ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA

K120338 · Astra Tech, Inc. · NHA · Jul 5, 2012 · Dental

Device Facts

• Record ID: K120338
• Device Name: ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
• Applicant: Astra Tech, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants. The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. 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: the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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.

Device Story

Device consists of zirconia abutments and titanium alloy screws; placed into endosseous dental implants to support prosthetic restorations (cemented, screw-retained, or friction-fit). Used by dental professionals in clinical settings. Abutments serve as interface between implant and final prosthesis; crown abutments function as both substructure and final restoration. Provides mechanical support for tooth replacement; benefits patients by restoring function and aesthetics in edentulous cases. Operation involves securing abutment to implant via titanium screw; design allows for angulation up to 30 degrees, widths up to 6.5mm, and heights up to 15mm.

Clinical Evidence

Bench testing only. Static and fatigue compression testing performed on worst-case implant assemblies. Results confirmed compatibility with Dentsply Ankylos implants and demonstrated that the system supports appropriate static and fatigue 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. Dimensions: 3.5mm, 4.5mm, 5.5mm, 7.0mm diameters; up to 30-degree angulation; up to 6.5mm width; up to 15mm height. Mechanical fixation via screw.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support via endosseous implants. Compatible with Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm, and 7.0mm implants. Highly angled abutments on small diameter implants restricted to anterior region of the mouth.

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 Dentsply Ankylos Implant (K101004)

Submission Summary (Full Text)

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Kl20338

Premarket Notification Section 5: Page - 4

#### 5 2012 JUL

### 510(k) Summary

# Astra Tech Inc. Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant

# ADMINISTRATIVE INFORMATION

| 510K Summary preparation date: | July 5, 2012 |
|--------------------------------|--------------------------------|
| Manufacturer Name: | Astra Tech Inc. |
| | 590 Lincoln Street |
| | Waltham, Massachusetts 02541 |
| | Telephone: [phone] |
| | Fax: [phone] |
| Official Contact: | Frank Uyleman |
| Representative/Consultant: | Betsy A. Brown |
| | B.A. Brown and Associates Inc. |
| | Telephone: [phone] |
| | Fax: [phone] |

### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | AtlantisTM Abutment and AtlantisTM Crown Abutment in<br>Zirconia for Dentsply Ankylos Implant |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment<br>21 CFR 872.3630 |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |

### INTENDED USE

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

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

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The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. 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: the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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.

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment screw is intended to secure the abutment to the endosseous implant.

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Premarket Notification Section 5: Page - 5

# DEVICE DESCRIPTION AND CLINICAL USE

The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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 angulated abutments on small implants are to be used for the anterior region of the mouth only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

# EQUIVALENCE TO MARKETED DEVICE

Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant is substantially equivalent in indication and design principles to the AtlantisTM Abutment for Dentsply Ankylos Implant cleared under K#101004 which has been determined by FDA to be substantially equivalent to preamendment devices.

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Premarket Notification Section 5: Page – 6

