SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM

K051859 · Sin Sistema DE Implante Nacional Ltda · DZE · Sep 23, 2005 · Dental

Device Facts

• Record ID: K051859
• Device Name: SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM
• Applicant: Sin Sistema DE Implante Nacional Ltda
• Product Code: DZE · Dental
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sistema de Implante Nacional Dental Implant System is intended to be surqically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.

Device Story

Sistema de Implante Nacional Dental Implant System consists of threaded, tapered, and straight endosseous dental implants; manufactured from commercially pure titanium; available in multiple lengths and diameters; surface options include machined or acid-etched. Implants are surgically placed into maxillary or mandibular bone by dental professionals to provide support for prosthetic restorations (crowns, bridges, overdentures). Immediate loading is indicated when primary stability is achieved. Device functions as a mechanical anchor for dental prosthetics; benefits include restoration of oral function and aesthetics. No electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Commercially pure titanium meeting ASTM F 67 and ISO 5832-2; threaded, tapered, and straight geometry; machined or acid-etched surface; radiation sterilization.

Indications for Use

Indicated for patients requiring dental restoration via crowns, bridges, or overdentures; implants placed in maxillary or mandibular bone; suitable for immediate or delayed placement following tooth extraction or bone healing; 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.

Submission Summary (Full Text)

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SEP 2 3 2005

Telephone [phone]

FAX [phone]

## ADMINISTRATIVE INFORMATION

#### Sistema de Implante Nacional, Ltda Manufacturer Name: Av. Paes de Barros, 485 Mooca Sao Paulo - SP CEP: 03115-020 Brazil Telephone [phone] FAX [phone]

Official Contact: Wladimir Estanquiere

Floyd G. Larson Representative/Consultant: PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130

## DEVICE NAME

| Classification Name: | Implant, Dental, Root Form (DZE) ; |
|-------------------------|---------------------------------------------|
| | Abutment, Implant, Dental, Endosseous (NHA) |
| Trade/Proprietary Name: | Sistema de Implante Nacional (S. I. N.) |
| | Dental Implant System |
| Common Name: | Endosseous Dental Implant and Abutment |

# ESTABLISHMENT REGISTRATION NUMBER

The Establishment Registration number for Sistema de Implante Nacional, Ltda is 3004201263. The Owner/Operator number is 9059509.

# DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as Class II devices.

### CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to endosseous dental implants have been established by FDA. However, CP titanium used to manufacture Systema de Implante Nacional dental implants meet the chemical and mechanical requirements of ASTM F 67 and ISO 5832-2.

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#### PACKAGING/LABELING/PRODUCT INFORMATION

Sistema de Implante Nacional Dental Implants will be packaged in a radiation sterilizable package consisting of a primary container, with implant and auxiliary parts, sealed with a peel-off wrapping and grouped in storage packs.

#### INTENDED USE

The Sistema de Implante Nacional Dental Implant System is intended to be surqically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.

#### DEVICE DESCRIPTION

Sistema de Implante Nacional Dental Implants are threaded, tapered and straight endosseous dental implants made of commercially pure titanium and intended for use with Sistema de Implante Nacional System abutments and instruments. The implants are offered in a multiple of lengths and diameters. They are offered with a machined surface or acid etched.

### EQUIVALENCE TO MARKETED PRODUCT

The Sistema de Implante Nacional Dental Implant System is substantially equivalent, for the purposes of FDA's requlation of medical devices, to Class II medical devices that are cleared for marketing in the United States.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is a simple, bold design, and the text is in a clear, sans-serif font. The overall design is clean and professional.

'JUN 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sin Sistema De Implante Nacional LTDA C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K051859

Trade/Device Name: Sistema de Implante Nacional Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 6, 2005 Received: July 8, 2005

Dear Mr. Larson:

This letter corrects our substantially equivalent letter of September 23, 2005.

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 (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 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- Mr.Larson

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 (OS) 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Kuna

Susan Runner, D.D.S., M.A.
Acting 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

510(k) Number: K051859

Device Name: Sistema de Implante Nacional Dental Implant System

Indications for Use:

The Sistema de Implante Nacional Dental Implant System is intended to be surqically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Implants may be placed immediately after tooth extraction or following bone healing. Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(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)

Kim Morley for ICSR

n of Anesthesiology, General Hospital Infection Control, Dental

510(k) Number:

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