NOBELPROCERA PEEK ABUTMENTS

K120954 · Nobel Biocare AB · NHA · Jun 5, 2013 · Dental

Device Facts

• Record ID: K120954
• Device Name: NOBELPROCERA PEEK ABUTMENTS
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Jun 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Device Story

NobelProcera PEEK Abutments are endosseous dental implant abutments fabricated from PEEK (natural or white). Available in preformed or customized shapes; used as provisional or healing abutments. Customized versions shaped to match tissue contours. Device connects directly to endosseous dental implants via screw retention (engaging or non-engaging). Used in clinical dental settings by dental professionals. Provides temporary prosthetic support during rehabilitation period (up to 180 days). Benefits include tissue contouring and provisional restoration support.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by non-clinical bench testing, including biocompatibility (ISO 10993-5 cytotoxicity) and sterilization validation (ISO 17665).

Technological Characteristics

Material: Polyetheretherketone (PEEK). Attachment: Screw-retained (engaging/non-engaging). Design: Preformed or customized shapes. Sterilization: ISO 17665 compliant. Connectivity: None (mechanical component).

Indications for Use

Indicated for patients requiring provisional prosthetic rehabilitation via endosseous dental implants. Intended for use as provisional or healing abutments for up to 180 days.

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

• Brånemark System Temporary Solutions (K925766)
• Neo Implant System (K043195)

Submission Summary (Full Text)

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# K120954

#### 1.4 510(k) Summary

#### 5 2013 JUN

| Submitted by: | Phuong Nguyen Son<br>Requlatory Affairs Manager |
|----------------------------------------|--------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone] ext 7830 |
| Facsimile: | [phone] |
| Date Prepared: | 4 June, 2013 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Product Code: | NHA |
| Trade or Proprietary<br>or Model Name: | NobelProcera PEEK Abutments |
| Legally Marketed Device(s): | Brånemark System Temporary Solutions (K925766)<br>Neo Implant System (K043195) |

# Device Description:

NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural color or white. The PEEK Abutments are available in a variety of preformed and customized shapes that can be used either as provisional abutments or as healing abutments. The customized PEEK Abutments can be shaped to follow the contour of the tissue intended to surround the definitive abutment. Customized PEEK Abulments must be straight, further design limitations for customized shapes are given in the Instructions for Use.

#### Indications for Use:

The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

# Non-Clinical Testing:

Non-clinical testing was performed to support the decision of safety and effectiveness. Non-clinical testing consisted of Biocompatibility testing following ISO 10993. Cytotoxicity testing using the ISO Elution Method (ISO 10993-5) was performed. Also sterilization in accordance with ISO 17665 was performed.

#### Clinical Testing:

No Clinical test data was used to support the decision of safety and effectiveness.

#### Conclusions:

The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device.

Nobel Biocare 510(k) Notification NobelProcera PEEK Abutments March 2012

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# 510(k) Summar 1.4

Substantial Equivalence Comparison to Predicate Device

| CHARACTERISTIC | CANDIDATE<br>NobelProcera PEEK Abutments | PREDICATE<br>Brånemark System Temporary<br>Solutions<br>(K925766) | PREDICATE<br>Neo Implant System*<br>(K043195) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |
| Color | Natural & White | Natural | White |
| Attachment Method | Screw retained<br>Engaging & Non Engaging | Screw retained<br>Engaging & Non Engaging | Screw retained |
| Intended Use | Healing abutment<br>Provisional abutment | Provisional abutment | Healing abutment<br>Provisional abutment |
| Duration of Use | 180 days | 90 days | 180 days |
| Implant/Abutment<br>Connection | Nobel Biocare<br>- External Hex<br>- Internal Conical<br>- Internal Tri-lobe | Nobel Biocare<br>- External Hex<br>- Internal Conical<br>- Internal Tri-lobe | Neoss<br>- Internal Hex |
| Abutment Profile | Provisional abutments - Straight walled<br>or designed with Procera system<br>- Healing Abutments - Various<br>anatomical shapes intended for<br>different tooth locations or individually<br>designed with Procera system | Straight walled | Provisional abutments - Straight walled<br>- Healing Abutments - Various<br>anatomical shapes intended for different<br>tooth locations |

This predicate contains a full implant system including provisional and anatomical healing abutments made of PEEK. This 510(k) is only using these
abutments as a predicate

.

:

K120954

Nobel Biocare Traditional 510(k) Notification
NobelProcera PEEK Abutments
March 2012

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2013

Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, Limited Liability Company 22715 Savi Ranch Parkway YORBA LINDA CA 92887

Re: K120954

Trade/Device Name: NobelProcera PEEK Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 20, 2013 Received: May 21, 2013

Dear Ms. Son:

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,-1.976, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Son

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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Susan Runner DESIGNS Mary S. Runner

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### k120954 510(k) Number (if known):

### Device Name: NobelProcera PEEK Abutments

Indications For Use:

The Nobel Blocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental Implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen 2013.06.05 08:44:23 04'00'

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

510(k) Number: