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.

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.

AI/ML Overview

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.

Summary

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K112758

510 (k) Summary

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Page 1 of 7

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 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 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

Description of Devices:

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.

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:

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:

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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.

Summary of similarities and modifications between the devices which are subject of this 510(k) and predicate device is presented in the table below.

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Areas of Comparison	KAT Implants System Dental Implants	KAT Implants System Implants blasted with a soluble tricalcium phosphate media	KAT Implants System One-Piece Implants	IMTEC Sendax MDI 1.8mm	Maximus 3.0mm	KAT Implants System Angled Abutments 10° and 20°	KAT Implants System Straight (Prepable) Abutments	KAT Implants System Ball Abutments	O-ring Abutment
Regulatory Status	Predicate	Present submission	Present submission	Predicate	Predicate	Predicate	Predicate	Predicate	Predicate
510(k) Number	K083544 and K101201	Present submission	Present submission	K031106	K032351	Present submission	K101201	K083544	K99027
Intended Use	Endosseous dental implant	Endosseous dental implant	Endosseous dental implant	Endosseous dental implant	Endosseous dental implant	Dental Abutment	Dental Abutment	Dental Abutment	Dental Abutment
Device Nominal Dimensions (Diameter x length) in mm	2.5x10,2.5x12,2.5x14,3.0x10,3.0x12,3.0x14,3.5x8,3.5x10,3.5x12,3.5x14,4.3x6, 4.3x8, 4.3x10,4.3x12,4.3x14, 5.0x6,5.0x8, 5.0x10,5.0x12,5.0x14, 6.0x6,6.0x8, 6.0x10,7.0x6, 7.0x8,7.0x10, 8.0x6,8.0x8, 8.0x10	2.5x10,2.5x12,2.5x14,3.0x10,3.0x12,3.0x14,3.5x8,3.5x10,3.5x12,3.5x14,4.3x6, 4.3x8, 4.3x10,4.3x12,4.3x14, 5.0x6,5.0x8, 5.0x10,5.0x12,5.0x14, 6.0x6,6.0x8, 6.0x10,7.0x6, 7.0x8,7.0x10, 8.0x6,8.0x8, 8.0x10	2.5x10,2.5x12,2.5x14,3.0x10,3.0x12, 3.0x14	1.8x10,1.8x12,1.8x14	3.0x12,3.0x15,3.0x18	4.2x8.5,4.6x8.5,5.4x8.5	4.2x6.5,4.6x6.5,5.4x6.5	4.2x6.5,4.2x7.5,4.2x8.5	4.5, 6.5, 8.5 length provided in 3.5, 4.5 and 5.7 mm diameters
Device	N/A	N/A	N/A	N/A	N/A	10° and 20°	0°	0°	0°, 10° and 20° 0°

K112758

ー

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KII 2758

ਘ

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stability.
KAT ImplantsSystem 2.5mmimplants areself-tappingtitanium alloythreadedscrews	self-tappingtitanium alloythreadedscrews	indicated fortransitional andlong-term intra-bonyapplications,such asprovidingsupport fortransitional orlong termcrowns,bridges anddentures. KATImplantsSystem 2.5mmimplants mayalso be usedfor inter-radiculartransitionalapplication.	indicated fortransitional andlong-term intra-bonyapplications,such asprovidingsupport fortransitional orlong termcrowns,bridges anddentures. KATImplantsSystem2.5mmimplants mayalso be usedfor inter-radiculartransitionalapplication.	indicated fortransitional andlong-term intra-bonyapplications,such asprovidingsupport fortransitional orlong termcrowns,bridges anddentures.	incisors. Theimplantsmay berestoredafter aperiod oftime orplaced inimmediatefunction; (3)for denturestabilizationusingmultipleimplants inthe anteriormandibleand maxilla.The implantsmay berestoredafter aperiod oftime orplaced inimmediatefunction.	Immediateloading maynot beappropriatein Type IVbone due todifficulty inachievingprimarystability.	KATImplantsSystemAngledAbutmentsare notintended tobe used withunsplinted2.5mmdiameterimplants inposteriorregion.	Immediateloading maynot beappropriatein Type IVbone due todifficulty inachievingprimarystability.	Type IV bonedue todifficulty inachievingprimarystability.	stability.
indicated fortransitionaland long-termintra-bonyapplications,		KAT ImplantsSystem 3.0mmimplants areindicated foruse inmaxillarylateral ormandibular	KAT ImplantsSystem3.0mmimplants areindicated foruse inmaxillarylateral ormandibular	KAT ImplantsSystem 3.0mmimplants areindicated foruse inmaxillarylateral ormandibularlateral andcentral incisorsin single ormultiple unitsto supportprosthesis,such asartificial teeth.The implantcan be placed

K110758

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central incisorsin single ormultiple unitsto supportprosthesis,such asartificial teeth.The implantcan be placedin extractionsites or healedalveolar ridgesand can beimmediatelyloaded whengood primarystability isachieved andthe functionalload isappropriate.Immediateloading maynot beappropriate inType IV bonedue to difficultyin achievingprimarystability.	to supportprosthesis,such asartificial teeth.The implantcan be placedin extractionsites orhealedalveolarridges andcan beimmediatelyloaded whengood primarystability isachieved andthe functionalload isappropriate.	sites or healedalveolar ridgesand can beimmediatelyloaded whengood primarystability isachieved andthe functionalload isappropriate.	Type ofimplant /abutmentconnection	Platform size
			1.5 ° press fitactivatedlocking taperconnection	3.1mmdiameter
			1.5 ° press fitactivatedlocking taperconnection	3.1mmdiameter
			N/AOne-PieceImplant	2mmdiameter
			N/AOne-PieceImplant	3.1mmdiameter
			1.5 ° press fitactivatedlocking taperconnection	3.1mmdiameter
			1.5 ° press fitactivatedlocking taperconnection	3.1mmdiameter
			Screwretained	3.5, 4.5 and5.7 mm

K112753

ব

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	Mode ofAbutment toimplantattachmentAssociatedClass Icomponents	implant post	implant post	implant post	implant post	implant post	implant post	implant post	diameter
	N/A	Implantplacement/removalinstrumentation	Implantplacement/removalinstrumentation	Implantplacement/removalinstrumentation	N/A	Torqueapplication(25 Ncm)	Torqueapplication(25 Ncm)	Torqueapplication(25 Ncm) ortapping force	Screwretained
Type ofimplant	Endosseousscrew typewith acontinuousthread andhorizontalcircumferentialfins.	Endosseousscrew typewith acontinuousthread andhorizontalcircumferential fins.	Endosseousscrew typewith acontinuousthread andhorizontalcircumferentialfins.	Endosseousscrew typewith acontinuousthread	N/A	Abutmentplacement/removalinstrumentation	Abutmentplacement/removalinstrumentation	Abutmentplacement/removalinstrumentation and O-ringhousing withEPDM rubberO-ring	Placementinstrumentation and O-ringhousing withSilicon O-ring
Materialsused	Titanium alloyTi6Al4V ELI	Titanium alloyTi6Al4V ELI	Titanium alloyTi6Al4V ELI	TitaniumalloyTi6Al4V ELI	N/A	TitaniumalloyTi6Al4V ELI	Titanium alloyTi6Al4V ELI	Titanium alloyTi6Al4V ELI	Titanium alloyTi6Al4V ELI
Biocompatibility	Titanium alloyTi6Al4V ELI isused formanufacturingof all implantsand abutmentsof KATImplantsSystem	Titanium alloyTi6Al4V ELI isused formanufacturing of allimplants andabutments ofKAT ImplantsSystem	Titanium alloyTi6Al4V ELI isused formanufacturingof all implantsand abutmentsof KATImplantsSystem	TitaniumalloyTi6Al4V ELI	N/A	TitaniumalloyTi6Al4V ELI isused formanufacturing of allimplants andabutments ofKATImplantsSystem	Titanium alloyTi6Al4V ELI isused formanufacturingof all implantsand abutmentsof KATImplantsSystem	Titanium alloyTi6Al4V ELI isused formanufacturingof all implantsand abutmentsof KATImplantsSystem	N/A
Blastingmedia	100 micronAluminumOxide	<300 gritsolubletricalciumphosphate	<300 gritsolubletricalciumphosphate	Aluminumoxide	N/A	<300 gritsolubletricalciumphosphate	N/A	N/A	N/A

KII8758

ഗ

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MechanicalSafety
Fatigue testingwas performedon a 3.0mmdiameterimplant and a8.5mm long20° angleabutmentaccording toISO14801:2007	Fatiguetesting wasperformed ona 3.0mmdiameterimplant and a8.5mm long20° angleabutmentaccording toISO14801:2007	Fatigue testingwas performedon a 3.0mmdiameterimplant and a8.5mm long20° angleabutmentaccording toISO14801:2007	Unknown:	Unknown	Fatiguetesting wasperformedon a 3.0mmdiameterimplant anda 8.5mmlong 20°angleabutmentaccording toISO14801:2007	Fatiguetesting wasperformed ona 3.5mmdiameterimplant anda 6.5mmlongimplantabutment aspart ofK083544	Fatiguetesting wasperformed ona 3.5mmdiameterimplant and a6.5mm longimplantabutmentas part ofK083544	Fatigue testingwas performedon a 3.0mmdiameterimplant and a8.5mm long20° angleabutmentaccording toISO14801:2007	Unknown	Unknown:.	Unknown

。 -

K112758

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K11a758

Summary of the non-clinical test submitted as part of this submission:

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".

Conclusions Drawn:

The following devices listed in this pre-marketing notification:

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, 7.0x10, 8.0x6, 8.0x8, 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°,

are substantially equivalent to the noted predicate devices based on tabulated device specifications and properties presented in the Summary of Technological Characteristics. These proposed devices are substantially equivalent to the predicate devices because they have:

same fundamental scientific technology and intended use as the predicate device; -
same materials, processing, packaging, sterilization and inspection methods; -
same manufacturing infrastructures (both human and physical); -
same instructions for use.

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Image /page/12/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Vitali Bondar President Kat Implants, LLC 15 Rye Street, Suite 115 Portsmouth, New Hampshire 03801

FEB 2 3 2012

Re: K112758

Trade/Device Name: 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, 3.0x10, 3.0x12, 3.0x14, 3.5x8, 3.5x10, 3.5x12, 3.5x14, 4.3x6, 4.3x10, 4.3x12, 4.3x14, 5.0x6, 5.0x8, 5.0x10, 5.0x12, 5.0x14, 6.0x6, 6.0x8, 6.0x10, 7.0x6, 7.0x8, 7.0x10, 8.0x6, 8.0x8, 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 10°, 3.5 20°, 4.5 20°, Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 15, 2012 Received: February 15, 2012

Dear Dr. Bondar:

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 (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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Bondar

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 modifined in any Federal statutes and regulations administered by other Federal agencies. or the rec or any 1 outs 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of incuretts as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, BS, MS, MBA Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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112758

Indications for Use Statement

510(k) Number (if known)

Device Name

One-Piece Implants 2.5x10, 2.5x12, 2.5x14; One-Piece Implants 3.0x10, 3.0x12, One-1 1000 Implants System Implants 2.5x10, 2.5x12, 2.5x14, 3.0x10, 3.0x12, 3.0x14, 3.5x8, 3.5x10, 3.5x12, 3.5x14, 4.3x6, 4.3x8, 4.3x10, 4.3x12, 4.3x14, 5.0x14, 5.0x10, 5.0x10, 5.0x12, 5.0x14, 6.0x6, 6.0x10, 7.0x6, 7.0x8, 7.0x10, 8.0x6, 8.0x8, 8.0x10; Angled Abutments 4.2 20°, 4.6 20°, 5.4 20°, 4.2 10°, 4.6 8.0x0, 0.0x0, 0.0x10, Anglour Bacher 13.5, 3.5, 10°, 4.5 10°, 3.5 20°, 4.5 20°,

Indications for Use

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.

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suken Reinos
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of 1

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.