(154 days)
KAT Implants System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges. KAT Implants System 2.5mm implants are self-tapping titanium alloy threaded screws indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT Implants System 2.5mm implants may also be used for inter-radicular transitional application.
KAT Implants System 3.0mm implants are indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate.
KAT Implants System Abutments are intended to be used with KAT Implants System Dental Implants aid in prosthetic rehabilitation of the edentulous areas in maxilla and mandible.
Like the predicate KAT Implants 2.5mm and 3.0mm KAT Implants System Onepiece implants 2.5mm and 3.0mm display the following characteristics: a) have a threaded body and a tapered post with an internal threaded bore, b) have the same indications, c) are manufactured from the same material (Ti6Al4V ELI alloy), c) have the same diameters (2.5 and 3.0mm) and implant body lengths (10, 12 and 14mm), d) are packaged with the same materials and undergo the same sterilization process. KAT Implants System One-piece implants 2.5mm and 3.0mm implants are not designed to receive any abutments; they are designed to receive the crowns directly via cementation procedure. KAT Implants System One-piece implants are blasted with a soluble tricalcium phosphate blasting media. All materials and manufacturing processes are the same for all KAT Implants System Dental Implants. The fatigue testing was executed per ISO 14801:2007, Dentisty - Implants - Dynamic fatigue testing on endosseous dental implants on a 4.2mm width by 8.5mm length abutment with 20 ° angularity and a 3.0mm diameter implant, which is considered worst-case representation for KAT Implants System implants having 3.0mm or greater diameter. In view of a fatigue test results (samples were able to withstand 440 N of force over 5 million cvcles) and considering the fact that KAT Implants System One-piece Implants 3.0 and predicate KAT Implants System 3.0mm implants (K083544) have identical dimensions, no further fatigue testing was deemed necessary.
Predicate one-piece implant devices (IMTEC Sedax MDI 1.8mm and Maximus 3.0mm Diameter Implant) are the same as One-piece implants 2.5 and 3.0 in respect to material composition, surface treatment, diameters and lengths (for the exception of One-piece implant 3.0 x 10). Predicate Maximus 3.0mm Diameter Implant is not provided in 10 mm length, but another predicate - KAT 3.0mm implant cleared under K083544 is provided in 10 mm length.
Since predicate KAT Implants System 2.5mm implants (K083544) are approved for use with abutments of KAT Implants System, and considering the fact that KAT Implants System Onepiece Implants 2.5 and predicate KAT Implants System 2.5mm implants (K083544) have identical dimensions, no further fatigue testing was deemed necessary.
KAT Implants System Angled Abutments are implant abutment devices intended to be distributed as part of the KAT Implants System. KAT Implants System currently consists of implants, abutments, and Class I accessory instrumentation cleared for marketing under Traditional 510(k) Pre-marketing Notification # K083544 and K101201. All dental abutments of the KAT Implants System are a) used for the same indication, b) are manufactured with the same Ti-6AI-4Va ELI alloy, c) undergo the same surface treatment and sterilization, d) packaged and labeled using the same packaging materials and Instructions for Use, and e) are intended to be assembled together during surgery utilizing the same locking-taper implant post/abutment connection, with the aid of the same KAT Implants System Class 1 accessories and instruments.
Like the predicate KAT Implants System Straight (Prepable) Abutments with outside diameters 4.2mm 4.6mm and 5.4mm (all available only in 6.5mm length), KAT Implants System Angled Abutments which are subject of this 510(k), consist of a same-dimension internal hollow bore on one end for connection with the abutment-receiving post of the KAT Implants System Dental Implants. Like the abutment predicate, they are similarly designed to be retained by the KAT Implants System Dental Implants through the abutment-receiving post. A locking-taper connection is activated with a torque wrench set at 25 Ncm.
KAT Implants System Ball Abutments are implant abutment devices intended to be distributed as part of the KAT Implants System.
Like the predicate KAT Implants System Straight (Prepable) Abutments with outside diameters 4.2mm, 4.6mm and 5.4mm (all available only in 6.5mm length), KAT Implants System Ball Abutments which are subject of this 510(k), consist of a same-dimension internal hollow bore on one end for connection with the abutment-receiving post of the KAT Implants System Dental Implants. Like the abutment predicate, they are similarly designed to be retained by the KAT Implants System Dental Implants through the abutment-receiving post. A locking-taper connection is activated with a tapping force – the same method used to activate locking taper connection on the other predicate - KAT Implants System Implant Abutment 4.2x6.5.
The material of construction (Ti-6Al-4Va ELI Alloy), all surface preparation, all packaging, labeling and sterilization of KAT Implants System Angled Abutments and Ball Abutments are the same as previously cleared KAT Implants Straight and Implant Abutments. The outside diameters are the same, however, dimensional characteristics which differ from KAT Implant System Straight Abutments predicate duly noted below:
Angled Abutments: outside diameter availability in 4.6mm, and 5.4mm (within the range of previously cleared KAT Implant System Straight Abutments outside diameters), all with an 8.5mm length at 10° and 20° angulation. Mesial-distal width of Angled Abutment 4.2 10° and Angled Abutment 4.2 20° is 4.2mm.
