KAT Implant System Dental Implants are indicated for restoration of edentulous 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 implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.

KAT Implant System Straight Abutment devices are intended to be used with KAT Implant System Dental Implants to aid in prosthetic rehabilitation.

KAT Implant System (Dental Implants and Straight Abutment) is indicated for the restoration of edentulous areas in maxilla and mandible.

Device Description

KAT Implant System Dental Implants (with outside diameters 6.0mm, 7.0mm and 8.0mm) and KAT Implant System Straight (Prepable) Abutments (with outside diameters 4.2mm, 4.6mm, 5.0mm, 5.4mm, and 6.4mm) are root-form, endosseous dental implant and implant abutment devices intended to be distributed as part of the KAT Implant System platform. KAT Implant System currently consists of implants, abutments, and Class I accessory instrumentation cleared for marketing under Traditional 510(k) Prc-marketing Notification # K083544.

Like the predicate KAT Implant System Dental Implant with outside diameter 5.0mm, the KAT Implant System Dental Implants which are subject of this 510(k) are provided in lengths of 6.0mm, 8.0mm, and 10.0mm. External V-shaped thread is similarly utilized in these new sizes of KA I Implant System Dental Implants in order to screw the implants into the bone. Horizontal fins are also placed between the thread and the abutment receiving portion of these dental implants. The abutment receiving portion of all KAT Implant System Dental Implants consists of a 3.1mm outside diameter post with a 1.5 degree taper. All KAT Implant System Dental Implants are intended to be used with previously cleared KAT Implants System Implant Abutments, as stated in Instructions for Use.

Like the predicate KAT Implant System Implant (Indexed) Abutments with outside diameters 4.2mm, 4.7mm, 5.5mm and 6.5mm, the KAT Implant Straight (Prepable) Abutments which are subject of this 510(k) consist of outside diameters within the predicate's range of outside diameters, and are 6.5mm in length. KAT Implant System Straight (Prepable) Abutments are similarly retained by the KAT Implant System Dental Implants through the abutmentreceiving post. A locking-taper connection activates the seating of the abutment to the implant with the help of a torque wrench.

AI/ML Overview

This document is a 510(k) summary for a dental implant system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study with acceptance criteria and performance data in the traditional sense of an AI/ML device submission.

As such, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and ground truth is largely not applicable or not explicitly detailed in this type of submission for a physical medical device like a dental implant.

However, I can extract the relevant information and approximate answers where possible based on the provided text, primarily focusing on the comparison to the predicate device.

Here's the breakdown of the information you requested:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in the format of specific quantitative benchmarks. Instead, it demonstrates substantial equivalence based on a comparison of technological characteristics and performance testing to a legally marketed predicate device. The "performance" here refers to the outcomes of bench testing designed to show comparable safety and efficacy to the predicate.

Acceptance Criteria (Implied from Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison/testing)
Materials: Same as predicate (Titanium-6Aluminum-4Vanadium ELI alloy per ASTM F136-2(a), biocompatibility per Class II Special Control Guidance Document).	The subject devices are manufactured using the same Titanium-6Aluminum-4Vanadium ELI alloy, certified to meet ASTM F136-2(a) and biocompatibility requirements of the Class II Special Control Guidance Document.
Surface Treatment: Same as predicate (aluminum oxide grit-blasting, alkaline ultrasonication, nitric acid passivation per ASTM F86-04).	The subject devices undergo the same aluminum oxide grit-blasting (compliant with Class II Special Control Guidance Document) and same surface preparation processes (alkaline ultrasonication and nitric acid passivation per ASTM F86-04).
Packaging: Same as predicate (material and process requirements of ISO 11607:2006).	The subject devices are packaged with the same size and material primary packaging, conforming to ISO 11607:2006.
Sterilization: Same as predicate (radiation sterilization per ISO 11137:2006 with SAL = 10^-6).	The subject devices are sterilized using the same sterilization process and sterility assurance level (SAL = 10^-6) per ISO 11137:2006.
Implant/Abutment Rotation/Loosening Performance: Comparable to predicate.	Predicate: Insertion of abutment with force not less than 15 N-cm (torque wrench) or tapping force. Rotation/loosening prevented by frictional fit and engagement between implant post grooves and key's protrusions. Subject Device (Implant): Same results as predicate (characterization performed as implant/abutment system). Subject Device (Abutment): Insertion with force not less than 25 N-cm (torque wrench) or tapping force. Demonstrated better resistance to rotation/loosening compared to predicate device. Justification for 25 N-cm torque provided in Section 18, Performance Testing.
Implant/Abutment Fatigue Performance: Meets guidance for fatigue testing per Class II Special Control Guidance Document, comparable to predicate.	Predicate: Meets guidance for Fatigue testing per Class II Special Control Guidance Document (tested on 3.5mm diameter implant). Has substantial equivalence with the predicate in terms of fatigue performance, if not better. Subject Device (Implant): Same results as predicate (characterization performed as implant/abutment system). Subject Device (Abutment): Same results as subject device implant (characterization performed as implant/abutment system).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes bench testing (non-clinical) rather than a clinical study.

