ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...

K113003 · Astra Tech, Inc. · NHA · Mar 1, 2012 · Dental

Device Facts

• Record ID: K113003
• Device Name: ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
• Applicant: Astra Tech, Inc.
• Product Code: NHA · Dental
• Decision Date: Mar 1, 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 endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained 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 titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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

Atlantis Abutment and Crown Abutment are dental components placed into endosseous implants to support prosthetic restorations. Titanium abutments support cemented or screw-retained restorations; zirconia crown abutments serve as both substructure and final screw-retained restoration. Used by dental professionals in clinical settings. Devices provide mechanical interface between implant and prosthesis; titanium screw secures abutment to implant. Benefits include restoration of dental function and aesthetics for edentulous patients. Compatibility with Keystone Genesis Tapered and Straight Implants (3.8mm–6.5mm).

Clinical Evidence

Bench testing only. Static and fatigue compression testing performed on worst-case implant assemblies using Atlantis angled titanium and zirconia abutments with Keystone Genesis implants. Results demonstrated compatibility and that the system supports appropriate loads.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI, ASTM F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP, ISO 6972 & 13356). Form factor: Abutments for 3.8mm, 4.5mm, 5.5mm, and 6.5mm implants. Mechanical interface: Screw-retained or cemented. No software or electronic components.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support via endosseous dental implants. Highly angled abutments on small diameter implants restricted to anterior region. Early loading dependent on specific implant system/protocol.

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

• Keystone Genesis Implant System (K101545)
• Astra Tech's Crown Abutment (K110356)

Submission Summary (Full Text)

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K.113003

Premarket Notification Section 5: Page - 4

## 510(k) Summary

# Astra Tech Inc. Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant

# ADMINISTRATIVE INFORMATION

Manufacturer Name:

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

Official Contact:

Representative/Consultant:

Betsy A. Brown

Franklin Uyleman

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

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:

Common Name:

Product Code: Classification Panel: Reviewing Branch:

Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant Endosseous dental implant abutment 21 CFR 872.3630 NHA Dental Products Panel 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 endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

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Premarket Notification: Section 5: Page - 5

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

The titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 DESCRIPTION

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The titanium and zirconia abutments are indicated for cemented or screw retained restorations. The crown abutment in zirconia is indicated for screw retained restorations. The titanium Atlantis™ Abutment for Keystone Genesis Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the zircoina Atlantis™ Abutment for Keystone Genesis Implant and the Atlantis™ Crown Abutment in Zirconia for the 3.8mm. 4.5mm. 5.5mm and 6.5mm sizes are made of biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and 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 the Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant are substantially equivalent in indications and design principles to Keystone's Genesis Implant System cleared under K#101545 and Astra Tech's Crown Abutment cleared

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Premarket Notification Section 5: Page – 6

under K#110356, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

.

| Technological<br>Characteristics | Atlantis™ Abutment<br>and Crown<br>Abutment in Zirconia<br>for Keystone Genesis<br>Implant | Keystone Genesis<br>Implant System<br>K#101545 | Astra Tech's<br>Atlantis™ Crown<br>Abutment in<br>ZirconiaK#110356 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | -Titanium Alloy<br>-Biocompatible<br>ceramic material | -Titanium Alloy | Titanium Alloy<br>-Biocompatible<br>ceramic material |
| Performance<br>characteristics | 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. | 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. | Allows the<br>prosthesis to be<br>screw retained to<br>abutment. |
| Intended Use | Titanium & zirconia<br>abutments:<br>Intended for use with<br>an endosseous implant<br>to support a prosthetic<br>device in a partially or<br>completely<br>endentulous patient.<br>Intended for use to<br>support single or<br>multiple tooth<br>prosthesis, in mandible<br>or maxilla.<br><br>Zirconia Crown<br>Abutment: Intended<br>for use with an<br>endosseus implant to<br>function as a<br>substructure that also<br>serves as the final<br>restoration, in a<br>partially or completely | Intended for use with<br>an endosseous implant<br>to support a prosthetic<br>device in a partially or<br>completely<br>endentulous patient.<br>Intended for use to<br>support single or<br>multiple tooth<br>prosthesis, in mandible<br>or maxilla. | Intended for use<br>with an endosseous<br>implant to function<br>as a substructure<br>that also serves as<br>the final<br>restoration, in a<br>partially or<br>completely<br>edentulous patient.<br>It is intended to<br>support single and<br>multiple tooth<br>prosthesis, in the<br>mandible or<br>maxilla. The<br>prosthesis is screw<br>retained. The<br>abutment screw is<br>intended to secure<br>the crown abutment<br>to the endosseous<br>implant. |
| edentulous patient. It is<br>intended to support<br>single and multiple<br>tooth prosthesis, in the<br>mandible or maxilla.<br>The prosthesis is screw<br>retained. The abutment<br>screw is intended to<br>secure the crown<br>abutment to the<br>endosseous implant. | | | |

- 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 titanium and zirconia abutments with the Keystone Genesis implant. Test results demonstrated that the Atlantis Abutments are compatible with the Keystone Genesis implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the left side of the logo.

#### Public Health Service

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

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

MAR - 1 2012

Re: K113003

Trade/Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 20, 2012

Received: February 22, 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

g

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

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Premarket Notification Section 4: Page - 3

### Indications for Use

510(k) Number (if known)

Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis 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 endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained 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 titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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)

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (O)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices .

510(k) Number: K113003