Predicate Devices

K083544, K101201, K031106, K032351, K99027

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental implant system and its components, focusing on materials, dimensions, mechanical testing, and comparison to predicate devices. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

Yes

The device, the KAT Implants System, is intended to restore edentulous areas and provide support for dental prostheses, which are therapeutic actions aimed at treating a medical condition (tooth loss).

Diagnostic

No

The device is an implant system (implants and abutments) used to restore edentulous areas and support dental prostheses. Its intended use is restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details physical implants and abutments made of titanium alloy, undergoing manufacturing processes, surface treatments, packaging, and sterilization. It also includes fatigue testing on physical samples. There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes the device as being used to restore edentulous areas, provide support for dentures and bridges, and act as single tooth replacements. These are all procedures performed in vivo (within the living body).
Device Description: The description details the physical characteristics of dental implants and abutments, their materials, dimensions, and how they are used in surgical procedures. This aligns with a medical device used for implantation.
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 compatibility testing.

Therefore, the KAT Implants System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

DZE, NHA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla and mandible

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 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° anqularity and a 3.0mm diameter implant. See Attachment 4 - "KAT Implants Fatigue Test".
Ball Abutment Rotational Stability Test was conducted to justify the use of a tapping force to seat ball abutments. See Attachment 5 - "Ball Abutment Rotational Stability Test".
Key results:

fatigue test results (samples were able to withstand 440 N of force over 5 million cvcles)

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.

K083544, K101201, K031106, K032351, K99027

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.

Not Found

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

Not Found

Regulation Number and Section

§ 872.3640 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.

Summary

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K112758

510 (k) Summary

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FEB 2 3 2012

This summary of safety and effectiveness information is being provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is:

Submitter's Information:

Vitali Bondar, CEO

KAT Implants LLC

15 Rye Street, Suite 115

Portsmouth, NH 03801

Phone: (603) 427-0084

Fax: (603) 427-0045

Date the Summary was Prepared: June 01, 2011

Device name:

Common Name: .

Endosseous Dental Implant, Root-form; Endosseous Dental Implant Abutment

Trade Name: t

One-Piece Implants 2.5x10, 2.5x12, 2.5x14; One-Piece Implants 3.0x10, 3.0x12, 3.0x14; KAT Implants System Implants 2.5x10, 2.5x12, 2.5x14, 3.0x12, 3.0x14, 3.5x8, 3.5x10, 3.5x12, 3.5x14, 4.3x6, 4.3x10, 4.3x12, 4.3x14, 5.0x6, 5.0x10, 5.0x10, 5.0x12, 5.0x14, 6.0x6, 6.0x8, 6.0x10, 7.0x6, 7.0x8, 7.0x10, 8.0x6, 8.0x10; Angled Abutments 4.2 20°, 4.6 20°, 5.4.20°, 4.2 10°, 4.6 10°, 5.4 10°, Ball Abutments 3.5, 4.5, 5.5, 3.5 10°, 4.5 20°, 4.5 20°,

Classification name:

Endosseous Dental Implant (21 CFR 872.3640, Product code DZE)

. Classification Panel:

Dental

Device classification: Class II

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Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The characters are 'K112758'.

Indications for Use:

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.

The legally marketed devices to which the equivalence is claimed [807.92(a)(3)]:

KAT Implants System Implants 2.5, 3.0, 3.5, 4.3 and 5.0 mm diameters Applicant: KAT Implants, LLC 510(k): K083544 KAT Implants System Implants 6.0, 7.0 and 8.0 mm diameters Applicant: KAT Implants, LLC 510(k): K101201 KAT Implants System Straight Abutments 4.2x6.5, 4.6x6.5 and 5.4x6.5 Applicant: KAT Implants, LLC : 510(k): K101201 KAT Implants System Implant Abutment 4.2x6.5 Applicant: KAT Implants, LLC 510(k): K083544 IMTEC Sendax MDI 1.8mm Applicant: IMTEC Corporation (USA) 510(k) Number. K031106 Maximus 3.0mm Diameter Implant Applicant: Biohorizons Implant Systems, Inc. 510(k) Number: K032351 O-ring Abutment Applicant: Biohorizons Implant Systems, Inc. 510(k) Number: K99027

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KII2758

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Description of Devices:

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

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12758

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.