Ball Abutments: outside diameter availability in 4.2mm (within the range of previously cleared KAT Implant System Straight Abutments outside diameters), and lengths between 6.5 and 8.5mm at 0°, 10° and 20° angulation.
The dimensional properties arising from differences in length between KAT Implants System Angled and Ball Abutments and the predicate KAT Implants System Straight Abutments were investigated by fatigue testing on KAT Implants System Angled Abutment 4.2mm x 8.5mm (20 ° anqularity) samples. The testing was executed per ISO 14801:2007, Dentistry - Implants -Dynamic fatique testing on endosseous dental implants. The use of a 4.2mm width by 8.5mm length Angled Abutment with 20° angularity is considered worst-case scenario representation for KAT Implants System abutments.
All KAT Implants System Dental Implant and Abutment devices which are subject of this 510(k) and the listed predicate devices are substantially equivalent because they are:
Manufactured using the same Titanium-6Aluminum-4Vanadium ELI alloy (certified to meet ASTM F136. Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications and biocompatibility requirements of Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments);
Packaged with the same size and material primary packaging (in conformance with material and process requirements of ISO 11607, Packaging for Terminally-Sterilized Medical Devices and ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials);
Are sterilized using the same sterilization process and sterility assurance level with SAL = 10-6 (per ISO 11137, Sterilization of Healthcare Products - Radiation).
Have the same Indications for Use.
Do not present any new dimensions and operating technology from endosseous dental implants and abutments already present in the market.
The only modifications that were made are:
-
Angle of the predicate Straight Abutments was changed from 0° to 10° and 20°;
-
Length of the predicate Straight Abutments was changed from 6.5mm to longer lengths. New abutment devices were named Angled Abutments 4.2 20°, 4.6 20°, 4.2 10°, 4.6 10°, 5.4 10°.
-
Internal thread of the Straight Abutments was removed and a ball element was added. New abutment devices were named Ball Abutments 3.5, 4.5, 5.5, 3.5 10°, 4.5 10°, 4.5 20°, 4.5 20°, 4.5 20°,
-
Abutment receiving post of the predicate KAT Implants 2.5 and 3.0 was made longer. New implant devices were named One-Piece Implants 2.5 and 3.0;
-
Implant blasting media was changed from aluminum oxide to a soluble tricalcium phosphate. All KAT Implants System Implants will be blasted with soluble tricalcium phosphate and will retain original names.
The document describes the K112758 submission for KAT Implants System components. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For the fatigue testing, the acceptance criterion implicitly comes from the predicate device and the ISO standard. The document states that the samples were able to withstand a certain force over a specified number of cycles. The fatigue testing for the new devices aims to show equivalent performance to maintain safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand dynamic fatigue testing per ISO 14801:2007 | Samples able to withstand 440 N of force over 5 million cycles |
| Demonstrate sufficient rotational stability for ball abutments | Ball Abutment Rotational Stability Test was conducted to justify the use of a tapping force to seat ball abutments. |
| Biocompatibility conforming to ASTM F136 | Manufactured using Titanium-6Aluminum-4Vanadium ELI alloy (certified to meet ASTM F136). |
| Packaging conforming to ISO 11607 and ASTM F88 | Packaged with the same size and material primary packaging (in conformance with material and process requirements of ISO 11607, Packaging for Terminally-Sterilized Medical Devices and ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials). |
| Sterilization conforming to ISO 11137 with SAL = 10^-6 | Sterilized using the same sterilization process and sterility assurance level with SAL = 10^-6 (per ISO 11137, Sterilization of Healthcare Products - Radiation). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Fatigue Testing: Not explicitly stated as a number, but refers to "samples" being able to withstand the force. For the "worst-case representation," a 4.2mm width by 8.5mm length Angled Abutment with 20° angularity and a 3.0mm diameter implant were tested. Without specific numbers, it is difficult to determine if statistical significance was met.
- Data Provenance: The studies are non-clinical (mechanical testing) conducted by the manufacturer, KAT Implants LLC. There is no information regarding country of origin of data (likely US, given the submission to FDA) or if it's retrospective or prospective (typically, this type of testing is prospective for new or modified devices).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission type. The studies described are non-clinical (mechanical and material testing), not involving human reader studies or expert ground truth generation for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable as there are no human reader studies described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance
This information is not applicable as there are no human reader studies described, and the device is a physical dental implant system, not an AI-based diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable as the device is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by recognized engineering standards and specifications:
- Fatigue Testing: ISO 14801:2007 (Dentistry - Implants - Dynamic fatigue testing on endosseous dental implants).
- Biocompatibility: ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications) and biocompatibility requirements of the Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- Packaging: ISO 11607 (Packaging for Terminally-Sterilized Medical Devices) and ASTM F88 (Standard Test Method for Seal Strength of Flexible Barrier Materials).
- Sterilization: ISO 11137 (Sterilization of Healthcare Products - Radiation).
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
§ 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.