(349 days)
Not Found
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is a dental implant system used for the "restoration of edentulous maxilla and mandible," and to "provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement," which are therapeutic applications.
No
The device is a dental implant system used for restoration, not for diagnosing medical conditions or diseases. Its intended use is to provide physical support for dentures or as a single tooth replacement.
No
The device description clearly states that the device consists of physical dental implants and abutments, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for restoring edentulous areas in the mouth and supporting dental prosthetics. This is a direct medical intervention on the patient's body.
- Device Description: The description details physical components (implants and abutments) designed to be surgically placed into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is surgically implanted within the body for structural support.
N/A
Intended Use / 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.
KAT Implant System (Dental Implants and Straight Abutment) is indicated for the restoration of edentulous areas in maxilla and mandible.
Product codes
DZE
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) Pre-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 KAT 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 abutment-receiving post. A locking-taper connection activates the seating of the abutment to the implant with the help of a torque wrench.
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 oxide 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 = 10^-6 (per ISO 11137:2006, Sterilization of Healthcare Products - Radiation)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous maxilla and mandible, extraction sites or healed alveolar ridges
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing: Testing performed on Implant/Abutment System as presented in Section 18, Performance Testing – Bench yielded results indicating similar threshold in applied forces as the predicate that could affect co-axial implant/abutment rotation when used as instructed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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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:
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
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(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: