Straumann Screw Retained Abutments

K171757 · Straumann USA, LLC (On Behalf of Institut Straumann Ag) · NHA · Nov 27, 2017 · Dental

Device Facts

• Record ID: K171757
• Device Name: Straumann Screw Retained Abutments
• Applicant: Straumann USA, LLC (On Behalf of Institut Straumann Ag)
• Product Code: NHA · Dental
• Decision Date: Nov 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetions such as crowns, bridges and bass. 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 consist of one-piece straight or angled (17°/30°) abutments, basal screws, and carrier pins. Devices are placed into Straumann® Dental Implant System implants by dental professionals to support prosthetic reconstructions (crowns, bridges, bars) for restoring chewing function. Subject device is identical to predicate K133421 in design, material, and operating principle, but is supplied sterile via gamma irradiation, whereas predicates were non-sterile. Packaging ensures sterility maintenance. Clinical benefit is restoration of chewing function via screw-retained prosthetic support.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Ti-6Al-7Nb titanium alloy. Design: One-piece straight and angled (17°, 30°) abutments with basal screws and carrier pins. Connection: Engaging Narrow CrossFit (NC) and Regular CrossFit (RC). Sterilization: Gamma irradiation (25 kGy minimum) validated per ISO 11137-1 and ISO 11137-2 to SAL 10^-6.

Indications for Use

Indicated for patients requiring prosthetic reconstruction (crowns, bridges, bars) supported by Straumann Dental Implant System implants to restore chewing function; indicated for screw-retained restorations.

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)

Reference Devices

• Straumann Bone Level NC Angled Screw Retained Abutments (K141871)
• Straumann Screw Retained Abutments (K151247)
• Straumann Screw-Retained Abutment (K150814)
• Straumann Healing Abutments, Healing Caps, Closure Screws (K130808)

Submission Summary (Full Text)

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Straumann USA, LLC (on behalf of Institut Straumann AG) % Jennifer M. Jackson, MS Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

November 27, 2017

Re: K171757

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: October 25, 2017 Received: October 26, 2017

Dear Jennifer M. Jackson:

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.

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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 of medical device-related 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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)

K171757

Device Name Straumann® Screw Retained Abutments

Indications for Use (Describe)

Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetions such as crowns, bridges and bass. 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) | <div>×</div> |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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Straumann® Screw Retained Abutments

510(k) Summary

#### 5 510(k) Summary

#### 5.1 Submitter

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

| Phone Number: | 1-978-747-2614 |
|---------------|----------------|
|---------------|----------------|

Fax Number: 1-978-747-0041

Contact Person: Chanrasmey White

Date of Submission: 10/25/2017

## 5.2 Device

| Trade Name: | Straumann® Screw Retained Abutments |
|----------------------|-------------------------------------|
| Common Name: | Endosseous Dental Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulatory Class: | II (21 CFR §872.3630) |
| Product Code: | NHA (21 CFR §872.3630) |

## 5.3 Predicate Device

Primary Predicate:

- (K133421) Straumann® Magellan™ Screw Retained Abutment System ●
Reference Predicate:

- (K141871) Straumann Bone Level NC Angled Screw Retained Abutments ●
- (K151247) Straumann Screw Retained Abutments ●
- (K150814) Straumann Screw-Retained Abutment .
- (K130808) Straumann Healing Abutments, Healing Caps, Closure Screws ●

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## Straumann® Screw Retained Abutments

510(k) Summary

#### Device Description 5.4

Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.

### 5.5 Indications for Use

Straumann® Screw Retained Abutments are indicated to be placed into the 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.

#### Technoloqical Characteristics 5.6

The proposed Straumann® Screw Retained Abutments intended use, material, fundamental operating principles and overall design are identical to the primary predicate device. The subject device is identical to the primary predicate. K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices. Packaging materials and configuration is equivalent to reference predicate device, Straumann® Straumann Healing Abutments, Healing Caps, Closure Screws, K130808. The technological characteristics of the subject devices are compared to the non-sterile predicate devices (K133421, K141871, K150814 and K151247) in the following table.

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# Straumann® Screw Retained Abutments

## 510(k) Summary

| Feature | Subject Device | Primary PREDICATE<br>Device | Reference DEVICE | Reference DEVICE | Reference DEVICE |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | | K133421 | K141871 | K150814 | K151247 |
| Indication | Straumann® Screw<br>Retained Abutments are<br>indicated to be placed into<br>the implants of the<br>Straumann® Dental Implant<br>System to provide support<br>for prosthetic<br>reconstructions such as<br>crowns, bridges and bars.<br>The final processed devices<br>have the purpose of<br>restoring chewing function.<br>Straumann® Screw<br>Retained Abutments are<br>indicated for screw-retained<br>restorations. | Straumann® Magellan ™<br>Screw Retained Abutments<br>are indicated to be placed<br>into the implants of the<br>Straumann® Dental Implant<br>System to provide support<br>for prosthetic<br>reconstructions such as<br>crowns, bridges and bars.<br>The final processed devices<br>have the purpose of<br>restoring chewing function.<br>Straumann® Screw<br>Retained Abutments are<br>indicated for screw-retained<br>restorations. | Straumann® Screw<br>Retained Abutments are<br>indicated to be placed into<br>the implants of the<br>Straumann® Dental Implant<br>System to provide support<br>for prosthetic<br>reconstructions such as<br>crowns, bridges and bars.<br>The final processed devices<br>have the purpose of<br>restoring chewing function.<br>Straumann® Screw<br>Retained Abutments are<br>indicated for screw-retained<br>restorations. | Straumann® Screw<br>Retained Abutments are<br>indicated to be placed into<br>the implants of the<br>Straumann® Dental Implant<br>System to provide support<br>for prosthetic<br>reconstructions such as<br>crowns, bridges and bars.<br>The final processed devices<br>have the purpose of<br>restoring chewing function.<br>Straumann® Screw<br>Retained Abutments are<br>indicated for screw-retained<br>restorations. | Straumann® Screw<br>Retained Abutments are<br>indicated to be placed into<br>the implants of the<br>Straumann® Dental Implant<br>System to provide support<br>for prosthetic<br>reconstructions such as<br>crowns, bridges and bars.<br>The final processed devices<br>have the purpose of<br>restoring chewing function.<br>Straumann® Screw<br>Retained Abutments are<br>indicated for screw-retained<br>restorations. |
| Implant-to-Abutment<br>Connection | Narrow CrossFit (NC)<br>Regular CrossFit (RC) | Narrow CrossFit (NC)<br>Regular CrossFit (RC) | Narrow CrossFit (NC) | Narrow CrossFit (NC) | Narrow CrossFit (NC)<br>Regular CrossFit (RC) |
| Interface Type | Engaging | Engaging | Engaging | Engaging | Engaging |
| Platform Diameter(s) | NC Straight and Angled: | NC Straight: | NC Angled:<br>Ø3.5 mm, Ø4.6 mm | NC Straight:<br>Ø3.5 mm, Ø4.6 mm | NC Angled:<br>Ø3.5 mm, Ø4.6 mm<br>RC Angled: |
| Feature | Subject Device | Primary PREDICATE Device | Reference DEVICE | Reference DEVICE | Reference DEVICE |
| K Number | | K133421 | K141871 | K150814 | K151247 |
| | Ø3.5 mm, Ø4.6 mm<br>RC Straight and Angled:<br>Ø4.6 mm | Ø3.5 mm, Ø4.6 mm<br>RC Straight and Angled:<br>Ø4.6 mm | | | Ø4.6 mm |
| Abutment Angulation(s) | 0°, 17°, 30° | 0°, 17°, 30° | 17°, 30° | 0° | 17°, 30° |
| Gingival Height(s) | NC and RC Straight:<br>1.0, 2.5 and 4.0 mm<br>NC and RC Angled:<br>2.5, 4.0 and 5.5 mm | NC and RC Straight:<br>1.0, 2.5 and 4.0 mm<br>RC Angled:<br>2.5 and 4.0 mm | NC Angled:<br>2.5 and 4.0 mm | NC Straight:<br>1.0 mm | NC and RC Angled:<br>5.5 mm |
| Orientation of Angulation<br>to Engagement Features | Type A (45°), Type B (0°) | Type A (45°), Type B (0°) | Type A (45°), Type B (0°) | N/A | Type A (45°), Type B (0°) |
| Device Material | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy |
| Sterilization | End user receives product<br>sterilized per Gamma<br>Irradiation, 25 kGy minimum<br>Validated per ISO 11137-1<br>and ISO<br>11137-2 to an SAL of 10 x<br>10-6 | End user to sterilize product<br>per IFU Method: Autoclave<br>moist heat fractionated<br>vacuum or gravity<br>displacement<br>Conditions: 134°C (273°F)<br>for 5 minutes | End user to sterilize product<br>per IFU Method: Autoclave<br>moist heat fractionated<br>vacuum or gravity<br>displacement<br>Conditions: 134°C (273°F)<br>for 5 minutes | End user to sterilize product<br>per IFU Method: Autoclave<br>moist heat fractionated<br>vacuum or gravity<br>displacement<br>Conditions: 134°C (273°F)<br>for 5 minutes | End user to sterilize product<br>per IFU Method: Autoclave<br>moist heat fractionated<br>vacuum or gravity<br>displacement<br>Conditions: 134°C (273°F)<br>for 5 minutes |

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# Straumann® Screw Retained Abutments

510(k) Summary

Table 1: Comparison of Subject Devices to non-sterile Predicates