatment	UnicCa®	SimilarThe surface treatment applied to subject and predicate devices is to achieve similar resulting surface characteristics.
Abutment	Titanium grade V	Pure Titanium	EquivalentTitanium materials meeting standard specifications are used.
Compatibility	Abutments are only compatible with T Implants	Abutments are only compatibles with BTI Implants	Equivalent
Sterilization	Implants:Delivered sterile via gamma radiationAbutments:Non-sterile	Implants:Delivered sterile via Gamma RadiationAbutments:Non-Sterile	Equivalent
Packaging	Implants are supplied individually packed inside a container body (vial) that maintains sterility through the use of a sealing barrier system. The container body is thermally sealed inside a blister to maintain sterility.	Unique container (vial with clamp)	SimilarThe sterile barrier and container achieve the same results.
Shelf life	5 Years	5 Years	Equivalent

Table 05.02 Comparison of Principle of Operation and Technological Characteristics – Primary Predicate

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SECTION 05 - 510(k) SUMMARY

TICARE DENTAL IMPLANTSYSTEMQuattroInhex/Osseous			Reference Predicate	Reference Predicate	EquivalenceDiscussion
			NobelActive®	OSSEOTITE® Dental Implants
Manufacturer	Mozo Grau S.A		Nobel Biocare AB	BIOMET 3i
510 (k) N°	Pending		K142260	K111216
ProductClassification	Device Class IIRegulation No: 21 CFR872.3640.Product code DZE; Endosseousdental implant		Device Class IIRegulation No: 21 CFR872.3640.Product code DZE; EndosseousDental implant	Device Class IIRegulation No: 21 CFR872.3640.Product code DZE; EndosseousDental implant	-
Implant Design	Image: InHex Quattro	Image: Osseous Quattro	Image: NobelActive	Image: OSSEOTITE	SimilarIn particular the threaddesign
	InHexQuattro	OsseousQuattroThreaded, root form	Threaded, root form	Threaded, root form
Restoration	Single-unitMulti-Unit		Single-Unit	Single-UnitMulti-Unit	Identical
Surgery Type	One or two stage		One or two stage	Not available	Identical
ConnectionType	Internal and External Connection		Internal Hex Connection	External Hexagon Connection	Equivalent
Implant bodyDiameterRanges	Internal3.3, 3.75, 4.25and 5 mm	External3.3, 3.4, 3.754.25 and 5.0 mm	3.0, 3.5, 4.3, 5.0, and 5.5 mm	3.25, 3.75, 4.0, 5.0 and 6.0 mm	EquivalentSubject device diametersare within the range of the

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SECTION 05 - 510(k) SUMMARY

(mm)					diameters of the predicate devices.
Implant Length (mm)	Internal	External			EquivalentSubject implant lengths are within the range of the predicate devices.
	Ø3.3: L10, L11.5, L13 and L15 mmØ3.75: L8, L10, L11.5, L13 and L15Ø4.25: L6, L8, L10, L11.5, L13 and L15Ø5: L6, L9, L10, L11.5, L13 and L15	Ø3.3: L10, L11.5, L13 and L15 mmØ3.4: L10, L11.5, L13 and L15 mmØ3.75: L8, L10, L11.5, 13 and L15 mmØ4.25: L8, L10, L11.5, L13 and L15 mmØ5: L6, L8, L10, L11.5, L13 and L15	7.0, 8.5, 10.0, 11.5, 13.0, 15.0, 18.0 mm	3 mm to 15 mm
Implant material	Comercially pure titanium Grade IV, except InHex "Mini" and InHex Quattro "Mini" implants which are Grave V titanium alloy.	Commercially pure titanium	Commercially pure titanium	Commercially pure titanium	SimilarThe subject and the predicate devices are made of the similar raw materials meeting established standards.

