NC Straumann Screw Retained Abutments

K151247 · Straumann USA, LLC · NHA · Aug 10, 2015 · Dental

Device Facts

• Record ID: K151247
• Device Name: NC Straumann Screw Retained Abutments
• 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

The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System 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.

Device Story

Straumann Screw Retained Abutments are dental components used to support prosthetic reconstructions; placed into Straumann NC and RC Bone Level implants. Devices are one-piece straight or angled (17° and 30°) abutments with 5.5 mm gingival height. Used by dental professionals in clinical settings to restore chewing function. Abutments are manufactured from titanium alloy via precision machining. Output is a stable interface for prosthetic crowns, bridges, or bars. Benefit is restoration of dental function for patients with missing teeth.

Clinical Evidence

Bench testing only. Dynamic fatigue testing performed in accordance with ISO 14801 and FDA guidance for Class II Special Controls for Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

Technological Characteristics

Material: Titanium-6aluminum-7niobium alloy (ISO 5832-11). Construction: One-piece precision machined. Connection: Narrow Cross Fit (NC) and Regular Cross Fit (RC). Angulation: 17° and 30°. Gingival Height: 5.5 mm. Sterilization: Non-sterile, intended for terminal moist heat (autoclave) sterilization.

Indications for Use

Indicated for patients requiring prosthetic reconstruction (crowns, bridges, bars) supported by Straumann NC and RC Bone Level dental implants to restore chewing function.

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 Abutment System (K133421)
• NC Angled Screw Retained Abutments (K141871)

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: K151247

Trade/Device Name: Straumann Screw Retained Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 10, 2015 Received: July 13, 2015

Dear Mr. Christopher 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 I. 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) K151247

Device Name

Straumann® Screw Retained Abutments

Indications for Use (Describe)

The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System 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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## K151247

## 510(k) Summary

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Director of Regulatory Affairs and Clinical Research |
| Date Prepared: | August 9, 2015 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® Screw Retained Abutments |
| Predicate Device(s): | • K133421, Straumann® Magellan Abutment System<br>Primary Predicate<br>• K141871, NC Angled Screw Retained Abutments<br>Reference Predicate |
| Device Description: | The proposed Bone Level Screw Retained Abutments are a line<br>extension of the Screw Retained Abutments previously cleared<br>to market per K133421 and K141871. The proposed Screw<br>Retained Abutment devices include one-piece straight and<br>angled (17° and 30°) abutments, having a gingival height of 5.5<br>mm. |
| Indications For Use: | The Straumann® Screw Retained Abutments are indicated to be<br>placed into the NC and RC Bone Level implants of the<br>Straumann® Dental Implant System to provide support for<br>prosthetic reconstructions such as crowns, bridges and bars.<br><br>The final processed devices have the purpose of restoring<br>chewing function.<br><br>Straumann® Screw Retained Abutments are indicated for<br>screw-retained restorations. |

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- Intended Use : Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Materials : The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11. This is the same material as for the predicate devices previously cleared to market per premarket notification submissions K133421 and K141871. The proposed Straumann® Screw Retained Abutments are Technological
- manufactured using precision machining systems from solid Characteristics : material (i.e. one-piece construction). All technological characteristics of the subject devices are the same as for predicate devices as shown in the table below.

| Feature | Subject Devices<br>NC & RC Screw Retained<br>Abutments | Predicate Devices<br>Screw Retained Abutments<br>(K133421, K141871) |
|-----------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Implant-to-Abutment<br>Connection | Narrow Cross Fit (NC)<br>Regular Cross Fit (RC) | Narrow Cross Fit (NC)<br>Regular Cross Fit (RC) |
| Platform Diameter(s) | NC: Ø4.6 mm<br>RC: Ø4.6 mm | NC: Ø3.5 mm, Ø4.6 mm<br>RC: Ø4.6 mm |
| Abutment Angulation(s) | NC: 17°, 30°<br>RC: 17°, 30° | NC: 0°, 17°, 30°<br>RC: 0°, 17°, 30° |
| Gingival Height(s) | NC: 5.5 mm<br>RC: 5.5 mm | NC: 1.0, 2.5 and 4.0 mm<br>RC: 1.0, 2.5 and 4.0 mm |
| Orientation of Angulation<br>to Engagement Features | NC: Type A (45°), Type B (0°)<br>RC: Type A (45°), Type B (0°) | NC: Type A (45°), Type B (0°)<br>RC: Type A (45°), Type B (0°) |
| Material | Ti-6Al-7Nb titaniumalloy | Ti-6Al-7Nb titaniumalloy |
| Primary Package | Medical grade polyethylene blister<br>with a sealing lid | Medical grade polyethylene blister<br>with a sealing lid |
| Sterilization | Non-sterile; intended for terminal<br>sterilization via moist heat<br>(autoclave) | Non-sterile; intended for terminal<br>sterilization via moist heat<br>(autoclave) |

Performance Data: Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.

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Conclusions : Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.