STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,

Q: Who is the manufacturer of STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,?

Kat Implants, LLC filed the 510(k) submission for STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, (K101201).

Q: What is the FDA product code for STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K101201 · Kat Implants, LLC · DZE · Apr 13, 2011 · Dental

Device Facts

Record ID	K101201
Device Name	STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
Applicant	Kat Implants, LLC
Product Code	DZE · Dental
Decision Date	Apr 13, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

The KAT Implant System consists of root-form endosseous dental implants and straight (prepable) abutments. Implants feature an external V-shaped thread and horizontal circumferential fins for bone integration. The system utilizes a 1.5-degree torque-activated locking-taper connection between the implant post and the abutment. The device is used by licensed dentists in clinical settings for prosthetic rehabilitation. The clinician selects the appropriate implant size (6.0mm-8.0mm diameter) and length, surgically places the implant, and secures the abutment using a torque wrench (minimum 25 N-cm) or tapping force. The abutment provides a platform for fixed or removable dental prosthetics. The system is designed to provide mechanical stability for tooth replacement, improving patient masticatory function and aesthetics. The device is not for home use.

Clinical Evidence

Bench testing only. Performance testing evaluated the implant/abutment system for fatigue and rotational resistance. Results demonstrated that the subject devices exhibit similar or better resistance to rotation/loosening compared to the predicate device when seated with the specified torque (25 N-cm).

Technological Characteristics

Materials: Titanium-6Al-4V ELI (ASTM F136-2(a)). Surface: Aluminum oxide grit-blasted, alkaline ultrasonication, nitric acid passivated (ASTM F86-04). Connection: 1.5-degree torque-activated locking-taper. Dimensions: Implants 6.0-8.0mm diameter; Abutments 4.2-6.4mm diameter. Sterilization: Radiation (ISO 11137:2006, SAL 10^-6). Packaging: ISO 11607:2006 compliant.

Indications for Use

Indicated for restoration of edentulous maxilla and mandible in patients requiring support for removable dentures, fixed bridges, or single tooth replacement. Implants may be placed in extraction sites or healed alveolar ridges. Immediate loading is contraindicated in Type IV bone due to primary stability concerns.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

KAT Implant System Dental Implant 5.0mm x 6.0mm; Dental Implant 5.0mm x 8.0mm; Dental Implant 5.0mm x 10.0mm (K083544)
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 (K083544)