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SECTION 05 -510(k) SUMMARY

Implant design	Implant with straight side walls,with a conical core of the externalthread and flat tip of the apex.	Not Available	Straight- walled implant body	Identical
Implant SurfaceTreatment	R.B.M surface treatment	TiUnite ® (oxidized surface)	Full OSSEOTITE	SimilarBoth subject andpredicate devices havesurface treatments toenhanceosseointegration.
AbutmentCompatibility	Titanium grade VAbutments are only compatiblewith Ticare Implants	TitaniumThe implants are Compatible withNobelBiocare Abutments	TitaniumCompatible with all BIOMET 3iexternal Hex restorativecomponents	IdenticalEquivalentCompatibility with otherimplant systems is notclaimed.
Supplied sterile	Yes	Yes	Yes	Identical
Sterilization	Sterilization by gamma radiation	Sterilization by gamma radiation	Sterilization by gamma radiation	Identical
Packaging	Implants are supplied individuallypacked inside a container body(vial) that maintainssterilitythrough the use of a sealing barriersystem. The container body isthermally sealed inside a blister tomaintain sterility.	Packaged in a double aseptic vialsystem	Packaged in sterile tray withcover screw	Similar
Shelf life	5 years	5 years	5 years	Identical

Table 05.03 Comparison of Principle of Operation and Technological Characteristics – Reference Predicates

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SECTION 05 -510(k) SUMMARY

	TICARE DENTALIMPLANTSYSTEM QuattroInhex/Osseous	ReferencePredicateTiUltra Implants andXeal Abutments	ReferencePredicateTSV BellaTek Expressand BellaTek FlexAbutments	Equivalencediscussion
Manufacturer	Mozo Grau S.A.	Nobel Biocare AB	BIOMET 3i LLC	-
510 (k) Nº	Pending	K202344	K192522	-
ProductClassification	Device Class IIRegulation No: 21CFR 872.3640.Product code DZE;Endosseous dentalimplant	Device Class IIRegulation No: 21CFR 872.3640.Product code DZE,NHA, PNP;Endosseous DentalImplant abutment	Device Class IIRegulation No: 21CFR 872.3640.Product code NHA;Endosseous DentalImplant abutment	-
		STRAIGHT ABUTMENT
Material	Titanium grade V	Titanium	Titanium alloy	Similar
Gingival Height	0.75mm, 1.11 mm,1.40mm, 2mm, 3mm,4mm	1.5mm, 3mm and4.5 mm	2 mm, 4 mm	Similar,
Post Height	6.5 mm	6.5 mm	7 mm	Similar, the post height doesnot present significantdifferences. Post height canbe modified to equivalentheights.
Diameter	3.7 mm, 4.8 mm and 6mm	Min 3mm Max 5.5mm	3.8 mm, 5 mm and 6mm	Similar, the dimensions donot present significant

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SECTION 05 - 510(k) SUMMARY

Connection type	Hex and non hex	Internal, hex	External Hex	differences.Same hex features. Internal or external connection depending on the implant to which it is to be connected.
	ANGLED ABUTMENTS
Material	Titanium grade V	Titanium	Titanium alloy	Similar
Angulation	15° and 20°	18° and 25°	15°	Similar
Gingival Height	1.8 mm	1.5mm and 3mm	2 mm, 4 mm	Similar
Post Height	6.5 mm	6.5 mm	7 mm	Similar, the length does not present significant differences.
Diameter	3.7 mm, 4.8 mm and 6 mm	Min 3mm Max 5.5mm	3.8 mm, 5 mm and 6 mm	Similar, the dimensions do not present significant differences.
Connection type	Hex	External hex	External Hex	Similar
	COVER SCREW
Material	Titanium Alloy	Titanium Alloy	Titanium Alloy	Similar
Angulation	Straight	Straight	Straight	Similar
Gingival Height	0 mm, 1 mm	0 mm	1 mm	Same diameter asNobelactive (3.5 mm) andOsseotite (3.4 mm and 4.1)
Diameter	2.5 mm, 3 mm, 3.4 mm,4 mm, 4.1 mm and 5 mm	2.5 mm, 3 mm,4 mm	3.4 mm, 4.1 mm, 5 mm, 6 mm	Same diameter asNobelactive (3.5 mm) andOsseotite(3.4 mm and 4.1)
Connection type	Internal cone,External	Internal cone	External	Same diameter asNobelactive (3.5 mm) and

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SECTION 05 -510(k) SUMMARY

				Osseotite (3.4 mm and 4.1)
HEALING ABUTMENT
Material	Titanium grade V	Titanium andpeek	Titanium alloy	Similar
Angulation	Straight	Straight	Straight	Yes
Gingival Height	2 mm, 3 mm, 4mm, 5 mm,6 mm and 7 mm	3 mm, 4 mm, 5mmand 7 mm	2 mm, 3 mm, 4mm,6 mm and 8 mm	Yes
Diameter	4.1 mm, 5 mm and6 mm	3, 3.2, 3.5, 3.6, 3.8, 4,4.2, 4.3, 4.5, 5.3, 5,5.5, 6, 6.5 and 7 mm	3.4 mm, 4.1 mm,5 mm and 6 mm	Same diameter asOsseotite (4.1 mm, 5mmand 6mm)
Connection type	Inhex	Inhex andinternal conic	Internal conic	Same as Nobel Active

Table 05.04 Comparison of Principle of Operation and Technological Characteristics – Reference Predicate

BALL ABUTMENT COMPARISON

	TICARE DENTALIMPLANTSYSTEM QuattroInhex/Osseous	ReferencePredicate	ReferencePredicate	Equivalencediscussion
Manufacturer	Mozo Grau S.A.	Biotech Dental, SAS	BioHorizons ImplantSystem	-
510 (k) Nº	Pending	K210220	K990277	-

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SECTION 05 -510(k) SUMMARY

ProductClassification	Device Class IIRegulation No: 21CFR 872.3640.Product code DZE;Endosseous dentalimplant	Device Class IIRegulation No: 21CFR 872.3640Product code DZE,NHA;Endosseous Dentalimplant	Device Class IIRegulation No: 21 CFR872.3640Product code DZE;Endosseous Dentalimplant	-
	BALL ABUTMENT + retention cap
Material	Ball abutment:Titanium grade VRetention cap:Elastic Polymer	Ball abutment:Titanium alloyRetention cap:Elastic Polymer	Ball abutment:Titanium alloyRetention cap:Elastic Polymer	Similar
Angulation	Straight	Straight	Straight	Similar
Gingival Height	0,73 mm, 2 mm, 3mm, 4 mm and 5.5mm	1mm, 2mm,3mm, 4mm and5 mm	1 mm, 2 mm, 3mm, 4 mm, 5 mmand 6 mm	Similar
Post Height	3 mm	3 mm	3.5 mm	Same with Biotech Dental.Similar, the length does notpresent significant differences.
Diameter	3.4 mm, 4,1 mmand 5 mm	4,1 mm	3.5mm 4mm and5mm	Same diameter as BiotechDental (4.1mm) andBioHorizons(5mm). Similar asBioHorizons(3.5mm).
Connection type	Non Hex	Internal conic,Non Hex	External, NonHex	Same as Biotech dental andBioHorizons.

Table 05.05 Comparison of Principle of Operation and Technological Characteristics – Reference Predicate

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SECTION 05 -510(k) SUMMARY

TAPERED ABUTMENT COMPARISON

	TICARE DENTAL IMPLANTSYSTEM Quattro Inhex/Osseous	ReferencePredicate	Equivalencediscussion
	TAPERED ABUTMENT	Medentika Abutment SystemK142167
Manufacturer	Mozo Grau S.A.	Medentika GmbH	-
510 (k) Nº	Pending	K142167	-
Product Classification	Device Class II Regulation No: 21CFR 872.3640.Product code DZE; Endosseousdental implant	Device Class II Regulation No: 21CFR 872.3630.Product code NHA; EndosseousDental Implant abutment	-
Material	Titanium grade V	Titanium grade V	Same
Angulation Cone 1, 2,3, 4 and 5	Straight	Not available	Similar, the post height does not presentsignificant differences. Post height can bemodified to equivalent heights.
Angulation Cone 6	Straight, 17°, 30°	Straight	Similar, the gingival height does not presentsignificant differences.
Gingival Height	2 mm, 3 mm, 4 mm,and 5 mm	1.5 mm, 2.5 mm, 3.5 mm and 5.5mm	Similar, the gingival height does not presentsignificant differences.
Post Height	2 mm	2 mm	Similar, the post height does not presentsignificant differences.

Table 05.06 Comparison of Principle of Operation and Technological Characteristics – Tapered Abutment – Reference Predicate

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SECTION 05 - 510(k) SUMMARY

UCLA ABUTMENT COMPARISON

	TICARE DENTALIMPLANTSYSTEM QuattroInhex/OsseousUCLA ABUTMENT	ReferencePredicateTiUltra Implantsand XealAbutments	ReferencePredicateTemporary SnapAbutment	ReferencePredicateTSV BellaTekExpress andBellaTek FlexAbutments	ReferencePredicateB.T.I. DentalImplant System	ReferencePredicateOsseoSpeed TMProfile EV	Equivalencediscussion
Manufacturer	Mozo Grau S.A.	Nobel Biocare AB	Nobel BiocareAB.	Biomet 3i LLC	B.T.I.BiotechnologyInstitute, S.L.	Dentsply Implants	-
510 (k) Nº	Pending	K202344	K161435	K192522	K022258	K130999	-
ProductClassification	Device Class IIRegulation No: 21CFR 872.3640.Product code DZE;Endosseous dentalimplant	Device Class IIRegulation No: 21CFR 872.3640.Product code DZE,NHA, PNP;Endosseous DentalImplant abutment	Device Class IIRegulation No:21 CFR872.3630.Product codeNHA,EndosseousDental Implantabutment	Device Class IIRegulation No: 21CFR 872.3630.Product codeNHA; EndosseousDental Implantabutment	Device Class IIRegulation No: 21CFR 872.3640.Product codeDZE, EndosseousDental Implantabutment	Device Class IIRegulation No: 21CFR 872.3640.Product code DZE,NHA; EndosseousDental Implantabutment	-
UCLA ABUTMENT
Material	Titanium grade V	Titanium Alloy	Titanium	Titanium	Titanium	Titanium	Similar
Angulation	Straight	Straight	Straight	Straight	Straight	Straight	Similar
GingivalHeight	1.11 mm	1.5 and 3mm	1.2 mm,1.5mmand 2mm	0.8 mm	1.5 mm	1 mm	Similar, thegingival heightdoes not presentsignificantdifferences

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SECTION 05 - 510(k) SUMMARY

TICARE DENTALIMPLANT	ReferencePredicate	ReferencePredicate	ReferencePredicate	ReferencePredicate	ReferencePredicate	Equivalencediscussion
SYSTEM QuattroInhex/OsseousUCLA ABUTMENT	TiUltra Implantsand XealAbutments	Temporary SnapAbutment	TSV BellaTekExpress andBellaTek FlexAbutments	B.T.I. DentalImplant System	OsseoSpeed TMProfile EV
Post Height	10 mm	10 mm	12 mm	12 mm	12 mm	9 mm	Similar, the postheight does notpresentsignificantdifferences. Postheight can bemodified toequivalentheights
Diameter	3.7mm, 4.8mm and6mm	3.5 mm, 5 mm and6.3 mm	4.5mm, 5.5 mmand 6mm	3.4 mm, 4.1 mm5 and 6 mm	3.5 mm and 6.3mm	3.4 mm, 4.1 mmand 4.5 mm	Similar, thediameter does notpresent significantdifferences.
Connectiontype	Hex and non-hex	Hex and non-hex	Hex and non-hex	Hex and non-hex	Hex and non-hex	N Hex and non-hex	Same
TEMPORARY ABUTMENT ENGAGING AND NON-ENGAGING
Material	Titanium grade V	Titanium and peek					Similar
Angulation	Straight	Straight					Yes
GingivalHeight	1.11 mm	1.5 and 3 mm					Similar
Post Height	10 mm	10 mm					Same

