KAT IMPLANT SYSTEM

K083544 · Kat Implants, LLC · NHA · Feb 2, 2009 · Dental

Device Facts

• Record ID: K083544
• Device Name: KAT IMPLANT SYSTEM
• Applicant: Kat Implants, LLC
• Product Code: NHA · Dental
• Decision Date: Feb 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KAT Implant System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. KAT 3.0mm implant is indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT 2.5mm may also be used for inter-radicular transitional application.

Device Story

KAT Implant System comprises dental implants, abutments, and associated surgical/restorative instruments. Implants feature external V-shaped threads for bone insertion; 3.5mm-5.0mm diameters include horizontal fins. All implants utilize a 3.1mm diameter 1.5-degree taper abutment receiving post; components connect via locking taper. Used by dentists/oral surgeons in clinical settings to restore edentulous sites. Implants placed in extraction sites or healed alveolar ridges; support removable dentures, fixed bridges, or single crowns. Immediate loading possible given sufficient primary stability and appropriate occlusal loading. System provides mechanical foundation for prosthetic teeth; improves patient masticatory function and aesthetics.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F136). Surfaces: Machined, aluminum oxide grit blasted, and nitric acid passivated. Design: Threaded screw with 1.5-degree taper locking connection. Diameters: 2.5mm to 5.0mm. Lengths: 6mm to 14mm. Mechanical fixation via external threads and horizontal fins.

Indications for Use

Indicated for patients requiring restoration of edentulous areas in maxilla or mandible, including single tooth replacement, removable dentures, or fixed bridges. KAT 3.0mm indicated for maxillary lateral or mandibular lateral and central incisors. KAT 2.5mm indicated for transitional and long-term intra-bony applications. Contraindicated for immediate loading in Type IV bone due to primary stability concerns.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• LaminOss® Osteocompressive Dental System (K982925)
• Bicon Dental Implant 4.5 x 6.5mm (K050712)
• IMTEC Sedax MDI 1.8mm (K031106)
• OsseoSpeed 4.0S-6mm (K063779)
• OsseoSpeed Narrow (K080396)

Submission Summary (Full Text)

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K083544

### 5. 510(k) Summary

## -2 2009

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

#### Submitter's Information:

Vitali Bondar, D.D.S. Owner and CEO KAT Implants LLC 15 Ryc Street, Suite 115 Portsmouth, NH 03801 Phone: [phone] Fax: [phone]

## Date the Summary was Prepared: November 20, 2008

#### Device name:

- Common Name: Dental Implant and Abutment .
- 하 Trade Name: KAT Implant System
- Classification name: Endosseous Dental Implant (21 CFR 872.3640, # Product code DZE) and Endosseous Dental Implant Abutment (21 CFR 872.3630, Product Code NHA)

Device classification: Class II

#### Intended use

KAT Implant System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The 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 3.0mm implant is indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artifical teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.

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K 083544

ு

KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-term intra-bony applications, such as providing support for transitional and crowns, bridges and dentures. KAT 2.5mm may also be used for inter-rollul br transitional application.

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

Predicate device: LaminOss® Osteocompressive Dental System Applicant: Impladent Inc. (USA) 510(k) number: K982925

Predicate device: Bicon Dental Implant 4.5 x 6.5mm Applicant: Bicon Inc. (USA) 510(k) number: K050712

Predicate device: IMTEC Sedax MDI 1.8mm Applicant: IMTEC Corporation (USA) 510(k) number; K031106

Predicate device: OsseoSpeed 4.0S-6mm Applicant: Astra Tech Inc. (USA) 510(k) number: K063779

Predicate device: OsseoSpeed Narrow Applicant: Astra Tech Inc. (USA) 510(k) number: K080396

> KAT Dental Implant System has the following similarities to the predicate devices:

- Has the same intended use; .
- Uses the same operating principles; .
- Incorporates the same basic design; 1
- Incorporates the same materials; and
- Is packaged and sterilized using the same or equivalent materials and processes.

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K083544

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#### Description of Device

KAT implant system consists of dental implants, implant abutments, healing abutments, temporary abutments, screw retained framework abutment, spacer, cylinder, healing collar and the instruments for placement and restoration of the implants. KAT implants are supplied in 2.5, 3.0, 3.5, 4.3 and 5.0mm diameters. KAT 2.5 and 3.0mm implants are supplied in 10, 12 and 14mm length. IAAT 3.5mm is supplied in 8, 10, 12 and 14mm length. KAT 4.3 and 5.0mm inplants are supplied in 6, 8, 10, 12 and 14mm length. External V-shaped thread is utilized to screw the implants into the bone. Horizontal fins are placed in between the thread and the abutment receiving portion of 3.5, 4.3 and 5.0mm implace All implants have 3.1mm diameter 1.5 degree taper abutment receiving post. KAT abutments are available in 4.2, 4.7, 5.5 and 6.5mm diameter. KAT abutments can be attached to any KAT implant via locking taper connection.

#### Material composition

Titanium alloy Ti-6Al-4V ELI is used to manufacture implants, abutments and other components of the KAT implant system conforming to ASTM F136. Surfaces of the implants and abutments include: machined surfaces and aluminum oxide grit blasted and nitric acid passivated surfaces.

## Summary of the technological characteristics:

The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices. The components of KAT dental implant system are substantially equivalent to the listed predicate devices because of the similarities in design, material and intended use.

#### Conclusions Drawn:

KAT Dental Implant System has the same intended use as, and technological characteristics similar to the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety and effectiveness. Therefore the new implant system is substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB -2 2009

Vitali Bondar, D.D.S. Owner and Chief Executive Officer KAT Implants L.L.C. 15 Rye Street, Suite 115 Portsmouth, New Hampshire 03801

Re: K083544

> Trade/Device Name: KAT Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 27, 2009 Received: January 27, 2009

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Watson for
Cindy V. Reichard, M.D.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K083544

# 4. Indications for Use Statement

510(k) Number: KO835 YU

Device Name: KAT Implant System

#### Indications for Use: -

KAT Implant System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.

KAT 3.0mm implant is indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.

KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-lerm intra-bony applications, such as providing support for transitional or long term trowns, bridges and dentures. KAT 2.5mm may also be used for inter-radicular transitional application.

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K083544

X 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 Runon
(Division Sign-Off)

appenenen Sign-Olf)
Division of Anesthesiology, General Hospital Infection Control Ancsthestology, General
Infection Control, Dental Devices

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510(k) Number: K083544

## FEB - 2 2009

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