P.004 ABUTMENTS

K072679 · Institut Straumann AG · NHA · Oct 12, 2007 · Dental

Device Facts

• Record ID: K072679
• Device Name: P.004 ABUTMENTS
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The NC Temporary Abutment is intended for use with the P.004 Dental Implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months. Healing abutments, often referred to as healing caps, are intended to be used with the P.004 Dental Implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase for up to six months and should be placed out of occlusion.

Device Story

Device consists of temporary and healing abutments for Straumann P.004 NC Bone Level dental implants. Abutments feature basal grooves engaging implant protrusions; secured via integrated screw. Used by dental professionals in clinical settings to support temporary crowns/bridges or protect implant internal configuration and contour soft tissue during healing. Output is physical support/protection for dental implant site. Benefits include temporary restoration functionality and guided soft tissue healing during the osseointegration phase.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarity to legally marketed predicate devices.

Technological Characteristics

Endosseous dental implant abutments. Design features basal grooves for mechanical engagement with P.004 implants and integrated screw fixation. Materials and design are identical to predicate devices. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring temporary restoration of single crowns and bridges (up to 6 months) or soft tissue healing/stabilization (up to 6 months) using Straumann P.004 NC Bone Level implants. Healing abutments must be placed out of occlusion.

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

• Straumann P.004 Dental Implants (K062129)
• P.004 RC Temporary Abutments (K070478)

Submission Summary (Full Text)

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# Section I 510(k) Summary

### Applicant's Name and Address 1.

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: September 20, 2007

#### 2. Name of the Device

| Trade Name: | P.004 NC Temporary Abutments |
|----------------------|---------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | §872.3630 |

- 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Straumann P.004 Dental Implants, K062129 P.004 RC Temporary Abutments, K070478

#### 4. Description of the Device

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.

The basal portion of the abutment has 4 grooves diametrically opposed that engage in the 4 protrusions of the P.004 implant. The abutment is seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained and directly veneered restorations. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.

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# 5. Intended Use of the Device

The NC Temporary Abutment is intended for use with the P.004 Dental Implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.

Healing abutments, often referred to as healing caps, are intended to be used with the P.004 Dental Implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase for up to six months and should be placed out of occlusion.

# 6. Technological Characteristics

The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 1 2 2007

Re: K072679 Trade/Device Name: P.004 Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 20, 2007 Received: September 21, 2007

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 (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.

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,

Guyite Y. Michaud.

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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# Indications for Use Statement

Device Name: P.004 Abutment

Indications for Use:

P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.

P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the umplant and maintains, stabilizes and forms the soft tissue during the healing process for up to six months and should be placed out of occlusion.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
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(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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| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| Page 1 of 1 | |
| 510(k) Number: | K072679 |