Sample Size: Not explicitly stated in terms of the number of units tested for each specific performance characteristic (e.g., how many abutments were tested for rotation/loosening, or how many implant-abutment systems were tested for fatigue). The document refers to "Testing performed on Implant/Abutment System as presented in Section 18, Performance Testing – Bench." Section 18 is not provided in this excerpt, but it would typically contain the specific number of test articles.
Data Provenance: Bench test data originating from the manufacturer (KAT Implants LLC, Portsmouth, NH 03801, USA). This is non-clinical data, not patient data, so "country of origin of the data" and "retrospective or prospective" are not applicable in the patient data sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is a physical medical device 510(k) submission, not an AI/ML device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation is not applicable. The "ground truth" for this device's performance is established by engineering and materials science testing standards (e.g., ASTM, ISO standards, and FDA guidance documents like the Class II Special Control Guidance Document for Root-form Endosseous Dental Implants). These standards define how to objectively measure properties like material composition, strength, fatigue resistance, and sterilization effectiveness.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of physical device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human experts are interpreting data (e.g., images) to establish "ground truth" or resolve disagreements. Here, the "truth" is determined by objective physical measurements according to established engineering protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to diagnostic devices (often AI-powered) where human readers (e.g., radiologists) interpret cases, and the study evaluates the impact of an AI tool on their performance. This document is for a physical dental implant system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on:

Compliance with material specifications (e.g., ASTM F136-2(a) for alloy, ASTM F86-04 for surface preparation).
Compliance with packaging and sterilization standards (ISO 11607:2006, ISO 11137:2006).
Results from mechanical bench testing (e.g., for rotation/loosening, fatigue) against benchmarks implied or referenced by the FDA's "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and comparison to the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a "training set."

Summary

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Page 1 of __

APR 1 3 2011

510(k) Summary

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: K101201

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

FDA CDRH DMC

JAN 3 1 2011

Received

Date the Summary was Prepared: November 11, 2010

Device name:

. Common Name:
Endosseous Dental Implant, Root-form; Endosseous Dental Implant Abutment

Trade Name: .

KAT Implant System Dental Implant 6.0mm x 6.0mm; Dental Implant 6.0mm x 8.0mm; Dental Implant 6.0mm x 10.0mm; Dental Implant 7.0mm x 6.0mm; Dental Implant 7.0mm x 8.0mm; Dental Implant 7.0mm x 10.0mm; Dental Implant 8.0mm x 6.0mm; Dental Implant 8.0mm x 8.0mm; Dental Implant 8.0mm x 10.0mm

KAT Implant System Straight (Prepable) Abutments 4.2mm x 6.5mm, Straight (Prepable) Abutments 4.6mm x 6.5mm, Straight (Prepable) Abutments 5.0mm x 6.5mm, Straight (Prepable) Abutments 5.4mm x 6.5mm, Straight (Prepable) Abutments 6.4mm x 6.5mm

Classification name: �

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

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Classification Panel:

Dental

Device classification: Class II

Indications for Use:

KAT Implant System Straight Abutment devices are intended to be used with KAT Implant System Dental Implants to aid in prosthetic rehabilitation.

Removed transitional applications

KAT Implant System (Dental Implants and Straight Abutment) is indicated for the restoration of edentulous areas in maxilla and mandible.