Related Devices

K083544 — KAT IMPLANT SYSTEM · Kat Implants, LLC · Feb 2, 2009
K141159 — KONUS DENTAL IMPLANT SYSTEM · Argon Med. Productions Vertriebs Gesellschaft Mbh · Mar 11, 2015
K191443 — MSDI Dental Implants System · Medical Systems and Devices International , Ltd. · Jun 26, 2020
K113779 — CONELOG IMPLANT SYSTEM · Altatec GmbH · Dec 14, 2012
K042971 — TITAN DENTAL IMPLANT SYSTEM · Titan Implants, Inc. · Jan 14, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ ડી 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) {1}------------------------------------------------ #### Classification Panel: Dental ### Device classification: Class II ### Indications for Use: 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. 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 {2}------------------------------------------------ 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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - {3}------------------------------------------------ #### Description of Devices: 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. {4}------------------------------------------------ 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: {5}------------------------------------------------ | Summary of Technological Characteristics | ENDOSSEOUS DENTAL IMPLANT, ROOTFORM | | IMPLANT ABUTMENT | | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | KAT Implant System Dental Implant 5.0mm | KAT Implant System Dental Implants | KAT Implant System Implant (Indexed) Abutment 4.2mm, 4.7mm, 5.5mm, 6.5mm | KAT Implant System Straight (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 Dental Implant 5.0mm | KAT Implant System Dental Implants 6.0mm, 7.0mm and 8.0mm | Class II KAT Implant System Implant (Indexed) Abutment 4.2mm, 4.7mm, 5.5mm, 6.5mm | KAT Implant System Straight (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 and 10.0mm | 6.5mm | 6.5mm | | Essential Design Output Specifications: | ENDOSSEOUS DENTAL IMPLANT, ROOTFORM | | IMPLANT ABUTMENT | | | Common Name | KAT Implant System Dental Implants 5.0mm | KAT Implant System Dental Implants 6.0mm, 7.0mm and 8.0mm | KAT Implant System Implant (Indexed) Abutment 4.2mm, 4.7mm, 5.5mm, 6.5mm | KAT Implant System Straight (Prepable) Abutment 4.2mm, 4.6mm, 5.0mm, 5.4mm, 6.4mm | | Device Name | | | | | | Indications for Use | Predicate KAT Implant System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable | Current 510(k) KAT Implant System Dental Implants are indicated for restoration of edentulous maxilla and mandible, to provide support for | Predicate KAT Implant System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable | Current 510(k) KAT Implant System Straight Abutment devices are intended to be used with KAT Implant System Dental Implants to aid in | | | | | | | | Intended Use | 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. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. | 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. | 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. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. | prosthetic rehabilitation. | | | Intended for use by a licensed dentists familiar with surgical and prosthetic applications that uses KAT Implant System dental implants, implant abutments and Class I accessories and instrumentation. Device is not intended for use at home and is for prescription use only. | Intended for use by a licensed dentist familiar with surgical and prosthetic applications that uses KAT Implant System dental implants, implant abutments and Class I accessories and instrumentation. Device is not intended for use at home and is for prescription use only. | Intended for use by a licensed dentist familiar with surgical and prosthetic applications that uses KAT Implant System dental implants, implant abutments and Class I accessories and instrumentation. Device is not intended for use at home and is for prescription use only. | Intended for use by a licensed dentist familiar with surgical and prosthetic applications that uses KAT Implant System dental implants, implant abutments and Class I accessories and instrumentation. Device is not intended for use at home and is for prescription use only. | | Device Compatibility | KAT Implant System Implant Abutments and Class I accessories and instrumentation | KAT Implant System Implant Abutments and Class I accessories and instrumentation | KAT Implant System Dental Implants and Class I accessories and instrumentation | KAT Implant System Dental Implants and Class I accessories and instrumentation | | Environmental Compatibility | No known compatibility issues with devices, chemicals, and other environmental factors | No known compatibility issues with devices, chemicals, and other environmental factors | No known compatibility issues with devices, chemicals, and other environmental factors | No known compatibility issues with devices, chemicals, and other environmental factors | {6}------------------------------------------------ . . . . . . . . . . . . . : : : {7}------------------------------------------------ | | reasonably expected to be present in area of device distribution and device's intended use. | reasonably expected to be present in area of device distribution and device's intended use. | reasonably expected to be present in area of device distribution and device's intended use. | reasonably expected to be present in area of device distribution and device's intended use. | | interface | | | | | | |--|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Software Component Component with Biological Origin | n/a | n/a | n/a | | Angularity of Implant Abutment | implants. n/a | implants. n/a | implants. 0 degrees | | | | | Design Output Specifications (General Performance and Safety) | | | | | Performance of the Implant/Abutment System: Rotation/Loosening | Insertion of the abutment can be implemented using a torque wrench with force not less than 15 N-cm. Insertion of the abutment can be implemented via tapping force but better calibration of force is possible when torque wrench is utilized. | Insertion of the abutment can be implemented using a torque wrench with force not less than 25 N-cm*. Insertion of the abutment can be implemented via tapping force but better calibration of force is possible when torque wrench is utilized. | Same results as stated for KAT Implant System Dental Implant predicate. (characterization performed as implant/abutment system). | | | | | Type of implant | Endosseous screw type with a continuous thread and horizontal circumferential fins. | Endosseous screw type with a continuous thread and horizontal circumferential fins. | n/a | | | Rotation / loosening of the abutments are prevented not only by frictional fit, but also by the engagement between the implant post grooves and the key's protrusions. | Abutments demonstrated better resistance to rotation / loosening when compared to predicate device. *(Refer to Section 18, Performance Testing, Bench for the justification of application of 25 N-cm torque in seating abutment to implant and comparison of applied torques to rotate abutment seated on an implant) | | | | | | Type of abutment | n/a | n/a | Consists of abutment and indexing key which is welded to form a single piece abutment intended to be seated to implant using applied force not less than 15N-cm using a torque wrench or by using tapping force. | n/a | Consists of a single piece abutment intended to be seated to implant using applied force not less than 25N-cm using a torque wrench or by using tapping force. | n/a | Performance of the Implant/Abutment System: Fatigue | | | Same results as stated for KAT Implant System Dental Implant subject of this current 510(k). (characterization performed as implant/abutment system). | | | Platform size | 3.1mm abutment receiving post | 3.1mm abutment receiving post | 3.1mm internal bore | 3.1mm internal bore | | | Implants have greater outside diameter than the predicate device and are designed with the same 3.1mm diameter /3.5mm length abutment-receiving post. This dimensional property correlates to | | | | | | Type of implant / abutment connection | 1.5 ° torque-activated locking taper connection | 1.5 ° torque-activated locking taper connection | 1.5 ° locking-taper connection with an indexing key for either: a) a torque-wrench assisted connection; b) tapping force connection; | 1.5 ° locking-taper connection without an indexing key for either: a) a torque-wrench assisted connection; b) tapping force connection; | to KAT Implant System Dental Implant. | to KAT Implant System Dental Implant. | | | | implants. 0 degrees | | | Surface area of the abutment / implant | 3.1mm diameter / 2,75mm length connection for all | 3.1mm diameter / 2.75mm length connection for all | 3.1mm diameter / 2.75mm length connection for all | 3.1mm diameter / 2.75mm length connection for all | | | | Same results as stated for KAT Implant System Dental Implant subject of this current 510(k). (characterization performed as implant/abutment system). | | | | | | | Same results as stated for KAT Implant System Dental Implant predicate. (characterization performed as implant/abutment system). | | | | | | | | | | | | Meets guidance for Fatigue testing per Class II Special Control Guidance Document: Root-form Endosseous Dental Implant and Endosseous Implant Abutment as tested on 3.5mm diameter implant and | | | | | | | | | | . {8}------------------------------------------------ {9}------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | | 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、 | · : {10}------------------------------------------------ # 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. {11}------------------------------------------------ # 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. {12}------------------------------------------------ ## 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 {13}------------------------------------------------ # Indications for Use Statement ### 510(k) Number: K101201 ### 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 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 #### 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: