Who is the manufacturer of Ticare Dental Implant Systems?

Mozograu S.A. filed the 510(k) submission for Ticare Dental Implant Systems (K233137).

What is the FDA product code for Ticare Dental Implant Systems?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Ticare Dental Implant Systems?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like Ticare Dental Implant Systems?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ticare Dental Implant Systems

Q: What are the predicate devices for Ticare Dental Implant Systems?

BTI Dental Implant System UnicCa® (K151391).

K233137 · Mozograu S.A. · DZE · May 16, 2024 · Dental

Device Facts

Record ID	K233137
Device Name	Ticare Dental Implant Systems
Applicant	Mozograu S.A.
Product Code	DZE · Dental
Decision Date	May 16, 2024
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Ticare Dental Implant Systems consist of threaded, root-form endosseous titanium implants (Grade IV or V) and associated prosthetic components (abutments, healing screws, cover screws). Implants are surgically placed in the maxilla or mandible by dental clinicians to anchor dental prostheses. The system utilizes internal or external hex connections to secure abutments. The device transforms the jaw bone into a stable foundation for fixed or removable restorations. The system includes various diameters and lengths to accommodate different bone types and anatomical locations. The device benefits patients by restoring chewing function and aesthetics. Clinical decision-making is supported by the clinician's assessment of primary stability and occlusal loading requirements. The system is used in dental clinics.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by bench testing, including fatigue testing (ISO 14801), sterilization validation (ISO 11137, ISO 17665), shelf-life testing (ASTM F1980), biocompatibility (ISO 10993), bacterial endotoxin testing (USP <85>, <161>), and mechanical/dimensional testing (insertion/removal torque, pull-out strength).

Technological Characteristics

Materials: Commercially pure Grade IV titanium (implants), Grade V titanium alloy (InHex Mini/Quattro implants, abutments, screws), Vestakeep D4 R (retention cap). Surface: RBM. Connection: Internal/External hex. Sterilization: Gamma radiation (implants), non-sterile (abutments). Connectivity: Standalone mechanical system.

Indications for Use

Indicated for edentulous patients requiring partial or total tooth replacement via endosseous dental implants in the maxilla or mandible. Supports single-stage or two-stage procedures, screw-retained restorations, and immediate loading (if primary stability is achieved). Small diameter (3.3mm) implants restricted to maxillary lateral incisors and mandibular central/lateral incisors; contraindicated in molar regions. 6mm length implants restricted to two-stage procedures, delayed loading, and straight abutments.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

BTI Dental Implant System UnicCa® (K151391)

Reference Devices

NobelActive® (K142260)
Biomet 3i OSSEOTITE® 2 Dental Implants (K111216)
Biohorizons (K172576)
Medentika (K142167)
Nobel Biocare AB (K202344)
B.T.I. Biotechnology Institute (K022258)
Nobel Biocare AB (K161435)
Biomet 3i LLC (K192522)
KontactTM Dental Implant System (K210220)
O-Ring Abutment System (K990277)
OsseoSpeed TM Profile EV (K130999)

