STRAUMANN NARROW NECK IMPLANTS

K060958 · Straumann USA · DZE · Aug 24, 2006 · Dental

Device Facts

• Record ID: K060958
• Device Name: STRAUMANN NARROW NECK IMPLANTS
• Applicant: Straumann USA
• Product Code: DZE · Dental
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Straumann Narrow Neck implants are intended for single-stage or two-stage surqical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Straumann Narrow Neck implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Device Story

Straumann Narrow Neck Implants are endosseous dental implants designed for surgical placement in maxillary or mandibular arches; provide support for prosthetic restorations. Implants feature SLA or SLActive surfaces; identical design and dimensions to predicate Straumann implants. Used by dental surgeons in clinical settings to restore chewing function in edentulous or partially edentulous patients. Supports single or multiple tooth applications; allows immediate function when primary stability is achieved. Benefits patients by providing stable foundation for dental prosthetics.

Technological Characteristics

Endosseous dental implants; SLA or SLActive surface treatment; design and dimensions identical to predicate Straumann implants; 21 CFR 872.3640; Class II.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring prosthetic restoration support in maxillary or mandibular arches; supports single or multiple tooth applications; allows immediate function if primary stability and appropriate occlusal loading are achieved; requires minimum of four implants for immediate loading in edentulous patients.

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

• Straumann Implants (K010291)
• Straumann Implants (K030007)
• Straumann Implants (K053088)
• Friadent XiVE Dental Implant System (K021318)
• Astra Tech Implants - Dental System Fixture MicroMacro (K024111)
• Nobelbiocare Replace Select Straight Dental Implants (K022562)
• Nobelbiocare Replace Select Straight Dental Implants (K023113)

Submission Summary (Full Text)

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AUG 2 4 2006

K060958

# 510(k) Summary

#### 1. Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0031 Contact Person: Elaine Alan Regulatory Affairs

#### 2. Name of the Device

| Trade Name: | Straumann Narrow Neck Implants |
|----------------------|--------------------------------------------|
| Common Name: | Dental Implants |
| Classification Name: | Endosseous dental implants 21 CFR 872.3640 |

#### 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

Straumann Implants, originally cleared under K010291, K030007 and K053088 Friadent XiVE Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro, K024111 Nobelbiocare Replace Select Straight Dental Implants, K022562 and K023113

#### 4. Description of the Device

The Straumann Narrow Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants have an SLA or SLActive surface and have the same design and dimensions as the predicate device.

#### 5. Intended Use of the Device

The Straumann Narrow Neck Implants have the same intended use as the predicate Straumann Implants. The indications for use have been expanded to include cleared indications of the predicate Astra, Nobel and Dentsply devices.

#### 6. Basis for Substantial Equivalence

The subject Narrow Neck implants are substantially equivalent to the previously cleared Straumann implants, K010291, K03007 and K053088. There is no change to the implant design or dimensions. The intended use is identical to predicate devices.

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Image /page/1/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 in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 4 2006

Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K060958

Trade/Device Name: Narrow Neck Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 15, 2006 Received: August 16, 2006

Dear Ms. Alan:

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 – Ms. Alan

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Chiu Lin, Ph.D.

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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## Indications for Use Statement

510(k) Number (if known): K060958

Device Name: Narrow Neck Implants

### Indications for Use:

ﺎﻡ ﻣﺮ

Straumann Narrow Neck implants are intended for single-stage or two-stage surqical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Straumann Narrow Neck implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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