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

Predicate device: KAT Implant System Dental Implant 5.0mm x 6.0mm; Dental Implant 5.0mm x 8.0mm; Dental Implant 5.0mm x 10.0mm Applicant: KAT Implants, LLC 510(k) number: K083544

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Predicate device: KAT Implant System Implant (Indexed) Abutment 4.2mm x 6.5mm, Implant (Indexed) Abutment 4.7mm x 6.5mm, Implant (Indexed) Abutment 5.5mm x 6.5mm, Implant (Indexed) Abutment 6.5mm x 6.5mm Applicant: KAT Implants, LLC 510(k) number: K083544

4 240 - 2 2 2 2 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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Description of Devices:

thread is similarly utilized in these new sizes of KA I Implant System Dental Implants in order to screw the implants into the bone. Horizontal fins are also placed between the thread and the abutment receiving portion of these dental implants. The abutment receiving portion of all KAT Implant System Dental Implants consists of a 3.1mm outside diameter post with a 1.5 degree taper. All KAT Implant System Dental Implants are intended to be used with previously cleared KAT Implants System Implant Abutments, as stated in Instructions for Use.

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Like the predicate KAT Implant System Dental Implant Abutments, KAT Implant System Dental Implants and Abutments which are subject of this 510(k) are manufactured:

a) using the same Titanium-6Aluminum-4Vanadium ELI alloy (certified to meet ASTM F136-2(a), 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),

b) undergoes the same aluminum oxidc grit-blasting (compliant with blasted surfaces requirements of Class II Special Control Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments) and;

c) undergoes the same surface preparation processes (alkaline ultrasonication and nitric acid passivation per ASTM F86-04, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants);
d) packaged with the same size and material primary packaging (in conformance with material and process requirements of ISO 11607:2006, Packaging for Terminally-Sterilized Medical Devices);
e) and are sterilized using the same sterilization process and sterility assurance level with SAL = 1066 (per ISO 11137:2006, Sterilization of Healthcare Products - Radiation)

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

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Summary of Technological Characteristics	ENDOSSEOUS DENTALIMPLANT, ROOTFORM		IMPLANT ABUTMENT
Common Name	KAT Implant SystemDental Implant 5.0mm	KAT Implant SystemDental Implants	KAT Implant SystemImplant (Indexed)Abutment 4.2mm, 4.7mm,5.5mm, 6.5mm	KAT Implant SystemStraight (Prepable)Abutment 4.2mm, 4.6mm,5.0mm, 5.4mm, 6.4mm
Device Name
510(K) Reference	Predicate	Current 510(k)	Predicate	Current 510(k)
Device Code	K083544	DZE	K083544	NHA
Device Class	Class II	Class II	NHA	Class II
Trade Name	KAT Implant System DentalImplant 5.0mm	KAT Implant System DentalImplants 6.0mm, 7.0mmand 8.0mm	Class IIKAT Implant SystemImplant (Indexed)Abutment 4.2mm, 4.7mm,5.5mm, 6.5mm	KAT Implant SystemStraight (Prepable)Abutment 4.2mm, 4.6mm,5.0mm, 5.4mm, 6.4mm
Outside Diameter	5.0mm	6.0mm, 7.0mm and 8.0mm	4.2mm, 4.7mm, 5.5mm,6.5mm	4.2mm, 4.6mm, 5.0mm,5.4mm, 6.4mm
Length	6.0mm, 8.0mm, 10.0mm,12.0mm, 14.0mm	6.0mm, 8.0mm and10.0mm	6.5mm	6.5mm
Essential Design Output Specifications:	ENDOSSEOUS DENTALIMPLANT, ROOTFORM		IMPLANT ABUTMENT
Common Name	KAT Implant SystemDental Implants 5.0mm	KAT Implant SystemDental Implants 6.0mm,7.0mm and 8.0mm	KAT Implant SystemImplant (Indexed)Abutment 4.2mm, 4.7mm,5.5mm, 6.5mm	KAT Implant SystemStraight (Prepable)Abutment 4.2mm, 4.6mm,5.0mm, 5.4mm, 6.4mm
Device Name
Indications for Use	PredicateKAT Implant System isintended to restoreedentulous areas of maxillaand mandible, to providesupport for removable	Current 510(k)KAT Implant System DentalImplants are indicated forrestoration of edentulousmaxilla and mandible, toprovide support for	PredicateKAT Implant System isintended to restoreedentulous areas of maxillaand mandible, to providesupport for removable	Current 510(k)KAT Implant SystemStraight Abutment devicesare intended to be usedwith KAT Implant SystemDental Implants to aid in