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SECTION 05 - 510(k) SUMMARY

	TICARE DENTALIMPLANTSYSTEM QuattroInhex/OsseousUCLA ABUTMENT	ReferencePredicateTiUltra Implantsand XealAbutments	ReferencePredicateTemporary SnapAbutment	ReferencePredicateTSV BellaTekExpress andBellaTek FlexAbutments	Equivalencediscussion
Diameter	3.7 mm, 4.8 mm and6 mm	3.5 mm, 5 mm and6.3 mm			Similar
Connectiontype	Non Hex	Non Hex			Same asNobelActive
			OSSEOUS UCLA ABUTMENTS
Material	Titanium grade V			Titanium	Same
Angulation	Straight			Straight	Same
GingivalHeight	1.11 mm			0.8 mm	Similar, thegingivalheight doesnot presentsignificantdifferences
Post Height	10 mm			12 mm	Similar, thepost heightdoes notpresentsignificantdifferences
Diameter	3.7 mm, 4.8 mm and6 mm			3.4 mm, 4.1 mm.5 and 6 mm	Similar
Connection	Non Hex			Non Hex	Same

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Image /page/31/Picture/0 description: The image shows the word "MOZOGRAU" in a bold, sans-serif font. There is a horizontal line above the letter "O" and "G", connecting them. A circled "R" symbol is located to the right of the word.

SECTION 05 - 510(k) SUMMARY

	TICARE DENTALIMPLANTSYSTEM QuattroInhex/OsseousUCLA ABUTMENT	ReferencePredicateTemporary SnapAbutment	ReferencePredicateB.T.I. DentalImplant System	ReferencePredicateOsseoSpeed TMProfile EV	Equivalencediscussion
Type
		INHEX ABUTMENTS
Material	Titanium grade V			Titanium	Same
Angulation	Straight			Straight	Same
GingivalHeight	1.11 mm			1 mm	Similar, thegingivalheight doesnot presentsignificantdifferences
Post Height	10 mm			9 mm	Similar, the postheight does notpresent significantdifferences
Diameter	3.7 mm, 4.8 mm and6 mm			3.4 mm, 4.1 mm and4.5 mm	Similar
ConnectionType	Non Hex			Non-Hex	Same
	EXTERNAL POST ENGAGING AND NON-ENGAGING
Material	Titanium grade V		Titanium		Same
Angulation	Straight		Straight		Same
GingivalHeight	1.11 mm		1.5 mm and 2 mm		Similar, thegingival height

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SECTION 05 -510(k) SUMMARY

	TICARE DENTALIMPLANTSYSTEM QuattroInhex/OsseousUCLA ABUTMENT	ReferencePredicateB.T.I. DentalImplant System	Equivalencediscussion
			does not presentsignificantdifferences
Post Height	10 mm	9 mm	Similar, the postheight does notpresent significantdifferences
Diameter	3.7 mm, 4.8 mm and6 mm	3.4 mm, 4.1 mmand 4.5 mm	Similar
ConnectionType	Non Hex	Non-Hex	Same

Table 05.07 Comparison of Principle of Operation and Technological Characteristics – Reference Predicate

