P.0004 IMPLANTS

K062129 · Institut Straumann AG · DZE · Oct 20, 2006 · Dental

Device Facts

• Record ID: K062129
• Device Name: P.0004 IMPLANTS
• Applicant: Institut Straumann AG
• Product Code: DZE · Dental
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Meso abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.

Device Story

P.004 Implant is a solid screw-type endosseous dental implant; used to support prosthetic restorations (crowns, bridges, overdentures). Composed of Grade 4 commercially pure titanium; features SLA (grit-blasted/acid-etched) or SLActive surface. Includes titanium Meso abutments and healing caps as accessories. Used by dental professionals in clinical settings for single or multiple tooth replacement. Implant provides structural foundation for prosthetic reconstruction; abutment connects implant to restoration. Benefits include restoration of chewing function and esthetic support in oral cavity.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Material: Grade 4 commercially pure titanium. Surface: SLA (grit-blasted/acid-etched) or SLActive. Form factor: Solid screw implant with associated abutments and healing caps. Energy source: None (mechanical).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring support for crowns, bridges, or overdentures in the maxilla or mandible. Supports immediate, delayed, or conventional placement and immediate function 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

• ITI Tapered Dental Implant (K012757)
• ITI Dental Implant System, synOcta Meso Abutment (K033243)

Submission Summary (Full Text)

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K062129

510(k) Summary

OCT 2 0 2006

## Applicant's Name and Address 1.

Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Elaine Alan Contact Person: Regulatory Affairs

### Name of the Device 2.

| Trade Name: | P.004 Imp |
|----------------------|-----------|
| Common Name: | Endossec |
| Classification Name: | Endossec |
| | 21 CFR 8 |

plants us dental implants ous dental implants 21 CFR 872.3640

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

ITI Tapered Dental Implant, K012757 ITI Dental Implant System, synOcta Meso Abutment, K033243

### Description of the Device 4.

The P.004 Implant is an addition to the currently distributed Straumann Dental Implant System. The P.004 implant is a solid screw with a SLA (grit blasted then acid etched) or SLActive surface. The implants are composed of Grade 4 commercially pure Titanium and are available in a range of lengths and diameters.

This submission also includes a Titanium Meso abutment and healing caps which are used as accessories to dental implants.

## Intended Use of the Device ട്.

The P.004 is intended for immediate, delayed, or conventional placement in the anterior maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Meso abutments are indicated for cemented restorations particularly in esthetic

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K062129
P-2

areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.

#### Basis for Substantial Equivalence 6.

The subject dental implant is substantially equivalent to the previously cleared ITI Tapered Dental Implant. The intended use is identical to the predicate device.

The subject implant has the same material composition and the same surface treatments as previously cleared Straumann implants. In addition, the design of the subject implant is similar to, and in some respects identical to, the previously cleared Straumann implant.

The subject Meso abutment is to be used with the P004 implant and has the same intended use and is made of the same material as the previously cleared synOcta Meso Abutment. The design of the subject abutment is substantially equivalent to the previously cleared predicate device.

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Public Health Service

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 2 0 2006

Re: K062129

Trade/Device Name: P.004 Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 6, 2006 Received: October 10, 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 Eederal 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 vour 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

Enclosure

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K062129

# Indications for Use Statement

Device Name: P.004 Implants

Indications for Use:

The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients.

They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used.

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Meso abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.

Prescription Use (Part 21 CFR 801 Subpárt 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Kein Mulvey for MSE

Cirnsion Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number: K062129

510(k) P.004 Implants Page 6 of 60