Intended Use	dentures, fixed bridges, or tobe used as a single toothreplacement. Single orsplinted implants can beimmediately loaded if goodprimary stability andappropriate occlusal loadingare achieved. The implantcan be placed in extractionsites or healed alveolarridges. Immediate loadingmay not be appropriate inType IV bone due to difficultyin achieving primary stability.	removable dentures, fixedbridges, or to be used as asingle tooth replacement.Single or splinted implantscan be immediately loadedif good primary stability andappropriate occlusalloading are achieved. Theimplants can be placed inextraction sites or healedalveolar ridges. Immediateloading may not beappropriate in Type IVbone due to difficulty inachieving primary stability.	dentures, fixed bridges, orto be used as a single toothreplacement. Single orsplinted implants can beimmediately loaded if goodprimary stability andappropriate occlusalloading are achieved. Theimplant can be placed inextraction sites or healedalveolar ridges. Immediateloading may not beappropriate in Type IVbone due to difficulty inachieving primary stability.	prosthetic rehabilitation.
	Intended for use by alicensed dentists familiar withsurgical and prostheticapplications that uses KATImplant System dentalimplants, implant abutmentsand Class I accessories andinstrumentation. Device isnot intended for use at homeand is for prescription useonly.	Intended for use by alicensed dentist familiarwith surgical and prostheticapplications that uses KATImplant System dentalimplants, implantabutments and Class Iaccessories andinstrumentation. Device isnot intended for use athome and is forprescription use only.	Intended for use by alicensed dentist familiarwith surgical and prostheticapplications that uses KATImplant System dentalimplants, implantabutments and Class Iaccessories andinstrumentation. Device isnot intended for use athome and is forprescription use only.	Intended for use by alicensed dentist familiarwith surgical and prostheticapplications that uses KATImplant System dentalimplants, implantabutments and Class Iaccessories andinstrumentation. Device isnot intended for use athome and is forprescription use only.
Device Compatibility	KAT Implant System ImplantAbutments and Class Iaccessories andinstrumentation	KAT Implant SystemImplant Abutments andClass I accessories andinstrumentation	KAT Implant System DentalImplants and Class Iaccessories andinstrumentation	KAT Implant SystemDental Implants and Class Iaccessories andinstrumentation
EnvironmentalCompatibility	No known compatibilityissues with devices,chemicals, and otherenvironmental factors	No known compatibilityissues with devices,chemicals, and otherenvironmental factors	No known compatibilityissues with devices,chemicals, and otherenvironmental factors	No known compatibilityissues with devices,chemicals, and otherenvironmental factors

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. . . . . . . . . . . . .

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reasonably expected to bepresent in area of devicedistribution and device'sintended use.	reasonably expected to bepresent in area of devicedistribution and device'sintended use.	reasonably expected to bepresent in area of devicedistribution and device'sintended use.	reasonably expected to bepresent in area of devicedistribution and device'sintended use.		interface
Software ComponentComponent withBiological Origin	n/a	n/a	n/a		Angularity of ImplantAbutment	implants.n/a	implants.n/a	implants.0 degrees
Design Output Specifications (General Performance and Safety)					Performance of theImplant/AbutmentSystem:Rotation/Loosening	Insertion of the abutment canbe implemented using atorque wrench with force notless than 15 N-cm.Insertion of the abutment canbe implemented via tappingforce but better calibration offorce is possible when torquewrench is utilized.	Insertion of the abutmentcan be implemented usinga torque wrench with forcenot less than 25 N-cm*.Insertion of the abutmentcan be implemented viatapping force but bettercalibration of force ispossible when torquewrench is utilized.	Same results as stated forKAT Implant System DentalImplant predicate.(characterization performedas implant/abutmentsystem).
Type of implant	Endosseous screw type witha continuous thread andhorizontal circumferentialfins.	Endosseous screw typewith a continuous threadand horizontalcircumferential fins.	n/a			Rotation / loosening of theabutments are prevented notonly by frictional fit, but alsoby the engagement betweenthe implant post grooves andthe key's protrusions.	Abutments demonstratedbetter resistance to rotation/ loosening when comparedto predicate device.*(Refer to Section 18,Performance Testing,Bench for the justification ofapplication of 25 N-cmtorque in seating abutmentto implant and comparisonof applied torques to rotateabutment seated on animplant)
Type of abutment	n/a	n/a	Consists of abutment andindexing key which iswelded to form a singlepiece abutment intended tobe seated to implant usingapplied force not less than15N-cm using a torquewrench or by using tappingforce.	n/a	Consists of a single pieceabutment intended to beseated to implant usingapplied force not less than25N-cm using a torquewrench or by using tappingforce.	n/a	Performance of theImplant/AbutmentSystem: Fatigue		Same results as stated forKAT Implant SystemDental Implant subject ofthis current 510(k).(characterization performedas implant/abutmentsystem).
Platform size	3.1mm abutment receivingpost	3.1mm abutment receivingpost	3.1mm internal bore	3.1mm internal bore			Implants have greateroutside diameter than thepredicate device and aredesigned with the same3.1mm diameter /3.5mmlength abutment-receivingpost. This dimensionalproperty correlates to
Type of implant /abutment connection	1.5 ° torque-activated lockingtaper connection	1.5 ° torque-activatedlocking taper connection	1.5 ° locking-taperconnection with an indexingkey for either:a) a torque-wrenchassisted connection;b) tapping forceconnection;	1.5 ° locking-taperconnection without anindexing key for either:a) a torque-wrenchassisted connection;b) tapping forceconnection;	to KAT Implant SystemDental Implant.	to KAT Implant SystemDental Implant.			implants.0 degrees
Surface area of theabutment / implant	3.1mm diameter / 2,75mmlength connection for all	3.1mm diameter / 2.75mmlength connection for all	3.1mm diameter / 2.75mmlength connection for all	3.1mm diameter / 2.75mmlength connection for all				Same results as stated forKAT Implant SystemDental Implant subject ofthis current 510(k).(characterization performedas implant/abutmentsystem).
		Same results as stated forKAT Implant System DentalImplant predicate.(characterization performedas implant/abutmentsystem).
	Meets guidance for Fatiguetesting per Class II SpecialControl Guidance Document:Root-form EndosseousDental Implant andEndosseous ImplantAbutment as tested on3.5mm diameter implant and

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			LAND STATE



substantial equivalence with the predicate in terms of fatigue performance, if not better.connected to abutment via a 3.1mm diameler /2.75mm length abutment-receiving post.	a manufacturer and comments and the many more of the many of the many of the many comments of the comments of the comments of the comments of the count	.	のものは、その他のところになると、「ここで、」と、「アイトー」、「「ここでアーで、こので、このですが、この時には、「この時間には、「この時間にはないか」というのです。その他の場合が出来ないので、

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

Testing performed on Implant/Abutment System as presented in Section 18, Performance Testing – Bench yield results indicating similar threshold in applied forces as the predicate that could affect co-axial implant/abutment rotation when used as instructed.

Conclusions Drawn:

The following devices listed in this pre-marketing notification:

a) KAT Implant System Dental Implant 6.0mm x 6.0mm, Implant 6.0mm x 8.0mm, Implant 6.0mm x 10.0mm, Implant 7.0 x 6.0, Implant 7.0mm x 8.0mm, Implant
- 7:0mm×-10:0mm,-Implant-8:0mm-x-6:0mm,-Implant-8:0mm-x-8:0mm,-Implant-8.0mm x 10.0mm;
b) KAT Implant System Straight (Prepable) Abutments 4.2mm x 6.5mm, 4.6mm x 6.5mm, 5.0mm x 6.5mm, 5.4mm x 6.5mm, 6.4mm x 6.5mm;

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

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

Vitali Bondar, DDS Chief Executive Officer KAT Implants、LLC 15 Rye Street, Suite 115 Portsmouth, New Hampshire 03801

APR 1 3 2511

Re: K101201

Trade/Device Name: KAT Implant System Dental Implant 6.0mm x 6.0mm, Dental Implant 6.0mm x 8.0mm; Dental Implant 6.0mm x 10.0mm; Dental Implant 7.0mm x 6.0mm; Dental Implant 7.0mm x 8.0mm; Dental Implant 7.0mm x 10.0mm; Dental lmplant 8.0mm x 6.0mm; Dental Implant 8.0mm x 8.0mm; Dental Implant 8.0mm x 10.0mm & KAT Implant System Straight (Prepable) Abutments 4.2mm x 6.5mm, Straight (Prepable) Abutments 4.6mm x 6.5mm, Straight (Prepable) Abutments 5.0mm x 6.5mm, Straight (Prepable) Abutments 5.4mm x 6.5mm, Straight(Prepable) Abutments 6.4mm x 6.5.mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 31, 2011 Received: January 31, 2011

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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Division 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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Indications for Use Statement

510(k) Number: K101201

Device Name:

Indications for Use:

KAT Implant System dental implants and abutments are indicated for restoration of edentulous 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 implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.

Prescription Use --------(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number:

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.