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SECTION 05 - 510(k) SUMMARY

ABUTMENT POST COMPARISON

	TICARE DENTAL IMPLANTSYSTEM QuattroInhex/Osseous	ReferencePredicate	ReferencePredicate	Equivalencediscussion
	ABUTMENT POSTS	B.T.I. Dental Implant System	TiUltra Implants and Xeal Abutments

Manufacturer	Mozo Grau S.A.	B.T.I. Biotechnology Institute,S.L.	Nobel Biocare AB	-
510 (k) Nº	Pending	K022258	K202344	-
Product Classification	Device Class II Regulation No:21CFR 872.3640.Product code DZE; Endosseousdental implant	Device Class II Regulation No:21 CFR 872.3640.Product code DZE,Endosseous Dental Implantabutment	Device Class II Regulation No: 21CFR 872.3640.Product code DZE, NHA PNP:Endosseous Dental Implant abutment	-
		POST FOR TAPERED ABUTMENT
Material	Titanium grade V	Titanium	Titanium	Same
Angulation	Straight	Straight	Straight	Same
Gingival Height	3.10 mm	1.5 mm and 2 mm	1.5 mm	Similar, the gingivalheight does not presentsignificant differences.
Post Height	7.9 mm	8 mm	10 mm	Similar, the post heightno present significantdifferences. Post heightcan be modified toequivalent heights.
Diameter	3.7 mm, 4.8 mm and 6 mm	3.5 mm, 4.1 mm	4.8 mm	Similar
Connection Type	Non Hex	Non Hex	Non Hex	Same

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Image /page/34/Picture/0 description: The image shows the word "MOZGGRAU" in bold, black letters. There is a horizontal line going through the two G's in the middle of the word. There is a circled R symbol to the right of the word, indicating that it is a registered trademark. The background is white.

SECTION 05 -510(k) SUMMARY

TEMPORARY COPING MULTIUNIT TITANIUM COMPARISON
Material	Titanium grade V	Titanium	Same
Angulation	Straight	Straight	Same
Gingival Height	3.10 mm	1.5 mm	Similar, the gingivalheight does not presentsignificant differences.
Post Height	7.9 mm	10 mm	Similar, the post heightdoes not presentsignificant differences.
Diameter	3.7 mm, 4.8 mm and 6 mm	4.8 mm	Same as 4.8 mm
Connection Type	Non Hex	Non Hex	Same

Table 05.08 Comparison of Principle of Operation and Technological Characteristics – Reference Predicates

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

510(k) SUMMARY SECTION 05 -

SUBSTANTIAL EQUIVALENCE DISCUSSION:

The subject device is substantially equivalent to BTI Dental Implant System Unic Ca® (K151391) by Biotechnology Institute, S.L

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 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.

In terms of equivalence, the indications for use of the subject device are aligned with the indications for use of the primary predicate, including the indications for shorter implants (e.g. 6mm length) and small diameter implants (e.g. 3.3mm).

Regarding the implant design, both subject and predicate devices present internal and external connections with a range of specific diameters and lengths to be combined with abutments within the same system, including angled abutments, to support dental prosthetic restorations.

They both use the same materials, meeting standard specifications.

SUMMARY DISCUSSION OF NON-CLINICAL DATA:

The subject device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices:

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 -510(k) SUMMARY

Fatigue testing under the worst-case scenario in accordance with ISO 14801. ●
Gamma Sterilization Validation Test under ISO 11137-1 and ISO 11137-2.
Sterilization validating testing has been performed under ISO 17665-1 for steam sterilization. ●
Shelf-life testing according with ASTM F1980, ASTM F88, ASTM F1929 and ISO 11737-2. ●
Biocompatibility Tests were performed in accordance with ISO 10993-5 and ISO 10993-23.
Bacterial Endotoxin Testing (LAL) under USP <85> and USP <161>.
. SEM (Scanning Electron Microscope) and EDS (Energy-dispersive X-ray spectroscopy) were performed to evaluate the final cleaning after surface treatment in Mozo Grau implants.
. Dimensional and mechanical tests on Mozo Grau short implants (< 7 mm length).