Related Devices

K111120 — CSM SUBMERGED-R IMPLANT SYSTEM · Csm Implant · Oct 14, 2011
K240837 — TOV Dental Implant System · Rdj Tov Implant, Ltd. · Aug 15, 2024
K111003 — BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL · Biodenta Swiss AG · Sep 15, 2011
K042971 — TITAN DENTAL IMPLANT SYSTEM · Titan Implants, Inc. · Jan 14, 2005
K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233137 Device Name Ticare Dental Implant Systems ### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 7 47197 Valladolid SPAIN | | 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ Ticare Dental Implant Systems 510(k) Premarket Notification Submission #### SECTION 05 - 510(k) SUMMARY ## 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 ## Page 3 | 35 {7}------------------------------------------------ #### 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. 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, {8}------------------------------------------------ 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. 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 {9}------------------------------------------------ Ticare Dental Implant Systems 510(k) Premarket Notification Submission #### SECTION 05 -510(k) SUMMARY 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. ## 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) {10}------------------------------------------------ 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 Dental Implant Systems | Ticare Dental Implant Systems are endosseous dental implants intended to be implanted in 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. | (Subject device) | | | 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. | | | | | | | PRIMARY PREDICATE BTI Dental Implant System UnicCa® K151391 | The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations. In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load. | Equivalent 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). | | REFERENCE PREDICATE NobelActive® K142260 | NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive® implants are indicated for single or multiple unit restorations in splinted or non- splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. NobelActive® 3.0 implants are indicated for single unit restorations only. | Equivalent Indications for use of the subject device are aligned with the indication of the predicate devices. | | REFERENCE PREDICATE | BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in | Equivalent Indications for use of the | | Dental Implants K111216 | edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. OSSEOTITE® 2 Dental Implants are intended for immediate 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. | aligned with the indication of the predicate devices. | | REFERENCE PREDICATE BioHorizons Tapered Short Implants K172576 | BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures. | Similar The general indications for use of this reference predicate are similar to those of the subject device. Specific features of this reference predicate (tapered short implants) are similar to a subset of specific references within the subject device family. | | REFERENCE PREDICATE Medentika Abutment System K142167 | Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Abutments are compatible with the following implant systems: Nobel Biocare Replace Select E -Series 3.5, 4.3, 5.0, 6.0 Nobel Biocare NobelActive F -Series 3.5, 4.3, 5.0 Biomet 3i Osseotite® Certain H -Series 3.25, 4.0, 5.0 Biomet 3i Osseotite I -Series 3.25, 3.75, 4.0, 5.0 Nobel Biocare Branemark K -Series 3.3, 3.75, 4.0, 5.0 Straumann Bone Level L -Series 3.3, 4.1, 4.8 Straumann Standard N -Series 3.3, 4.1, 4.8 Zimmer Tapered Screw-vent R -Series 3.3 3.7, 4.1, 4.7, 6.0 | Similar The general indications for use of this reference predicate are similar to those of the abutments included in the subject device. Specific features of this reference predicate (tapered abutments) are similar to a subset of specific abutment references within the subject device family. | | REFERENCE PREDICATE Kontact™ Dental Implant System K210220 | Astra Tech OsseoSpeed S -Series 3.5, 4.0, 4.5, 5.0 Dentsply Friadent Frialit/Xive T -Series 3.4, 3.8, 4.5, 5.5 Dentsply Friadent Ankylos Y -Series 3.5, 4.5, 5.5, 7.0 KontactTM Dental Implant System is indicated for use in partially or fully endentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. KontactTM Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. | Similar The general indications for use of this reference predicate are similar to those of the abutments included in the subject device | | REFERENCE PREDICATE TiUltra Implants and Xeal Abutments K202344 | NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive TiUltra implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as an artificial tooth | Equivalent Indications for use of the subject device are aligned with the indication of this reference predicate device. Specific features of this reference predicate (Inhex abutments with diameters ranging from 3mm to 7mm and posts with tapered abutments with wide diameters, 4.8mm) are similar to a subset of specific abutment references within the subject device family. | | REFERENCE PREDICATE BTI Dental Implant System K022258 | in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC TiUltra implants can be used in splinted or non- splinted applications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with <7 mm length are for delayed loading only when appropriate stability has been achieved. 