ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT

K110356 · Astra Tech, Inc. · NHA · Jun 10, 2011 · Dental

Device Facts

• Record ID: K110356
• Device Name: ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
• Applicant: Astra Tech, Inc.
• Product Code: NHA · Dental
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra - Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mm. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

Device Story

Atlantis Crown Abutment in Zirconia; single restorative component for dental implants; integrates coping and abutment functions. Device design based on final crown geometry minus porcelain thickness; provides substructure for porcelain application. Placed over implant shoulder; secured to endosseous implant via titanium alloy screw. Used by dental professionals in clinical settings. Provides screw-retained restoration for edentulous patients; eliminates need for separate coping path of insertion or angular correction relative to implant axis. Benefits include simplified prosthetic workflow and structural support for final restoration.

Clinical Evidence

Bench testing only. Static and fatigue compression testing performed on worst-case implant assemblies using Astra implants. Results demonstrate compatibility and that the system supports appropriate test loads.

Technological Characteristics

Abutment material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) per ISO 6972 & 13356. Screw material: Titanium grade Ti-6Al-4V ELI per ASTM F-136. Form factor: Custom-designed crown-shaped abutment. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for partially or completely edentulous patients requiring screw-retained dental implant restorations. Compatible with Astra Microthread ST 3.5mm-5.0mm implants. Highly angled abutments on small diameter implants restricted to anterior region.

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

• Atlantis™ Abutment for Astra Implants (K071946)

Submission Summary (Full Text)

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K110356

JUN 1 0 2011

Premarket Notification Section 5: Page - 4

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### 510(k) Summary

# Astra Tech Inc. Atlantis™ Crown Abutment in Zirconia

## ADMINISTRATIVE INFORMATION

510K Preparation Date:

Manufacturer Name:

January 4, 2011

Astra Tech Inc. 590 Lincoln Street Waltham, Massachusetts 02541 Telephone: [phone] Fax: [phone]

Official Contact:

Representative/Consultant:

Franklin Uyleman

Betsy A. Brown B.A. Brown and Associates Inc. Telephone: [phone] Fax:

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Product Code: Classification Panel: Reviewing Branch:

Atlantis™ Crown Abutment Endosseous dental implant abutiment 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

#### INTENDED USE

The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

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Premarket Notification Section 5: Page - 5

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# INTENDED USE (continued)

This device is compatible with the following manufacturers' implant systems:

Astra - Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mm

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

# DEVICE DESCRIPTION

The device covered in this submission is a single restorative component for dental implants that integrates all aspects of the coping and abutment functionalities. The device has a crown shape exterior which allows the porcelain to be applied directly to the surface of the screw retained abutment and provides support for the described prosthetic restoration. The Atlantis Crown Abutment in Zirconia design is different than an Atlantis Abutment for cement-retained restoration in that the basis for its individualized design is the final crown.

Please see Figure #1 and Figure #2 for additional detail:

## Figure #1:

Atlantis abutment for cement-retained restorations - The abutment shown in green (crown is shown for completeness in yellow) is intended to simulate the geometry of a prepped tooth. It has a core axis which may be different than the implant axis. The difference in these axes is referred to as angular correction. In addition, the design of this abutment takes into consideration the "path of insertion" of the coping and provides the necessary taper geometry and retention aspects to accommodate this separate component.

Image /page/1/Picture/11 description: The image shows a black and white drawing of a spherical object with a grid-like pattern on its surface. The object appears to be suspended in space, with some tendrils or extensions emanating from it. The drawing style is somewhat abstract and technical, suggesting it could be a diagram or illustration of a scientific concept or a piece of conceptual art. The contrast between the dark object and the white background makes the grid pattern stand out.

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Premarket Notification Section 5: Page - 6

#### Figure #2:

Atlantis crown abutment in zirconia for screw-retained restorations -The abutment shown in the illustration has a shape that is closer to the final geometry of the crown. The intent of the design is not to provide full anatomical features of a finished crown but to provide just enough structure to fill the edentulous space and to provide an appropriate substructure to support porcelain. As such, the basis of an Atlantis crown abutment in zirconia design is the final crown minus the desired porcelain thickness the customer intends to apply. An Atlantis crown abutment in zirconia does not have a "correction angle" relative to the implant axis or a coping "path of insertion" as described for conventional cement retained abutments.

Image /page/2/Picture/3 description: The image shows a close-up view of what appears to be a dental structure, possibly teeth or a dental appliance. The image is in black and white, with a high level of contrast, which makes it difficult to discern fine details. The shapes are somewhat abstract, but they suggest a curved or rounded structure with some linear elements.

The subject crown abutment is indicated for screw retained restorations. The Atlantis™ Crown Abutment in Zirconia is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI and complies with ASTM Standard F-136. The zirconia screw retained abutments are placed over the implant shoulder and are mounted into the implant with the titanium screw.

## EQUIVALENCE TO MARKETED DEVICE

Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Crown Abutment in Zirconia is substantially equivalent in indications and design principles to the Atlantis™ Abutment for Astra Implants cleared under K071946 which has been determined by FDA to be substantially equivalent to preamendment devices.

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Premarket Notification
Section 5: Page – 7

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| Table 1: Substantial Equivalence Summary | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | Atlantis™ Crown<br>Abutment in Zirconia | Atlantis™ Abutment<br>for Astra Implants<br>(K071946) |
| Material | -Titanium Alloy<br>(screw)<br>-Biocompatible<br>ceramic material<br>(abutment) | -Titanium Alloy<br>(screw)<br>-Biocompatible<br>ceramic material<br>(abutment) |
| Performance<br>characteristics | Allows the prosthesis<br>to be screw retained to<br>the endosseous implant. | Allows the prosthesis<br>to be cemented or<br>screw retained to<br>abutment. While the<br>abutment screw is<br>intended to secure the<br>abutment to the<br>endosseous implant. |
| Intended Use | The Atlantis crown<br>abutment in zirconia is<br>intended for use with<br>an endosseous implant to<br>function as a<br>substructure that also<br>serves as the final<br>restoration, in a<br>partially or completely<br>edentulous patient. The<br>prosthesis is screw<br>retained. The abutment<br>screw is intended to<br>secure the crown<br>abutment to the<br>endosseous implant | Intended for use with<br>an endosseous implant<br>to support a prosthetic<br>device in a partially or<br>completely edentulous<br>patient. Intended for<br>use to support single or<br>multiple tooth<br>prosthesis; in mandible<br>or maxilla. |

# Table 1: Substantial Equivalence Summary

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Premarket Notification Section 5: Page - 7A

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# Summary of Non-clinical Testing

Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies for the Atlantis angled zirconia crown abutments with the Astra implant. Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized tail.

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

JUN 1 0 2011

Astra Tech, Incorporated C/ O Ms. Betsy A. Brown Regulatory Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K110356

Trade/Device Name: AtlantisTM Crown Abutment in Zirconia Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 27, 2011 Received: June 1, 2011

Dear Ms. Brown:

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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### Page 2 - Ms. Brown

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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

inh for

Anthony D. Watson. B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Section 4: Page - 3

## Indications for Use

510(k) Number (if known)_(0356

Device Name: Atlantis™ Crown Abutmen in Zirconia

Indication for Use:

The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mm Implants

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)

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10(k) Number: ________________________________________________________________________________________________________________________________________________________________