(232 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical performance of dental implants and related components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is a dental implant system intended for the replacement of teeth in edentulous patients, which involves restoring physiological function, a clear therapeutic purpose.
No
Explanation: The device described is a dental implant system, which is a prosthetic device intended for the replacement of teeth. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a system of physical components including dental implants, abutments, screws, and caps made of titanium and other materials. There is no mention of software as a component of this device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system designed to be surgically implanted in the jaw bone to support dental prostheses. This is a surgical device used in vivo (within the body).
- Device Description: The description details the physical components of the implant system (implants, abutments, screws, etc.) and their materials. These are all physical devices for surgical implantation and prosthetic attachment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting outside the body.
The device is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible jaw bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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 and USP .
- . 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 ( "Bacterial Endotoxins Test", and USP "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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K142260, K111216, K172576, K142167, K202344, K022258, K161435, K192522, K210220, K990277, K130999
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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,
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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.
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
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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°.
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)
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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 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 and USP .
- . 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 ( "Bacterial Endotoxins Test", and USP "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.
38
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.