| Technological<br>Characteristics | Atlantis™ Abutment and<br>Atlantis™ Crown<br>Abutment in Zirconia for<br>Dentsply Ankylos Implant | Atlantis™ Abutment for<br>Dentsply Ankylos Implant<br>K#101004 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material<br>Composition | -Biocompatible ceramic<br>material (abutment)<br>- comparable compatible<br>titanium grade Ti-6A-4V ELI<br>material (screw assembly) | -comparable compatible titanium<br>grade Ti-6A-4V ELI material |
| Performance<br>characteristics | Allows the prosthesis to be<br>cemented or screw retained<br>to abutment. While the<br>abutment screw is intended<br>to secure the abutment to the<br>endosseous implant. | Allows the prosthesis to be<br>cemented or screw retained to<br>abutment. While the abutment<br>screw is intended to secure the<br>abutment to the endosseous<br>implant. |
| Intended Use | The Atlantis Abutment is<br>intended for use with an<br>endosseous implant to<br>support a prosthetic device in<br>a partially or completely<br>edentulous patient. It is<br>intended for use to support<br>single and multiple tooth<br>prosthesis, in the mandible or<br>maxilla. The prosthesis can<br>be cemented, screw retained<br>or friction fit to the abutment.<br>The abutment screw is<br>intended to secure the<br>abutment to the endosseous<br>implant.<br>This device is compatible<br>with the following<br>manufacturers' implant<br>systems:<br>The Atlantis Abutment in<br>Zirconia for Dentsply<br>Ankylos Implant is<br>compatible with the Dentsply<br>Ankylos 3.5mm, 4.5mm, | The Atlantis Abutment is<br>intended for use with an<br>endosseous implant to support a<br>prosthetic device in a partially or<br>completely edentulous patient. It<br>is intended for use to support<br>single and multiple tooth<br>prosthesis, in the mandible or<br>maxilla. The prosthesis can be<br>cemented, screw retained or<br>friction fit to the abutment. The<br>abutment screw is intended to<br>secure the abutment to the<br>endosseous implant.<br>The Atlantis™ Crown Abutment<br>in Zirconia is intended for use<br>with an endosseous implant to<br>function as a substructure that<br>also serves as the final<br>restoration, in partially or<br>completely edentulous patients.<br>The prosthesis is screw retained. |
| Intended Use<br>(continued) | 5.5mm and 7.0mm Implants.<br><br>The Atlantis™ Crown<br>Abutment in Zirconia is<br>intended for use with an<br>endosseous implant to<br>function as a substructure<br>that also serves as the final<br>restoration, in partially or<br>completely edentulous<br>patients. The prosthesis is<br>screw retained. The abutment<br>screw is intended to secure<br>the crown abutment to the<br>endosseous implant.<br><br>This device is compatible<br>with the following<br>manufacturers' implant<br>systems:<br>the Dentsply Ankylos<br>3.5mm, 4.5mm, 5.5mm and<br>7.0mm Implants.<br><br>Please note: This device may<br>be used in an early load<br>situation, but is dependent on<br>the specific implant system<br>and protocol used by the<br>dental professional.<br><br>Highly angled abutments on<br>small diameter implants are<br>intended for the anterior<br>region of the mouth only. | The abutment screw is intended<br>to secure the crown abutment to<br>the endosseous implant. |
| Device Description and<br>Clinical Use | The Atlantis Abutment and<br>Atlantis™ Crown Abutment<br>in Zirconia for Dentsply<br>Ankylos | The Atlantis Abutment and<br>Atlantis™ Crown Abutment in<br>Zirconia for Dentsply Ankylos<br><br>Implant is compatible with the |
| Implant is compatible with<br>the Dentsply Ankylos<br>3.5mm, 4.5mm, 5.5mm and<br>7.0mm Implants.<br><br>Please note: This device may<br>be used in an early load<br>situation, but is dependent on<br>the specific implant system<br>and protocol used by the<br>dental professional.<br><br>Highly angulated abutments<br>on small implants are to be<br>used for the anterior region<br>of the mouth only. The<br>devices covered in this<br>submission are abutments<br>which are placed into the<br>dental implant to provide<br>support for a prosthetic<br>restoration. The subject<br>abutments are for cemented,<br>screw retained or friction fit<br>restorations. | Dentsply Ankylos 3.5mm,<br>4.5mm, 5.5mm and 7.0mm<br>Implants.<br><br>Please note: This device may be<br>used in an early load situation,<br>but is dependent on the specific<br>implant system and protocol used<br>by the dental professional.<br><br>Highly angulated abutments on<br>small implants are to be used for<br>the anterior region of the mouth<br>only.<br><br>The devices covered in this<br>submission are abutments which<br>are placed into the dental implant<br>to provide support for a prosthetic<br>restoration. The subject<br>abutments are for cemented,<br>screw retained or friction fit<br>restorations. | |
| Dimensions and<br>Angulation | Abutment sizes: 3.5mm,<br>4.5mm, 5.5mm and 7.0mm<br><br>Atlantis Abutments design<br>only allows for geometry<br>within the following limits:<br>-Angles up to 30 degrees<br>from the implant axis<br>-Widths up to 6.5 mm from<br>the implant axis<br>-Heights (length) up to 15<br>mm from the implant<br>interface | Implant sizes: 3.5mm, 4.5mm,<br>5.5mm and 7.0mm<br><br>Atlantis Abutments design only<br>allows for geometry within the<br>following limits:<br>-Angles up to 30 degrees from the<br>implant axis<br>-Widths up to 6.5 mm from the<br>implant axis<br>-Heights (length) up to 15 mm<br>from the implant interface |

# Table 1: Substantial Equivalence Summary

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# Summary of Non-clinical Testing

Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled zirconia abutments with the Dentsply Ankylos Implant. Test results demonstrated that the Atlantis Abutments and Atlantis Crown Abutments are compatible with the Dentsply Ankylos Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.

## Conclusion for Substantial Equivalence:

The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant is substantially equivalent to the Atlantis™ Abutment for Dentsply Ankylos Implant K#101004 predicate device based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.

### Public Health Service

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

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

5 2012 JUL

### Re: K120338

Trade/Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 9, 2012 Received: June 12, 2012

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 (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 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 vours.

Anthony D. Awater

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

| 510(k) Number (if known) | K120338 |
|--------------------------|---------|
|--------------------------|---------|

Indications for Use

| Device Name: | Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant |
|--------------|------------------------------------------------------------------------------------------|
|--------------|------------------------------------------------------------------------------------------|

Indication for Use:

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended
for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment.
The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:
The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration,
in partially or completely edentulous patients. 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:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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<br>(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)

*(Division Sign-Off)*

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

i, Dol Infection

K 120 338 510(k) Number: __

510K Number: