STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW

K133421 · Straumann USA, LLC · NHA · Apr 17, 2014 · Dental

Device Facts

• Record ID: K133421
• Device Name: STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
• Applicant: Straumann USA, LLC
• Product Code: NHA · Dental
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Straumann® Magellan™ abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Magellan™ abutments are indicated for screw-retained restorations.

Device Story

Magellan™ Abutment System consists of one-piece straight and angled (17° and 30°) abutments, basal screws, occlusal screws, protective caps, and restorative copings. Device interfaces with Straumann Bone Level implants via CrossFit® connection; provides support for screw-retained prosthetic reconstructions (crowns, bridges, bars). Used by dental professionals to restore patient chewing function. Manufactured via precision machining from solid material. Output is a mechanical interface for dental prosthetics; clinical decision-making involves selecting appropriate abutment geometry and height to match implant site requirements. Benefits include restoration of masticatory function.

Clinical Evidence

Bench testing only. Dynamic fatigue performance evaluated per ISO 14801. No animal or human clinical data provided.

Technological Characteristics

One-piece construction; precision machined. Materials: Ti-6Al-7Nb alloy (ISO 5832-11) for abutments/screws; Ceramicor® alloy for gold copings; PEEK for protective caps. CrossFit® connection with anti-rotation feature. Dimensions: RC (Ø4.6 mm), NC (Ø3.5, 4.6 mm). Gingival heights: 1.0, 2.5, 4.0 mm.

Indications for Use

Indicated for patients requiring prosthetic reconstruction (crowns, bridges, bars) supported by Straumann dental 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® synOcta screw-retained 1.5 mm Abutment Line (K990342)
• Straumann® RC/NC Bar and Bridge Abutment Line (K080239)
• Straumann® Bone Level Cementable Screw (K072071)
• Neodent CM Exact Mini Angled Abutment (K101945)

Submission Summary (Full Text)

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Traditional 510(k) Submission – Straumann® Magellan™ Abutment System

APR 1 7 2014

| 5. 510(k) Summary - K133421 | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Straumann USA, LLC<br>(on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810 |
| CONTACT PERSON: | Charlotte Ringleb<br>Regulatory Affairs Associate<br>[e-mail]<br>978-.747.2552 |
| SUBMISSION DATE | November 5, 2013 |
| 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 Magellan Screw-Retained Abutment System |
| PREDICATE DEVICES | (K990342) Straumann® synOcta screw-retained 1.5 mm<br>Abutment Line<br>(K080239) Straumann® RC/NC Bar and Bridge Abutment<br>Line<br>(K072071) Straumann® Bone Level Cementable Screw<br>(K101945) Neodent CM Exact Mini Angled Abutment |
| DEVICE DESCRIPTION | This proposed Magellan™ Bone Level Abutment System is<br>based upon the currently cleared Regular CrossFit® (RC)<br>and Narrow CrossFit® (NC) screw-retained Bar and Bridge<br>Abutment Line under premarket notification K080239.<br>The Magellan product line includes one-piece straight<br>abutments for the NC interface, straight and angled (17° and<br>30°) abutments for the RC interface, basal screws, occlusal<br>screws, protective caps and titanium and gold restorative<br>copings. |

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#### INDICATIONS FOR USE

The Straumann Magellan abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.

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

Magellan abutments are indicated for screw-retained restorations.

# TECHNOLOGICAL CHARACTERISTICS

The Straumann Magellan Screw-Retained Abutments, and associated subject devices are manufactured using precision machining systems from solid material (i.e. one-piece construction). Device features faciliate a precise fit with mating features of the previously cleared Straumann Bone Level implants.

| FEATURE | SUBJECT DEVICE<br>Magellan Screw-<br>Retained Abutments | PREDICATE DEVICE<br>Bar & Bridge Abutment<br>(K080239) | EQUIVALENCE<br>DISCUSSION |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Implant/Abutment<br>Connection | CrossFit® connection with<br>anti-rotation feature | CrossFit® connection<br>without anti-rotation<br>feature | Equivalent<br>Anti-rotation feature not<br>reqired for bar and bridge<br>constructs |
| Diameter | The diameters are as noted<br>for Regular CrossFit (RC)<br>and Narrow Crossfit (NC):<br>RC: Ø4.6 mm<br>NC: Ø3.5, 4.6 mm | The diameters are as noted<br>for Regular CrossFit (RC)<br>and Narrow Crossfit (NC):<br>RC: Ø4.0, 4.5, 6.5 mm<br>NC: Ø3.5, 4.5 mm | Equivalent<br>The diameters of the<br>subject devices are within<br>the range of the predicate<br>devices. |
| Gingival Height (GH) | The gingival heights<br>offered follow:<br>1.0mm<br>2.5 mm<br>4.0 mm | The gingival heights<br>offered follow:<br>1.0 mm<br>2.5 mm<br>4.0 mm | Equivalent<br>The gingival heights of the<br>subject devices are within<br>the range of the predicate<br>devices. |
| Abutment Height | The height of the<br>abutments are as noted:<br>1.7 mm<br>1.9 mm | The height of the<br>abutments are as noted:<br>1.0 mm<br>4.6 mm | Equivalent<br>The abutment heights of<br>the subject devices are<br>within the range of the<br>predicate devices. |

# MATERIALS

The Straumann Magellan Screw-Retained Abutments, basal screws and occlusal screws are manufactured from a titanium-aluminium-niobium alloy (Ti-6AI-7Nb or TAN) meeting the requirements of ISO 5832-11. The material for the gold copings is Ceramicor® alloy. The protective caps are produced from polyether ether ketone (PEEK).

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### PERFORMANCE TESTING

Performance testing of the subject devices was conducted per the FDA guidance Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments dated May 12, 2004. Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. No animal or human clinical data was provided in support of this submission.

### CONCLUSION

The documentation submitted in this premarket notification demonstrates the subject devices and are substantially equivalent to the identified predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

April 17, 2014

Straumann USA, LLC Ms. Charlotte Ringleb Regulatory Affairs Specialist 60 Minuteman Road Andover, MA 01810

Re: K133421

Trade/Device Name: Straumann® Magellan™ Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 14, 2014 Received: March 18, 2014

Dear Ms. Ringleb:

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 addition " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 I least of devised that I Dr. o lessan that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I cochar salates and registements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Ringleb

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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 yours,

# Erin Keith -S

Erin I. Keith, M.S. 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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#### 4. Indications for Use

510(k) Number (if known): K | 33401

Straumann® Magellan™ Abutment System Device Name:

Indications for Use:

The Straumann® Magellan™ abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.

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

Magellan™ abutments are indicated for screw-retained restorations.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A: Green-S
2014.04.17 15:54:46 -04'00'

Straumann USA, LLC

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