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. | Similar The general indications for use of this reference predicate are similar to those of the subject device. Specific features of this reference predicate (post with tapered abutments for diameters up to 4.1mm) are similar to a subset of specific abutment | | | | references within the subject device family. | | REFERENCE PREDICATE Temporary Snap Abutment K161435 | The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days. | Similar The general indications for use of this reference predicate are similar to those of the subject device. Specific features of this reference predicate are similar to a subset of specific abutment references within the subject device family (UCLA abutments with diameters from 4.5mm to 6 mm). | | REFERENCE PREDICATE TSV BellaTek® Express and BellaTek® Flex Abutments K192522 | TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained. All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture. | Similar The general indications for use of this reference predicate are similar to those of the subject device. Specific features of this reference predicate are similar to a subset of specific abutment references within the subject device family (Osseous abutments with diameters from 3.4mm to 6 mm). | | REFERENCE PREDICATE OsseoSpeedTM Profile EV K130999 | Implants: The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: * replacing missing teeth in single or multiple unit applications in the mandible or maxilla. * immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge | Similar The general indications for use of this reference predicate are similar to those of the subject device. Specific features of this reference predicate are similar to a subset of specific abutment references | | | * especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective * immediate and early loading for all indications * together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate * only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components Abutments: ASTRA TECH Inriplant SyStemTM - OsseoSpeedTm EV abutments are intended to be used in conjunction with ASTRA TECH Implant SystemTrM - OsseoSpeedTM EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. The ATLANTISTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | within the subject device family (UCLA abutments with diameters from 3.4mm to 4.5 mm). | | REFERENCE PREDICATE O-Ring Abutment System K990277 | The BioHorizons O-Ring Abutment System is intended to provide a direct a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence. | Similar The general indications for use of this reference predicate are similar to those of the abutments included in the subject device | {11}------------------------------------------------ #### SECTION 05 - 510(k) SUMMARY Page 8 | 35 {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "MOZOGRAU" in bold, black letters. There is a horizontal line going through the middle of the "O" and "G" in the word. A circled "R" symbol is located to the upper right of the word. #### SECTION 05 - 510(k) SUMMARY {13}------------------------------------------------ #### SECTION 05 -510(k) SUMMARY {14}------------------------------------------------ #### SECTION 05 - 510(k) SUMMARY Page 11 | 35 {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the word "MOZOGRAU" in a bold, sans-serif font. There is a horizontal line going through the middle of the "O" and "G", connecting the two letters. A circled "R" trademark symbol is located to the right of the word. #### SECTION 05 - 510(k) SUMMARY Page 12 | 35 {16}------------------------------------------------ #### SECTION 05 - 510(k) SUMMARY ## Table 05.01 Comparison of Intended Uses The comparison of the subject device with the primary predicate device is summarized in the following table: Page 13 | 35 {17}------------------------------------------------ Image /page/17/Picture/0 description: The image shows the word "MOZOGRAU" in a bold, sans-serif font. There is a horizontal line going through the two O's in the middle of the word. A circled R symbol is located to the right of the word. #### SECTION 05 - 510(k) SUMMARY | | TICARE DENTAL IMPLANT SYSTEM | | Predicate device | | | |------------------------------------|---------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | Primary predicate BTI Dental Implant System Unic 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 | | Equivalent 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. | | | Threaded root form | | Threaded root form | | | | Restoration | Single-unit Multi-unit | | Single-unit Multi-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) | | Equivalent Generally, 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 | | Equivalent 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. | | Implant Diameter Ranges (mm) | Internal 3.3, 3.75, 4.25 and 5 mm | External 3.3, 3.4, 3.75, 4.25 and 5.0 | Internal 3.3 to 6.0 | External 3.0 to 5.5 | Equivalent Subject device diameters are within the range of diameters of the predicate device or larger. Larger dimeters do not represent | Page 14 | 35 {18}------------------------------------------------ Image /page/18/Picture/0 description: The image shows the word "MOZOGRAU" in bold, black letters. The "O" in the middle of the word has a horizontal line going through it. There is a circled "R" symbol to the right of the word, indicating that it is a registered trademark. #### 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 and L15 mm | Ø3.3: L10, L11.5, L13 and L15 mm | 5.5 to 18 mm | 7 to 18 mm | Subject implant lengths are within the range of the predicate device for internal connec…