CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS

K080286 · Straumann USA · NHA · Mar 7, 2008 · Dental

Device Facts

• Record ID: K080286
• Device Name: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
• Applicant: Straumann USA
• Product Code: NHA · Dental
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Device Story

Straumann P.004 NC system consists of endosseous dental implants, cementable abutments, temporary copings, and protective caps. Abutments provide support for prosthetic restorations (crowns, bridges, overdentures) in single or multiple tooth replacements. Temporary copings serve as a base for temporary restorations for <30 days. Protective caps maintain soft tissue contours during healing for up to 6 months. Used in dental clinics by dental professionals. Devices integrate with existing dental implant systems to restore patient dentition.

Clinical Evidence

Bench testing only.

Technological Characteristics

Endosseous dental implant abutments, temporary copings, and protective caps. Materials and design are identical to previously cleared predicate devices. Mechanical interface for dental implant support.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implant-supported prosthetic restorations (crowns, bridges, overdentures), temporary restorations (copings), or soft tissue healing support (caps).

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

• P.004 RC Cementable Abutments (K072071)
• RC Temporary Copings (K072071)
• RC Protective Caps (K072071)

Submission Summary (Full Text)

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# 1080286

Section H 510(k) SUMMARY

MAR - 7 2008

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

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 978-747-2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: February 1, 2008

#### 2. Name of the Device

| Trade Name: | P.004 NC Cementable Abutments<br>P.004 NC Temporary Copings<br>P.004 NC Protective Caps |
|----------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | 21 CFR 872.3630 |

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

P.004 RC Cementable Abutments, K072071 RC Temporary Copings, K072071 RC Protective Caps, K072071

#### 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, abutments and surgical and prosthetic parts and instruments.

Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.

#### 5. Intended Use of the Device

Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures.

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Abutments can be used in single tooth replacements and multiple tooth restorations. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

#### 6. Technological Characteristics

The modified P.004 NC Cementable Abutments, Temporary Copings and Protective Caps are substantially equivalent to the currently cleared devices. The intended use is identical to the predicate devices. The proposed devices have the same material composition, basic design and fundamental operating principles to the currently cleared devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA (On Behalf Of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810

Re: K080286 Trade/Device Name: P.004 NC Cementable Abutments P.004 NC Protective Caps P.004 NC Temporary Copings Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 29, 2008 Received: March 3, 2008

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,

Syurte J. Michie Oms.

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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K080286

## INDICATIONS FOR USE STATEMENT

Device Name: P.004 NC Cementable Abutments

Indications for Use:

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Device Name: P.004 NC Protective Caps

Indications for Use:

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Device Name: P.004 NC Temporary Copings

Indications for Use:

Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Bevice Evaluation (ODE)

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

510(k) Number: K080286

RE: K080286, P.004 NC Cementable Abutments Straumann USA
Supplement 1

February 29, 2008

Proprietary and Confidential

umann OCR

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