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

For devices delivered sterile such as dental implants, a sterility assurance level (SAL) of 10 € have been validated in accordance with ISO 11137-1 "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" and ISO 11137-2 "Sterilization of Health Care Products – Radiation – Part 2: Establishing the sterilization dose". The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device.

For devices delivered non-sterile to be end-user sterilized, the recommended sterilization condition has been validated through the end-user sterilization, according to ISO 17665-1 "Sterilization of health care products – Moist heat – part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices". After a worst-case scenario analysis two steam sterilizations were conducted, selecting two abutments with the largest masses in two different materials. The results showed equivalence to the predicate device.

Shelf-life Testing was performed on the devices provided sterile in accordance with ASTM F1980 "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". The worstcase scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life is guaranteed up to 5 years, and the devices will function adequately as intended without any degradation during the shelf-life.

Packaging tests were carried out according to ASTM F88 to test the seal strength of flexible barrier materials and ASTM F 1929 to detect seal leaks in porous medical packaging by dye penetration. The

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

SECTION 05 -510(k) SUMMARY

results guarantee shelf life up to 5 years under transport and storage conditions during the shelf-life of <55ºC and humidity <75%.

Sterility tests were performed in accordance with ISO 11737-2 "Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process", with no microbial growth being detected.

Biocompatibility was assessed under ISO 10993-1. As a result, cytotoxicity and intracutaneous reactivity tests were conducted on several Mozo Grau samples from Mozo Grau Dental Implant System and Abutments in accordance with ISO 10993-5 and ISO 10993-23. The parts selected for testing took into account the worst-case scenario in terms of materials, surfaces, more challenging geometries for cleaning process and direct body tissue contact. The result demonstrated the biocompatibility of the materials used.

Endotoxin (LAL) tests are intended to ensure that devices are not likely to cause pyrogenic reaction. The product selected for testing from Mozo Grau Dental Implant System took into account the worstcase scenario in terms of manufacturing process and was tested for bacterial endotoxin under USP <85> "Bacterial Endotoxins Test", and USP <161> "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". The test results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.

SEM/EDS chemical characterization was conducted to review the chemical composition of the blasted surface in order to verify that any chemicals used to clean the implant surface after the blasting process have been removed. Characterization of Mozo Grau Sterile Dental Implants concludes that implants are completely clean with no residues from the blasting processes on the implant surface, confirming the effectiveness of the cleaning process applied to Mozo Grau dental implants.

A dimensional and mechanical test batch has been performed for the worst-case implant from Mozo Grau Dental Implant System in terms of length. The shortest implant (6 mm long) from Mozo Grau was selected and compared with reference device K172576.

The bone to implant contact surface (BIC) was evaluated under bone level insertion condition and 3mm resorption condition. A favorable result was obtained.

Insertion and removal torque and pull-out strength tests were also performed.

All test results have indicated that the subject device is less critical, having more BIC in all conditions, higher insertion and removal torque and higher pull-out forces, indicating favorable substantial equivalence.

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Ticare Dental Implant Systems 510(k) Premarket Notification Submission

510(k) SUMMARY SECTION 05 -

SUMMARY DISCUSSION OF CLINICAL DATA:

Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic Ticare devices 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 Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental 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.

SUMMARY OF SUBSTANTIAL EQUIVALENCE DISCUSSION:

When compared to the primary and reference predicate devices, the intended use and technological characteristics of Ticare Dental Implant Systems raise no new issues related to safety and effectiveness. Ticare Dental Implant Systems are found to be substantially equivalent to the primary predicate device BTI Dental Implant System UnicCa® (K151391).

CONCLUSIONS:

Based on the results of the bench testing performed and information included in this submission, we conclude that the Ticare Dental Implant Systems are substantially equivalent to the primary predicate device.

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.