Straumann Screw-Retained Abutment

K150814 · Straumann USA, LLC · NHA · Aug 10, 2015 · Dental

Device Facts

• Record ID: K150814
• Device Name: Straumann Screw-Retained Abutment
• Applicant: Straumann USA, LLC
• Product Code: NHA · Dental
• Decision Date: Aug 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® Screw-Retained Abutments are intended to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

Device Story

Straumann Screw-Retained Abutment; titanium alloy (Ti-6Al-7Nb) component; placed into dental implants by clinicians; provides support for prosthetic reconstructions (crowns, bridges, bars); restores chewing function. Modification of predicate (K133421) involves increased platform thickness to improve dynamic fatigue performance, allowing use in pre-molar region in addition to incisors. Device provided non-sterile; requires clinician-performed steam sterilization (134°C for 5 minutes).

Clinical Evidence

Bench testing only. Dynamic fatigue testing conducted per FDA guidance (May 12, 2004) and ISO 14801 to evaluate fatigue load limits.

Technological Characteristics

Material: Titanium Alloy (Ti-6Al-7Nb). Platform diameter: 4.6 mm. Platform thickness: 0.55 mm. Geometry: Straight, 22° conic taper, 1.9 mm tall with milled flats. Sterilization: Non-sterile; steam sterilization (134°C, 5 min) by clinician. Packaging: PETG tray with Tyvek lid.

Indications for Use

Indicated for patients requiring prosthetic restoration of chewing function via screw-retained crowns, bridges, or bars supported by Straumann dental implants.

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® Magellan™ Screw Retained Abutment System (K133421)

Submission Summary (Full Text)

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

August 10, 2015

Straumann USA, LLC Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810

Re: K150814

Trade/Device Name: Straumann Screw-Retained Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 6, 2015 Received: July 8, 2015

Dear Mr. Klaczyk:

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. 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.

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

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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Erin | Keith -S

Erin I. Keith, M.S. 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

510(k) Number (if known) K150814

Device Name Straumann Screw Retained Abutments

Indications for Use (Describe)

The Straumann® screw-retained abutments are indicated to be placed implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.

The final processed devices have the purpose of restoring chewing function.

Straumann® screw-retained abutments are indicated for screw-retained restorations.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## K150814

| Submitter: | Straumann USA, LLC<br>(on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Director of Regulatory and Clinical Affairs<br>[e-mail]<br>978.747.2575 |
| Preparation Date: | August 5, 2015 |
| Product Code: | NHA (21 CFR §872.3630) |
| Device Class: | II (21 CFR §872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR §872.3630) |
| Proprietary Name: | Straumann® Screw-Retained Abutment |
| Primary Predicate: | (K133421) Straumann® Magellan™ Screw Retained Abutment System |
| Reference Devices: | None |
| Device Description: | The subject device is a modification of the NC Straight Ø4.6 mm GH<br>1.0 mm Screw Retained Abutment originally cleared to market per<br>K133421. Dimensional changes have resulted in improved dynamic<br>fatigue performance such that this device can now be used in the pre-<br>molar region of the mouth in addition to the incisors. |

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| Indications For Use: | The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.<br><br>The final processed devices have the purpose of restoring chewing function.<br><br>Straumann® Screw-Retained Abutments are indicated for screw-retained restorations. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Straumann® Screw-Retained Abutments are intended to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns and bridges. |
| Technological Characteristics: | See table below. |

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| Feature | Subject Device Straumann®<br>Screw-Retained Abutment | Primary Predicate Device<br>Straumann® Magellan™ Screw-<br>Retained Abutments<br>(K133421) | Equivalence Discussion |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Straumann® Screw-Retained<br>Abutments are indicated to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crown,<br>bridges and bars. The final<br>processed devices have the<br>purpose of restoring chewing<br>function. Straumann® screw-<br>retained abutments are<br>indicated for screw-retained<br>restorations. | Straumann® Magellan™ Screw-<br>Retained Abutments are indicated<br>to be placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crown,<br>bridges and bars. The final<br>processed devices have the<br>purpose of restoring chewing<br>function. Magellan™<br>abutments are indicated for<br>screw-retained restorations. | Equivalent<br>Magellan project name is not<br>being used as a trade name. |
| Abutment Material | Titanium Alloy (Ti-6Al-7Nb) | Titanium Alloy (Ti-6Al-7Nb) | Identical |
| Abutment Platform<br>Diameter | Ø 4.6 mm | Ø 4.6 mm | Identical |
| Abutment Platform<br>Thickness | 0.55 mm | 0.20 mm | Equivalent<br>The platform thickness does not<br>affect the implant or the prosthetic<br>interfaces of the abutment;<br>affecting only the emergence<br>profile between the implant and<br>the abutment platform. |
| Gingival Height | 1 mm | 1 mm | Identical |
| Abutment Apical<br>Geometry | Engaging Bone Level NC | Engaging Bone Level NC | Identical |
| Feature | Subject Device Straumann®<br>Screw-Retained Abutment | Primary Predicate Device<br>Straumann® Magellan™ Screw-<br>Retained Abutments<br>(K133421) | Equivalence Discussion |
| Abutment Coronal<br>Geometry | Straight, 22° Conic taper, 1.9 mm<br>tall, with milled flats; supports<br>engaging and non-engaging<br>prostheses | Straight, 22° Conic taper, 1.9 mm<br>tall, with milled flats; supports<br>engaging and non-engaging<br>prostheses | Identical |
| Packaging | PETG thermoformed tray with<br>Tyvek 1073B lid | PETG thermoformed tray with<br>Tyvek 1073B lid | Identical |
| Sterilization | Device provided non-sterile.<br>Instructions provided for terminal<br>sterilization by the clinician via<br>steam at 134℃ for 5 minutes. | Device provided non-sterile.<br>Instructions provided for terminal<br>sterilization by the clinician via<br>steam at 134℃ for 5 minutes. | Identical |

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| Substantial<br>Equivalence<br>Discussion: | The Indications For Use of the subject and predicate devices are the<br>same. The overall abutment material, height, diameter, implant-to-<br>abutment interface, coronal geometry, packaging and sterilization<br>method are unchanged.<br><br>The only difference between the subject Straumann® NC Straight Ø4.6<br>mm GH 1.0 mm Screw-Retained Abutment and the predicate<br>Straumann® NC Straight Ø4.6 mm GH 1.0 mm Screw-Retained<br>Abutment cleared to market per K133421 is the angle of the transition<br>between the apical implant-to-abutment interface and the coronal<br>restoration platform resulting from a change in the thickness of the<br>restoration platform. This change in the external geometry has resulted<br>in greater wall thickness in the flexure zone of the abutment which has<br>resulted in improved dynamic fatigue performance. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing: | Bench testing was performed to evaluate the fatigue load limits of the<br>proposed Straumann® Screw-Retained Abutment. Dynamic fatigue<br>tests were conducted in accordance with the FDA guidance document<br>dated May 12, 2004: “Guidance for Industry and FDA Staff – Class II<br>Special Controls Guidance Document: Root-form Endosseious Dental<br>Implants and Endosseous Dental Abutments“ and ISO 14801. |
| Conclusion: | Based upon our assessment of the design and applicable performance<br>data, the subject devices have been determined to be substantially<br>equivalent to the identified predicate devices. |