TIARRAY DENTAL IMPLANT SYSTEM

K131345 · Nasseo, Inc. · DZE · Aug 7, 2013 · Dental

Device Facts

• Record ID: K131345
• Device Name: TIARRAY DENTAL IMPLANT SYSTEM
• Applicant: Nasseo, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Device Story

The TiArray Dental Implant System consists of endosseous dental implants and abutments designed to restore chewing function. Implants are fabricated from commercially pure titanium with an etched and anodized surface, featuring a tapered, threaded body, micro-grooves at the neck, and two cutting flutes. Abutments are manufactured from titanium alloy. The system is used by dental professionals in a clinical setting to provide prosthetic support. Implants are surgically placed into the maxillary or mandibular bone; abutments are attached to support crowns, bridges, or overdentures. The device functions as a mechanical anchor for dental prosthetics. Clinical benefit is the restoration of oral function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data were submitted in this premarket notification. Substantial equivalence is supported by bench testing only, including biocompatibility, engineering analysis, and dimensional analysis.

Technological Characteristics

Endosseous dental implants and abutments. Materials: Commercially pure titanium (implants) and Ti-6Al-4V ELI titanium alloy (abutments). Design: Tapered, threaded body with micro-grooves and internal hex interface. Diameters: 3.5, 4.3, 5.0 mm. Lengths: 8.0, 10.0, 11.5, 13.0 mm. Surface: Etched and anodized. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring dental restoration via crowns, bridges, or overdentures in the maxillary or mandibular arch. Suitable for immediate or delayed surgical placement; immediate loading permitted if primary stability is achieved.

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

• Nobel Biocare USA LLC., SFB & CFB Implants (K061003)
• Nobel Biocare USA LLC., NobelActive Internal Connection Implant (K071370)
• Implant Direct LLC., Spectra-System (K061319)

Submission Summary (Full Text)

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K131345-

510(k) Summary

TiArray Dental Implant System

## 510(k) Summary

## Nasseo, Inc.

# TiArray Dental Implant System

AUG 07 2013

July 25, 2013

#### ADMINISTRATIVE INFORMATION

Manufacturer Name

Nasseo, Inc. 632 Missouri St., Unit 6 San Diego, CA 92109 Telephone: [phone]

Official Contact

Garrett Cale Smith, Ph.D. CEO

Representative/Consultant

Allison C. Komiyama, Ph.D. Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]

### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name TiArray Dental Implant System Common Name Dental implants and dental implant abuments Classification Names Endosseous dental implant Endosseous dental implant abutment Classification Regulation 21 CFR 872.3640, Class II Product Codes DZE, NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch

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## INTENDED USE

The TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns. bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

## DEVICE DESCRIPTION

TiArray Dental Implant System implants included in this submission are endosseous dental implants with an internal hex implant/abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. The implants are made of commercially pure titanium, with a surface that is etched and anodized. Implants are provided in a tapered, threaded design with micro-grooves around the neck of the implant and two cutting flutes. Straight abutments made of titanium alloy are provided for each diameter implant for cement-retained prostheses. The implant is available in three diameters (3.5, 4.3, and 5.0 mm), each in four lengths (8.0, 10.0, 11.5, and 13.0). The abutments come in three platform diameters (3.5, 4.3, and 5.0 mm) that correspond to the diameters of the implant.

## EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent to the following predicate devices:

- Nobel Biocare USA LLC., SFB & CFB Implants (K061003) .
- Nobel Biocare USA LLC., NobelActive Internal Connection Implant (K071370) .
- Implant Direct LLC., Spectra-System (K061319) .

The implants of the subject TiArray Dental Implant System have a similar design (threaded body) with micro-grooves at the collar) and dimensions (03.5, 4.3, and 5 mm x 8, 10, 11.5, and 13 mm), use similar materials (CP titanium grade 4) and have a similar surface (titanium oxide) as those cleared under K061003 and K071370. The implants also have a similar design and dimensions and an identical internal connection (internal hex) as those cleared under K061319. The abutments of the subject TiArray Dental Implant System have a similar design and material (Ti-6A14-V ELI titanium alloy) as those cleared under K061003, K071370 and K061319.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis and dimensional analysis. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Clinical data were not submitted in this premarket notification.

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TiArray Dental Implant System K131345

## CONCLUSIONS

The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy. The device is safe and effective for its intended use and performs as well as or better than the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three wavy lines representing the three branches of government.

Public Health Service

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

## August 7, 2013

Nasseo. Incorporated C/O Allison C. Komiyama, PhD Senior Regulatory Specialist PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K131345

Trade/Device Name: TiArray Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 9, 2013 Received: May 13, 2013

#### Dear Dr. Komiyama:

We have reviewed your Scction 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. Komiyama

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 devicerelated 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Kwame O. Ulmer -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TiArray Dental Implant System

510(k) Summary

# Indications for Use

510(k) Number:

િક્તિકનેટ

Device Name:

TiArray Dental Implant System

Indications for Use:

The TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Andrew I. Steen -S 2013.08.06 14:39:26 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospitai Infection Control, Dental Devices

**510(k) Number:** K131345